Program Manager(PM) is responsible for the overall day-to-day administration, management, and implementation oversight of a National Institutes of Health R01 grant. PM will be a study liaison across departments/colleges/centers on campus and the appointed study liaison with of-campus study sites, external agencies, and vendors. The PM will direct and provide management and supervisory oversight to all on- and of-campus study related activities and personnel. PM is responsible for: directing, managing, and supervising study personnel, budget management, developing and maintaining positive UofSC and of-campus site relations; developing study specific policies and operating procedures, recruitment plan, development and validation of REDCap study databases, internal compliance and regulatory monitoring, ensuring adherence to project timelines and milestone, generating IRB, DSMB, and Sponsor communications and reports, and, for making recommendations to the PI and the Executive Committee regarding the need for protocol and programming revisions. Assists the PI in long-range strategic planning for research portfolio growth.

Directs, manages, and provides supervision and training to on-campus (and off campus) study staff in study protocols, policies and procedures, and performs protocol fidelity monitoring. Provides timely and ongoing performance feedback. Oversight for recruitment, measurement, and intervention staff (including full-time and part-time staff, graduate assistants, and student volunteers). Supervise daily operations; prioritizes, develops, implements, and monitors effective processes to ensure efficient workflow. Organizes project meetings, taking and maintaining meeting minutes, and coordinates with Co-Is. Establishes and implements plans to promote the professional development of employees through the conduct of continued education, training and promotes an environment that encourages and motivates employees and teams to higher levels of performance.

Serves as a liaison with all community partners; Identifies, establishes, and nurtures relationships with external key community stakeholders and agencies with access/services to study populations. Assists in the development of and leads the implementation of study recruitment plans. Provides monthly study recruitment metrics and makes recommendations in a timely manner to the PI of needed changes to meet study specific target recruitment goals.

Develops study specific standard operating policy and procedures, study recruitment and advertising materials, Data Safety and Monitoring Reports, IRB Continuing Reviews and protocol amendments, Sponsor progress reports, study dissemination plans, data quality assurance, and other study supply(ies) inventory control. Assists PI with grant submissions, manuscript writing, and publications.

Devises study budgets in concert with PI, assists vendors with set-up (e.g., service agreements, FWAs, and SAMS registration) monitors project expenditures, orders study supplies, verifies compensation payments to participants in accordance with study protocols to include dispensing and reconciling petty cash accounts. Verifies the accuracy and submits study invoices for payment within 30 days. Meets routinely with PI to review status of grants, contracts, and other sponsored agreements.

Assis PI in maintaining the overall scientific integrity of the study. Works closely with PI to ensure that protocols are followed during recruitment and data collection. Supervises data collection, implements an internal compliance and quality assurance monitoring program to ensure all research study activities are conducted in accordance with institutional IRB policy and DHHS regulations for the conduct of Human Subject Research. Develops and implements Corrective Action Plans.

Provides significant contribution and influence upon research work, activities, or productivity of project teams. Maintains a strong relationship with the College of Nursing Business Director, Human Resources, Posi Award Coordinator and university offices/personnel to ensure grant compliance. Organizes project meetings, taking and maintaining meeting minutes, and coordinates with Co-Is. The PM may be appointed to lead committee, task force, ad-hoc groups at the departmental, institutional, or community level. Proactively communicates project specific concerns to the PI and departmental research leadership.

Perform special projects and/or additional assignments, as needed.

Master's degree in related field and 2 years related program experience, or bachelor's degree and 4 years related experience. Experience in leading and managing large multisite clinical trials in academic and/or community-based settings among historically marginalized, under resourced populations/communities. Research experience includes experience with federally funded grants, IRB processes, contracts administration, oversight of clinical and public/population health research studies, working knowledge of formal interviewing techniques and administration of standardized assessments, knowledge of Good Clinical Practice (GCP), eIRB, regulatory compliance, performance of data quality audits, solicitation, grading, reporting and monitoring of Adverse Events; and, study REDCap database development and quality control. This position requires occasional travel to off-site locations for meetings. Flexibility in work schedule to include evening hours.