Clinical Trials Manager

Georgetown University • Washington, DC

50d • Onsite

About The Position

The Clinical Trial (CTM) is responsible for managing and coordinating 7 out of approximately 55 ongoing clinical trials... requires refined technical knowledge gained through formal education in a health-related or scientific field, as well as strong organizational, interpersonal, and coordination skills. The CTM 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 CTM 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 CTM 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 CTM 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. Therefore, additional job requirements include, but are not limited to: regulatory maintenance, development and adherence of training requirements/materials, accurate reporting of clinical trial visits in 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 CTM for this position will is responsible for coordinating 7 studies, which will be conducted at the Georgetown University Hospital Dept. of Neurology. 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.

Requirements

• Bachelor's degree in a health-related or scientific field (e.g., Biology, Nursing, Public Health, Clinical Research, or a related discipline)
• 3 years of experience working in a clinical setting that involves direct patient interaction, in a full time, part time, or extensive volunteer experience
• 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 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).
• Must have experience working with Neurology patients
• Must be able to demonstrate knowledge of their experience working with such patients and possess an understanding of the unique characteristics of these disease
• Previous experience with regulatory maintenance, preparation, and IRB submission activities
• 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, 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).
• Highly detail oriented, organized
• Able to follow directions
• Able to work respectfully in a team
• Must be able to 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 (manager, 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

Responsibilities

• managing and coordinating 7 out of approximately 55 ongoing clinical trials
• learning the schedule of assessments for each trial
• coordinating each visit, which involves extensive preparatory work/pre-visit planning
• conducting the entire study visit for each patient
• ensuring that the protocol is followed
• regulatory maintenance
• development and adherence of training requirements/materials
• accurate reporting of clinical trial visits in OnCore/CTMS system
• accurate and timely data entry
• accurate and timely reporting of adverse events
• timely communication with team members and clinical trial sponsors
• coordinating 7 studies, which will be conducted at the Georgetown University Hospital Dept. of Neurology

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Educational Services
• Number of Employees: 1,001-5,000 employees