Clinical Research Associates (CRAs) are essential to any successful clinical trial. They are responsible for monitoring and managing Phase I-III clinical trials to assess the study’s progress in assigned trial sites (either on-site or remotely). They ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, company, sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local regulatory requirements.
At PiVOT, we understand the importance of CRAs in clinical trial management. We have developed a comprehensive program to ensure our CRAs are well-trained and experienced. By providing our CRAs with the necessary training and experience, we can ensure that our clinical trials are conducted according to the highest safety, accuracy, and efficiency standards.
Primary Duties & Responsibilities
Ensures submission of protocol and all related documents to the Institutional Review Board (IRB)/ Institutional Ethics Committee (IEC);
Coordinates with project and study sites for the response to IRB/IEC inquiries;
Monitors study IRB/IEC submissions/approvals according to study plan;
Monitors and provides study interim reports to IRB/IEC;
Tracks implementation of the study according to the study monitoring plan;
Prepares Clinical Study report submission to IRB/IEC.
Conducts site monitoring visits and follow-ups to identify significant problems and issues and ensure that all clinical aspects of studies are carried out in accordance with state and federal regulations, guidelines and policies.
Ensures studies conducted at sites are in compliance with ICH-GCP, local laws and sponsor/Pi Health SOPs and procedures;
Ensures patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements;
Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies; provides remedial training and/or initiates corrective action as required.
Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems and clarifies and/or obtains changes to data as appropriate.
Participates in the identification of potential investigators and clinical sites, both nationally and internationally; conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites;
Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings and prepares reports.
Informs the investigators and site staff of all issues;
Agrees and develops corrective and preventive actions (CAPA) with investigator and site personnel to close all open issues;
Assists in the close-out activities of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site close-out visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.
Audits and Inspection
Supports local audits and inspections, including management of corrective action and preventive action plans.
Knowledge of a CRA
Skills of a CRA
Excellent analytical, organizing, and problem-solving skills;
Excellent computer skills including computer statistical, technical, and database applications, proficient in Microsoft Office tools, and Google workspace.
Proficient and effective communication skills both oral, written and presentation in English: able to communicate at all levels and functions within a broad and complex clinical research environment in a positive and influential manner.
Good Clinical Practice (GCP) certification
GCP is an essential requirement for any Clinical Research Associate (CRA) involved in clinical trials and clinical research. GCP certification ensures high standards of research conduct, patient safety, and ethical practice, and is an integral part of the clinical research process. With GCP certification, CRAs are better equipped to ensure the quality and integrity of clinical trials and research, and to protect the rights and welfare of participants in the research process. GCP certification provides an assurance to those who are involved in clinical research that the research is being conducted in accordance with the relevant regulations, ethical standards, and best practices.
Inside the leading and largest local CRO in the Philippines