Project Manager/Clinical Research Associate, Clinical Research Management Office - Georgetown Unive
Project Manager/Clinical Research Associate, Clinical Research Management 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 Comprehensive Cancer Care (LCCC) 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 is responsible for monitoring the timelines/milestones of the assigned clinical studies and developing strategies for staying on track; for ensuring 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 for ensuring that study payments to participating sites are issued as per study agreements. Reporting to the CRMO Director, the Project Manager/Clinical Research Associate has duties that include but are not limited to:
- Participates in the development of study-related documents, such as study protocol, informed consent template, Manual of Procedures, Case Report Forms, and monitoring plan/guidelines.
- Participates in the development of the electronic tools to be utilized for the study.
- Identifies, requests, and facilitates collection of all required regulatory documents required in the conduct of the assigned studies.
- Serves as the liaison, as necessary, between the sites and lead PI (or other assigned personnel) in the negotiation of site budgets.
- Serves as the liaison, as necessary, between the sites and Georgetown Office of Sponsored Research in the negotiation and execution of contracts.
- Prepares agenda and supporting information/documentation for site initiation visit (SIV).
- Serves as the point of contact for the site study staff for all study start-up related questions.
- Assists in the development of project timelines and study metrics to assist in the management of the study.
- Tracks, measures and reports to lead CRA/PM and lead PI.
- Assists in the collection of information required for SAE reporting.
- Assists lead CRA/PM and PI in the preparation of the necessary reports to the FDA, drug manufacturer and/ or participating sites, as applicable.
- Assists in the collection of information required by the Georgetown LCCCC DSMC for other protocols.
- Assists lead CRA/PM and PI in the preparation and dissemination of the necessary reports to the committee, as well as the drug manufacturer and/ or participating sites, as applicable.
- Assists in the drafting and dissemination of the protocol and/or informed consent modifications.
- Attends applicable study team meetings and provided minutes.
Study Budgets Management
- Determines whether proposed clinical projects are a qualifying clinical trial as defined by Medicare Clinical Trial Policy and relevant National Coverage Decisions and with input from the Principal Investigators and study coordinators, the proper allocation of items and services between routine costs vs. research costs in order to support the reasoning for billing.
- Prepares individual study budgets
- Prepares site budgets and statements of work and serve as liaison between participating sites and OSR to get subcontracts issued.
- Creates budgets for sub-sites when Lombardi CRMO is coordinating center.
- Ensures that study payments to participating sites are issued as per study agreements.
Study Monitoring and Management
- Facilitates completion, collection, maintenance and management of all regulatory documents required from participating sites.
- Participates in the development of processes, when applicable, to ensure adequate study drug supply at each participating study site.
- Monitors investigator conduct at all assigned participating sites, ensuring compliance with all applicable regulations and guidelines.
- In accordance with the monitoring plan/guidelines developed for each study, conducts source document verification of data submitted by the study sites, ensuring the quality, integrity and validity of the data collected.
- Generates, disseminates, tracks and processes data queries.
- Conducts regulatory review of signed informed consent forms.
- Conducts review of study data to verify satisfaction of all eligibility criteria.
- Conducts drug/device accountability review when applicable.
- Monitors study site regulatory documents.
- Ensures study staff at participating sites is following the approved protocol and adhering to all applicable regulations/guidelines (e.g., FDA, ICH).
- Performs close-out activities for each site upon study completion.
- Documents and reports the status and findings from monitoring activities.
- Reports monitoring findings to lead CRA/PM and lead PI and, as appropriate, collaborates to develop action plans.
- Bachelor's degree - Master‘s degree preferred, as is a degree in biological, health sciences or related field
- 4 years of clinical research experience, including 2 years of project management experience and experience in clinical operations OR equivalent combination of education, training and experience
- 4 years of experience in a clinical research setting, providing direction on interpreting federal, state, and sponsor policies and regulations
- Preference foe experience in clinical research settings - ideally cancer trials
- 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 communication and interpersonal skills, including good command of English language
- Strong organizational and problem solving skills
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics
- Good team leadership skills
- Effective mentoring, training, and presentation skills
- Excellent customer service skills
- Good judgment and the ability to manage competing priorities
- Strong software and computer skills, including MS Office applications
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Proficiency with Microsoft Word, Excel, and PowerPoint
- Availability and willingness to travel as needed
Current Georgetown Employees:
If you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.
Please note that in order to be considered an applicant for any position at Georgetown University you must submit a cover letter and resume for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions.
If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or firstname.lastname@example.org.
Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website.
Georgetown University is an Equal Opportunity/Affirmative Action Employer fully dedicated to achieving a diverse faculty and staff. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected veteran status, or any other characteristic protected by law.