Overview

Join our expanding Clinical Trials team at SRI’s Clinical Trial Unit (CTU) in Plymouth, Michigan. Advanced Practice Providers (APPs) such as Physician’s Assistants and Nurse Practitioners with a strong clinical background and experience conducting clinical trials are highly encouraged to apply. We are a small but mighty team conducting life-changing clinical trials since 2013. The clinical trial work we do is largely related to the safety of society, such as radiation therapeutics, or vaccine development, and continuing to grow in other therapeutic areas, including neurology and pain management.

The ideal candidate will play a pivotal role in conducting clinical research studies, providing expert care to research participants, and collaborating with investigators and other healthcare professionals to ensure the success of research initiatives. The APP is an integral member of the team conducting clinical trials and provides hands-on care of the study participants in collaboration with other medical and operational personnel. The APP plays a vital role in identifying and enrolling appropriate patients, educating participants, and providing supportive care throughout the process. This is a great opportunity for an APP to grow their knowledge and scope of practice as a Sub-Investigator in various therapeutic areas within clinical research. The APP will report to the Director of the Clinical Trials Unit, and work with the Principal Investigator, Clinical Site Manager, and Research staff. This position requires strong organizational and communication skills, attention to detail, and a passion for clinical research with a commitment to the growth of our site. There are also opportunities to apply for grant funding and write research proposals.

We look for an APP with flexible schedules seeking part-time positions starting at 24-32 hours (set hours depending on your desired level of commitment) including benefits. Future opportunities may allow for a change to a full-time position. This role is mostly during the daytime but may include night and/or weekend shifts depending on the needs of the clinical trial. 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.

SRI is an independent nonprofit research institute headquartered in Menlo Park, California with a rich history of supporting government and industry. We create and deliver world-changing solutions for a safer, healthier, and more sustainable future. For more than 75 years, we have collaborated across technical and scientific disciplines to discover and develop groundbreaking products and technologies and bring innovations and ideas to the marketplace. Learn more at www.sri.com.

SRI Biosciences develops transformative approaches and platforms for challenging therapeutic problems. We conduct basic and translational research, have the breadth — and depth — to deliver the latest in biomedical research through technology development.

Our researchers have a rich legacy of collaboration with government agencies and industry partners that improve health outcomes and well-being around the world. SRI Biosciences projects range from high-impact, early-stage research to drug co-development with pharmaceutical and biotech companies. Biosciences integrates basic biomedical research with drug and diagnostics discovery, and preclinical and clinical development. They have advanced more than 200 drugs to clinical trials, and 25 have reached the market. Learn more at www.sri.com/research/biosciences/

SRI’s Clinical Trials Unit fills needs, particularly for small or virtual biotechnology companies, which are not prioritized by large Contract Research Organizations. The unit, open since 2014, leverages existing core competencies and relationships to provide an agile, top-tier development organization with the capacity to carry programs from concept to clinic. Our 13-bed, 3-infusion recliner, state-of-the-art clinical trial facility is located at the Michigan Life Science and Innovation Center in Plymouth, MI. The backbone of our success at the CTU is our strong-knit team. www.sri.com/research/biosciences/clinical-trials-unit-ctu/

What is it like to work with us? Our team most enjoys the people they work with and the diverse backgrounds of our team. They are excited that we are a “newer” department which encourages staff to give their input and express new ideas of growth. The growth of staff is a priority to us, and we continue to learn new things every day. This is an intimate environment where we depend on each other for the successful outcome of the clinical trials.

Responsibilities

Successful candidates will have the following attributes:

• Excellent clinical and communication skills
• Able to make medical decisions in a fast-paced environment
• Strong understanding of regulatory requirements, principles of Good Clinical Practice (GCP), and biomedical research ethics
• Proficiency in electronic medical record systems and Microsoft Office Suite
• Strong interpersonal and leadership skills, self-motivation, and high personal integrity
• Ability to manage multiple tasks and prioritize responsibilities
• An established reputation for working well in a team environment and are active in team building
• Strong sense of commitment to reach objectives despite challenges
• Perform confidently under pressure
• Work well under pressure and able to adapt to changes
• Willingness to adapt, learn, and to continue gaining knowledge

Duties and Responsibilities

Clinical

• Evaluates and reviews potential study participants’ eligibility under the direction of the Principal Investigator (PI)
• Performs comprehensive assessments of research participants, including medical history review, physical examinations, and laboratory tests
• Reviews lab results imaging reports, and other study-specific reports
• Determines clinical significance of examination and laboratory findings under the supervision of the PI
• Provides participant consultations and education as applicable to study and participant care under the direction of the PI
• Monitors study participants and ensures their safety and well-being
• Administers study interventions and treatments according to protocol requirements and clinical standards
• Monitors participants for adverse reactions and provide appropriate nursing interventions as needed
• Participates in the resolution of study-related issues or adverse events

Regulatory

• Maintains accurate and detailed documentation of study procedures, participant data, and adverse events
• Reviews and adheres to assigned research study protocol
• Recording accurate and complete study data and maintaining study documentation
• Ensures that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements
• Stays current with industry developments and regulatory requirements
• Reviews and maintains study-related records, such as case report forms (CRFs)

Leadership and Growth Opportunities

• Works with site team to coordinate all aspects of clinical research studies, including participant recruitment, screening, enrollment, and follow-up
• Serves as a liaison between research participants, healthcare providers, and study sponsors to facilitate communication and optimize participant care
• Provides support to the PI, Director of Clinical Trials Unit, and Clinical Site Manager with study-related activities
• Contributes to the development and implementation of research protocols, standard operating procedures, and quality improvement initiatives
• Attends study-related meetings, training, and workshops
• Participates in ongoing training and professional development activities to enhance knowledge and skills in clinical research and evidence-based practice

Qualifications

Required:

• Unencumbered and current license to practice as an NP/PA in the state of MI
• At least 3 years of experience as a provider within the healthcare industry in the US, such as a clinic, hospital, ER or other medical office setting
• Expertise in primary care, acute care, and chronic care practices
• Knowledge of health and patient care regulations
• 2-3 years of experience conducting clinical trials (federal or commercial, experience in both is a bonus)
• No prior sanctions by a state licensing agency; not disqualified from or restricted in the participation of clinical research by FDA
• Compliant with Good Clinical Practices (GCPs)

Preferred:

• Past or current experience as a Sub-Investigator in clinical trials
• Proficiency in procedures like EKG, phlebotomy, and injections/IVs
• Experience with ordering labs and lab processing

The salary range is: $77,500 -$102,808 annually, based on full-time hours. Pay will be pro-rated based on candidate hours. Salary ranges will vary and are based on several factors, market competitiveness and equity amongst internal employees in similar roles. Positions may also qualify for SRI's Pay for Outstanding Performance program or the annual Performance Based Compensation program.

SRI also has a competitive benefits package, to view details please go to https://www.sri.com/resources/benefits/. SRI is an independent nonprofit research institute headquartered in Menlo Park, Calif., with a rich history of supporting government and industry. We create and deliver world-changing solutions for a safer, healthier, and more sustainable future. For more than 75 years, we have collaborated across technical and scientific disciplines to discover and develop groundbreaking products and technologies and bring innovations and ideas to the marketplace.