Job Archives

Full-time
Queensland
Posted 2 days ago

About the job

Southern Star Research is a leading Australian, privately owned CRO headquartered in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and the Asia Pacific region.

We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients' projects and to the Company. Southern Star Research's culture is focused on fostering and maintaining a positive, professional and productive work environment.

Due to continued growth and a strong project pipeline, we’re looking for a talented full-time Project Manager to join our team in Queensland, Australia although other states also considered.

If you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you.

About the role

Reporting to the Head of Projects, you’ll be responsible for:

  • Proactively managing all aspects of the trial process including trial timelines, budgets, resources and vendor relationships;
  • Acting as the central point of contact for all client trial enquiries;
  • Preparing and managing project plans as well as implementing quality standards and risk mitigation strategies as required;
  • Managing a cross-functional project team through all phases of the clinical trial;
  • Leading sponsor study start-up process, including kick off meetings, site selection as well as other various agreements and budgets;
  • Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs and ICH/GCP guidelines;
  • Development and review of documents to ensure alignment with standard operation procedures and local regulations;
  • Lead assigned team/s in the delivery of contracted project services; and
  • Train and mentor project team members and other staff as needed.

Does this sound like you?

To be successful in the role, we’re looking for candidates with:

  • Minimum 5 years of experience working in clinical research in a pharmaceutical company, CRO or other research setting;
  • 2+ years of experience as an independent Project Manager;
  • HV, Oncology and/or Radio-Oncology experience is preferred;
  • International Project Management Experience across APAC and US is preferred;
  • A solid understanding and knowledge of appropriate therapeutic indications as they relate to the conduct of clinical trials;
  • A sound knowledge and understanding of ICH-GCP;
  • Exposure to a broad range of trials across multiple therapeutic areas;
  • Ability to work independently; and
  • Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).

Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region and this is an ideal opportunity for someone who is looking to be involved in all aspects of clinical trials across a range of different therapeutic areas and progress their skills in project management. Southern Star Research are also proud to be certified as a Great Place To Work in Australia!

We offer:

  • An attractive remuneration and benefits package;
  • Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work);
  • We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing;
  • Career stability and security;
  • Office located in Gordon - under cover parking provided and close to public transport;
  • STAR day - one extra day off per year for you to recharge

We'd love to connect with you!

Don't have the all the requirements of this role, but still interested? Please still apply!

Inclusivity, Diversity and Equality

Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Please note that only successful candidates will be contacted.

Job Features

Job Category

Research

About the job Southern Star Research is a leading Australian, privately owned CRO headquartered in Sydney. We specialise in providing clinical research services to a range of clients across the pharma...

About the job

Southern Star Research is a leading Australian, full service CRO headquartered in Sydney, Australia. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and Asia Pacific Region.

We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients' projects and to the Company. Southern Star Research's culture is focused on fostering and maintaining a positive, professional and productive work environment.

Due to continued growth and a strong project pipeline, we’re looking for a talented full-time Safety Officer/Pharmacovigilance Officer to join our team in either the Philippines, Malaysia or India.

If you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you.

About the role

Reporting to the Head of Clinical Operations, you’ll be responsible for:

  • Ensure that all Safety Information, including SAE/SADE initial and follow-up reports, are completed and reported accurately;
  • Act as the primary point of contact with Investigator and site personnel to resolve safety-related queries and obtain missing data;
  • Serve as the main contact for the appointed client safety or pharmacovigilance officer, ensuring timely communication of safety data;
  • Ensure that all SAE/SADE reports are forwarded to the client safety or pharmacovigilance officer within the defined timelines;
  • Address safety queries and assist in preparations for data lock;
  • Review closed cases for archiving readiness and ensure they are archived according to local filing procedures;
  • Report SAE/SADEs to local regulatory authorities in accordance with local regulations;
  • Maintain compliance with all applicable regulations, including CFR, ICH/GCP/ISO14155, and internal SOPs;
  • Assist in the development of training materials and guides for sites, investigators, monitoring teams, and other junior safety staff;
  • Write safety reporting plans and ensure staff compliance with safety reporting protocols;
  • Track and enter safety data into tracking databases and assist in the analysis of safety queries and data quality;
  • Mentor and assist new hires in their professional development and understanding of safety reporting procedures;
  • Take initiative in improving processes, including Standard Operating Procedures related to safety;
  • Lead the implementation of new Safety/PV systems as required; and
  • Perform any additional responsibilities as assigned.

