Clinical Research Coordinator I

Georgetown University•Vinalhaven, ME

11d•$47,586 - $87,558•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 Multiple Sclerosis (MS). 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 MS 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, at minimum.
Rare exceptions may be made for a candidate 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 minimum experience as a Clinical Trial Coordinator, Clinical Research Assistant, or equivalent position.
Experience working with Neurology patients, specifically in the MS clinics.
Demonstrated knowledge of experience working with such 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.
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.
Obtaining patient medical histories (e.g., knows how to read a medical record and is able to determine which information in the medical record needs to be capture in the patient’s research record, and knows how to ask both doctors and patients to clarify ambiguous information in a medical record).
Highly detail oriented.
Organized.
Able to follow directions.
Able to work respectfully in a team.
Highly motivated.
Committed to providing exceptional service.
Ability to demonstrate moral and ethical responsibility.
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

Candidates with at least 3 years’ work experience in the following areas will be considered: 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).

Responsibilities

Managing and coordinating clinical trials.
Learning the schedule of assessments for each trial.
Coordinating each patient visit, including extensive preparatory work/pre-visit planning.
Conducting the entire study visit for each patient, ensuring protocol adherence.
Maintaining comprehensive functional knowledge of ancillary departments involved in trial visits (e.g., Radiology, CRU, Cardiology).
Communicating and coordinating effectively with ancillary departments.
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.
Timely communication with team members and clinical trial sponsors.
Responding to patient inquiries within 24 hours.
Maintaining regular contact with each patient in their respective trials.
Triage issues as they arise.
Facilitating communication between the PI/Sub-Is and patients for adverse events and clinical concerns.
Scheduling future visits.
Sending reminders for upcoming visits.
Ensuring the timing of the visit will work for any PIs/Sub-Is involved.
Rescheduling visits when necessary.