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Clinical Research Coordinator II

Employer
Georgetown University
Location
Washington D.C.

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Administrative Jobs
Academic Affairs, Research Staff & Technicians
Employment Type
Full Time
Institution Type
Four-Year Institution


Clinical Research Coordinator II

Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.

Requirements

Job Overview
The Clinical Research Coordinator II (CRC II) is responsible for managing and coordinating 4-6 out of approximately 30 ongoing clinical trials, Phases I-IV, in the Dept. of Neurology, primarily in the disease states of Multiple Sclerosis, Parkinson Disease, Headache, Stroke, ALS, and Epilepsy. S/he learns the schedule of assessments for each trial, and coordinates each visit, which involves extensive preparatory work/pre-visit planning described in the “Responsibilities” section. Reporting to the Director of Clinical Trials, the CRC II has additional duties that include but are not limited to:
  • Maintains a comprehensive functional knowledge of the ancillary departments to be involved in trial visits (such as Radiology, CRU, and Cardiology), communicating and coordinating with such departments effectively.
  • Maintains patient confidentiality at all times, adhering to the university requirements for the conduct of clinical research.
  • Oversees regulatory maintenance, adherence with ongoing training requirements, and accurate reporting of clinical trial visits via the OnCore/CTMS system.
  • Ensures accurate and timely data entry, accurate and timely reporting of adverse events, and timely communication with team members and clinical trial sponsors.
  • Coordinates 3 Parkinson Disease studies and 1 epilepsy trial, with specific trial assignments changing based on study timelines.
  • Maintains 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.
  • indirectly and directly supports multiple departments, such as the Clinical Research Operations Office (CROO), the Clinical Research Unit (CRU), the Research Pharmacy, the Radiology Department, Ophthalmology, and Gastroenterology.
  • Manages 4-6 trials out of the overall portfolio of approximately 30 ongoing trials within our specific department.
  • Provides project-specific deliverables to others such as the PI for each trial, and to the sponsor contact (the study monitor appointed by the sponsor for each trial), and to the Regulatory Manager.
  • Responds to questions from patients in their portfolio in a timely manner.
  • Triages issues as they arise, facilitating communication between the PI/Sub-Is and patients for adverse events and clinical concerns.
  • Schedules future visits, sends reminders for upcoming visit, and ensures that the timing of the visit will work for any PIs/Sub-Is involved, rescheduling when necessary.

Qualifications
  • Bachelor's Degree, or an Associate's Degree and 5 years' minimum work experience as a Clinical Trial Coordinator
  • 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
  • At least 2 years' work experience in the following areas will be considered: human subjects research, social work, nursing, occupational health, Emergency Medical Technician, or ancillary departments that directly support Clinical Trials
  • Experience working with Neurology patients in some capacity
  • Ability to demonstrate knowledge of their experience working with such patients and possess an understanding of the differences between neurological disorders such as Parkinson Disease, Multiple Sclerosis, and epilepsy
  • Current CITI Group 1 Biomedical, HIPAA, and IATA Training with previous exposure to/experience handling human biological specimens
  • Previous experience accessing and reading patient medical records and must have a general working knowledge of medical care/medical operations and regulations
  • Basic clinical experience measuring vital signs (Blood Pressure, Respiratory Rate, Temperature, Height, Weight), administering EKGs, and obtaining patient medical histories
  • Highly detail oriented, organized, able to follow directions, able to work respectfully in a team, highly motivated, and committed to providing exceptional service
  • Ability to demonstrate moral and ethical responsibility and maintain professionalism at all times
  • Excellent communication skills with respect to external communication and internal communication, with written communication being clear, detailed, and free of errors


Current Georgetown Employees:
If you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.

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 wide variety of comprehensive and competitive benefits. Benefits packages include comprehensive health, dental and vision plans, disability and life insurance coverage, retirement savings programs, tuition assistance, voluntary insurance options (including group legal, accident, and critical illness), and much more. Whatever your need, the Office of Faculty and Staff Benefits will be standing by to support you. You can learn more about the benefits offered to eligible faculty and staff at https://benefits.georgetown.edu or view the online interactive benefits guide for more information.


To apply, visit https://georgetown.wd1.myworkdayjobs.com/en-US/Georgetown_Admin_Careers/job/Medical-Center/Clinical-Research-Coordinator-II_JR07293





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