The Clinical Research Coordinator/Site Manager manages all aspects the clinical research clinic, overseeing the running of several clinical trials, managing the day to day operations of the clinic, interfacing with the Sponsor and the PI, and managing research budgets.
Job Description Duties and Responsibilities
Responsible for overall conduct of research program.
Coordinates all aspects of clinical research activities.
Develops, coordinates, and reviews research study procedures to ensure receipt, completeness, and accuracy of research data required for studies.
Directs conduct of research studies to ensure adherence to protocol and provides updates to PI as needed.
Coordinates all regulatory aspects, such as preparing regulatory packets, safety reports, adverse events.
May develop and monitor budgets; negotiates participant rates; approves expenditures; pays invoices.
Develops procedures to determine subject eligibility; screens, recruits, and enrolls subjects, ensuring and documenting proper informed consent.
Coordinates collection of all trial data and completes Case Report Forms
Draws, prepares, ships laboratory samples as needed
Prepares IRB submission documents and informs IRB of amendments to research studies; SAEs, or Unanticipated Problems as needed.
Oversees drug accountability and maintains drug accountability.
Schedules screening visits and any follow up visits with patients.
Maintains research office functionality and requirements for study equipment calibration.
Performs additional tasks as assigned by PI.
Bachelor's degree in a healthcare or clinical research related field Minimum of five (5) years clinical research experience Certified Clinical Research Coordinator (CCRC) Solid understanding of GCP/ICH requirements and FDA regulations Proficient in Microsoft Office Ability to organize a high-volume workload and prioritize tasks accordingly Strong work ethics and personal integrity
**Only applicants with a minimum 5 years' experience in clinical research will be considered** **Please attach a resume/cover letter to your application
Total Clinical Trial Management (TCTM), is a full service contract research organization based in Dallas, Texas. TCTM has a wide range of therapeutic expertise with recent areas of focus including pain, orthopedic injury, dermatology, cosmetics, over-the-counter (OTC) and generic studies.
Dermatolgy, Ophthalmology, Acute Pain, Women's Health, Aesthetics, Gastroenterology, and Ophthalmology