Does this sound like you?

To be successful in the role, we’re looking for candidates with:

  • Minimum 2 years’ experience working in safety / pharmacovigilance / regulatory within a pharmaceutical company or CRO focused on clinical trials. CRO experience is preferred;
  • Experience using Safety/PV database platforms. Oracle Agrus Safety is preferred;
  • Strong understanding of APAC safety operations from a regulatory perspective, including regulatory safety reporting timelines;
  • Ability to analyse safety information (SAE/SADE initial and follow up reports), identify and raise queries;
  • Excellent interpersonal and communication skills (verbal & written), including proficiency in medical terminology;
  • High degree of computer literacy specifically experienced in Word, Excel, Power Point, Outlook, Web-Browser applications and capable of learning new systems; and
  • Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).

Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region and this is an ideal opportunity for someone who is looking to contribute towards our expansion into the APAC region. Southern Star Research are also proud to be certified as a Great Place To Work in Australia!

We offer:

  • An attractive remuneration and benefits package;
  • Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work);
  • We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing;
  • Career stability and security and more!

We'd love to connect with you!

Don't have the all the requirements of this role, but still interested? Please still apply!

Inclusivity, Diversity and Equality

Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Please note that only successful candidates will be contacted.

Job Features

Job Category

Research

About the job Southern Star Research is a leading Australian, full service CRO headquartered in Sydney, Australia. We specialise in providing clinical research services to a range of clients across th...

Full-time
Brisbane
Posted 1 week ago

About the job

Southern Star Research is a leading Australian, full service CRO based in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and Asia Pacific Region.

We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients' projects and to the Company. Southern Star Research's culture is focused on fostering and maintaining a positive, professional and productive work environment.

Due to continued growth and a strong project pipeline, we’re looking for a talented, full-time Senior Clinical Research Associate or Clinical Research Associate to join our team in Brisbane, Australia.

If you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you.

About the role

Reporting to the Senior Clinical Team Leader, you’ll be responsible for:

  • Conducting site qualification, interim monitoring and study closeout visits;
  • Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines;
  • Act as a central point of contact at investigator meetings and site initiation visits;
  • Manage all aspects of the clinical monitoring process;
  • Build and develop relationships with site stakeholders;
  • Identify, evaluate and recommend new potential investigators and sites on an ongoing basis; and
  • Mentoring of junior Clinical Research Associate's.

To be successful in the role, we’re looking for candidates with:

  • A minimum of 5 years experience in clinical research and 2 years of independent monitoring experience for a SCRA or a minimum of 1 year of independent monitoring for a CRA;
  • A solid understanding and knowledge of appropriate therapeutic indications as they relate to the conduct of clinical trials;
  • A sound knowledge and understanding of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations;
  • Strong planning and organisational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines;
  • Exceptional communication skills as well as strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated;
  • Demonstrated business ethics and integrity.
  • Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines

Why Southern Star Research?

Southern Star Research is a growing business and this is an ideal opportunity for someone who is looking to be involved in all aspects of clinical trials across a range of different therapeutic areas. Southern Star Research are also proud to be certified as a Great Place To Work in Australia!

We offer:

  • An attractive remuneration and benefits package;
  • Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work);
  • We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing;
  • Career stability and security;
  • Office located in Gordon - under cover parking provided and close to public transport;
  • STAR day - one extra day off per year for you to recharge and more!

We'd love to connect with you!

Don't have the all the requirements of this role, but still interested? Please still apply!

Inclusivity, Diversity and Equality

Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Please note that only successful candidates will be contacted.

