PHARMAFull-time
Clinical Research Associate (CRA) II (remote, Client based)
By Admin · Clinical Research & Clinical Operations
MUMBAI (IN)REMOTEPOSTED: 9/2/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE DEFINITION & RESPONSIBILITIES
Job Overview
Full-time Clinical Research Associate II position supporting global clinical trials in a remote/client-based environment.
Remote opportunity supporting a Mumbai-based client.
Responsible for end-to-end clinical site monitoring, site management, regulatory compliance, patient safety, clinical data integrity and study execution.
The role may operate within a Functional Service Provider partnership or a Full-Service clinical research environment.
For Real World Late Phase studies, the business card title may be Site Management Associate II.
Core Responsibilities
Perform site qualification, site initiation, interim monitoring, site management and close-out visits either on-site or remotely.
Evaluate investigator site and site staff performance using professional judgment and monitoring experience.
Identify site-specific issues, risks and performance gaps and provide recommendations for corrective actions.
Immediately communicate and escalate serious issues to the project team and support development of action plans.
Assess site processes according to the Clinical Monitoring Plan and Site Management Plan.
Act as a primary liaison with study site personnel independently or in collaboration with a Central Monitoring Associate.
Ensure assigned sites and project-specific site team members receive required training and remain compliant with applicable requirements.
Support subject/patient recruitment, retention and study awareness strategies.
Manage site-level activities and communications to support project objectives, deliverables, budgets and timelines.
Adapt quickly to changing priorities while maintaining achievement of study goals and performance targets.
Clinical Monitoring & Data Quality
Conduct Source Document Review of relevant site source documents and medical records.
Verify that clinical data entered into Case Report Forms is accurate, complete and supported by source documentation.
Apply remote and on-site query resolution techniques and guide site staff when necessary.
Drive clinical data query resolution to closure within agreed timelines.
Use available hardware and software to support effective clinical study data review and capture.
Verify investigator site compliance with electronic data capture requirements.
Track observations, site status and assigned action items through required tracking systems until resolution.
Patient Safety & Regulatory Compliance
Verify that the informed consent process has been adequately performed and documented for every applicable subject or patient.
Protect subject and patient confidentiality throughout monitoring activities.
Assess factors that may affect patient safety and clinical data integrity.
Identify and assess protocol deviations and violations.
Monitor and escalate pharmacovigilance-related issues.
Maintain working knowledge of ICH-GCP Guidelines, applicable regulatory requirements and company SOPs and processes.
Ensure monitoring activities comply with applicable regulatory, ICH-GCP, Good Pharmacoepidemiology Practice and protocol requirements.
Investigational Product Responsibilities
May perform investigational product inventory and reconciliation.
Review investigational product storage and security requirements.
Verify investigational products are dispensed and administered according to the approved protocol.
Identify and assess issues or risks involving blinded or randomized investigational product information.
Apply knowledge of GCP, local regulations and organizational procedures to ensure investigational products are appropriately labelled or relabelled, imported, released, returned and managed.
Documentation & Site File Management
Routinely review the Investigator Site File for accuracy, completeness and timeliness.
Reconcile Investigator Site File contents with the Trial Master File.
Ensure investigator sites understand requirements for archiving essential documents according to local regulations and guidelines.
Document monitoring and study activities through confirmation letters, follow-up letters, trip reports, communication logs and other required project documents.
Complete documentation in accordance with company SOPs and the Clinical Monitoring Plan or Site Management Plan.
Project Collaboration & Meetings
Prepare for and attend Investigator Meetings.
Participate in sponsor face-to-face meetings when required.
Participate in global clinical monitoring and project staff meetings, including sponsor representation where applicable.
Attend project-specific clinical training sessions.
Collaborate with project teams, sponsor representatives, site personnel and other cross-functional stakeholders.
Audit Readiness & Quality
Provide site-level and project-level guidance to support audit readiness standards.
Support preparation for audits and implementation of required follow-up actions.
Identify compliance risks and contribute to timely corrective and preventive actions.
Maintain required training and continuously update knowledge of applicable regulations, guidance and company procedures.
Real World Late Phase / Site Management Associate II Responsibilities
Support sites throughout the complete study lifecycle from site identification through close-out.
Apply knowledge of local requirements relevant to real world late phase study designs.
Perform chart abstraction activities and data collection where required.
Collaborate with sponsor affiliates, Medical Science Liaisons and local country staff.
May provide training to junior staff.
Identify and communicate out-of-scope activities to the Lead CRA or Project Manager.
