Clinical Research Coordinator I (103304)

Job Summary:

Under the general supervision of a physician and the clinical and clinical research team in an outpatient setting, the Clinical Research Coordinator I (CRC I) is responsible for executing study-related activities from study startup through closeout. All tasks are conducted in compliance with Good Clinical Practice (GCP), ALCOA-C principles, sponsor requirements, and USDP standards. The CRC I supports the Principal Investigator in the conduct of clinical trial visits, ensuring that participants are appropriately scheduled and that all protocol-specified procedures are completed accurately and in a timely manner.

Duties and Responsibilities:

• Maintain all aspects of study protocol during recruitment, screening, enrollment, and follow-up visits
• Assist the PI, and team when applicable, the informed consent process with patients and their families
• 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
• 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 efficient and accurately
• Maintain regulatory documents related to ISF
• Follow SOPs, policies, and procedures as set forth by the company
• Review EDC for accuracy and completion, and resolve queries as they arise
• Assists with direct patient care procedures, as required by the study, including biopsies, surgeries, cosmetic procedures and related tasks
• Process prescriptions and prior authorizations as directed by physician. Address patient and/or pharmacy questions concerning medication. Enroll patients in patient education/assistance programs
• Ensure necessary study related documentation and correspondence study subjects, study teams, vendors, and sponsors
• Scans correspondence into EMR
• Practices safety, environmental, and/or infection control methods
• Assist clinical research manager in delegated tasks
• Performs miscellaneous job-related duties as assigned
• Process blood and urine samples in accordance with IATA and OSHA standards
• Prepare necessary documentation for SIV, IMV, COVs and other sponsor related meetings
• 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

Experience Requirements:

• At least 1 year of research experience, preferred
• At least 1 year of direct patient experience, preferred

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

Supervisory Responsibilities:

• This position has no supervisory responsibilities.

Benefits:

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