Job Features

Job Category

Research

About the job Southern Star Research is a leading Australian, full service CRO based in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, m...

Full-time
Sydney
Posted 2 weeks ago

About the job

Southern Star Research is a leading Australian, privately owned CRO headquartered in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and the Asia Pacific region.

We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients' projects and to the Company. Southern Star Research's culture is focused on fostering and maintaining a positive, professional and productive work environment.

Due to continued growth and a strong project pipeline, we’re looking for talented Data Management Team Leader to join our team in Sydney, Australia. Other locations in Australia will be considered.

If you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you.

About the role

Reporting to the Head of Data Management, you’ll be responsible for:

  • Line management of a team of Data Managers ensuring alignment with project goals, quality standards, and timely deliverables;
  • Implement effective strategies for data cleaning and reconciliation, ensuring high-quality and accurate clinical data;
  • Assist in the recruitment process for new Data Management team members;
  • Oversee the training and onboarding of all team members;
  • Plan and execute DM projects following Southern Star Research SOPs, while working with both internal and external stakeholders to meet project goals;
  • Oversee the creation of plans, guidelines, training materials, and other essential DM documentation to facilitate smooth data collection and review processes;
  • Lead user acceptance testing of electronic case report forms (eCRFs) and consistency checks to ensure quality and accuracy;
  • Supervise the medical coding process and review of coded terms to ensure proper classification and consistency;
  • Ensure the collection and filing of all Data Management-related documentation in the Trial Master File (TMF), adhering to Good Documentation Practices;
  • Contribute to the development and review of Standard Operating Procedures (SOPs) and processes to improve operational efficiency;
  • Ensure familiarity with and compliance to CDISC, GCP, GCDMP, and other relevant guidelines to uphold the highest standards of data quality and regulatory compliance;
  • Participate in business development activities as required;
  • Perform the duties of a Senior Data Manager as needed; and
  • Perform additional duties as required.

To be successful in the role, we’re looking for candidates with:

  • A minimum of 7 years' experience in clinical data management, preferably in the CRO environment;
  • Prior line management experience is preferred but not essential;
  • A sound knowledge and understanding of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations;
  • Strong planning and organisational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines;
  • Exceptional communication skills as well as strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity;
  • Demonstrated business ethics and integrity;
  • Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines.

Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region, this is an ideal opportunity for someone who is looking to contribute towards our expansion into the APAC region and develop their leadership experience within data management. Southern Star Research are also proud to be certified as a Great Place To Work in Australia!

We offer:

  • An attractive remuneration and benefits package;
  • Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work);
  • We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing;
  • Career stability and security;
  • Office located in Gordon - under cover parking provided and close to public transport;
  • STAR day - one extra day off per year for you to recharge and more!

We'd love to connect with you!

Don't have all the requirements of this role, but still interested? Please still apply!

Inclusivity, Diversity and Equality

Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Please note that only successful candidates will be contacted.

Job Features

Job Category

Research

About the job Southern Star Research is a leading Australian, privately owned CRO headquartered in Sydney. We specialise in providing clinical research services to a range of clients across the pharma...

Full-time
Australia
Posted 2 weeks ago

Southern Star Research is a leading Australian, privately owned CRO based in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and the Asia Pacific region.

We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients' projects and to the Company. Southern Star Research's culture is focused on fostering and maintaining a positive, professional and productive work environment.

Due to continued growth and a strong project pipeline, we’re looking for talented Senior/Statistical Programmer to join our team in Australia.

If you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you.

About the role

Reporting to the Manager, Statistical Programming, you’ll be responsible for:

  • Review of the statistical analysis plans and mock outputs;
  • SAS programming of randomization schedules, derived datasets and study outputs;
  • Validation of SAS programs;
  • SDTM & ADaM programming;
  • Review of study database designs and data management documentation;
  • Provide SAS programming support to Data Management including data reconciliations, complex consistency checks and raw data listings;
  • Contribute to the development of new SOP's and the review of SOP's; and
  • Perform additional duties as required.

