Opportunity for a dynamic doctor to join our growing team at our Clinical Research site in Miranda- a 1 minute walk from Miranda train station!
:: Role Overview ::
The primary responsibility of the sub-Investigator is to ensure the well-being, safety and interests of all participants taking part in clinical trials. The sub-Investigator may perform all or some of the Principal Investigator (PI) functions, but they do not accept primary responsibility for the research study. The Principal Investigator has overall responsibility for the conduct of the clinical trials and will delegate specific duties to an appropriately trained and qualified sub-Investigator.
:: General accountabilities as Investigator (Sub-Investigators and Principal Investigators) ::
- 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).
- Assessing participant eligibility in accordance with Protocols
- 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 (eg. 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.
- Bachelor of Medicine/Bachelor of surgery or Medical Doctorate
- General registration (Post graduate year 3 and above)
- Qualified by training, education and experience in Clinical Research
- GCP certificate
- 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
- Clinical research experience and clinical acumen
- Proficiency in use of electronic medical record
How to apply
Click the APPLY button and include your Resume and Cover Letter.