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Clinical Research Coordinator

Planned Parenthood of Greater Texas, Inc.
Austin, TX
Overview

The Clinical Research Coordinator is responsible for coordinating clinical research studies at Planned Parenthood of Greater Texas (PPGT), ensuring compliance with regulatory requirements, protocols, and internal Standard Operating Procedures (SOPs). Reporting to the Clinical Research Project Manager, this role involves coordinating regulatory submissions, subject recruitment and management, investigational product accountability, data quality assurance, and audit preparation. The position also involves supporting training, communicating with stakeholders, and maintaining research documentation and databases. 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

• Coordinates research activities as appropriate based on training, licensure, and delegation by the Principal Investigator (PI) and as assigned by supervisor.

• Coordinates timely, complete, and accurate submission of regulatory documents and contracts to Institutional Review Boards, Sponsors, and Planned Parenthood Federation of America (PPFA) Research as required by protocol, regulations, and PPGT/PPFA Research SOPs to maintain appropriate regulatory compliance. Report to and collaborate with supervisor as needed or according to standard practices and policies to rectify issues related to regulatory submission.

• Implements a quality assurance process for all PPGT data before submission to the sponsor in either electronic or paper format. Report on significant findings to supervisor.

• Assists in the coordination of bi-monthly auditing/monitoring visits between sponsor/contract research organization (CRO), PI, and staff as requested by sponsors, and according to study-specific protocol requirements, without conflicting with other departmental activities. Maintain regulatory binders and source/case report form (CRF) to ensure compliance with audit activities and minimize deviations. Report findings to the PI and supervisor promptly.

• Performs all laboratory functions, including collecting specimens (if clinically applicable), performing investigational tests and controls on instruments, processing, and shipping subject samples per study protocol, accepted research guidelines, and PPGT Research SOPs. Assists in training relevant health center staff on study protocols in collaboration with supervisor.

• Assists in communication and presentation of training materials to health center staff to provide requisite, and documented evidence of protocol/procedure training.

• Maintains current knowledge of research guidelines.

• Creates, organizes, and maintains all source documents, medical records, CRFs, regulatory and other research documents according to study protocol, applicable policies, procedures, regulations, and guidelines. Record, transcribe and maintain accurate sources and CRF data for multiple studies within deadlines. Maintain a record of training for all eCRF platforms.

• Assists in the maintenance of Research and Health Center staff in Curriculum Vitae (CVs), licenses and training records as required by PPGT/PPFA Research SOPs. Updates forms and communicate with staff, supervisors, and other departments as needed to facilitate the implementation of these documents.

• Trains and supports health center staff on study participation according to PPGT Research SOPs and protocol including ensuring complete confidentiality of subjects and patients services, including proper and prompt transfers, purging and storage of records; schedule subject follow-up appointments within designated protocol timeframes; recruit, screen, consent and manage study subjects per protocol and GCP guidelines and PPGT Research SOPs; record and accurately reconcile subject stipends; dispense investigational product according to protocol and maintain accurate and timely product accountability.

• Assists and facilitates advance preparation for audits, monitoring visits, and all on-site Sponsor activities to ensure compliance with contractual obligations, study protocols, and industry standards.

• 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

  • High School Diploma (or equivalent) + 3 years of relevant experience or Associate's or Bachelor's degree + 2 years of relevant experience.
  • Relevant experience: medical/clinic assistant-related experience providing direct patient care or with clinical research subjects.
  • A medical assistant/certified nurse assistant/phlebotomy/emergency medical technician (EMT) certificate, national certification or diploma from fully accredited educational program as identified in the Database of Accredited Postsecondary Institutions and Programs may be substituted for up to 6 months of experience. Note: Advanced education or applicable certification will not exceed a total of 1 year of relevant experience). Preferred: Electronic Practice Management system or Electronic Health Records system experience (EPM/EHR).
  • 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.

Essential Physical Requirements/Working Conditions

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.

Required Knowledge, Skills, And Abilities

• 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.

• Fluency in Spanish/English may be required (if a job requirement it is documented in your employee records).

• 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 exercise initiative, sound judgment, and problem-solving techniques in the decision-making process.

• Embraces innovation and champions change initiatives supporting the team to adapt and grow.

• The ability to set the tone for respectful, ethical, and professional communication by consistently demonstrating the behaviors expected of others.

• Must be able to build strong, respectful relationships with peers and foster collaboration and teamwork.

• Capable of inspiring action and alignment without relying on formal authority.through credibility, trust, and clear communication, without a direct supervisory role.

• Maintains an ownership mindset, taking responsibility for tasks, outcomes, and the overall success of the health center, and modeling accountability for others.

• 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 effectively use organization's computer systems.

• Be discreet and safeguard confidential information.

• Possess integrity and compliance – can be relied upon to act ethically.

• 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.

• 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.

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.Â

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.
Posted 2026-02-09

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