Clinical Research Coordinator, Center for Translational Transplant Medicine - Georgetown University
Clinical Research Coordinator, Center for Translational Transplant Medicine - Georgetown University Medical Center (GUMC)
Georgetown's Center for Translational Transplant Medicine (CTTM) seeks an independent, highly organized, motivated, detail-oriented, and technically talented Research Associate to support the cutting edge translational research of Alexander Kroemer, MD, PhD. The Research Associate will work closely with Dr. Kroemer as the team lead providing daily oversight in the preclinical laboratory research efforts from bench top to bedside. The Kroemer Laboratory studies immune responses in abdominally transplanted organs.
The Clinical Research Coordinator (CRC) ensures that all protocol requirements and regulations for human subject research are met, submits regulatory documents to sponsors, and maintains protocol submissions with the IRB. Reporting to the Nurse Manager and Interim Senior Research Administrator, the Clinical Research Coordinator has duties that include but are not limited to:
- Coordinates multiple clinical trials simultaneously, and manages multiple Principal Investigator relationships.
- Serves as point person for assigned clinical trials.
- Assists with, or plans and implements, the clinical study's goals and objectives, including organizing patient enrollment planning and meeting enrollment goals; and compiles and analyzes data.
- Serves as the liaison with the sponsor for assigned studies.
- Understands and executes the basics of clinical research - Good Clinical Practice (GCP), Good Documentation Practices (GDP), and Standard Operating Procedures (SOPs).
- Performs study initiation, enrollment, conduct, and closeout.
- Prepares and compiles data and documents during internal and external audits, and is ultimately responsible for quality of submissions.
- Develops and implements procedures, maintain records, tracks progress, and conducts quality assurance on data collected.
- Assists in the financial accounting of multiple clinical research projects, including budget development and billing reconciliation.
- Oversees research participant stipends.
- Manages IRB submissions and develops regulatory submission strategies as applicable.
- Prepares documents and reports for the IRB, including IND Safety Letters, Protocol Amendments, Continuing Review Reports, Protocol Violations and Deviations, and Serious Adverse Event Reports as necessary
- Complies with all Georgetown University Medical Center (GUMC) and Clinical Trial Management procedures, as well as all Medicare compliance procedures.
- Complies with all GUMC training requirements as applicable to position (CITI, COI, ACRP/SOCRA or equivalent, blood borne pathogens, and billing compliance).
- Attends a minimum of 6 GUMC research meetings (CRN, CROO, and LCC) per year.
- Completes and uploads time and effort forms on-time each month into designated university Box folder.
- Bachelor's degree in a scientific or related field
- 2 - 4 years of clinical research experience in coordinating Clinical research/clinical trials
- Excellent organizational and communication skills and the ability to work both independently and collaboratively with investigators and patients
- In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures
- 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 demonstrated interpersonal, verbal, and written communication skills
- Ability to operate effectively in a changing organizational and technological environment
- Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs
- Ability to interpret and apply GUMC policies and federal, state, and local regulations
- 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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