Director of Clinical Research

Planned Parenthood of Greater Texas • Austin, TX

97d

About The Position

The Clinical Research Director oversees Planned Parenthood of Greater Texas’ (PPGT) clinical research program. This includes supervising the Clinical Research Coordinator, managing activities, agreements, and compliance with relevant regulations and policies. The role involves collaboration with various stakeholders, budget management, and ensuring confidentiality and proper handling of research documents. Supports the organization’s strategic plan and workplace inclusion initiatives. Abides by the organization’s mission in performing job duties. Demonstrates an understanding and commitment to PPGT’s culture of quality, safety and risk awareness.

Requirements

• Bachelor’s degree + 3 years of relevant exempt experience or Associate’s degree + 5 years of relevant exempt experience or High School diploma or equivalent + 7 years of relevant exempt experience.
• Relevant exempt experience: clinic management or in an exempt research leadership position.
• Healthcare or clinical research experience preferred.
• Supervisory or management experience preferred.
• Integrated Approaches to Testing and Assessment (IATA) certification, Collaborative Institutional Training Initiative (CITI) Training, Good Clinical Practice (GCP), Human Subjects Protection (HSP), Responsible Conduct of Research (RCR) modules must be successfully completed.

Responsibilities

• Oversees the clinical research program, coordinating activities and agreements with Institutional Review Boards (IRBs), Planned Parenthood Federation of America (PPFA), educational institutions, pharmaceutical companies, commercial laboratories, and affiliate legal counsel.
• Coordinates and communicates with the Associate Medical Director of Research and the Principal Investigator(s) regarding the feasibility of new studies, the status of existing studies, and requests for audits/monitoring visits.
• Maintains Standard Operating Procedures (SOPs) for the Research program.
• Directly supervises the Clinical Research Coordinator.
• In collaboration with the Associate Medical Director of Research, interprets research protocols, determines subject eligibility, implements study-related procedures, establishes subject visit schedules, determines investigational product dosing schedules, creates and reviews informed consent forms, maintains drug/investigational product accountability, and creates color-code/randomization schedules for In Vitro Diagnostic (IVD) protocols.
• Represents the organization at conferences and promotes the organization as a research site with potential industry partners.
• Develops relationships with new and existing research partners to add new studies as feasible.
• Coordinates advertising and marketing to promote the research department to industry sponsors and affiliated agencies or specific studies to the community in collaboration with the organization’s Communications and Marketing Department.
• Develops a project plan for each research study project that includes budget, data collection, study protocols, staff training, submission of documents, coordination of specimens, and quality assurance that meets the organization’s and sponsor requirements.
• Develops the Research Department's annual budget and revenue goals including health center allocations.
• Creates study-specific budgets ensuring compliance with Fair Market Value stipulations and Internal Revenue Service (IRS) regulations for non-profit entities.
• Reports monthly Health Center revenue by tracking accounts payable and accounts receivable (AR), stipends, and department revenue.
• Manages the research department’s budget to achieve net revenue goals, including monthly revenue reporting, AR account reconciliation, invoicing to sponsors, and check requests.
• Ensures Research staff is adequately trained on regulations/guidelines such as Integrated Approaches to Testing and Assessment (IATA), Human Subjects Protection (HSP), PPFA SOPs, Good Clinical Practices (GCP), and protocol-specific information.
• Maintains documentation centrally and in study-specific files for continuity of communication with regulatory bodies.
• Maintains knowledge of laboratory functions, including collecting, performing investigational tests, processing, and shipping subject samples per study protocol, IATA, and Research SOPs.
• Ensures timely, complete, and accurate submission of regulatory documents and contracts to IRBs, Sponsors, and PPFA Research as required by protocol, regulations, and Research SOPs.
• Collaborates with supervisor to rectify issues related to regulatory submission.
• Ensures compliance with PPFA, Texas Department of State Health Services (TDSHS), the state of Texas, and U.S. policies, procedures, regulations, and laws related to human subjects research.
• Ensures all medical records, source documents, case report forms, and other research and clinical documents are managed and maintained according to applicable policies, procedures, regulations, and laws, focusing on confidentiality, privacy, and HIPAA.
• Creates, organizes, and maintains all source documents, medical records, case report forms, regulatory documents, and other research documents according to the study protocol and applicable guidelines.
• Has unrestricted access to patient protected health information (PHI) on paper and electronic forms health records for purposes of treatment, payment, and/or healthcare operations.
• Embraces the organization’s ‘In This Together customer service standards and uses them with internal and external customers, every person, every time.
• Duties and responsibilities may be added, deleted, or changed at any time at the discretion of management, formally or informally, either verbally or in writing.

What This Job Offers

• Job Type: Full-time
• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees