Clinical Trials Data Manager, Center for Translational Transplant Medicine - Georgetown University
Clinical Trials Data Manager, Center for Translational Transplant Medicine - Georgetown University Medical Center
Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center whose missions of research, teaching and patient care are carried out with a strong emphasis on community outreach and the Jesuit principle of cura personalis — care of the whole person. GUMC consists of the School of Medicine, the School of Nursing & Health Studies, Georgetown Lombardi Comprehensive Cancer Center, and Biomedical Graduate Research and Education.
The Clinical Trials Data Manager is responsible for the administration of the large volume of data that is collected in every clinical trial to meet FDA requirements for bringing a drug to market, to include the meticulous tracking of every single patient thru data-input on Case Report Forms (CRFs), study files, Data Safety Monitoring Forms, IRB forms, and other related documentation. S/he ensures that data is accurately gathered, organized, and placed accordingly. Reporting to the Senior Research Administrator, with an indirect report to the Senior Clinical Research Coordinator, and accountability to each Principal Investigator, the Clinical Trials Data Manager has duties that include but are not limited to:
- Ensures query resolution and/or data clarifications forms in a timely manner.
- Requests radiology images and upload the images into the imaging platforms.
- Facilitates the scheduling of the sponsor's monitor visit and audits, supports the CRCs as they organize the data in preparation for monitor visits and audits, and participates as needed in the site initiation visits.
- Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.
- Collects and organizes research data in paper charts for sponsors, institutional and cooperative studies.
- Accurately captures data in appropriate format in electronic or paper Case Report Form (CRF) within the expected time frame.
- Enters data into the Georgetown applications relevant at the time, such as Red Cap, IRB's system, Office of Sponsored Research system, and Clinical Trials Management System.
- Complies with all GUMC and Clinical Trial Management procedures, as well as all Medicare compliance procedures.
- Complies with all GUMC training requirements as applicable to position.
- Attends a minimum of 6 GUMC research meetings (CRN, CROO, and LCC) per year.
- Manages the processing of EKG, CT/MRI scans, and lab tests reports, including physicians' signatures.
- Maintains Human Subject Protection compliance adhering to patient confidentially throughout the clinic.
- Collaborates closely with study coordinators to maintain protocol integrity in preparation for sponsor or FDA audits.
- Assists CRCs and Lab Technicians in preparation of research kits.
- Assists Study Coordinators on requesting and submitting pathology specimens.
- Bachelor's degree in a scientific or related field
- 1 to 3 years of clinical research experience in coordinating clinical research/clinical trials
- Excellent organizational and communication skills, with the ability to work both independently and collaboratively with investigators and patients
- Support interdisciplinary team to achieve optimal clinical research compliance and outcomes
- Knowledgeable about email, basic computers, and Excel and Microsoft word applications
- Competent clinical trial management experience, including regulatory and compliance responsibilities
- Exceptional analytical skills to address complex and non-routine issues requiring the development of innovative solutions
- Excellent interpersonal, verbal, and written communication skills
- Ability to operate effectively in a changing organizational and technological environment.
- Ability to interpret and apply GUMC policies and federal, state, and local regulations
- Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs
- Knowledge of all applicable laws and regulations for research involving human subjects, as well as Med-Star and Georgetown University's philosophy, policies, procedures, and standards
- Hospital-based drug and device research experience
- Knowledge of database and statistical software
- BLS certification
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