Clinical Research Prime is looking for a Clinical Research Director to join their team!
Type: Full Time
Location: The Healing Sanctuary
Experienced research coordinator with an RN license is strongly preferred. The licensed professional will use medical knowledge and clinical experience in multiple functions with this position, including but not limited to, analyzing and/or evaluating clinical data, developing and implementing clinical workflows for studies/protocols, performing medical reviews, and training clinical research coordinators within Clinical Research Prime.
With minimal supervision, the Clinical Director will be responsible for the direct management of personnel, including projects, and studies. The Clinical Director will provide support to their Clinical Coordinators and oversee all functions.
The Clinical Director is responsible for directly overseeing the planning, organization and implementation of all aspects of CRP’s daily clinical research functions including but not limited to, coordination of clinical research prime, maintaining protocol compliance, meeting clinical data quality standards, and continuous monitoring/oversight of clinical trial operations.
Responsibilities include, but are not limited to:
Oversee, assess and ensure participant safety and strict protocol implementation/adherence. Oversee compliance guidelines and federal regulations.
Assist in the development of study materials and protocols; oversee compliance to protocol, manage quality control, completion and submission of study related documentation; and prepare reports for organizations and agencies.
Participate in calls for enrollment as dictated by the study protocol.
Monitor enrollment goals and initiate strategies to promote enrollment and participant compliance.
Analyze study monitoring and operational reports to monitor production and data collection.
Recognize, track and report adverse events and protocol deviations.
Implement procedure to prevent future events, including staff education and retraining
Prepare for and coordinate site visits made by sponsors or federal agencies during the course of and at the close of the study.
Develop and maintain a system to track data entry and audit for completeness, accuracy, and timeliness of data collection.
Develop and maintain patient databases, investigational logs and records of drugs administered and/or procedures followed.
This job description is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.