Research Study Coordinator- Center for Translational Transplant Medicine
The Research Study Coordinator is responsible for coordinating clinical trials in human subjects within the Center for Translational Transplant Medicine. The Clinical Research Coordinator is responsible for ensuring that all protocol requirements and regulations for human subject’s research are met. Duties include but are not limited to:
- Submit regulatory documents to sponsors and prepare and maintain protocol submissions with the IRB. Review protocol logistics and meet with relevant hospital departments and staff to conduct training and in-services for protocol procedures.
- Ensure adherence to all IRB, HHS, FDA, and OHRP regulations governing investigational drugs and human subjects.
- Manage patient screening, informed consent, enrollment, randomization, patient tracking, follow-ups and data collection.
- Assist investigators in monitoring research subjects for adverse events, tracking concomitant medications and all applicable device and drug regulations.
- Responsible for accurate research data abstraction from medical records and EMR, adherence to departmental and hospital policies and procedures and ensure full compliance with research regulations for all trials assigned.
- Provide timely, consistent, error-free written and verbal communications of a sufficient quality to meet departmental standards and be able to work a flexible schedule.
Requirements:
- Bachelor’s degree in related field with at least one year of experience in coordinating clinical research/clinical trials.
- Minimum two years experience in clinical research with knowledge of GCP/ICH required with previous experience in business in a healthcare setting and or financial management.
- Computer proficiency and knowledge of Microsoft applications is required.
- Knowledge of database and statistical software preferred, BLS certification preferred.
- Excellent organizational and communication skills with the ability to work independently as well as collaboratively with investigators and patients.
- Ability to produce clear, error-free written and verbal communications to internal and external collaborators and regulatory agencies is essential.
- Knowledge of all applicable laws and regulations for research involving human subjects as well as MedStar and Georgetown University’s philosophy, policies, procedures, and standards. Hospital based drug and device research experience strongly preferred.
