Full Job Description
*This is a temporary contract role needed from Nov 1st, 2024, to mid-January 2025 with possibility for additional PRN work.
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 Principal 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: 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
Schedule:
- Day shift
- Monday to Friday
Work Location: In person
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