Clinical Trials Investigator

**The next step in your professional medical career**:

- ** Be at the forefront of leading research and development**:

- ** Lead and work closely with a collaborative team**

Our client, PCRN Limited is a private medical research company, with sites across New Zealand. Running clinical trials across a multitude of therapeutic areas, each site is staffed by a small, dedicated team with a national support team providing administrative and recruitment services. PCRN believe in promoting a supportive and professional work environment. Bringing new treatment opportunities to a community of volunteers is what makes working with them so rewarding. This rare opportunity for a registered Medical Practitioner to join the team is located in central Christchurch.

The role of Investigator is a specialised and important role, performing critical trial-related procedures and making important trial related decisions. The Investigator will at times be designated to work as the Principal Investigator for a clinical trial and will incur additional duties and responsibilities, if this is the case. Currently being offered as a part time position of 16-20 hours per week, hours may increase over time.

**The 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
- Flexibility, although this work is typically Monday to Friday, able to meet changing requirements associated with the nature of clinical trials (including early morning and weekend work at times)
- 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

**RECRUITMENT INFORMATION**

You must be currently located in New Zealand and have the legal right to work here. A good command of the English Language and strong written communication skills are essential.

**CONFIDENTIALITY ASSURED