SUMMARY The Medical Officer / Sub-Investigator is responsible for providing medical oversight and ensuring the safety and well-being of clinical trial participants across Phase I-IV clinical studies. Working closely with the Principal Investigator (PI), this role supports the conduct of clinical trials in compliance with ICH-GCP, protocol requirements, regulatory obligations, and ethical standards.

The Medical Officer will perform delegated Sub-Investigator responsibilities, conduct participant assessments, review safety data, support trial execution, and contribute to the successful delivery of high-quality clinical research.

If you are a Medical Doctor excited by the prospect of working in the clinical trial sector please get in touch - both part time and full-time applicants are to be considered!

KEY RESPONSIBILITIES

Clinical Trial Medical Oversight

- Provide medical assessment and ongoing clinical care of study participants throughout the conduct of clinical trials.
- Review participant eligibility against protocol inclusion and exclusion criteria.
- Conduct medical evaluations including medical history reviews, physical examinations, and clinical assessments.
- Assess participant suitability for enrolment and continued participation in studies.
- Provide medical management and treatment recommendations for adverse events and concomitant medical conditions.
- Serve as a medical resource to clinical operations and study teams.

Sub-Investigator Duties
- Act as a delegated Sub-Investigator under the supervision of the Principal Investigator, including:
- Perform protocol-required medical assessments and participant evaluations.
- Review and sign off delegated source documentation, medical notes, and clinical assessments.
- Evaluate screening and baseline data to determine participant eligibility.
- Assess laboratory results, ECGs, vital signs, imaging, and other clinical data.
- Determine subject continuation, withdrawal, or discontinuation based on safety and protocol requirements.
- Participate in monitoring visits, sponsor meetings, audits, and regulatory inspections.
- Ensure protocol compliance and participant safety throughout study conduct.
- Support investigational product administration where medically required.




- Complete investigator training and maintain study-specific competency requirements.

Safety & Pharmacovigilance
- Review and evaluate adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), and other safety findings.
- Assess causality, severity, expectedness, and clinical significance of safety events.
- Ensure timely reporting and documentation of SAEs and other safety events according to protocol, sponsor, and regulatory requirements.
- Collaborate with sponsors, monitors, and pharmacovigilance teams on safety management activities.
- Provide medical oversight during participant admissions and safety follow-up visits.

Participant Care
- Ensure participant rights, safety, and welfare remain the highest priority throughout study participation.
- Obtain or support informed consent discussions where delegated by the Principal Investigator.
- Address participant medical concerns and provide appropriate referrals when required.
- Maintain accurate and contemporaneous participant medical records.

Regulatory & Quality Compliance
- Conduct all activities in accordance with:
- ICH-GCP Guidelines
- National regulatory requirements
- Human Research Ethics Committee (HREC)/IRB requirements
- Site SOPs and quality systems
- Study protocols and sponsor requirements
- Support internal quality assurance initiatives and inspection readiness activities.
- Participate in sponsor audits and regulatory inspections.
- Ensure ALCOA+ principles and data integrity standards are maintained.

Cross-Functional Collaboration
- Work closely with:
- Principal Investigators
- Clinical Research Coordinators
- Research Nurses
- Clinical Trial Assistants
- Sponsors and CROs
- Laboratory and Pharmacy teams
- Provide medical input during study feasibility assessments, protocol reviews, and operational planning.
- Contribute to continuous improvement initiatives across the clinical research unit.

QUALIFICATIONS





- Medical Degree (MBBS, MD, MBChB, or equivalent).
- Current unrestricted medical registration with the relevant medical board.
- Eligibility to practice medicine in the applicable jurisdiction.

Experience
- Previous experience in clinical research, clinical trials, or pharmaceutical medicine preferred.
- Experience assessing and managing patients in a hospital, emergency, acute care, internal medicine, intensive care, or related clinical setting.
- Working knowledge of ICH-GCP and clinical research regulations.
- Experience reviewing laboratory data, ECGs, adverse events, and participant safety information.

DURATION Full-time, permanent

SALARY

Attractive salary and benefits package

LOCATION

On-site - Brisbane, Australia

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognized by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery.

We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com TO APPLY

Please click ‘apply’ or contact Sam Chapple (Director, Recruitment - APAC & RoW) at Planet Pharma for more information:

E: [email protected]

T: : +61 (0) 37 068 9299

Linkedin: https://www.linkedin.com/in/sam-chapple-42b459131/

📌 Medical Officer / Sub-Investigator - (Part-time & Full-time considered) (Brisbane)
🏢 Planet Pharma
📍 Brisbane