Senior Clinical Research Associate

Job Description

This role is accountable for the performance and compliance of assigned clinical trial protocols and sites within the country.

Under the oversight of the CRA Manager or Clinical Research Director (CRD), the incumbent ensures that study conduct complies with ICH/GCP guidelines, country regulations, company policies and procedures, quality standards, and adverse event reporting requirements.

The role serves as the primary site contact and site manager throughout all phases of a clinical research study, assuming overall responsibility for assigned sites. The incumbent will also contribute to expanding the local clinical research footprint by identifying and developing new research sites and participating as a Subject Matter Expert (SME) in monitoring processes and systems.

Key Responsibilities

Site Management & Monitoring

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.

Regulatory & Documentation Management

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

Site Performance, Quality & Compliance

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.

Cross-Functional Collaboration

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

Clinical Research Site Development

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.

Knowledge Sharing & Mentorship

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

Key Success Factors

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.

Required Skills:

Accountability, Adaptability, Adverse Event Report, Biopharmaceutical Industry, Clinical Data Management, Clinical Development, Clinical Research, Clinical Research Organizations (CRO) Management, Clinical Site Management, Clinical Site Monitoring, Clinical Study Management, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Customer-Focused, Good Clinical Data Management Practice (GCDMP), Medical Research, Patient Recruitment, Pharmacokinetics, Pharmacotherapeutics, Pharmacovigilance, Regulatory Documents, Task Management

Preferred Skills:

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/6/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.