Proactively suggest potential study sites based on local treatment patterns, patient advocacy knowledge and Health Care Provider associations.
Qualifications & Experience
Bachelor's degree or Registered Nurse qualification in a related field, or an equivalent combination of education, training and experience.
Minimum 3 years of onsite monitoring experience in global clinical trials.
Strong knowledge of Good Clinical Practice and ICH Guidelines.
Knowledge of applicable regulatory requirements.
Good computer skills and willingness to adopt new technologies.
Excellent communication, presentation and interpersonal abilities.
Ability to travel up to 75% on a regular basis.
Therapeutic Area Experience
Oncology experience of approximately 1-2 years is preferred.
Experience in Neuroscience is preferred.
Experience in Haematology is preferred.
Experience in Cardiovascular studies is preferred.
Experience in Rare Disease studies is preferred.
Company & Career Environment
Syneos Health describes itself as a fully integrated life sciences services organization supporting drug development and commercialization.
Employees are offered career development and progression opportunities.
The organization highlights supportive and engaged line management.
Technical and therapeutic-area training opportunities are provided.
Peer recognition and total rewards programs are part of the employee value proposition.
The company emphasizes an inclusive culture and collaboration across global teams.
The organization reports experience supporting a substantial portion of novel FDA-approved drugs and EMA-authorized products, providing exposure to large-scale global clinical research operations.
REQUIRED VERIFIED SKILLS
Onsite Clinical Monitoring
Global Clinical Trials
Site Qualification
Site Initiation Visits
Interim Monitoring
Site Management
Close-Out Visits
ICH-GCP
Good Clinical Practice
Regulatory Compliance
Protocol Compliance
Source Document Review
Medical Record Review
Clinical Data Review
Case Report Forms
Query Resolution
Electronic Data Capture
Patient Safety
Informed Consent Verification
Confidentiality
Protocol Deviation Management
Pharmacovigilance Issue Identification
Investigator Site File Management
Trial Master File Reconciliation
Investigational Product Management
Clinical Documentation
Audit Readiness
Site Training
Clinical Study Tracking
Computer Skills
Communication Skills
Presentation Skills
Interpersonal Skills
Ability to Travel
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
No salary range or compensation figures are disclosed in the source posting. Compensation is therefore dependent on Syneos Health's internal salary structure, candidate experience, therapeutic-area expertise, monitoring experience, client requirements and geographic considerations. The posting highlights a total rewards program and career development opportunities, along with technical and therapeutic-area training and peer recognition. Candidates should discuss fixed compensation, variable or performance-related incentives, travel-related benefits, insurance coverage and other applicable employee benefits during the recruitment process.
ORGANIZATION CONTEXT & CULTURE
Syneos Health is a leading fully integrated biopharmaceutical solutions organization. They provide end-to-end clinical and commercial solutions designed to accelerate the development and commercialization of new therapies worldwide. The company combines clinical development, medical affairs, and commercialization expertise to help clients bring innovative treatments to patients faster.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare Services
EXPECTED CAREER ROADMAP
This CRA II role provides a strong pathway toward senior clinical operations and clinical research leadership positions. Candidates can progress into Senior CRA, Lead CRA, Clinical Trial Manager, Project Manager, Clinical Operations Manager or specialized site management and real-world evidence roles. The position offers broad exposure to global clinical trial execution, sponsor collaboration, regulatory compliance, site performance management and therapeutic-area expertise. Experience across oncology, neuroscience, haematology, cardiovascular and rare disease programs can support future specialization in complex clinical development areas. The opportunity to work with global project teams and participate in investigator and sponsor meetings can also strengthen leadership, stakeholder management and project delivery capabilities.
APPLICATION ADVISORY
Highlight at least 3 years of onsite monitoring experience in global clinical trials prominently on your resume. Clearly list experience with qualification, initiation, monitoring and close-out visits, along with the therapeutic areas you have supported. Demonstrate practical knowledge of ICH-GCP, regulatory compliance, informed consent verification, patient safety, source document review, CRF review, EDC systems, query resolution, Investigator Site File management and Trial Master File reconciliation. If you have Oncology experience, quantify the duration and type of studies supported; otherwise emphasize relevant Neuroscience, Haematology, Cardiovascular or Rare Disease experience. Prepare interview examples demonstrating how you identified site risks, escalated serious issues, improved data quality, resolved monitoring findings and maintained audit readiness. Also be prepared to discuss your willingness and ability to travel up to 75% and work effectively in a remote, client-based environment.
RECOMMENDED TRAINING
1/5
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