Senior/Clinical Research Associate

Accountabilities

• Oversee and manage clinical trial site activities to ensure compliance with protocols, GCP, and applicable regulatory requirements.
• Conduct site visits including initiation, monitoring (on-site and remote), qualification, and close-out visits.
• Ensure patient safety, data integrity, and high-quality study conduct across assigned sites.
• Perform ongoing review of investigator site files (ISF) and ensure alignment with the Trial Master File (TMF).
• Support site start-up activities including feasibility, ethics/IRB submissions, and regulatory documentation.
• Track study progress, maintain clinical trial management systems, and prepare accurate monitoring reports.
• Identify, document, and escalate protocol deviations, safety concerns, and site risks.
• Support investigational product (IP) accountability, including storage, dispensing, reconciliation, and compliance checks.
• Review clinical data, resolve queries, and support data management in ensuring data quality.
• Collaborate with investigators and internal teams to ensure timely resolution of issues and successful study delivery.
• Participate in investigator meetings, training sessions, and global study team discussions.
• Maintain strong communication with sites and act as a key point of contact throughout the study lifecycle.

Requirements

• Bachelor’s degree in Life Sciences, Healthcare, Pharmacy, or a related scientific discipline (or equivalent experience).
• Minimum of 3 years of on-site clinical monitoring experience, preferably with oncology and Phase I studies exposure.
• Strong knowledge of ICH-GCP guidelines, clinical trial processes, and regulatory requirements.
• Experience conducting site visits and managing end-to-end monitoring activities independently.
• Strong attention to detail with the ability to ensure accuracy in documentation and data review.
• Excellent communication and interpersonal skills, with the ability to build strong site relationships.
• Ability to manage multiple studies and priorities in a fast-paced, remote-enabled environment.
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook).
• Willingness and ability to travel extensively (approximately 60–70%).
• Strong problem-solving skills, self-motivation, and ability to work both independently and in teams.

Benefits

• Competitive compensation aligned with experience and clinical expertise.
• Comprehensive health and wellness coverage, including medical support programs.
• Paid time off, holidays, and flexible working arrangements where applicable.
• Strong professional development and training opportunities in clinical research.
• Exposure to global clinical trials in oncology and rare disease therapeutic areas.
• Travel opportunities as part of international study monitoring responsibilities.
• Collaborative, science-driven work environment focused on innovation and impact.
• Career growth opportunities within clinical operations and research leadership paths.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

#LI-CL1