Job Description

Position Overview:

The Clinical Research Site Manager (CRSM) is responsible for overseeing and managing clinical trial operations at assigned research sites. The CRSM ensures that clinical trials are conducted in compliance with regulatory requirements, good clinical practice (GCP), and study protocols. This role is key to ensuring efficient and smooth operations within the site, coordinating between all involved parties, and acting as the primary point of contact for both internal and external stakeholders.

Key Responsibilities:

Site Management & Coordination :

• Oversee day-to-day operations of clinical research sites.
• Ensure that studies are conducted in compliance with protocol, Good Clinical Practice (GCP), and regulatory requirements.
• Collaborate with Principal Investigators (PIs), sub-investigators, and site staff to facilitate study operations.
• Monitor site progress, identify potential issues, and take corrective actions as necessary.

Regulatory and Compliance :

• Ensure all necessary regulatory documents (e.g., IRB submissions, informed consent forms, and safety reports) are completed and up-to-date.
• Maintain adherence to GCP, local regulations, and standard operating procedures (SOPs).
• Oversee the preparation for site audits and inspections, ensuring that all documentation and records are complete and in accordance with regulatory standards.

Study Start-Up & Close-Out :

• Coordinate the start-up process, including investigator meetings, site qualification, and initiation activities.
• Assist in the management of site close-out activities, including completion of study documentation and final regulatory filings.

Subject Recruitment & Retention :

• Support recruitment efforts to meet enrollment targets and timelines.
• Develop strategies for patient retention throughout the study duration.
• Ensure effective patient communication and follow-up to maintain high patient retention rates.

Training and Mentoring :

• Provide training to site staff on protocol-specific requirements, compliance, and best practices.
• Mentor new or junior staff at the site, ensuring high standards of performance and accountability.

Site Budget & Financial Oversight :

• Assist in managing site budgets, ensuring that financial resources are allocated effectively.
• Track and monitor the payment schedule, ensuring that all expenses are accounted for and within the study’s financial plan.

Communication & Reporting :

• Serve as the primary point of contact between the sponsor, CRO, and the site.
• Provide regular progress updates to stakeholders, including sponsors, internal management, and regulatory bodies.
• Ensure timely and accurate reporting of adverse events, protocol deviations, and other critical events.

Problem Resolution & Issue Escalation :

• Address any issues or concerns that arise during the course of the trial.
• Escalate any significant issues to senior management in a timely manner, while working to resolve site-specific challenges.

Qualifications

Education & Experience :

• Bachelor’s degree in Life Sciences, Nursing, or a related field (or equivalent experience).
• At least 3-5 years of experience in clinical research, preferably with experience as a Site Manager or in a similar role.
• Experience with site management, clinical trial processes, and GCP guidelines.

Skills & Competencies :

• Strong understanding of clinical trial protocols and regulatory guidelines.
• Excellent organizational skills with the ability to prioritize tasks effectively.
• Ability to work independently, as well as part of a multidisciplinary team.
• Excellent communication and interpersonal skills, with the ability to liaise effectively with a wide range of stakeholders.
• Proficient in using clinical trial management software (CTMS), electronic data capture (EDC) systems, and Microsoft Office Suite.
• Strong attention to detail and problem-solving abilities.

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