Job Description

Overview

Overview

Vitalief is a fast growing, \xe2\x80\x9cbest of breed\xe2\x80\x9d Research and Clinical Trial Solutions Company committed to identifying talented and passionate clinical research professionals to join our exceptional team and support our clients in planning and executing successful clinical trials. We make a difference in people\xe2\x80\x99s lives.

Vitalief has partnered with Walgreens on a clinical research diabetes Type 2 device study in New Jersey, and as a result we are seeking to hire a Principal Investigator on a part-time basis (6 to 12 hours per week) that will work for and represent Vitalief as a consultant for this engagement with Walgreens. The resource must be an MD licensed in New Jersey with experience in Endocrinology / Diabetes and Insulin Pump Therapy; and must have prior experience functioning as a Principal Investigator on at least one clinical research study. The assignment is projected to start around July and last for approximately 10 months. There will be minimal travel to trial sites local in NJ.

If you are interested in working with a team that respects and encourages your voice, then we want to speak with you!

NOTE: The position is 100% remote, overseeing a clinical trial for patients in the New Jersey region. The position may require up to 10% travel locally within New Jersey. Travel will be to trial sites overseen by the Principal Investigator. Travel may or may not be required for individual studies but typically includes a site initiation visit and travel to site for any visits that require the Principal Investigator to be present.

Responsibilities:

• Overall responsibility for Vitalief\xe2\x80\x99s client interaction and the technical conduct of a diabetes device study in accordance with the signed agreement with the Sponsor, as well as the interpretation, analysis, documentation, monitoring progress of the study, and reporting of results.
• Oversight of patient safety, data integrity including reviewing study source data, review and sign off on CRFs, and review data queries, etc. Study participant interaction will be minimal.
• Supervisory responsibility for any/all delegated site staff including CRCs and research nurses and conducts routine meetings with staff and monitors to ensure site goals are met.
• Assists and provides guidance to clinical operations, research staff, and to sponsor client managers as required.
• Must be aware of and comply with all applicable regulatory requirements.
• Ensures that any unforeseen circumstances that may affect the quality and integrity of the study are identified and documented as they occur, and corrective action is taken.
• Documents and reports Adverse Events (AEs) or any abnormalities affecting participants\xe2\x80\x99 safety to sponsors in a timely manner.
• Reviews participants medical history and ensures patient enrollment criteria is in alignment with the protocol.
• Participates in monitoring visits and sponsor meetings.
• Provides and maintains updated study related documentation as required by the clinical research trial to ensure data integrity as required per protocol.

Required Skills:

• Active U.S. MD or DO to practice in the State of New Jersey; and 5 or more years of experience as a practicing physician in the U.S.
• Successful track record functioning as a Principal Investigator on at least one (or more) Clinical Trials.
• Experience as Endocrinologist or GP experience in treatment of Diabetes. Experience with insulin pump therapy.
• Ability to demonstrate the proper education, training and experience to conduct clinical investigation.
• Good understanding of ICH-GCP guidelines.
• Strong knowledge of good documentation practices.
• Strong written and verbal communication skills including good command of English language.
• Demonstrated ability to effectively prioritize and anticipate workload constraints.
• Strong attention to detail and accuracy.
• Ability to establish and maintain effective working relationships with coworkers, managers, clients and trial sponsors.
• Applicable certifications and licenses as required by local regulations.
• Experience with Curebase study system preferred.
• Proficiency in project management skills
• Excellent interpersonal and mentoring skills.
• Strong executive presence, focus and drive to succeed \xe2\x80\x94 confidence, passion and high energy.
• Highly driven, results oriented, competitive, positive person who thrives in a small, team oriented, fast paced, environment.

PHYSICAL DEMANDS: Standing, sitting, walking, talking and hearing. No special vision requirements. Lifting up to 25lbs.

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