• This position requires an Associate's Degree in Nursing; Bachelor's Degree is preferred
• RN license required
• At least one year of experience in patient care setting required
• Proficient in various electronic applications, Microsoft Office, EDC, CTMS required
• Knowledge of basic medical terminology required

Job Responsibilities:

• Supports 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.
• 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

• 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