Clinical Trials Coordinator

2 weeks ago

Silver Spring, United States U.S. Dermatology Partners Full time
Job Details

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.

Qualifications

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.

SECTION 4: Knowledge, Skills and Abilities Requirements
  • 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

SECTION 5: Supervisory Responsibilities:
  • This position has no supervisory responsibilities.

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