Nurse Practitioner/Physician Assistant, Clinical Research

Kelly Science & Clinical is seeking a two Sub-Investigators for a full-time, direct-hire position with a clinical research site in northern California.

Sub – Investigator

Nurse Practitioner/Physician Assistant

Modesto, CA or Redding, CA

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 oversees 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 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.
• Liaise 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.