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Clinical Investigator

5 months ago

Auckland City, New Zealand PeopleHQ Full time

Our client, Pacific Clinical Research Network is a group of private research facilities, with sites located across New Zealand.
**This is a rare opportunity for a registered Medical Practitioner to join the team in a leadership position at the currently under construction, Phase I Unit in North Auckland.** The new clinic will open its doors mid 2023. PCRN believe in promoting a supportive and professional work environment and have a well-established Leadership Team and Board leading PCRN into new ventures.

The role of the Investigator is a specialised and important role, performing critical trial-related procedures and making important trial related decisions.

The Principal Investigator will:

- Ensure compliance with all ICH-GCP guidelines, local regulations, sponsors and company policies and procedures
- Communicate with the research team to ensure all clinical trial-related tasks are conducted appropriately and ethically
- Ensure compliance with standard of care, consent, and documentation requirements
- Assist with participant recruitment and retention
- Notify participants primary care physician about their clinical trial participation
- Inform participants when medical care is needed for inter-current illnesses
- Ensure that investigational products are only used in accordance with the approved protocols
- Ensure participants are fully informed and give consent to be part of the trial
- Conduct the trial, following all compliances and protocols, overseeing staff compliance
- Ensure all quality assurance, regulatory, documentation and reporting compliances are met
- Complete all trial paperwork correctly and accurately, reporting any adverse events within required time frames

**In addition to the above, the Principal Investigator will**:

- Communicate with the sponsoring company
- Ensure requirements are met for each trial
- Maintain a list of qualified personnel whom significant trial-related duties have been delegated to
- Ensure medical care is provided to participants for any adverse events, including clinically significant laboratory values
- Review proposed protocol synopsis in a timely manner and assist with completion of all feasibility documentation
- Review current resources to assess site capabilities to conduct proposed research projects
- Ensure all start-up processes are followed, and documents are accurate
- Assist with budget proposals and contract negotiations
- Participate in site initiation visits, monitoring visits and investigator meetings
- Direct or delegate appropriate participant recruitment and retention
- Completion of written summaries of trial status to ethics committee, including trial outcomes
- Current New Zealand Medical Council Registration
- Experience with clinical trials (preferable, but not essential)
- Excellent leadership and mentoring skills, leading by example, and providing direction
- Excellent administration and computing skills
- High attention to detail, maintaining excellent documentation practices
- Awareness of fundamental business principles and an awareness of the clinical trial industry
- A high degree of judgement, discretion, and confidentiality

**Why PCRN?**

Working as part of an expert team with competitive remuneration and an exciting place to work. PCRN is built on, and values working as a team. You’ll experience absolute professionalism, with a hint of humour and collaboration. This is an exciting new role, with a strong and supportive management team and a great reputation.

**RECRUITMENT INFORMATION**

Applications will be reviewed as received.