Job Description
Position Summary
The Senior Clinical Research Associate (Sr. CRA) plays a critical role in the successful execution of Phase I–III clinical trials by conducting monitoring visits, ensuring compliance with regulatory guidelines, and supporting site management activities. The Sr. CRA serves as a key liaison between Ascentage Pharma and clinical trial sites, working to ensure the quality and integrity of study data and site adherence to study protocols, GCP, ICH, and company SOPs.
Key Responsibilities
- Conduct site qualification, initiation, routine monitoring, and close-out visits in accordance with GCP/ICH and Ascentage Pharma SOPs.
- Participate in site identification and investigator recruitment activities.
- Evaluate site feasibility and readiness to conduct clinical trials.
- Provide training to site staff on study protocols, EDC systems, and study-related procedures.
- Ensure timely IRB/IEC submissions and approvals; assist sites in obtaining required regulatory documents.
- Monitor data quality and compliance by performing source document verification (SDV) and resolving data queries.
- Verify appropriate handling, storage, and accountability of investigational product and other study supplies.
- Ensure proper biological sample collection, processing, and shipping, escalating issues as needed.
- Document monitoring activities using company templates; generate timely and accurate monitoring reports and follow-up letters.
- Collaborate with vendors, CROs, central labs, and other service providers to ensure coordinated study execution.
- Serve as the primary contact for site communications and issue resolution throughout the trial lifecycle.
- Participate in protocol and study-related document reviews (e.g., CRFs, study manuals, monitoring plans).
- Support and attend investigator meetings and internal/external study-related meetings.
- Maintain trial documentation and ensure sites are audit-ready at all times.
- Assist with audits and respond to findings appropriately.
Additional Duties and Leadership Responsibilities
- Serve as mentor to junior CRAs and support their onboarding and field training.
- Conduct co-monitoring visits and field evaluations to ensure monitoring consistency.
- May act as Lead CRA, overseeing site activities and compliance with the monitoring plan.
- Support the development of study tools and contribute to SOP reviews and revisions.
- Track and ensure timely resolution of site-level action items and data queries.
- May manage aspects of vendor performance, including oversight of CROs or specialty labs.
Education:
- Bachelor’s degree in a life sciences field, nursing, pharmacy, or a related healthcare discipline (BS, BSN, RPh, RN, or equivalent).
Experience:
- Minimum 5 years of clinical research experience, including at least 2 years of independent on-site monitoring.
- Recent experience with oncology studies, particularly in Phase I–II trials, strongly preferred.
- Experience with electronic data capture (EDC) systems and TMF management.
Knowledge, Skills, and Abilities:
- In-depth knowledge of clinical research practices, GCP, ICH guidelines, and applicable regulatory requirements.
- Excellent communication and interpersonal skills, with the ability to build strong relationships with site staff and cross-functional teams.
- Strong organizational and time-management skills with the ability to manage multiple priorities across complex studies.
- High attention to detail, with strong documentation and report-writing skills.
- Ability to work both independently and collaboratively in a fast-paced, matrixed environment.
- Ability to identify and resolve problems proactively and efficiently.
- Proficient in Microsoft Office Suite and clinical trial management systems.
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