To be successful in the role, we’re looking for candidates with:

  • A minimum of 2 years' experience in statistical programming, preferably in the CRO environment;
  • Familiarity with CDISC and industry-related standards and guidelines;
  • A sound knowledge and understanding of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations;
  • Strong planning and organisational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines;
  • Exceptional communication skills as well as strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity;
  • Demonstrated business ethics and integrity;
  • Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines.

Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region, and this is an ideal opportunity for someone who is looking to progress their SAS Programming skills by being involved in all aspects of programming across a range of different therapeutic areas.

We offer:

  • An attractive remuneration and benefits package;
  • Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work);
  • We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing;
  • Career stability and security;
  • Office located in Gordon - under cover parking provided and close to public transport;
  • STAR day - one extra day off per year for you to recharge.

We'd love to connect with you!

Don't have all the requirements of this role, but still interested? Please still apply!

Inclusivity, Diversity and Equality

Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Please note that only successful candidates will be contacted.

Job Features

Job Category

Research

Southern Star Research is a leading Australian, privately owned CRO based in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical...

About the job

Southern Star Research is a leading Australian, full service CRO headquartered in Sydney, Australia. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and Asia Pacific Region.

We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients' projects and to the Company. Southern Star Research's culture is focused on fostering and maintaining a positive, professional and productive work environment.

Due to continued growth and a strong project pipeline, we’re looking for a talented full-time Contracts Manager to join our team in Malaysia.

If you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you.

About the role

Reporting to the Contracts Manager, you’ll be responsible for:

  • Ensuring that client requests are appropriately addressed during the Master Service Agreements (MSA)/Contract and Work Order generation stages of the sales cycle;
  • Manage the generation of contractual documents, including MSAs, Work Orders and Change Orders;
  • Work with internal and external stakeholders to determine appropriate terms and conditions of contracts, negotiate contractual terms with clients and ensure appropriate procedures have been followed;
  • Work with accounts and finance teams in overseeing timely invoicing and accurate tracking of projects;
  • Review of CDAs;
  • Attend bid defence meetings, client meetings and calls and study handovers as required;
  • Manage the tracking and preparation of Change Orders and ensuring contracts, budgets and scope of work has been revised and defined correctly into the study contracts; and
  • Perform any additional responsibilities as assigned.

Does this sound like you?

To be successful in the role, we’re looking for candidates with:

  • Minimum 5 years’ experience working in an industry orientated clinical research role such as a pharmaceutical company or CRO. CRO experience is preferred;
  • Operations background or prior contracts/proposals experience in a clinical research environment;
  • Proven ability to manage and develop budgets effectively;
  • Experience in the development of contracts and proposals in a clinical research environment is preferred;
  • Advanced Excel spreadsheet experience;
  • Understanding of marketing and business development; and
  • Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).

Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region and this is an ideal opportunity for someone who is looking to contribute towards our expansion into the APAC region and develop their experience within contracts. Southern Star Research are also proud to be certified as a Great Place To Work in Australia!

We offer:

  • An attractive remuneration and benefits package;
  • Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work);
  • We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing;
  • Career stability and security and more!

We'd love to connect with you!

Don't have the all the requirements of this role, but still interested? Please still apply!

Inclusivity, Diversity and Equality

Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Please note that only successful candidates will be contacted.

Job Features

Job Category

Research

About the job Southern Star Research is a leading Australian, full service CRO headquartered in Sydney, Australia. We specialise in providing clinical research services to a range of clients across th...

About the job

Southern Star Research is a leading Australian, full service CRO headquartered in Sydney, Australia. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and Asia Pacific Region.

We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients' projects and to the Company. Southern Star Research's culture is focused on fostering and maintaining a positive, professional and productive work environment.

Due to continued growth and a strong project pipeline, we’re looking for a talented full-time Contracts Manager to join our team in India.

If you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you.

