JOB DESCRIPTION

Overview
The Clinical Research Project Manager 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.

Responsibilities

• Manages the 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 Medical Director responsible for 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.
• Develops the Research Department’s annual budget and revenue goals. 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 allocations, Research accounts payable and accounts receivable (AR), Health Center Research, 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, to provide support to research-trained center staff.
• 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.
• In collaboration with the Medical Director of Research interpret research protocols, determine subject eligibility, implement study-related procedures, establish subject visit schedules, determine investigational product dosing schedules, create and review informed consent forms, maintain drug/investigational product accountability, and create color-code/randomization schedules for In Vitro Diagnostic (IVD) protocols.
• Marketing and Promotion: 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.
• 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. The use of a patient’s protected health information should be limited to information needed for the specific task that is being performed or requested by the individual patient. Disclosure of any patient information must be for purposes of treatment, payment or healthcare operation OR must be accompanied by a valid patient authorization. Must adhere to minimum necessary rule.
• 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.

QUALIFICATIONS

• Bachelor’s degree + 1 year of relevant exempt experience or Associate’s degree + 3 years of relevant exempt experience or High School diploma or equivalent + 5 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.
  Agency Standards
  Must have excellent computer skills with knowledge of Microsoft Word, Excel, PowerPoint, Outlook, and Internet. Must have the willingness and ability to adapt to change including advances or new technology. Must have excellent customer service skills and be committed to providing the highest level of customer satisfaction.

• Manages the 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 Medical Director responsible for 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.
• Develops the Research Department’s annual budget and revenue goals. 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 allocations, Research accounts payable and accounts receivable (AR), Health Center Research, 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, to provide support to research-trained center staff.
• 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.
• In collaboration with the Medical Director of Research interpret research protocols, determine subject eligibility, implement study-related procedures, establish subject visit schedules, determine investigational product dosing schedules, create and review informed consent forms, maintain drug/investigational product accountability, and create color-code/randomization schedules for In Vitro Diagnostic (IVD) protocols.
• Marketing and Promotion: 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.
• 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. The use of a patient’s protected health information should be limited to information needed for the specific task that is being performed or requested by the individual patient. Disclosure of any patient information must be for purposes of treatment, payment or healthcare operation OR must be accompanied by a valid patient authorization. Must adhere to minimum necessary rule.
• 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