Research Project Manager

Cost Center

643 Research

20

As a Research Project Manager at Pine Rest, you’ll conduct, monitor, and coordinate the day-to-day activities of assigned research projects, while actively contributing to the quality and improvement of the research program. Key responsibilities include, but are not limited to, developing and maintaining research records, generating reports, recruiting participants, tracking research activities, and analyzing program activity. The Research Project Manager carries out clinical research involving human subjects, ensures compliance with study protocols, adheres to all regulatory requirements, and maintains participant safety, while identifying opportunities to enhance the processes and efficiency of clinical human research studies.

This person also engages with industry partners to identify new research opportunities and promote Pine Rest’s clinical research capabilities. The Research Project Manager must demonstrate excellent customer service, strong attention to detail, and enthusiasm for the program and the Pine Rest organization.

• Manages assigned human clinical research studies in psychology and psychiatry conducted at Pine Rest CMHS and Michigan State University College of Human Medicine (MSU-CHM), and in collaboration with academic leaders and industry partners as applicable.
• Identifies and pursues opportunities for the department to participate in industry-sponsored clinical studies, including outreach to potential sponsors and promoting the organization’s research capabilities.
• Supports evaluation and preparation of research studies for implementation including assessment of operational feasibility; of IRB documents; generation of data collection tools, case report forms; and attends study meetings.
• Works closely with the Principal Investigator (PI) of each study to implement the study protocol and confer regularly with PI, study team, and Research Department leadership to ensure high quality implementation.
• Identifies and recruits eligible subjects, screens for eligibility, obtains informed consent, and enrolls participants per protocol.
• Manages and/or performs the daily study operations, including overseeing study visits, identification of adverse events, compiling, filing and reporting data.
• Ensures protocol-required assessments are completed for each study participant at designated research visits, including but not limited to physical exams, laboratory work, psychiatric and psychological assessments; with appropriate training and delegation, perform required research activities and procedures in accordance with the study protocol.
• Assists with the management of investigational product receipt, storage, dispensing, and accountability in accordance with study protocols, sponsor requirements, and regulatory guidelines.
• Facilitates and/or performs biospecimen collection, processing, transport, and shipping in accordance with study protocols and regulatory requirements.
• Maintains and reviews study source documentation and regulatory binders, supporting monitoring visits, audits, and regulatory inspections as needed.
• Maintains research studies in compliance with federal, state, and local law, GCP, contracts, and institutional policies; keeps current with applicable regulations regarding research on human subjects.
• Facilitates processing and tracking of study-related invoices; collaborates with finance to verify appropriate allocation of costs to the correct study and budget.
• Promotes research and the Research Department throughout Pine Rest CMHS, and supports continuous enhancement of study processes and operational efficiency in clinical human research within the organization.
• Supports development and dissemination of research findings, including preparation and submission of manuscripts, abstracts, and related materials.

• Project specific study team personnel and contractors.

• Bachelors required or Master’s degree (preferred) in public health, healthcare administration, project management, or equivalent.
• Minimum of 5 years of experience in…