Clinical Research Director

4 days ago

Marlton, New Jersey, United States CenExel Full time
About Us

CenExel Clinical Research is a leading provider of clinical trials services, with a strong presence in the industry. Our research sites specialize in Phase I to Phase IV trials, and our Centers of Excellence are comprised of some of the most well-respected and long-standing research facilities in the country.

We have a strong focus on quality, teamwork, and highly experienced clinical research managers with a history of success. Our employees enjoy an exceptional work environment that promotes positive leadership, work-life balance, and highly competitive compensation and benefits packages.

Job Summary

The Principal Investigator/Physician will be responsible for conducting clinical trials in accordance with research protocols, Good Clinical Practices (GCPs), and federal/state regulations. The successful candidate will generate independent, high-quality, and reproducible results, collaborate with study teams and regulatory personnel, and ensure the health and welfare of study participants.

Key Responsibilities
  • Maintain current licensure to practice medicine and board certification, if applicable.
  • Assume responsibility as the Principal Investigator for the duration of clinical trials.
  • Demonstrate a strong working knowledge of regulatory requirements and GCP standards.
  • Possess a thorough understanding of the clinical research protocol and patient population for which the trial is designed.
  • Ensure recruitment goals are reasonable and attainable.
  • Perform evaluations deemed necessary for the conduct of the trial.
  • Complete training as required per sponsor's vendors to obtain certification to conduct testing and rating scales for specific protocols.
  • Conduct testing and rating scales per sponsor's instructions and protocols.
  • Evaluate participants for clinical research trials based on their past medical history in comparison to the protocol-specific inclusion and exclusion criteria.
  • Ensure appropriate delegation and training of the clinical research staff.
  • Educate study staff on patient population and mechanism of action of the investigational product.
  • Evaluate subject safety and compliance with the investigational product as specified in the clinical research protocol.
  • Collaborate with the medical director to assess participant's response to investigational therapy and evaluate any adverse events.
  • Adhere to reporting requirements for safety reports, protocol non-compliance, and any other protocol-required reports.
  • Ensure subject's informed consent is obtained appropriately throughout the duration of the clinical trial.
  • Adhere to the requirements detailed on the FDA 1572 or Statement of Investigator form.
Requirements and Qualifications
  • Must be able to effectively communicate verbally and in writing.
  • Possess a valid M.D. or D.O. degree and be board certified or eligible.
  • 1-3 years' experience conducting clinical research trials as either a PI or Sub-investigator, or other relevant experience.
  • Demonstrate medical knowledge and ability to provide clinical information to study teams.
  • Show knowledge of medications and general medical conditions.
  • Understand GCP/ICH guidelines and the requirements of each protocol.
  • Possess experience in the conduct of clinical trials.
  • Demonstrate the proper education, training, and experience to conduct the clinical investigation.
  • Have knowledge of drug delivery systems and ability to prepare injections, infusions, etc.
  • Show skill in organization and record maintenance.
  • Be able to develop and maintain effective working relationships with supervisors and co-workers.
  • Have the ability to complete paperwork with precision and attention to detail.
  • Be able to react calmly and effectively in emergency situations.
  • Have the ability to interpret, adapt, and apply guidelines and procedures.
  • Be able to work independently as well as function as part of a team.
  • Have the ability to communicate clearly, both verbally and in writing.
Compensation and Benefits

CenExel Clinical Research offers highly competitive compensation and a generous benefits package to full-time employees after 30 days of employment, including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Estimated Salary: $120,000 - $150,000 per year

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