PA or NP (Clinical Trials)

Job DescriptionJob Description

The PA or NP will be responsible for direction, implementation, coordination, control and execution of global-scale clinical projects. This individual will perform in the capacity of a sub-investigator on phase I, II & III clinical research trials involving healthy subjects and patient populations.

Essential Responsibilities Include:

• Participates in the ongoing process of assessing potential study protocols for feasibility at our site, providing regular feedback on the medical aspects of the trials to the Business Development team.
• Liaises with sponsors on study conduct and study progression when required.
• Provides support for the preparation of clinical protocols, integrated clinical and statistical summary reports, and other documents when required.
• Along with Medical Director, is responsible for orienting and training newly hired PAs and NPs.
• Assists with the medical and clinical oversight of all aspects of clinical work performed within the clinic.
• Records, evaluates and reviews adverse events and concomitant medications.
• Participates in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data, as appropriate, with the clinical team, project team, sponsor, investigator, and regulatory agencies.
• With Project Managers, ensures that all established timelines relating to areas of responsibility and assigned projects are met.
• Participates in the ongoing process of assessing potential study protocols for feasibility at our site, providing regular feedback on the medical aspects of the trials to the Business Development team.
• Upholds Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and all work processes to ensure efficiency and compliance.

Qualifications:

• Must have completed an accredited Nurse Practitioner Program and certified by the American Nurse Credentialing Center or the National Certification Board of Pediatric Nurse Practitioners and Nurses OR
• Sr PA: Graduate of an accredited Physician Assistant Program; AND Phase 1 clinical research experience, minimum of 5 years