Clinical Research Associate

Role Overview

The Clinical Research Associate (CRA) plays a crucial role in safeguarding the rights and well-being of participants involved in clinical trials, ensuring that reported trial data remain accurate, complete, and verifiable against source documents. As the main liaison between investigational sites and sponsors, the CRA manages site relationships and oversees clinical trials' adherence to ICH GCP guidelines, local and global regulatory standards, and client standard operating procedures.

Key Duties

• Establish and maintain effective working relationships with Principal Investigators, study coordinators, pharmacists, and other site personnel to support efficient and smooth operation of clinical studies.
• Cultivate productive internal and external customer partnerships to facilitate timely and efficient project delivery in alignment with study goals and timelines.
• Collaborate with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA) to prepare essential site documentation and support ethics and regulatory submissions and approvals.
• Partner with the Regulatory Start-Up (RSU) team to comprehend applicable local and international regulatory requirements relevant to each clinical trial.
• Drive participant recruitment at study sites according to target goals; develop and update site-specific recruitment strategies.
• Monitor investigational sites following ICH GCP 5.18 and the Clinical Monitoring Plan (CMP), including site selection, initiation, monitoring visits, closeout, unblinded pharmacy visits, and co-monitoring; visits may be onsite or remote per CMP guidelines.
• Ensure participant rights and welfare by conducting informed consent form audits, confirming patient eligibility, monitoring protocol compliance and investigational drug usage, and overseeing adverse events and serious adverse events reporting to sponsors promptly.
• Verify accuracy and completeness of trial data and ensure timely resolution of case report form queries within study timelines.
• Ensure investigational drugs are correctly stored, dispensed, tracked, and reconciled according to protocol and monitoring plans.

Qualifications and Experience

• Degree in clinical or life sciences or related allied professions; relevant experience in pharmaceuticals or related sectors is preferred.
• Strong time management, attention to detail, teamwork abilities, and computer proficiency.
• Experience levels categorized as:
• CRA I: Entry-level training position.
• CRA II: Approximately 1-2 years of CRA or equivalent related clinical industry experience.
• CRA III: 2-3 years of experience as a CRA.
• Senior CRA (SCRA): 3-5 years of CRA experience.
• Principal CRA (PCRA): Over 5 years of CRA experience.

Progression and Role Specifics

• CRA II: Undergo company cultural integration and policies training with practical observational experience, supporting clinical team members with moderate oversight.
• CRA III: Mentor junior staff and support managerial tasks with moderate oversight.
• Senior CRA: Mentor juniors, support line/project managers as Lead CRA, aid clinical services through presentations, SOP development, and process improvements.
• Principal CRA: Develop and deliver CRA training modules, serve as Lead CRA, mentor CRAs and IHCRAs, conduct monitoring visits and assessments, and potentially manage projects as a backup Project or Line Manager.