AddressPart-time & Full-time opportunities available
We have Multiple Opportunities for dynamic doctors to join our growing team at our Clinical Research sites across the Greater Sydney area (Sutherland, Wollongong & Brookvale).
The primary responsibility of the clinical Research Investigator is to ensure the well-being, safety and interests of all participants taking part in clinical trials. 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. 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.
General accountabilities as Clinical research Doctor (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.
Required qualifications:
- 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
- ICH-GCP certificate
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
- Clinical research experience and clinical acumen
- Proficiency in use of electronic medical record software
About us:
Walski Clinical Research is a dedicated, multi-site, private Clinical Trials network on the East-coast of Australia. We conduct trials on a broad therapeutic range, from Phase 1 through to Phase 4. We excel in generalist studies with a large volunteer recruitment pool and have proven to be equally capable in delivering results for more specialist indications requiring patients.
If this opportunity interests you, please apply with your current CV & a cover letter
