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Requirements

As a top academic health and science center in the United States, Georgetown University Medical Center (https://gumc.georgetown.edu/) seeks to provide, in a synergistic fashion, excellence in education — training physicians, nurses and other health care professionals, as well as biomedical scientists — and cutting-edge interdisciplinary research collaboration, enhancing our basic science and translational biomedical research capacity in order to improve human health. Emphasizing service, we are dedicated to the Catholic, Jesuit principle of cura personalis — “care of the whole person.” Our partnerships with organizations in the region strengthen our work and expand its reach.

The Clinical Research Coordinator 2 (CRC2) is responsible for managing and coordinating the ALL ALS studies, primarily in the disease states of Neuromuscular Disorders (ALS). 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. Additional responsibilities include, but are not limited to:

• 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 the ancillary departments to be involved in trial visits (e.g., Radiology, CRU), communicating and coordinating with such departments effectively.

• Perform his/her job maintaining patient confidentiality at all times, adhering to the university requirements for the conduct of clinical research.

• Oversee 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/ clinical trial sponsors.

• Coordinate the ALL ALS studies, which will be conducted at the Georgetown University Hospital Dept. of Neurology main site and with remote patients.

• Spend 5 days per week on site for these trials, which is a new national natural history/biobanking study with 35 sites around the country.

• Interact with other coordinators around the country on regular meetings and follow a central IRB protocol for all sites.

  Work Interactions As an employee of Georgetown University, the CRC2 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 CRC2 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 CRC2 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 coordinates with multiple divisions/departments such as the Clinical Research Operations Office (CROO), the Clinical Research Unit (CRU), Research Pharmacology, the Radiology Department, Department of Medicine, Dermatology, Ophthalmology, Pathology, and Gastroenterology.

  On a daily basis, the CRC2 will report to one of the following: Study PI, Study NP, and/or Associate Director of Clinical Trials. The CRC2 is part of a robust team comprised of approximately 7 CTM/CRC2s (including the CRC2), the Associate Directors, the Director of Clinical Trials, and up to 4 student hires. The CRC2 is responsible for managing the ALL ALS studies within our specific department. The CRC2 may also be asked to provide project-specific deliverables to other studies in the group, but additional studies will kept to a minimum and not the coordinator’s priority. The Study PIs, Associate Directors and the Director of Clinical Trials rely on timely responses from the CTM/CRC2s and Director of Clinical Trials to effectively execute their responsibilities.

  Requirements and Qualifications

• Bachelor’s degree; 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

• A B.A./B.S. or A.A + 5 year CTC experience, the CRC2 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 2-3 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 MS and neuromuscular clinics. If applicable, 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

• Current CITI Group 1 Biomedical, HIPAA, and IATA Training and 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 with 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.

• Highly detail oriented, organized, able to follow directions, able to work respectfully in a team, highly motivated, and committed to providing exceptional service

• Must be able to demonstrate moral and ethical responsibility and maintain professionalism at all times with excellent communication skills with respect to external communication (patients, sponsors, sponsor affiliates) and internal communication (supervisors, team members, PI, Sub-Is, ancillary department)

  Work Mode Designation

  This position has been designated as Hybrid . Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position’s mode of work designation. Complete details about Georgetown University’s mode of work designations for staff positions can be found on the Department of Human Resources website: https://hr.georgetown.edu/mode-of-work-designation.

  Pay Range:

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

$21.16 - $35.29

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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Submission Guidelines:

Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions.

Need Assistance:

If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here (http://ideaa.georgetown.edu/ada) for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or ideaa@georgetown.edu.

Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website (https://georgetownworks.georgetown.edu/) .

EEO Statement:

Georgetown University is an Equal Opportunity/Affirmative Action Employer (https://policymanual.hr.georgetown.edu/https%3A//policymanual.gudrupal.georgetown.edu/201-Equal-Employment-Opportunity-Affirmative-Action) fully dedicated to achieving a diverse faculty and staff. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation) , disability status, protected veteran status, or any other characteristic protected by law (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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 (https://benefits.georgetown.edu/staff/enrolling/) .