PRN Clinical Investigator

2 weeks ago

the villages, United States Charter Research Full time

Clinical Investigator (MD, DO, PA-C, NP)

The Villages


COMPANY DESCRIPTION

Charter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Orlando, FL that is looking to add to our team to help us fulfill our mission of discovering future medicines. Our company is locally owned and prides itself on providing exceptional patient experience to our participants, as well as offering agile recruitment strategies to our sponsors. Above all, we are a team, and we are seeking the right team member to add to our foundation in The Villages.


POSITION OVERVIEW

Under the direction of the Principal Investigator (PI), the Clinical Investigator promotes International Council for Harmonization - Good Clinical Practice (ICH-GCP) in the conduct of clinical investigations by ensuring adherence to protocol requirements, protecting the rights and welfare of study subjects, assuring the integrity of data generated at the site, and directing the conduct of the clinical investigation according to federal and state regulations and guidance documents and the site’s Standard Operating Procedures (SOPs).


Primary Responsibilities

  • Acquire and maintain an in-depth knowledge of study protocols and critical study documents.
  • Promote and support knowledge and understanding of the protocol within the organization.
  • Conduct patient procedures and visits, including informed consent, as dictated by the clinical trial protocol.
  • Manage the medical care of study participants, including clinical exams, evaluation of safety procedures, and medical documentation (i.e., vital signs, EKGs, laboratory reports, imaging reports, review of medical records).
  • Assist in identifying potentially appropriate subjects and evaluating their eligibility for clinical trials.
  • Evaluate and document adverse events (AEs) and serious adverse events (SAEs).
  • Protect the rights and welfare of study subjects.
  • Maintain all subject data in accordance with privacy regulations, as dictated by the clinical trial protocol, ICH-GCP, and the site’s SOPs.
  • Ensure documentation of study-related procedures, processes, and events according to the requirements of the protocol, ICH-GCP, and the site’s SOPs.
  • Ensure completion of all study-related documentation according to ALCOA-C standards.
  • Maintain professional and technical knowledge required for the performance of clinical trials.
  • Develop and maintain exceptional communication with CROs and sponsors of clinical trials.
  • Communicate clinical trial issues to sponsor, CRO, and internal leadership, as appropriate.
  • Prepare for and participate in quality assurance audits conducted by internal teams, study sponsors, federal agencies, or other review groups.


KNOWLEDGE, SKILLS, AND ABILITIES

  • Ability to think critically.
  • Strong medical knowledge supporting proper oversight of subjects participating in clinical trials.
  • Strong organizational, interpersonal, and leadership skills, self-motivation, and high personal integrity and ethics.
  • Ability to determine and prioritize workload.
  • Ability to communicate professionally and courteously, including facilitation, negotiation, and collaboration.
  • Ability to maintain sensitive patient information confidentially.


QUALIFICATIONS

Education and Experience

  • Board-certified Medical Doctorate (MD), Doctor of Osteopathic Medicine (DO), Physician Assistant (PA-C), or Advanced Registered Nurse Practitioner (ARNP).
  • Active medical license to practice medicine in the state of Florida, or an active license that is transferable to Florida within 3 months.
  • Prior experience as a Principal investigator or Sub-Investigator in clinical trials preferred.
  • Must be fluent in English.


Charter Research provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability status, genetic information, marital status, ancestry, protected veteran status, or any other characteristic protected by applicable federal, state, and local laws.

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