Director of Clinical Research bei Planned Parenthood of Greater Texas

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.

• 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, 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.
• 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.

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.

Must be able to bend, stoop, kneel, crouch, reach, and grasp. Must be able to stand, particularly for sustained periods of time. Must be able to move about on foot to accomplish tasks, such as moving from one work site to another. Must be able to push/pull. Must be able to work primarily with fingers such as picking, pinching, or typing. Must be able to communicate effectively. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly. Will have substantial movements of the wrists, hands, and/or fingers. Subject to hazards including a variety of physical conditions such as exposure to infectious diseases. Must be able to lift and/or exert up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently. Must be able to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects. Health Center environment.

• Must be able to work all health center hours of operation including evenings and weekends.
• Must be able to travel as required including overnight travel.
• Understanding of and compliance with established risk management and safety procedures.
• Understanding of how accreditation standards, regulatory agencies, funding, the external marketplace and a competitive environment drive change within a non-profit healthcare center.
• Ability to appropriately use medical terminology.
• Strong organizational skills and ability to multi-task.
• Ability to manage details and complexity, to handle a variety of tasks simultaneously and to work under pressure.
• Ability to exercise initiative, sound judgment, and problem-solving techniques in the decision-making process.
• Ability to effectively use organization’s computer systems.
• Be discreet and safeguard confidential information.
• Possess integrity and compliance – can be relied upon to act ethically.
• Ability to provide effective, equitable, understandable, and respectful quality care and services that are responsive to the diverse cultural health beliefs and practices, preferred language, health literacy and other communication needs.
• Ability to work effectively as a team member.
• Ability to lead, manage, direct, and motivate diverse groups of people and possess the skills to delegate, develop and supervise subordinates.
• Industry Awareness: Remains aware of Planned Parenthood Federation of America (PPFA) accreditation standards and of the reproductive health environment’s regulatory compliance requirements. Understands how accreditation standards, regulatory agencies, funding, the external marketplace and competitive environment drives change within the organization.
• Organizational Awareness: Demonstrates a comprehensive awareness of the impact and implications of decisions and actions on other areas (departments or clinics) within the organization.
• Work Management: Effectively manages time as a resource; establishes realistic priorities; schedules own time and activities effectively; gives balanced focus and attention to appropriate long- and short-term priorities. Develops action plans and budgets; leverages technology; anticipates obstacles; establishes check points and monitors progress.
• Recovery Skills: Responds effectively and acknowledges responsibilities when patients (internal or external) experience problems or mistakes; rectifies the situation to restore patient satisfaction; seeks information and collaborates with others to take action to implement permanent fixes. Maintains stable performance and emotions when faced with opposition, pressure, and or stressful conditions.
• Interpersonal Sensitivity: Acts in a way that indicates understanding and accurate interpretation of others’ concerns, feelings, strengths and limitations. Uses interpersonal understanding to shape one’s own response.
• Building Relationships: Shows genuine interest in others’ needs and opinions; establishes rapport; earns the confidence and trust of others; demonstrates consistency between words and actions; delivers on commitments.
• Adaptability or Flexibility: Responds with flexibility to shifting priorities and changing work situations; recovers quickly from problems and setbacks; develops new skills to remain competitive. Adapts easily to change, sees the merits of differing positions, and adapts own positions and strategies in response to new information or changes to a situation.
• Coping with Demands of the Position: Uses effective problem solving while working under stress, high volume of work demands and/or time demands; regularly meets deadlines.
• Exemplify the organization’s In This Together values: We Tend to the Team; We Respect and Honor All People; We Jump In; We Try and We Learn; We Care for our Business; and We Return to our Mission.

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. 

Other

PPGT is an equal opportunity employer.  We strictly prohibit unlawful discrimination of any kind, including discrimination on the basis of age; race, color, ancestry, national origin, or ethnicity; citizenship status; sex or gender; gender identity or gender expression or transgender status (including the individual's actual or perceived sex and the individual's gender identity, self-image, appearance, behavior, or expression); sexual orientation (including actual or perceived heterosexuality, homosexuality, bisexuality and asexuality); mental or physical disability; AIDS, AIDS Related Complex, or HIV status; perception of risk of HIV infection; or association with individuals who are believed to be at risk; religion or creed; genetic information; pregnancy status, including related medical conditions; marital status; past, current, or prospective service in the uniformed services; or any other basis protected by law.  We are a drug-free and tobacco-free workplace.

Applicants have rights under the Federal Employment Laws. To view these notices, please click on the following links: Family and Medical Leave Act (FMLA) poster: Equal Employment Opportunity (EEO) poster; and Employee Polygraph Protection Act (EPPA) poster.