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Clinical Trials Coordinator - Silver Spring, United States - U.S. Dermatology Partners
Description
Job DetailsJob LocationSilver Spring-Georgia - Silver Spring, MDDescriptionSECTION 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 principalinvestigator to complete clinical trial visits.
SECTION 2:
Duties and Responsibilities (Responsibilities necessary to accomplish job functions)Maintain all aspects of study protocol during recruitment, screening, enrollment, and follow-up visitsConduct 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 visitsEducate patients on study-specific protocol requirements, procedures, side effects and risks of trials and investigative medicationsCommunicate 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 trialsMaintain all source documents and investigational drug accountability recordsEnter source data into EDC within one calendar day of subject visitContinually review EDC for accuracy and completion, and resolve queries as they ariseAssists 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 performedProcess prescriptions and prior authorizations as directed by physician. Address patient and/or pharmacy questions concerning medication. Enroll patients in patient education/assistance programsScans correspondence into EMRStocks and organizes medical supplies in exam rooms as needed.Notify appropriate personnel when supplies are neededPractices safety, environmental, and/or infection control methodsPerforms miscellaneous job-related duties as assignedProcess blood and urine samples in accordance with IATA and OSHA standardsWorking 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.
QualificationsSECTION 3:
Experience Requirements4 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.
SECTION 4:
Knowledge, Skills and Abilities RequirementsMeticulously detail oriented, professional attitude, reliableOrganizational skills to support accurate record-keepingAbility to follow verbal & written instructionsInterpersonal skills to work as a team with patients and outside partiesAble to communicate effectively in English, both verbally and in writing, with proper grammar and spelling skills to avoid mistakes or misinterpretationsMathematical and analytical ability for basic to intermediate problem solvingBasic to intermediate computer operationProficiency with Microsoft Excel, Word, and OutlookSpecialty knowledge of systems relating to job functionKnowledge of state and federal regulations such as ICH GCP, IATA; general understanding of HIPAA guidelinesSECTION 5:
Supervisory Responsibilities:
This position has no supervisory responsibilities.