Planned Parenthood of Greater Texas, Inc. · 23 hours ago
Clinical Research Coordinator
Austin, TX
Full-time
Onsite
Entry, Mid Level
2+ years expPlanned Parenthood of Greater Texas, Inc. is seeking a Clinical Research Coordinator to manage clinical research studies while ensuring compliance with regulations and internal procedures. The role involves coordinating regulatory submissions, subject recruitment, and maintaining research documentation, while supporting the organization's mission and strategic plan.
Hospital & Health Care
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
Qualification
Required
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)
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 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
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
Recovery Skills: Responds effectively and acknowledges responsibilities when patients (internal or external) experience problems or mistakes; rectifies the situation to restore patient satisfaction
Interpersonal Sensitivity: Acts in a way that indicates understanding and accurate interpretation of others' concerns, feelings, strengths and limitations
Building Relationships: Shows genuine interest in others' needs and opinions; establishes rapport; earns the confidence and trust of others
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
Preferred
Electronic Practice Management system or Electronic Health Records system experience (EPM/EHR)
Company
Planned Parenthood of Greater Texas, Inc.
For more than 85 years, Planned Parenthood of Greater Texas has been a trusted source of reproductive healthcare, education, and advocacy.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Ken Lambrecht
President & CEO
Irene Arnold
Talent Acquisition Partner
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