Clinical Research Coordinator I (103351)

**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