Review the study design and inclusion/exclusion criteria with physician and patient Ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements/compliance Ensure the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data Create study specific tools for source documentation when not provided by sponsor Collect, complete, and enter data into study specific case report forms or electronic data capture systems Generate and track drug shipments, device shipments, and supplies as needed Report and follow up on serious adverse events as necessary Implement study-specific communications Ensure timely adherence to protocol requirements Responsible for completion of all required documentation according to site works guidelines Ensure timely and accurate data completion Maintain accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, drug dispensing logs, device utilization logs, subject logs and study-related communications Track and report adverse events, serious adverse events, protocol waivers, deviations, and violations Communicate all protocol-related issues to appropriate study colleagues or manager Attend study specific on site meetings, investigator meetings, conference calls and monthly CRC meetings as required or asked to do so Apprise the principal investigator, Research Operations Director and Regional Site Manager of all study specific medical issues for guidance Assist sponsor and US FDA audit teams Review and respond to any monitoring and auditing findings and escalates issues defined by Regional Site Manager What qualifications you will need: Bachelor's Degree preferred; experience in lieu of education is considered Knowledge of federal regulations, good clinical practices (GCP) Knowledge of medical and research terminology Computer skills including use of clinical trial database, electronic data capture, and MS Word or Excel Excellent Verbal and written communication skills Excellent interpersonal skills The ability to communicate and work effectively with a diverse team of professionals Organizational and prioritizing capabilities The ability to work independently in a fast pace environment with minimal supervision at off-site facilities At least one year of experience as a Clinical Research Coordinator Benefits Mission Health, offers a total rewards package that supports the health, life, career and retirement of our colleagues. Duties include but not limited to: Support enrolling patients onto clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements Responsible for working with the principal investigator to meet or exceed study enrollment.