About the role

Reporting to the Contracts Manager, you’ll be responsible for:

  • Ensuring that client requests are appropriately addressed during the Master Service Agreements (MSA)/Contract and Work Order generation stages of the sales cycle;
  • Manage the generation of contractual documents, including MSAs, Work Orders and Change Orders;
  • Work with internal and external stakeholders to determine appropriate terms and conditions of contracts, negotiate contractual terms with clients and ensure appropriate procedures have been followed;
  • Work with accounts and finance teams in overseeing timely invoicing and accurate tracking of projects;
  • Review of CDAs;
  • Attend bid defence meetings, client meetings and calls and study handovers as required;
  • Manage the tracking and preparation of Change Orders and ensuring contracts, budgets and scope of work has been revised and defined correctly into the study contracts; and
  • Perform any additional responsibilities as assigned.

Does this sound like you?

To be successful in the role, we’re looking for candidates with:

  • Minimum 5 years’ experience working in an industry orientated clinical research role such as a pharmaceutical company or CRO. CRO experience is preferred;
  • Operations background or prior contracts/proposals experience in a clinical research environment;
  • Proven ability to manage and develop budgets effectively;
  • Experience in the development of contracts and proposals in a clinical research environment is preferred;
  • Advanced Excel spreadsheet experience;
  • Understanding of marketing and business development; and
  • Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).

Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region and this is an ideal opportunity for someone who is looking to contribute towards our expansion into the APAC region and develop their experience within contracts. Southern Star Research are also proud to be certified as a Great Place To Work in Australia!

We offer:

  • An attractive remuneration and benefits package;
  • Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work);
  • We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing;
  • Career stability and security and more!

We'd love to connect with you!

Don't have the all the requirements of this role, but still interested? Please still apply!

Inclusivity, Diversity and Equality

Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Please note that only successful candidates will be contacted.

Job Features

Job Category

Research

About the job Southern Star Research is a leading Australian, full service CRO headquartered in Sydney, Australia. We specialise in providing clinical research services to a range of clients across th...

Full-time
Brisbane, Queensland
Posted 4 months ago

Southern Star Research is a leading Australian, full service CRO based in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and Asia Pacific Region.

We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients' projects and to the Company. Southern Star Research's culture is focused on fostering and maintaining a positive, professional and productive work environment. We are proud to be certified as a Great Place to Work 2024/2025.

Due to continued growth and a strong project pipeline, we’re looking for a talented, full-time Senior/Clinical Research Associate to join our team in Brisbane, QLD.

If you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you.

About the role

Reporting to the Clinical Team Leader, you’ll be responsible for:

  • Conducting site qualification, interim monitoring and study closeout visits;
  • Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines;
  • Act as a central point of contact at investigator meetings and site initiation visits;
  • Manage all aspects of the clinical monitoring process;
  • Build and develop relationships with site stakeholders;
  • Identify, evaluate and recommend new potential investigators and sites on an ongoing basis; and
  • Mentoring of junior Clinical Research Associate's.

To be successful in the role, we’re looking for candidates with:

  • A minimum of 5 years experience in clinical research and 2 years of independent monitoring experience for a SCRA;
  • A solid understanding and knowledge of appropriate therapeutic indications as they relate to the conduct of clinical trials;
  • A sound knowledge and understanding of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations;
  • Strong planning and organisational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines;
  • Exceptional communication skills as well as strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated;
  • Demonstrated business ethics and integrity.
  • Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines

Why Southern Star Research?

Southern Star Research is a growing business and this is an ideal opportunity for someone who is looking to be involved in all aspects of clinical trials across a range of different therapeutic areas.

We offer:

  • An attractive remuneration and benefits package;
  • Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work);
  • We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing;
  • Career stability and security;
  • Office located in Gordon - under cover parking provided and close to public transport;
  • STAR day - one extra day off per year for you to recharge

We'd love to connect with you!

Don't have the all the requirements of this role, but still interested? Please still apply!

Inclusivity, Diversity and Equality

Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Please note that only successful candidates will be contacted.

Job Features

Job Category

Research

Southern Star Research is a leading Australian, full service CRO based in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical de...