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Job: Lead Clinical Research Associate, Duke Clinical Research Institute, Durham, NC
Lead Clinical Research Associate
Durham, NC 27701 United States
Manage the development, coordination, and implementation of clinical operations site management and clinical monitoring responsibilities for assigned projects with guidance, including trial-specific processes and systems, and daily supervision of the clinical operations team.
Responsible for site management and clinical monitoring in accordance with contractual agreements, department guidelines, SOP's, applicable international, federal and state regulations and ICH guidelines. Half of the position responsibilities will involve providing leadership for functional group leaders for the execution of all monitoring services according to the project specific scope of work.
Position will also budget with minimal guidance. Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operations manual with guidance.
Position will serve as key site management trial team member to internal and external partners and to the project core team (project leader, principal investigator, and other functional group key representatives.)
Position will collaborate with clinical operations administration to identify and oversee trial related training and performance concerns of monitoring team members according totheir individual needs; maintain awareness of level of performance and training needs; provide ongoing input to senior clinical trials leader for development of individual training plan. Supervise and manage monitoring trial-team members adherence to sponsor specific administrative policies with guidance. Encourage team members to attend appropriate training and meetings. Support the department mission, goals and organizational activities.
Position reports for a Project leader as a line manager and for daily activities. Position typically leads the monitoring team composed on clinical research associates I, II, and III and Senior Staff for all Clinical Trials activities through startup, enrollments, closeout and archiving. Perform other related duties incidental to the work described herein.
Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus four years of healthcare experience; or one of the following equivalents:
1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of six years healthcare experience; or
2.Completion of a master's degree in Public Health, Health Administration or a related area with three years directly related clinical trials research experience; or
3. Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research; or
4. Completion of a bachelor's degree plus a minimum of five years closely related research experience.
**State of North Carolina license may be required.**
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North Carolina Biotechnology Center