Senior Clinical Research Associate

Job Description

• Develop and maintain strong relationships with investigators and study sites throughout all phases of the clinical trial.

• Perform site management and monitoring activities in compliance with:

  • ICH-GCP guidelines

  • Sponsor SOPs

  • Local laws and regulations

  • Study protocol

  • Site Monitoring Plan

  • Associated study documents

• Gain a thorough understanding of study protocols and related procedures.

• Coordinate and manage study start-up activities in collaboration with cross-functional stakeholders to achieve Site Ready status.

• Participate in site identification, selection, feasibility, and validation activities.

• Conduct remote and on-site monitoring activities to ensure:

  • Data generated by sites are complete, accurate, and unbiased.

  • Participant rights, safety, and well-being are protected.

• Conduct site visits, including:

  • Site validation visits

  • Site initiation visits (SIVs)

  • Routine monitoring visits

  • Close-out visits

• Prepare clear, comprehensive, and timely visit reports and non-visit contact documentation.

• Collect, review, and oversee required regulatory documentation for:

Study start-up

• Study maintenance

• Study close-out

• Ensure regulatory documents are complete, accurate, and maintained in accordance with applicable requirements.

• Maintain study information and documentation in:

  • Clinical Trial Management System (CTMS)

  • Electronic Trial Master File (eTMF)

  • Other relevant clinical systems

• Communicate with investigators and site personnel regarding:

  • Protocol conduct

  • Patient recruitment and retention

  • Protocol deviations

  • Regulatory requirements

  • Site audits and inspections

  • Overall site performance

• Identify, assess, and resolve site performance, quality, and compliance issues.

• Escalate significant issues through the established escalation pathway when appropriate.

• Support and/or lead audit and inspection activities.

• Perform quality control visits when delegated and appropriately trained.

• Partner with internal stakeholders, including:

  • Country Clinical Operations

  • Finance

  • Regulatory Affairs

  • Pharmacovigilance

  • Legal

  • Regional Operations

  • Global Functional Teams

• Collaborate with external stakeholders such as:

  • Investigators

  • Site staff

  • Vendors

  • Ethics Committees (IRBs/IECs)

  • Regulatory Authorities

• Support country clinical research strategies by identifying and developing new potential research sites.

• Work closely with investigators and site staff to enhance site capabilities and foster long-term partnerships.

• Contribute to the growth of the local clinical research network and trial delivery capacity.

• Act as a Subject Matter Expert (SME) for clinical monitoring processes and systems.

• Share best practices and recommend continuous process improvements.

• Provide training and guidance to team members as required.

• Mentor and support junior Clinical Research Associates through:

  • Buddy programs

  • Coaching

  • Co-monitoring visits

• Strong knowledge of ICH-GCP, local regulations, and clinical trial processes.

• Ability to independently manage multiple sites and priorities.

• Strong communication and stakeholder management skills.

• Excellent problem-solving and risk assessment capabilities.

• Commitment to quality, compliance, and patient safety.

• Ability to work effectively in a cross-functional and global environment.

Current Employees apply HERE

Current Contingent Workers apply HERE