Reviews the study design and inclusion/exclusion criteria with physician and patient Ensures the protection of study patients by verifying informed consent procedures and adhering to protocol requirements/compliance Ensures 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 Ensures that adequate and accurate records are maintained for inspecting Creates study specific tools for source documentation when not provided by sponsor Collects, completes, and enters data into study specific case report forms or electronic data capture systems Generates and tracks drug shipments, device shipments, and supplies as needed Reports and follows up on serious adverse events as necessary Implements study-specific communications Ensures timely adherence to protocol requirements Responsible for completion of all required documentation according to site works guidelines Ensures timely and accurate data completion Maintains 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 Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations Communicates all protocol-related issues to appropriate study colleagues or manager Attends study specific on site meetings, investigator meetings, conference calls and monthly CRC meetings as required or asked to do so Apprises principal investigator, Research Operations Director and Regional Site Manager of all study specific medical issues for guidance Assists sponsor and US FDA audit teams Reviews and responds to any monitoring and auditing findings and escalates issues defined by Regional Site Manager Maintains patient confidentiality according to ethical and legal requirements Assists in providing coverage for satellite clinic sites as necessary Responsible for coverage after hours and on weekends as necessary What qualifications you will need: Associate's Degree required, Bachelor's Degree preferred. Active RN License required 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 Benefits Mission Health, offers a total rewards package that supports the health, life, career and retirement of our colleagues.