Clinical Research Coordinator

Georgetown University•Vinalhaven, ME

3d•$44,022 - $73,407•Onsite

About The Position

The Clinical Research Coordinator 2 (CRC2) is responsible for managing and coordinating 7 out of approximately 55 ongoing clinical trials, Phases I-IV, in the Dept. of Neurology, primarily in the disease states of Movement Disorders, Stroke, and neuromuscular disease. Coordination and management of such studies is both a dynamic and demanding responsibility that requires refined technical, organization, interpersonal, and coordination skills. The CRC2 is responsible for learning the schedule of assessments for each trial, and for coordinating each visit, which involves extensive preparatory work/pre-visit planning described in the “Responsibilities” section. At the time of the visit, the CRC2 is responsible for conducting the entire study visit for each patient, ensuring that the protocol is followed, which requires an in-depth understanding of the intricacies of each individual protocol and patient needs. The CRC2 must maintain a comprehensive functional knowledge of the ancillary departments to be involved in trial visits (e.g., Radiology, CRU, Cardiology) and must be able to communicate and coordinate with such departments effectively. The CRC2 must be capable of performing his/her job maintaining patient confidentiality at all times, and must adhere to the university requirements for the conduct of clinical research. Additional job requirements include, but are not limited to: Regulatory maintenance Adherence with ongoing training requirements Accurate reporting of clinical trial visits via the OnCore/CTMS system Accurate and timely data entry, accurate and timely reporting of adverse events Timely communication with team members and clinical trial sponsors.

Requirements

Bachelor’s degree, at minimum or Associate’s Degree and 5 years’ minimum work experience as a Clinical Trial Coordinator or Clinical Research Assistant.
+ 5 year CTC experience
3 years of experience working in a clinical setting that involves direct patient interaction, in a full time, part time, or extensive volunteer experience.
2 year min. experience will be as a ClinicalTrial Coordinator, Clinical Research Assistant, or equivalent position.

Nice To Haves

At least 3 years’ work experience in human subjects research (e.g., working in a lab or on studies for PhD candidates at an academic institution)
At least 3 years’ work experience in social work
At least 3 years’ work experience in nursing
At least 3 years’ work experience in occupational health
At least 3 years’ work experience as an Emergency Medical Technician

Responsibilities

Manage and coordinate 7 out of approximately 55 ongoing clinical trials, Phases I-IV, in the Dept. of Neurology, primarily in the disease states of Movement Disorders, Stroke, and neuromuscular disease.
Learn the schedule of assessments for each trial, and coordinate each visit, which involves extensive preparatory work/pre-visit planning.
Conduct the entire study visit for each patient, ensuring that the protocol is followed, which requires an in-depth understanding of the intricacies of each individual protocol and patient needs.
Maintain a comprehensive functional knowledge of ancillary departments involved in trial visits (e.g., Radiology, CRU, Cardiology) and communicate and coordinate with such departments effectively.
Maintain patient confidentiality at all times and adhere to university requirements for the conduct of clinical research.
Perform regulatory maintenance.
Adhere to ongoing training requirements.
Accurately report clinical trial visits via the OnCore/CTMS system.
Perform accurate and timely data entry.
Perform accurate and timely reporting of adverse events.
Communicate in a timely manner with team members and clinical trial sponsors.
Respond to patient inquiries within 24 hours.
Maintain regular contact with each patient in their respective trials.
Triage issues as they arise.
Facilitate communication between the PI/Sub-Is and patients for adverse events and clinical concerns.
Schedule future visits.
Send reminders for upcoming visits.
Ensure that the timing of the visit will work for any PIs/Sub-Is involved.
Reschedule when necessary.