Physician’s Assistant – Clinical Research

Full Job Description

KEY FUNCTIONS AND RESPONSIBILITIES

The Sub-Investigator is a critical member of the study team as a mid-level practitioner responsible for providing medical guidance and management. The Sub-Investigator provides direct leadership, training, and oversight to site staff including study coordinators and research assistants. The Sub-Investigator overseas the care of study subjects under the guidance of the Principle Investigator.

The Sub-Investigator takes an active role in the Company’s growth objectives. The Sub-Investigator supports the development of new client relationships and the strengthening of existing account relationships with a view to expanding the Company’s portfolio of investigators, studies, clients and therapeutic area experience and expertise. The Sub-Investigator also assists in building and managing positive relationships in the clinical research community to increase the Company’s visibility, reputation, and stature consistent with being a recognized employer and partner of choice.

Responsibilities of Sub-Investigator

· Ensure PI provides sufficient oversight to meet ICH GCP requirements and the expectations of Company’s clients including sponsors and CROs.

· Ensure PI conducts study related activities and procedures as required of the PI according to ICH GCPs and sponsor requirements.

· Ensure enrollment expectations and commitments are met or exceeded.

· Participate in clinical studies according to ICH GCPs for sub-Investigators, ensuring adequate time and resources are available, as described in study protocols.

· Clinically evaluate study participants, answer their medical questions, and resolve medical issues, related to the clinical trial during study visits.

· Maintain records of each subject’s participation, which includes a review of participants’ past and current medical records, to be compared with visit medical history, concomitant medication and protocol inclusion and exclusion criteria.

· Determine participant’s eligibility for the study.

· Assess subjects’ response to therapy and subject compliance with use of the study drug at follow-up visits

· Administer study drug.

· Evaluate treatment of subjects for adverse events and reporting of all such events to the PI.

· Monitor use of concomitant therapy as authorized by the study protocol.

· Ensure that study drugs and devices are used for protocol purposes only.

· Provide leadership in identifying new clinical trials and assist in initiation of new trials.

· Play an active role in the recruitment of patients to designated studies, while ensuring that subject recruitment is conducted ethically and efficiently.

· Participate in pre-screening recruitment initiatives and activities for clinical trials participants, including presentations to healthcare professionals, public screening clinics, etc., as required.

· Liaises communication with PI’s, clinic staff, sponsor, sponsor representatives and vendors.

· Comprehensive understanding of the informed consent process and protocol so that proper written informed consent from each subject is received prior to participation in the study.

· Actively participate in audits and monitoring visits.

· Completion of all administrative tasks for patient files according to ICH GCP guidelines and best clinical practice.

· All other Sub-I duties as assigned or required by study protocol, regulatory agencies, sponsor or CRO.

Qualifications/Education

• Licensed Physician assistant or Nurse Practitioner with at least 2 years’ experience preferred

• Clinical research experience preferred

• Experience using a Clinical Trials Management System preferred. Demonstrated knowledge of Good Clinical Practice and ICH, and other site-specific regulations preferred

• Excellent interpersonal, verbal, and written communication skills, attention to detail, organizational and prioritizing skills, and time management skills required

• Proficient with PCs and Microsoft Office applications

Job Types: Full-time, Contract, Temporary

Pay: $115,000.00 – $140,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Healthcare setting:

• Clinic
• Outpatient

Schedule:

• Day shift
• Monday to Friday

Experience:

• Clinical: 1 year (Required)

License/Certification:

• Physician Assistant License (Required)

Work Location: In person

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