Clinical Research Coordinator, Center for Translational Transplant Medicine - Georgetown University
Clinical Research Coordinator, Center for Translational Transplant Medicine - Georgetown University Medical Center
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) is responsible for coordinating clinical trials in human subjects within the Center for Translational Transplant Medicine (CTTM). S/he ensures that all protocol requirements and regulations for human subjects research are met. Reporting to the Manager and Principal Investigator, the Clinical Research Coordinator has duties that include but are not limited to:
- Ensures adherence to protocol.
- Schedules study visits with the subject, Pl, and/or other necessary departments such as the CRU, laboratory, and/or radiology.
- Prompts Research Team about protocol requirements for upcoming study visits.
- Independently completes assessments of concomitant medications and AE/SAEs; and completes all adverse event reporting following institutional policies.
- Completes and maintains all source documentation of the study visit.
- Maintains all regulatory documentation and record keeping in the regulatory binder, such as protocol amendments, IRB annual renewal, ICF changes, and 1572 changes.
- Coordinates with the sponsor, Pl, and other departments as indicated regarding all study monitoring visits, and completes all queries generated form the visit in a timely manner.
- Tracks all study payments as assigned.
- Enters all study and/or research participant data into the Clinical Trial Management System (CTMS).
- Identifies and prescreens potential research participants to determine their initial eligibility and interest in a research study, while adhering to important guidelines to protect the privacy of the patient.
- Schedules all screening tests/procedures.
- Completes documentation of screening visits and completes source documentation and subject screening logs.
- Plans for subject tracking through the entire protocol.
Study Initiation Tasks
- Completes IRB submission of protocol, such as preparation of ICF and HIPAA documents, and advertisements.
- Facilitates study contract through GU-PASS.
- Works with Budget Analyst to negotiate study budget.
- Coordinates study procedures with necessary departments.
- Develops study flow sheets and/ or source documents as indicated.
- Attends, plans, or coordinates all study initiation meetings, such as GUMC, Investigator Meetings, Site and Initiation.
- Verifies that all subject visits including follow-up are complete, and that any associated Adverse Events are resolved, up-to-date, and reported.
- Completes all source documents, Case Report Forms, and queries are complete and ready for close -out.
- Ensures all study invoicing has been completed.
- Completes all regulatory closeout requirements, including notification of the IRB, retention of documents, final drug/device closeout, and clinical supply return.
- 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 (CITI, COI, ACRP/SOCRA or equivalent, Bloodborne Pathogens, and Billing Compliance).
- Attends a least 6 GUMC research meetings (CRN, CROO, LCC) per year.
- Completes and uploads time and effort forms on-time each month into designated University Box folder.
- Provides CRC support to multiple industry-sponsored and/or federal projects conducted at GUMC.
- Participates in Clinical Trial Feasibility, Site Selection Process, and Site Initiation Visit
- Coordinates with sponsor regarding site management, data management and query resolution issues, providing guidance and suggestions for resolution.
- Bachelor's degree in a scientific or related field
- 2 to 4 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
- 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
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