Clinical Research Coordinator II

Georgetown University•Vinalhaven, ME

24d•$44,022 - $73,407•Onsite

About The Position

The role of Clinical Research Coordinator II (CRCII) encompasses the management and coordination of a subset of ongoing clinical trials within the Department of Neurology, totaling approximately 7 out of 55 trials spanning Phases I-IV. These trials predominantly focus on neuroimmunology and neuromuscular diseases. The CRCII is entrusted with mastering the schedule of assessments for each trial and meticulously planning and coordinating every visit. This involves extensive preparatory work detailed in the "Responsibilities" section. During patient visits, the CRCII assumes responsibility for conducting the entire study visit, ensuring strict adherence to protocol. This necessitates an intimate understanding of each protocol's nuances and attending to individual patient needs. Furthermore, the CRCII must possess a thorough understanding of ancillary departments involved in trial visits, such as Radiology, CRU, and Cardiology. Effective communication and coordination with these departments are essential. Upholding patient confidentiality and adhering to university standards for clinical research conduct are paramount. Key responsibilities also include: Regulatory maintenance Compliance with ongoing training mandates, Accurate reporting of clinical trial visits via the OnCore/CTMS system, Precise and prompt data entry Reporting of adverse events, and consistent communication with team members and trial sponsors.

Requirements

Bachelor’s degree, at minimum with an Associate’s Degree and 5 years’ minimum work experience as a Clinical Trial Coordinator or Clinical Research Assistant.
At least 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 Clinical Trial Coordinator, Clinical Research Assistant, or equivalent position.
3 years’ work experience in human subjects research (e.g., working in a lab or on studies for PhD candidates at an academic institution), social work, nursing, occupational health, Emergency Medical Technician, or ancillary departments that directly support Clinical Trials (e.g., the GUMC Clinical Research Operations Office or Clinical Research Unit).
Experience working with Neurology patients.
Demonstrated knowledge of experience working with Neurology patients and an understanding of the unique characteristics of these disease states.
Previous experience with regulatory maintenance, preparation, and IRB submission activities.
Current CITI Group 1 Biomedical, HIPAA, and IATA Training.
Previous exposure to/experience handling human biological specimens.
Ability to operate a centrifuge and be capable of processing and shipping laboratory samples independently.
Phlebotomy experience.
Previous experience accessing and reading patient medical records.
General working knowledge of medical care/medical operations and regulations.
Clinical experience measuring vital signs (Blood Pressure, Respiratory Rate, Temperature, Height, Weight), administering EKGs, performing PFTs and obtaining patient medical histories.
Highly detail oriented, organized, able to follow directions, able to work respectfully in a team, highly motivated, and committed to providing exceptional service.
Ability to demonstrate moral and ethical responsibility and maintain professionalism at all times.
Excellent communication skills with respect to external communication (patients, sponsors, sponsor affiliates) and internal communication (supervisors, team members, PI, Sub-Is, ancillary department).
Written communication must be clear, detailed, and free of errors.
Verbal communication must be clear, relevant, and respectful at all times.

Nice To Haves

Experience with neuroimmunology and neuromuscular diseases.

Responsibilities

Mastering the schedule of assessments for each trial and meticulously planning and coordinating every visit.
Conducting the entire study visit, ensuring strict adherence to protocol.
Understanding ancillary departments involved in trial visits, such as Radiology, CRU, and Cardiology.
Upholding patient confidentiality and adhering to university standards for clinical research conduct.
Regulatory maintenance.
Compliance with ongoing training mandates.
Accurate reporting of clinical trial visits via the OnCore/CTMS system.
Precise and prompt data entry.
Reporting of adverse events.
Consistent communication with team members and trial sponsors.
Responding to patient inquiries within 24 hours.
Maintaining regular contact with each patient in their respective trials.
Coordinating with other departments such as the Clinical Research Operations Office (CROO), the Clinical Research Unit (CRU), the Research Pharmacy, the Radiology Department, Department of Medicine, Dermatology, Ophthalmology, and Gastroenterology.