Clinical Research Associate

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 ofapproximately 55 ongoing clinical trials, Phases I-IV, in the Dept. of Neurology, primarily in the in the diseasestates of neuroimmunology and neuromuscular conditions. Coordination and management of such studies isboth a dynamic and demanding responsibility that requires refined technical, organization, interpersonal, andcoordination skills. The CRCI is responsible for learning the schedule of assessments for each trial, and forcoordinating 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 visitfor each patient, ensuring that the protocol is followed, which requires an in-depth understanding of theintricacies of each individual protocol and patient needs.

The CRC I must maintain a comprehensive functional knowledge of the ancillary departments to be involvedin trial visits (e.g., Radiology, CRU, Cardiology) and must be able to communicate and coordinate with suchdepartments effectively. The CRC I must be capable of performing his/her job maintaining patientconfidentiality at all times, and must adhere to the university requirements for the conduct of clinicalresearch.

Additional job requirements include, but are not limited to:

• Regulatory maintenance,

• Adherence withongoing 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 studies which will be conducted at theGeorgetown University Hospital Dept. of Neurology main site. The CRC I will spend 5 days per week on sitefor these trials. The incumbent will spend 5 days per week on site for these trials. The CTM will meet projectdeadline 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 curapersonalis. Clinical Trials offer a unique opportunity for a patient to receive personalized and comprehensivecare in a manner that they may not experience otherwise as a patient. Per the requirements of each clinicaltrial protocol, the CRC I is required to be the main point of contact for a patient in a clinical trial and mustrespond to inquiries from any patient within 24 hours. The CRC I is instructed and required to maintainregular contact with each patient in their respective trials, because it is an FDA requirement to reportadverse events in a timely manner, no matter the severity. As such, clinical trial patients develop closerelationships 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 directlysupports multiple departments. From a fiscal perspective, the indirect/overhead costs generated by clinicaltrials support the GUMC operating costs. Without an experienced CRC I in this position, we cannotparticipate in the trials specified in this application, and/or future clinical trials, which would significantly hurtthe revenue that these trials generate. This would be detrimental to the ongoing clinical trial operations at oursite. Operationally, the CRC I coordinates with other departments such as the Clinical Research OperationsOffice (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 departmentsancillary to Neurology.

On a daily basis, the CRC I will report to the Associate Director of Clinical Trials. The CRC I is part of arobust team comprised of 6+ CRCs (including the CRC I), the Directors of Clinical Trials, and up to student hires. The CRC I is responsible for managing at least 6 trials out of the overall portfolio of approximately 55ongoing trials within our specific department. While the CRC I’s primary direct report is to the AssociateDirector of Clinical Trials, the CRC I will also provide project-specific deliverables to others such as, theDirector of Clinical Trials, the PI for each trial, and to the sponsor contact (e.g., the study monitor appointedby the sponsor for each trial). The Associate Director and the Director of Clinical Trials rely on timelyresponses from the CTM/CRC I s and Director of Clinical Trials in order to effectively execute theirresponsibilities.

On a regular basis (daily, weekly, or monthly, depending on the trial), management of the trials within theCRC I’s portfolio requires ongoing communication with patients currently enrolled in each trial. The CRC Imust 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 anyPIs/Sub-Is involved, reschedule when necessary, etc.

Requirements and Qualifications

• Bachelor’s degree

• 5 years’ minimum work experience as a Clinical Trial Coordinator or ClinicalResearch Assistant

• Must have 5 years CTC experience

• 3 years of experience working in a clinical setting that involves direct patient interaction, in a full time, part

• time, or extensive volunteer experience.

• Must have experience working with Neurology patients,specifically in the neurology clinics.

• Must be able to demonstrate knowledge of theirexperience working with such patients and possess an understanding of the unique characteristics of thesedisease states.

• 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 be able todemonstrate moral and ethical responsibility and maintain professionalism 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:

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

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 accommodations for any part of the application and hiring process, please visit the Office for Equal Opportunity Compliance website forgeneral information about requesting accommodations, as well asinformation about requesting accommodations specifically for applicants. You also can also contact the Office for Equal Opportunity Compliance at (202) 687-4798 oroeoc@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 Workswebsite.

EEO Statement:

GU is anEqual 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 characteristicprotected 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 theDepartment of Human Resources website.