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Project Manager/Clinical Research Associate, Clinical Management Research Office – Georgetown University Medical Center
Georgetown's Clinical Research Management Office (CRMO) provides administrative, nursing, and data management support for cancer treatment clinical trials conducted by Lombardi Investigators. This includes all regulatory documents, IRB submissions, budget and contract negotiations, consenting of subjects, case management of patients while on study, side effect management, completion of case report forms, meeting with monitors, maintaining trial information on Lombardi website, design of electronic case report forms for institutional trials.
The Project Manager/Clinical Research Associate supervises, monitors and supports the administration and progress of clinical trials at multiple institutions on behalf of the lead investigator. S/he monitors the timelines/milestones of the assigned clinical studies and developing strategies for staying on track; ensures that study personnel at all study sites conduct the applicable studies according to the clinical protocol, current Good Clinical Practices governing clinical research, and all applicable regulatory requirements; and ensures that study payments to participating sites are issued as per study agreements. Reporting to the Administrative Director, the Project Manager/Clinical Research Associate has duties that include but are not limited to:
Study Monitoring and Review
Facilitates completion, collection, maintenance and management of all regulatory documents from the participating sites.
Develops, implements and manages processes to ensure adequate study drug supply at each of the participating sites.
Reviews drug accountability documents at each participating site.
Monitors investigator conduct at each of the participating sites, ensuring compliance with all FDA regulations, as well as all applicable ICH and GCP guidelines.
Conducts source document verification of data submitted by participating sites, ensuring the quality, integrity and validity of the data collected.
Generates, disseminates and processes data clarifications/queries.
Conducts a regulatory review of signed informed consent forms.
Conducts a review of subject data to verify satisfaction of all eligibility criteria
Conducts drug accountability review.
Monitors regulatory documents at participating sites.
Ensures study staff at participating sites are following the approved clinical trial protocol and adhering to applicable FDA regulations and ICH guidelines.
Documents and reports the status and findings from monitoring activities.
Perform sclose-out activities for each site upon study completion.
Conducts frequent meetings including representatives from all sites.
Study Start-up Activities with Each Participating Site
Manages appropriate study-related documents – for example, study protocol, informed consent template, Manual of Procedures, and Case Report Forms.
Identifies, requests, collects and manages all regulatory documents required in the conduct of an FDA-regulated study.
Serves as the liaison between the sites and GU Office of Sponsored Research in the negotiation and execution of site budgets and contracts.
Prepares agenda and provides support for site study initiation.
Conducts site initiation with appropriate study staff at each participating site.
Serves as the point of contact for all study-related questions from participating study sites.
Develops overall project timelines and study metrics to assist in the management of the study.
Tracks, measures and reports status of each.
Collects data to provide enrollment reports to project team.
Manages the SAE reporting process.
Collates necessary information required by the Lombardi CC DSMC.
Disseminates DSMC reports to participating sites and drug manufacturer.
Serves as the liaison between the drug manufacturer, lead PI, and study staff at participating sites.
Manages IND processes and required documentation.
Drafts and disseminates protocol modifications as directed by lead PI.
Attends applicable study team meetings and provide minutes.
Facilitates payments for all study activities at affiliate sites.
Bachelor's degree, preferably in biological, health sciences or related field – Master's preferred
4 years clinical research experience (preferably cancer trials), providing direction on interpreting federal, state, and sponsor policies and regulations, and including 2 years of project management experience and experience in clinical operations or equivalent combination of education, training and experience
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements – that is, Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
Strong software and computer skills, including MS Office applications
Strong communications, presentation, interpersonal, organizational and problem solving skills
Demonstrated ability to deliver results to the appropriate quality and timeline metrics
Good team leadership, mentoring, training, and customer service skills
Ability to manage competing priorities, and to establish and maintain effective working relationships with coworkers, managers and clients
Ability to interact effectively with a wide variety of individuals including sponsors, investigators, clinical research coordinators, administrative staff, and representatives from office of sponsored programs, clinical research organizations, other institutions, and pharmaceutical companies
Availability for occasional travel
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Internal Number: JR05051
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