Clinical Trials Coordinator
3 weeks ago
Job Location
Silver Spring-Georgia - Silver Spring, MD
Description
SECTION 1: Job Summary (Summary of the basic functions of the position)
Under general supervision of a physician in an outpatient clinical setting, provides assistance to principal
investigator to complete clinical trial visits. Ensures that trial subjects are scheduled appropriately and all
protocol-specified tasks are performed in a timely manner.
SECTION 2: Duties and Responsibilities (Responsibilities necessary to accomplish job functions)
- Maintain all aspects of study protocol during recruitment, screening, enrollment, and follow-up visits
- Conduct and coordinate patient visits including patient demography, vitals, EKG, phlebotomy, photography, administering investigational drug, assisting PI and sub-investigators with physical exam, and scheduling appropriate follow-up visits
- Educate patients on study-specific protocol requirements, procedures, side effects and risks of trials and investigative medications
- Communicate frequently with contract research organizations, IRB, Sponsors, Central Lab Facilities, and other outside vendors to manage the day to day needs for current and prospective trials
- Maintain all source documents and investigational drug accountability records
- Enter source data into EDC within one calendar day of subject visit
- Continually review EDC for accuracy and completion, and resolve queries as they arise
- Assists with direct patient care procedures including biopsies, surgeries, cosmetic procedures and related tasks; records patient medical history and exam notes in EMR. Selects appropriate billing and diagnosis codes based on procedures performed
- Process prescriptions and prior authorizations as directed by physician. Address patient and/or pharmacy questions concerning medication. Enroll patients in patient education/assistance programs
- Scans correspondence into EMR
- Stocks and organizes medical supplies in exam rooms as needed. Notify appropriate personnel when supplies are needed
- Practices safety, environmental, and/or infection control methods
- Performs miscellaneous job-related duties as assigned
- Process blood and urine samples in accordance with IATA and OSHA standards
- Working knowledge, at minimum, of all applicable protocols. Some team members may be assigned as the primary coordinator for a specific protocol, and should therefore have in-depth knowledge of that protocol.
SECTION 3: Experience Requirements
- 4 years / Bachelor's Degree, or:
- Medical assistant or equivalent clinical training; at least 1 year of experience that is directly related to the duties and responsibilities specified.
- Meticulously detail oriented, professional attitude, reliable
- Organizational skills to support accurate record-keeping
- Ability to follow verbal & written instructions
- Interpersonal skills to work as a team with patients and outside parties
- Able to communicate effectively in English, both verbally and in writing, with proper grammar and spelling skills to avoid mistakes or misinterpretations
- Mathematical and analytical ability for basic to intermediate problem solving
- Basic to intermediate computer operation
- Proficiency with Microsoft Excel, Word, and Outlook
- Specialty knowledge of systems relating to job function
- Knowledge of state and federal regulations such as ICH GCP, IATA; general understanding of HIPAA guidelines
- This position has no supervisory responsibilities.
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