The Community Based Program Manager will lead community based research with partners across the state and will foster relationships with community groups and organizations in order to aid enrollment in on-campus clinical trials. The CBPM is responsible for assuming a leadership role and overseeing clinical trial research in multiple labs across Pennington Biomedical Research Center. The program manager will organize and monitor the provisions of research procedures to ensure accurate, timely collection of research data as well as ensure participant safety. Additionally, the program manager will ensure adherence to regulatory guidelines and study protocols, facilitate collaborations of internal and external departments and partners, and carry out administrative tasks to facilitate overall management of clinical studies and projects. Manage multiple clinical trials, including but not limited to paperwork processing, meeting coordination, design and implementation of project operations, utilization of data entry systems, and grant financial tracking. Supervise a project team to ensure participant safety and compliance with GCP guidelines and research study protocol. Foster cooperation and collaboration in a team environment including establishment of priorities, timelines and processes, conducting staff training, performing data review and process improvement. Perform research activities such as assisting with screening and follow up visits, overseeing intervention sessions, appointment scheduling and general interaction with study research participants. Act as central hub for trial communications within the team and study sponsor, investigators, and collaborators. Facilitate study budget and contract approvals, budget monitoring and project spending. Other duties as requested to support on-going clinical trials or longitudinal studies within the research group.

Responsible for the coordination, planning, and implementation of administrative, clinical, & intervention activities associated with Interventional Resources. Responsibilities including but not limited to the assignment of staff, establishing and maintaining community relations for partnerships, developing interventions and community programs, implementing and managing specific studies, executing lifestyle and/or behavioral change interventions and community programs (as identified by specific study protocols), and coordinating activities with department Director and Program Managers. The Research Specialist II also assists with onboarding, training, overseeing and managing activities associated with departmental students and interns.

Establishes and implements procedures to implement operational and personnel policies. Improves the operational systems, processes and policies in support of organizational missions. Supports effective management reporting, information flow and management, business process and organizational planning. manages and increases the effectiveness and efficiency of support services (such as but not limited to: HR, IT, Finance) through improvements to each function as well as coordination and communication between support and business functions. Plays a significant role in long-term strategic planning for the center. Serves as liaison with the contracted CPA, Insurance/Benefits and IT Firms. Coordinates services of vendors and utilities for both the main agency location and outreach. Receives and coordinates all mail delivery and shipping, ensures delivery of mail to residents. Serves as point-of-contact for the public for all inquiries regarding services, donations and volunteer opportunities. Coordinates the screening, training, supervision and management of volunteers. Provides oversight and support for project management. Oversees statistical and grant reporting.

Responsible for developing and negotiating clinical trial budgets and contracts as well as regulatory processing associated with activating clinical trials at GuideStar sites. Serves as the principal for Research Information Systems including the clinical trials management system (CTMS) and Document Management Center (DMC) by remaining fluent in these technologies and through conducting audits for regulatory and financial integrity. Responsible for development of efficient workflows and tools to document all processes associated with clinical research regulatory and finance dealings. Generate reports for monthly and quarterly reporting of protocols, enrollment and research finances. Facilitates the budget process and revises all clinical trial budgets and contracts for appropriate language, compliance and ensures all costs associated with trials are negotiated into the study budget for cost recovery. Responsible for developing and maintaining systems to track all IRB processes and incorporates new Federal regulations governing billing compliance and human subject research into regulatory and finance processes. Assures integrity of data entered into CTMS and DMC and provides training on these information systems to site investigators as well as research and hospital staff.GuideStar Clinical Trials Management works with hospitals, health systems and physician practices around the country to build, manage and support clinical research programs. Our expert team provides on-site program management, regulatory processing, strategic marketing consultation, a pipeline of clinical trials, budget development and negotiation, contract negotiation and technology tools to track clinical trial protocols and finances. From behind the scenes, GuideStar helps our partner facilities provide their community with the latest therapies, drugs and devices and be on the forefront of medical breakthroughs.

Scope of responsibility consists of coordinating, strategizing and prioritizing both daily and long-term operations for the Recruitment Core.Directly supervises the Recruitment Core support staff team consisting of part-time employees, student workers and interns. Designed and implemented new customer service and process training materials.Developed, implemented and currently manages an internship opportunity to meet Recruitment Core needs and introduce students to the community outreach, marketing and other non-medical aspects of clinical research. Assisted the Recruitment Core Director in restructuring the department in order to maximize efficiency. Continues to serve as the Community Outreach coordinator and SharePoint site managerReports to the Recruitment Core Director as Quality Improvement Coordinator which includes documenting and tracking all QI items, conducting evaluations on the QI plan and presenting the QI plan to the QI Committee annually.Continues to maintain a high level of efficiency in all Recruiter job duties as assigned.

Responsible for interview prospective participants for clinical trial eligibility while maintaining a high level of data accuracy, efficiency and service satisfaction.Attended community and on-campus events as a representative of Pennington Biomedical, educating the public and other community organizations on Pennington Biomedical, study specific topics and clinical trials in general. Designed, developed, implemented and managed a SharePoint site to improve departmental communication and efficiency.Served as Community Outreach Coordinator which included: assisting in literature development and community outreach display design, scheduled Recruiters and expert speakers for on-campus and community events, organized and conducted recruitment events, guided community tours of Pennington Biomedical.

Coordinated basic daily office operations including fax, voicemail and email communications and processing applications and payments for continuing education and licensing courses.Scheduled state-wide licensing courses conducted by video-conferencing.Assisted in event planning for financial literacy continuing education and summer camp programs.Developed Access database for tracking state-wide agency fax and email communications to ensure all video-conference sites had the appropriate schedule for class offerings.