Nurse II (Clinical Trial Nursing / Research) - OVERNIGHTS (RN)

Join our expanding Clinical Trials team at SRI's Clinical Trial Unit (CTU) in Plymouth, MI. Candidates with a background in clinical research are encouraged to apply. We are a small but mighty team conducting life-changing clinical trials since 2013. The CTU is looking to add to our clinical research nursing staff. The clinical trial work we do is largely related to the safety of society, for example, radiation therapeutics, or vaccine development, and continuing to grow in other therapeutic areas.

Nurses at the CTU are integral members of a team conducting clinical trials and providing hands-on care of the study participants in collaboration with medical and operational personnel. Because clinical trials are dependent on patient availability, we look for clinical research nurses with flexible schedules seeking part-time positions. This role includes night and/or weekend shifts depending on the needs of the clinical trial. We currently anticipate a need for around 10-24 hours per week, which may include 12-hour shifts. Candidates can look forward to flexible scheduling and the full support of an expert team of clinical research and healthcare professionals for mentorship, learning, and development while onboarding into this exciting role. This role will be in our Plymouth, MI facility.

Develops and maintains in-depth understanding of applicable studies by attending trainings as required and communicating with sponsor, PI, Clinical Site Manager, and other staff as needed
• Obtains informed consent and medical history from screened volunteers
• Assists with the monitoring of participant and institutional study compliance and maintaining effective data flow to the study investigators and sponsors
• Maintains basic understanding of current regulatory requirements
• Protects the rights, safety and welfare of study participants
• Ensures clinical trials are being conducted according to the investigational plan, ICH GCP Guidelines, SOPs and all applicable regulations under the supervision of clinic leadership and Physician Investigator (PI)
• Performs and/or assists with study-related physical examinations, procedures, specimen collection, EKG and vital sign collection, etc. in accordance with the protocol and in scope per state regulations for clinical licensure
• Perform timely study-specific data entry into applicable systems in accordance with GCP standards and study requirements, entering source data into study-specific databases and resolving applicable data queries
• Attend trainings and study-specific meetings as needed.
• Assist in providing 24-hour coverage when inpatient studies are being conducted (inclusive of nights/weekends)
• Assist medical staff with treatment for medical emergencies and recording of data for adverse events.
• Administers study medication and observes study participants for adverse events in accordance with the protocol and other applicable regulations
• Identifies study participants' care requirements by establishing personal rapport
• Facilitates a compassionate environment by gauging and meeting support needs of participants (physically, psychologically, and/or emotionally
• Collaborates with multidisciplinary team to avoid and/or resolve potential participant issues
• Maintains safe and clean working environment by complying with procedures, rules, and regulations; protects study participants and employees by adhering to infection-control policies and protocols, medication administration and storage procedures, and controlled substance regulations
• Documents study participant care services by charting in study records and CRFs as required
• Maintains continuity among nursing teams by documenting and communicating actions, irregularities, and continuing needs
• Maintains study participant confidence and protects operations by keeping information confidential
• Help maintain nursing supplies inventory by checking stock to determine inventory level; anticipating needed supplies; and using equipment and supplies as needed to accomplish job results
• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; and participating in professional societies

• Licensed RN in the state of Michigan, BSN or MSN a plus
• At least 3 years of experience as a practicing RN
• At least 1 year of experience with clinical research studies (preferred)
• Certified in BLS
• No prior sanctions by a state licensing agency; not disqualified from or restricted in the participation of clinical research by the FDA
• Strong interpersonal and leadership skill, self-motivation and high personal integrity and ethics
• High level of computer literacy (able to use Microsoft Word, PPT, Excel, Outlook) and demonstrate proficient typing in alignment with industry standards)
• U.S. Citizenship or U.S. Permanent Residency Required

The pay range is: $42.00 - $45.00 per hour. Salary ranges will vary and are based on several factors, including market competitiveness and equity amongst internal employees in similar roles.

SRI International, an over 75-year strong pioneering research institute, has a rich history supporting government and industry. Our innovations have created new industries, billions of dollars in market value and lasting benefits to society. SRI is organized around broad disciplines and capabilities, with research and development divisions and labs to groups who excel at identifying new opportunities, developing products and creating custom solutions. Our organization is driven by impact - delivering unique solutions for the world's important challenges and transforming ideas into reality for clients and partners.