JOB DESCRIPTION

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.
  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.

• 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