UNIV - Program Manager I - Department of Medicine: Division of Pulmonary

Medical University of South Carolina•Charleston, SC

17h•$66,400 - $119,500•Hybrid

About The Position

Serve as Program Manager for the Thoracic Oncology Research Group (TORG) within the Division of Pulmonary and Critical Care Medicine. While operating with a substantial amount of autonomy, this position will provide technical and clinical oversite for all research operations for the TORG. This may include studies investigating lung cancer screening, detection, evaluation, and disparities in cancer care. This position will supervise and provide administrative oversite to 10 or more research coordinators and trial operations oversite at 6 MUSC locations across the state of South Carolina. Additionally, the position oversees the expansion of the TORG’s program to MUSC’s Regional Hospital Network (RHN) sites, directly supervises coordinators at each RHN sites, and oversees daily operations at each site. Effective communication, organizational skills, customer service, ability to perform effectively with minimal supervision, and diligence are a vastly important requirement as this position collaborates with a wide range of individuals both internally and externally.

Requirements

A bachelor's degree
Three years relevant program experience.
Proven track record of detail-orientation and high level of accuracy.
Fluent in using computer data management software, such as Microsoft Office.
Ability to exercise judgment and discretion.
Ability to multi-task: conduct study activities for multiple protocols and sites, and set priorities against deadlines.
Ability to effectively communicate, both written and verbally.
Strong computer software knowledge and skills.
Excellent interpersonal skills.
Professional demeanor.

Responsibilities

Act as primary Point of Contact for industry sponsors and federal grant officers regarding budget negotiation, contract negotiation, and project start-up.
Develop and maintain system for tracking proposals, start-up progress, start date projections, and outstanding items to ensure project activation is on track and do not experience significant delays.
Oversee program operations, completion, and review of all subject screening and recruitment, data entry, routine data management tracking, and completion of study level visits.
Make initial and interval submission to regulatory agencies and federal and foundation grant partners including during study start-up, monitoring visits, audits, and event/final grant reporting.
Serve as liaison between MUSC and sponsor during study start-up and perform feasibility assessments on potential upcoming studies.
Act as a liaison for multi-site studies, managing regulatory submissions and reporting across all participating sites and with the IRB of record.
Supervise a group of 10 or more coordinators including direct supervision Program Coordinators stationed at 6 MUSC locations including MUSC Charleston, Florence, Lancaster, Chester, Columbia, and Kershaw.
Travel between sites, oversee daily operations, provide 1:1 training for all new staff, and provide support to the coordinators.
Work with physicians, clinic staff, and the RHN communities to promote research at MUSC’s RHN sites.
Oversee the operations of the MUSC Lung Cancer and Lung Cancer Screening Biorepository and Multi-Cancer Early Detection Biorepository.
Manage supply management, subject identification, barrier identification, recruitment optimization, cohort enrollment goals, and provide administrative oversight of the sample distribution governance process.
Reconcile study spending with budget reports received from the MUSC Office of Grants and Accounting.
Work with the Division of Pulmonary and Critical Care’s finance team to review accounts, evaluate TORG financial status, and problem solve any account issues that arise.
Perform regular internal financial audits of TORG accounts and be responsible for accurate personnel effort allocation for investigators and research staff at all TORG sites.
Regularly review study financial records to ensure accurate billing and resources assigned to each study.
Serve as the primary point of contact for all TORG grant submissions.
Authorship of key grant documents, generation of study budgets, budgeting revisions, and contractual/SOW/protocol revisions in collaboration with corporate sponsors and in compliance with federal grant guidelines.
Lead the grant team in meeting all time-sensitive requirements for an accurate and timely grant submission.
Guide the implementation of contracts with participating institutions and collaboration with interdepartmental research teams.
Authorship and submission of all quarterly and annual reports required by TORG research studies, annual renewal reports for MUSC IRB, monthly accrual reports for the Hollings Cancer Center, and revision and submissions of manuscripts generated by TORG research studies.
Report all applicable active studies to Clinicaltrials.gov and maintaining accurate and up to date metrics for all studies.
Represent the TORG at the Hollings Cancer Center Clinical Research Group (CRG) meetings and Protocol Review Committee (PRC) meetings.
Complete initial submission documents for CRG study prioritization and PRC evaluation and maintain accurate NCI-compliant accrual documentation per reporting requirements of the Hollings Cancer Center.
Oversee the reporting of enrollment metrics through the Clinical Trial Management System CTMS for all TORG studies.