What are the responsibilities and job description for the Medical Director position at Grace Fredericks Recruitment?
Job Title: Medical Director
Location: New South Wales, Australia - 3 sites available
Role Overview:
The Medical Director will be responsible for the oversight, efficiency, success, and conduct of the clinical trials at 1 (or more) sites and will delegate specific duties to appropriate employees.
This role offers vast career progression - The Medical Director will have the opportunity to progress to a Chief Medical Officer, in as little as 12 months.
Accountabilities as the Medical Director:
- Responsible for the oversight, efficiency, success, and conduct of the clinical trials at 1 (or more) sites.
- Influential in the hiring process and expansion of 1 (or more) sites.
- Involved in growth of the clinical research consultancy, supporting their upwards growth trajectory. Currently have 3 sites and looking to grow to 10 sites in the next 5 years.
- Conducting studies in accordance with ICH GCP guidelines and ensuring participant privacy and confidentiality in accordance with HIPAA guidelines and institutional regulations.
- Ensuring study subjects rights, safety and well-being prevails.
- Contribution to all study related meetings with CRO/Sponsor, as required, including investigator meetings, pre-selection visits, site initiation visits, monitoring visits and close out meetings.
- Understanding of study protocol, investigator’s brochure and informed consent form (ICF), which will include - assessing participant eligibility in accordance with Protocols and obtaining informed consent prior to any study activities.
- Maintain clinical oversight of medical care, procedures and decisions regarding the study.
- Ensure the trial is conducted in compliance with the protocol that has received prior IRB/IEC approval.
- Assist with other trial roles when required (e.g.. phlebotomy, ECGs, nasal swabs, etc).
- Responsible for the efficient running and improvement of the clinical function.
General accountabilities as Principal Investigator only:
- Oversight of and availability to sub-investigators/staff delegated to duties on study.
- Oversight of training log, delegation log and study specific training of all staff on trial.
- Responsibility for the overall conduct of the study and all completed tasks and procedures.
- Maintaining adequate records (in Investigator Site File) of each trial subjects participation including all investigations, adverse events, safety reports/issues, changes to the research/unanticipated risk, protocol deviations, final reporting at end of study.
- Meet regularly with study-assigned CRA to assess study progress and performance.
Compliance accountabilities:
- Data quality - ensure clinical trials are completed to the highest data quality standards.
- Make all reasonable efforts to retain participants on clinical trial.
- Ensure informed consent is adequately obtained for study subjects.
Qualifications:
- Bachelor of Medicine/Bachelor of surgery or Medical Doctorate
- Medically registered in Australia - Need to be licensed to practice
- Qualified by training, education and experience in clinical research
- GCP certificate
Experience:
- Clinical trial experience
- Management and oversight of clinical trials
- Vast/ specific therapeutic area knowledge
- Experience in building out teams
- Patient focused experienced
- Experience working, partnering, and dealing with CROs/ sponsors
- Good Clinical Practice training
Required Skills:
- Possesses ability for superior analytical thinking skill
- Excellent attention to detail and the ability to keep detailed, accurate medical records
- Ensuring up to date training with anaphylaxis/cardiac arrest management
- Phlebotomy skills