Clinical Trials Coordinator

**$2,500 Sign-On Bonus**

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.

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.

Benefits:

• Medical, Dental, & Vision
• 401k
• PTO & Paid Holidays
• Company Paid Life Insurance
• Employee Perks Program