- 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
- 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
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Clinical Research Sub-Investigator, PA/NP) - Modesto, United States - MyKelly
Description
Kelly Science & Clinical is seeking a Sub-Investigator for a full-time, direct-hire position with a research site in Modesto, CA. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Sub – Investigator
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
Qualifications/Education
