Clinical Research Coordinator I

Georgetown University comprises two unique campuses in the nation’s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.

Requirements

Job Overview
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 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 described in the “Responsibilities” section.
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.
Work Interactions
As an employee of Georgetown University, the CRC I directly supports the University’s mission of cura
personalis. Clinical Trials offer a unique opportunity for a patient to receive personalized and comprehensive
care in a manner that they may not experience otherwise as a patient. Per the requirements of each clinical
trial protocol, the CRC I is required to be the main point of contact for a patient in a clinical trial and must
respond to inquiries from any patient within 24 hours. The CRC I is instructed and required to maintain
regular contact with each patient in their respective trials, because it is an FDA requirement to report
adverse events in a timely manner, no matter the severity. As such, clinical trial patients develop close
relationships with the CTM/CRC for a trial, which provides unprecedented access to care when necessary.
In the overall scheme of the Georgetown University Medical Center, this position indirectly and directly
supports multiple departments. From a fiscal perspective, the indirect/overhead costs generated by clinical
trials support the GUMC operating costs. Without an experienced CRC I in this position, we cannot
participate in the trials specified in this application, and/or future clinical trials, which would significantly hurt
the revenue that these trials generate. This would be detrimental to the ongoing clinical trial operations at our
site. Operationally, the CRC I coordinates 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. By interacting with other
departments within the GUMC, the position indirectly supports research-related operations in departments
ancillary to Neurology.
On a daily basis, the CRC I will report to the Associate Director of Clinical Trials. The CRC I is part of a
robust team comprised of 6+ CRCs (including the CRC I), the Directors of Clinical Trials, and up to studenthires. The CRC I is responsible for managing at least 6 trials out of the overall portfolio of approximately 55
ongoing trials within our specific department. While the CRC I’s primary direct report is to the Associate
Director of Clinical Trials, the CRC I will also provide project-specific deliverables to others such as, the
Director of Clinical Trials, the PI for each trial, and to the sponsor contact (e.g., the study monitor appointed
by the sponsor for each trial). The Associate Director and the Director of Clinical Trials rely on timely
responses from the CTM/CRC I s and Director of Clinical Trials in order to effectively execute their
responsibilities.
On a regular basis (daily, weekly, or monthly, depending on the trial), management of the trials within the
CRC I’s portfolio requires ongoing communication with patients currently enrolled in each trial. The CRC I
must respond to questions from patients in their portfolio in a timely manner; 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 visit, ensure that the timing of the visit will work for any
PIs/Sub-Is involved, reschedule when necessary, etc.
Requirements and Qualifications
The candidate should have a 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. In addition to a B.A./B.S. or A.A + 5 year CTC experience, the CRC I must have 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. The ideal candidate’s 2 year min. experience will be as a Clinical
Trial Coordinator, Clinical Research Assistant, or equivalent position. However, as this is a niche area of
expertise, 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).
The ideal candidate for this specific position must have experience working with Neurology patients,
specifically in the MS clinics. The candidate 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. The candidate should also have previous experience with regulatory maintenance, preparation, and
IRB submission activities.
The CRC I must have current CITI Group 1 Biomedical, HIPAA, and IATA Training. He/She must also have
previous exposure to/experience handling human biological specimens; must be able to operate a centrifuge
and be capable of processing and shipping laboratory samples independently. Must have phlebotomy
experience. The candidate must have previous experience accessing and reading patient medical records

and must have a general working knowledge of medical care/medical operations and regulations. Must have
clinical experience measuring vital signs (Blood Pressure, Respiratory Rate, Temperature, Height, Weight),
administering EKGs, performing PFTs and 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).
The CRC I must be highly detail oriented, organized, able to follow directions, able to work respectfully in a
team, highly motivated, and committed to providing exceptional service. The candidate must be able to
demonstrate moral and ethical responsibility and maintain professionalism at all times. He/She must have
excellent communication skills with respect to external communication (patients, sponsors, sponsor affiliates)
and internal communication (supervisors, team members, PI, Sub-Is, ancillary department). Specifically,
written communication must be clear, detailed, and free of errors. Verbal communication must be clear,
relevant, and respectful at all times.
Sponsored Project Management (if applicable)
If this position serves as the Department Financial Manager for a Sponsored Project, please insert the text
found on the HR website:

http://hr.georgetown.edu/employment_services/costcentermanagers.html

Pay Range:

The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:

$47,586.00 - $87,558.13

Compensation is determined by a number of factors including, but not limited to, the candidate’s individual qualifications, experience, education, skills, and certifications, as well as the University’s business needs and external factors.

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EEO Statement:

GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law.

Benefits:

Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.