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Clinical Research Coordinator 2, Department of Neurology - Georgetown University Medical Center

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Requirements

Clinical Research Coordinator 2, Department of Neurology - Georgetown University Medical Center

Job Overview

The Clinical Research Coordinator 2 (CRC2) manages and coordinates 7 out of approximately 55 ongoing clinical trials, Phases I-IV, in the Department of Neurology, primarily in the neuromuscular disease. Coordination and management of such studies is both a dynamic and demanding responsibility that requires refined technical, organization, interpersonal, and coordination skills.

They are 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 CRC2 conducts the entire study visit for each patient, ensuring that the protocol is followed - both of which require an in-depth understanding of the intricacies of each individual protocol and patient needs.

The CRC2 maintains a comprehensive functional knowledge of the ancillary departments to be involved in trial visits (e.g., Radiology, CRU, and Cardiology), and effectively communicates and coordinates with such departments. They maintain patient confidentiality at all times, and adhere to the university's requirements for the conduct of clinical research. Additional job requirements include but are not limited to regulatory maintenance, adherence to 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 CRC2 coordinates 7 MS, ALS, gMG, & SMA trials within the Department of Neurology main site and Chevy Chase, spending 5 days per week on site for these trials. As the only Center Coordinator for ALS, gMG, CIDP & SMA trials who works exclusively in these disease states, they have a unique knowledge of the coordination for these trials.

Work Interactions

As an employee of Georgetown University, the CRC2 directly supports the University's mission of cura personalis - care for the whole person. 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 serves the main point of contact for a patient in a clinical trial and responds to inquiries from any patient within 24 hours.

Because it is an FDA requirement to report adverse events in a timely manner, no matter the severity, the CRC2 is instructed and required to maintain regular contact with each patient in their respective trials. As a result, clinical trial patients develop close relationships with the CTM/CRC for a trial, which provides unprecedented access to care when necessary. With an experienced CRC2 in this position, we can participate in the trials specified, and positively impact future clinical trials and enhance the revenue that these trials generate.

In the overall scheme of the Georgetown University Medical Center, the CRC2 indirectly and directly supports multiple departments. From a fiscal perspective, the indirect/overhead costs generated by clinical trials support the GUMC operating costs. Operationally, the CRC2 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 CRC2 indirectly supports research-related operations in departments that are ancillary to Neurology.

Qualifications

• Bachelor's degree (rare exception may be made for a candidate with an Associate's Degree and at least 5 years of work experience as a Clinical Trial Coordinator or Clinical Research Assistant)
• At least 2 years of experience working in a clinical setting that involves direct patient interaction, in a full time, part time, or extensive volunteer experience - preference for experience 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 years of 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). Ideal work experience is with Neurology patients - specifically in the MS and neuromuscular clinics - which provides an understanding of the unique characteristics of these disease states and experience with regulatory maintenance, preparation, and IRB submission activities
• Current CITI Group 1 Biomedical, HIPAA, and IATA Training
• Exposure to/experience handling human biological specimens, ability to independently operate a centrifuge and to process and ship laboratory samples
• Experience with phlebotomy experience and in 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 (e.g., know how to read a medical record and able to determine which information in the medical record needs to be capture in the patient's research record; and knowing how to ask both doctors and patients to clarify ambiguous information in a medical record
• High detail orientation and organization
• Ability to follow directions and to work respectfully within a team
• High motivation and commitment to providing exceptional service
• Ability to demonstrate moral and ethical responsibility and maintain professionalism at all times
• Excellent communication skills with respect to both external communication (patients, sponsors, sponsor affiliates) and internal communication (supervisors, team members, PI, Sub-Is, ancillary department). Specifically, ability to provide written communication that is clear, detailed, and free of errors - and verbal communication that is clear, relevant, and respectful at all times

Work Mode: On Campus. 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 and AAP positions can be found on the Department of Human Resources Mode of Work Designation.

Current Georgetown Employees:

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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 cover letter and resume for each position of interest for which you believe you are qualified. These 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 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.

EEO Statement:

Georgetown University is an Equal Opportunity/Affirmative Action Employer 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.

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.

COVID-19 Vaccination Requirements:

The Georgetown University community is committed to our public health approach and the important role that vaccines play in contributing to the safety of our University and our broader communities. Georgetown University requires students, faculty, staff and visitors to be fully vaccinated against COVID-19 and to have received a COVID-19 vaccine booster shot when eligible, or to have an approved medical or religious exemption. This requirement applies to all faculty and staff, including teleworking employees. Complete details and updates can be found in the Coronavirus (COVID-19) Resource Center.


To apply, visit https://georgetown.wd1.myworkdayjobs.com/en-US/Georgetown_Admin_Careers/job/Pasquerilla-Healthcare-Center-1st-Floor/Clinical-Research-Coordinator-2--Department-of-Neurology---Georgetown-University-Medical-Center_JR15200







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