Clinical Research Coordinator II

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 2 (CRC2) 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), Stroke, and Parkinson's Disease. 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 described in the "Responsibilities" section. At the time of the visit, the CRC2 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 CRC2 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 CRC2 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 II 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 II 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 II 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 II 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 II 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 II 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 II 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 II will report to the Associate Director of Clinical Trials. The CRC II is part of a robust team comprised of 6 CTM/CRC II s (including the CRC II), the Associate Director, the Director of

Clinical Trials, and up to 4 student hires. The CRC II 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 II's primary direct report is to the Associate Director of Clinical Trials, the CRC II 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 II 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 II's portfolio requires ongoing communication with patients currently enrolled in each trial. The CRC II 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

• Bachelor's degree, at minimum
• 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.
• Unit)directly support Clinical Trials (e.g., the GUMC Clinical Research Operations Office or Clinical Research social work, nursing, occupational health, Emergency Medical Technician, or ancillary departments that human subjects research (e.g., working in a lab or on studies for PhD candidates at an academic institution),
• Must have current CITI Group 1 Biomedical, HIPAA, and IATA Training.
• 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
• 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).
• 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 demonstrate moral and ethical responsibility and maintain professionalism at all times
• 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

Work Mode Designation

This position has been designated as 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 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:
$44,022.00 - $73,406.80

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:

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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.

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