Clinical Trials Investigator Rotorua

**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 located in Rotorua.

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. This role is being offered as a Contractor 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
- 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