Project Manager, Clinical Research Management Office, Lombardi Cancer Center - Georgetown Universit
Project Manager, Clinical Research Management Office, Lombardi Cancer Center - Georgetown University Medical Center
Georgetown Lombardi Comprehensive Care Center (LCCC) clinicians are dedicated to providing the best professional care, delivered with compassion, for all patients. We seek to prevent, treat, and cure cancers by linking scientific discovery, expert and compassionate patient care, quality education, and partnership with the community, guided by the principle of cura personalis - "care for the whole person.”
The Project Manager supervises, monitors and supports the Clinical Research Management Office (CRMO) administration and progress of clinical trials at multiple institutions on behalf of the lead investigator. S/he monitors the timelines and milestones of the assigned clinical studies and develops strategies for staying on track; and 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. Reporting to the CRMO Administrative Director, the Project Manager has additional duties that include but are not limited to:
Study Monitoring and Review
- Facilitates completion, and collects, maintains and manages all regulatory documents from the participating sites.
- Develops, implements, and manages processes to ensure adequate study drug supply at each of the participating sites, reviewing drug accountability documents at each participating site.
- Monitors investigator conduct at each of the participating sites, ensuring compliance with all FDA regulations and 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 process data clarifications/queries.
- Conducts a regulatory review of signed informed consent forms and subject data to verify satisfaction of all eligibility criteria.
- Conducts drug accountability reviews and frequent meetings including representatives from all sites.
- Ensures study staff at participating sites are following the approved clinical trial protocol and adhering to applicable FDA regulations and ICH guidelines.
Study Start-up Activities
- Develops appropriate study-related documents - for example, study protocol, informed consent template, Manual of Procedures, and Case Report Forms.
- Identifies requests, and 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 supporting information/documents 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, tracking and reporting the status of each.
- Collects data to provide enrollment reports to project team.
- Manages the reporting process, IND processes, and required documentation.
- Collates necessary information required by LCCC and disseminates DSMC reports to participating sites and drug manufacturer.
- Drafts and disseminates protocol modifications as directed by the PI.
- Facilitates payments for all study activities at affiliate sites through CTMS OnCore.
- Attends applicable study team meetings and provides minutes.
- Bachelor's degree - preferably in biological, health sciences or related field - Master's degree preferred
- 4 years of clinical research experience (preferably cancer trials) providing direction on interpreting federal, state, and sponsor policies and regulations, including 2 years of project management experience and experience in clinical operations or equivalent combination of education, training and experience
- Knowledge of applicable clinical research regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- Knowledge of Microsoft Word, Excel, and PowerPoint computer applications
- Strong communication, organizational, interpersonal, customer service, and problem-solving skills
- Ability to interact effectively with a wide variety of individuals, including sponsors, investigators, clinical research coordinators, administrative staff, and representatives from the office of sponsored programs
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics
- Effective mentoring and training skills, presentation skills, and good team leadership skills
- Willingness and availability to occasionally travel as required
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