This position requires a highly organized, motivated, and flexible individual. The position is responsible for the coordination, implementation and conduct of multiple research projects fully integrated with applicable research management systems and processes, as well as the practice of nursing. Provides nursing care to research subjects enrolled in studies and maintains continual clinical assessment of research subjects. Develops and maintains comprehensive knowledge of assigned research protocol to coordinate the comprehensive and compliant execution of assigned protocols in accordance with research governing entity requirements, including but not limited to Sponsor, FDA and IRB requirements. The employee is required to adhere to all TUC policies and procedures including HIPAA and OSHA regulations and standards.
- Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.
- Coordinates patient care in compliance with protocol requirements and maintains a working knowledge of all assigned study protocols and amendments. May disburse investigational drug and provide patient teaching regarding administration.
- Maintains accurate records of the receipt, inventory, and dispensation of study drug per protocol.
- Provides phlebotomy and lab processing for study patients
- Coordinates patient scheduling for research activities with standard of care appointments using our Electronic Medical Records System
- In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
- Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
- Maintains regulatory documents in accordance with USOR SOP and applicable regulations.
- Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research.
- May collaborate with Research Director in the study selection process.
- Additional responsibilities may include working directly with other research bases and/or sponsors.
- Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
- May be responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians.
- May oversee the preparation of orders by physicians to assure that protocol compliance is maintained.
- Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting.
- Occasional travel to Investigator meetings is required.
- Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- Perform other duties as assigned by the Clinical Operations Manager
- Works efficiently and conscientiously as part of a team in a fast-paced, complex environment.
- May be asked to provide support in Clinic and Procedure Room periodically and will need to follow all nursing policies and protocols.
- Current license as a registered nurse, BSN preferred.
- Minimum three years clinical experience and two years clinical research experience.
- Must be self-directed with demonstrated ability to work independently.
- Must have strong organizational and communication skills.
- Demonstrates basic computer proficiency.
- Meets clinical competency requirements and knowledge of good clinical practice, FDA, OHRP, and HIPAA Policies.
- Maintains current knowledge in specialty area.
- Research certification from a recognized clinical research organization or advanced degree in health services research or allied health profession preferred.
- Requires normal or corrected vision and hearing to normal range.
- Extensive sitting and frequent walking, occasional lifting or carrying of 5 to 15 pounds.
- May have some exposure to communicable disease or body fluids.
- May require working irregular hours.
If interested, please contact Anna McGrain, Clinical Operations Manager, 402-763-4502 or [email protected].