Clinical Research Associate

Georgetown University

4d•$44,022 - $73,407•Onsite

About The Position

The Clinical Research Coordinator I (CRCI) 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 neuroimmunology and neuromuscular conditions. Coordination and management of such studies is both a dynamic and demanding responsibility that requires refined technical, organization, interpersonal, and coordination skills. The CRCI is responsible for learning the schedule of assessments for each trial, and for coordinating each visit, which involves extensive preparatory work/pre-visit planning. At the time of the visit, the CRCI 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 CRC I 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 CRC I 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 and timely communication with team members and clinical trial sponsors. The CRC I for this position will is responsible for coordinating 7 studies which will be conducted at the Georgetown University Hospital Dept. of Neurology main site. The CRC I will spend 5 days per week on site for these trials. The incumbent will spend 5 days per week on site for these trials. The CTM will meet project deadline expectations, be proficient multitasker, patient-oriented and have the ability to prioritize tasks.

Requirements

Bachelor’s degree
5 years’ minimum work experience as a Clinical Trial Coordinator or Clinical Research Assistant
Must have 5 years 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.
Must have experience working with Neurology patients, specifically in the neurology clinics.
Must be able to demonstrate knowledge of their experience working with such patients and possess an understanding of the unique characteristics of these disease states.
Must have previous experience accessing and reading patient medical records.
Must have a general working knowledge of medical care/medical operations and regulations.
Must be able to demonstrate moral and ethical responsibility and maintain professionalism at all times.

Responsibilities

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 neuroimmunology and neuromuscular conditions.
Learning the schedule of assessments for each trial, and coordinating each visit, which involves extensive preparatory work/pre-visit planning.
Conducting the entire study visit for each patient, ensuring that the protocol is followed.
Maintaining a comprehensive functional knowledge of ancillary departments involved in trial visits (e.g., Radiology, CRU, Cardiology) and communicating and coordinating with such departments effectively.
Maintaining patient confidentiality at all times.
Adhering to university requirements for the conduct of clinical research.
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 and timely communication with team members and clinical trial sponsors.
Responding to inquiries from any patient within 24 hours.
Maintaining 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.