Syneos Health has announced an opportunity for experienced clinical research professionals for the position of Clinical Research Associate (CRA) II in India. This is a full-time, client-based role with a remote work arrangement and a Mumbai client alignment.

The Syneos Health Clinical Research Associate CRA II job is particularly relevant for professionals with at least 3 years of onsite monitoring experience in global clinical trials. Candidates with experience in Oncology are preferred, while experience in therapeutic areas such as Neuroscience, Haematology, Cardiovascular and Rare Disease may also be valuable.

As a CRA II, the selected professional will oversee clinical trial sites, perform monitoring activities, verify compliance with study protocols and ICH-GCP requirements, review clinical trial documentation and support high-quality, inspection-ready study conduct.

Syneos Health CRA II Job Overview

About Syneos Health

Syneos Health is a global, fully integrated life sciences services organization supporting companies across drug development and commercialization. Its clinical teams work with pharmaceutical and biotechnology organizations to support clinical development programs and accelerate the delivery of therapies to patients.

According to the employer’s job description, Syneos Health has worked with 94% of novel FDA-approved drugs, 95% of EMA-authorized products, and more than 200 studies across 73,000 sites and 675,000+ trial patients over the stated five-year period.

Clinical Research Associate CRA II Responsibilities

The Clinical Research Associate CRA II will be responsible for monitoring investigator sites and helping ensure that clinical trials are conducted according to the study protocol, applicable regulations, Good Clinical Practice requirements and company procedures.

Key responsibilities include:

• Conduct site qualification, site initiation, interim monitoring, site management and close-out visits, either onsite or remotely as applicable.
• Monitor investigator sites for compliance with the clinical study protocol, regulatory requirements, ICH-GCP guidelines and relevant SOPs.
• Evaluate site and site-staff performance and recommend appropriate site-specific corrective or preventive actions.
• Escalate serious site issues to the appropriate project team and assist with developing action plans.
• Verify that the informed consent process has been appropriately completed and documented for study participants.
• Protect subject confidentiality and assess potential risks affecting patient safety or clinical data integrity.
• Identify and evaluate protocol deviations, violations and relevant pharmacovigilance issues.
• Conduct Source Document Review (SDR) of relevant medical records and site source documentation.
• Review clinical data recorded in Case Report Forms (CRFs) for accuracy and completeness.
• Support query management and drive outstanding queries toward resolution within established timelines.
• Verify investigator-site compliance with Electronic Data Capture (EDC) requirements.
• Review investigational product inventory, storage, security, reconciliation, dispensing and administration when assigned.
• Review the Investigator Site File (ISF) for completeness, accuracy and timeliness.
• Reconcile essential documentation between the ISF and Trial Master File (TMF).
• Prepare monitoring documentation such as confirmation letters, follow-up letters, trip reports and communication logs.
• Support patient recruitment, retention and study-awareness activities where required.
• Track observations, action items and site status through applicable clinical trial systems.
• Manage assigned site-level activities against project scope, timelines and deliverables.
• Serve as a key liaison between investigator-site personnel and study teams.
• Participate in Investigator Meetings, sponsor meetings, project meetings and required clinical training.
• Help sites maintain audit and inspection readiness throughout the study lifecycle.

Qualifications for Syneos Health CRA II

Candidates interested in this Syneos Health CRA II job in India should meet the following core requirements:

• 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.
• Working knowledge of Good Clinical Practice (GCP), ICH Guidelines and other applicable regulatory requirements.
• Good computer skills and willingness to work with evolving clinical research technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage significant travel requirements, potentially up to 75% on a regular basis.

Equivalent experience, education and skills may also be considered by the employer according to the requirements of the position.

Preferred Therapeutic Area Experience

Syneos Health specifically indicates that 1–2 years of Oncology experience is preferred.

Candidates with clinical monitoring experience in other therapeutic areas may also be considered, including:

• Neuroscience
• Haematology
• Cardiovascular
• Rare Disease

Professionals with Oncology monitoring experience may therefore have a particularly strong alignment with this CRA II opening.

Key Skills for the CRA II Role

Successful candidates should have practical knowledge of clinical trial monitoring and site management, including:

ICH-GCP | Site Monitoring | Site Initiation | Source Document Review | CRF Review | EDC | Query Resolution | ISF | TMF | Investigational Product Accountability | Protocol Compliance | Informed Consent | Site Management | Audit Readiness | Clinical Trial Documentation

Because this is an experienced CRA position, practical onsite monitoring capability is a central requirement rather than theoretical clinical research knowledge alone.

Real World Late Phase Responsibilities

For Real World Late Phase assignments, the CRA II may use the business title Site Management Associate II (SMA II).

Additional responsibilities can include supporting sites from identification through close-out, understanding local requirements for real-world late-phase studies, conducting chart abstraction and data-collection activities, collaborating with sponsor affiliates and Medical Science Liaisons, identifying out-of-scope activities and potentially supporting the training of junior team members.

Why Consider a Career at Syneos Health?

The employer highlights several professional-development advantages for employees, including:

• Career development and progression opportunities
• Supportive line management
• Technical and therapeutic-area training
• Peer-recognition initiatives
• Total rewards programs
• Exposure to global clinical development programs
• Collaboration with multidisciplinary life sciences professionals
• Opportunities to develop within a large international organization

The breadth of Syneos Health’s clinical operations can provide experienced CRAs exposure to different customers, therapeutic areas and clinical development environments.

Is This Job Suitable for Freshers?

No. This particular CRA II vacancy is not intended for freshers.

Syneos Health specifically requires a minimum of 3 years of onsite monitoring experience in global clinical trials.

Candidates working as CRA I, Clinical Research Associate, Site Monitor or in comparable clinical monitoring positions who meet the required monitoring experience may be better aligned with this opportunity.

Fresh graduates should instead look for roles such as Clinical Trial Assistant (CTA), Clinical Research Coordinator (CRC), Clinical Research Associate trainee or other entry-level clinical operations opportunities.

How to Apply

Application Link