Syneos Health Hiring Senior Clinical Research Associate – Apply Now!

Syneos Health Hiring Senior Clinical Research Associate – Apply Now!

About Syneos Health

Syneos Health is a globally recognized biopharmaceutical solutions organization dedicated to accelerating the delivery of innovative therapies to patients worldwide. With over 29,000 employees across 110 countries, Syneos Health provides comprehensive clinical development services, ensuring high-quality research and streamlined operations.

If you’re passionate about clinical research and looking for a rewarding career, Syneos Health is the place for you!

Job Overview – Senior Clinical Research Associate (CRA II / Sr CRA)

Current Openings:

• Position: CRA II / Sr CRA
• Location: Mumbai, Delhi, Bangalore, Hyderabad (Client-Based)
• Experience Required: Minimum 4 years in clinical research, with oncology and cardiovascular therapeutic area experience preferred
• Qualification: Bachelor’s degree or RN in a relevant field
• Travel: Up to 75% (as required)

Key Responsibilities

•  Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely), ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. I have the judgment and experience to evaluate the site and staff’s overall performance and provide recommendations regarding site-specific actions, immediately communicate/escalate serious issues to the project team, and develop action plans. Contains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies that obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Identifies factors affecting the subject/patient’s safety and clinical data integrity at an investigator/physician site, such as protocol deviations/violations and pharmacovigilance issues.

Per the Clinical Monitoring/Site Management Plan (CMP/SMP):

• Assesses site processes
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies that required clinical data entered in the case report form (CRF) is accurate and complete
• Applies query resolution techniques remotely and on-site and guides site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
• Verifies site compliance with electronic data capture requirements

• May perform investigational product (IP) inventory, reconciliation and reviews storage and security. e if the IP has been dispensed and administered to subjects/patients according to the protocol. e files issues or risks associated with blinded or randomized information related to IP. p lies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
•  Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. e reconciles the contents of the ISF with the Trial Master File (TMF). Ensure the investigator/physician site knows the requirement to archive essential documents by local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. u orts subject/patient recruitment, retention and awareness strategies. Its data is stored in tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities/communication to meet project objectives, deliverables, and timelines—the ability to adapt quickly to changing priorities to achieve goals/targets.
• May act as primary liaison with study site personnel or in collaboration with the Central Monitoring Associate. Ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends investigator meetings and/or sponsors’ face-to-face meetings. Articles in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project-specific requirements.
• Guides at the site and project levels regarding audit readiness standards and supports preparation for audits and required follow-up actions.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.

For the Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. addition l responsibilities include:

•  Site support throughout the study lifecycle, from site identification through close-out
• Knowledge of local requirements for real-world late-phase study designs
• Chart abstraction activities and data collection
• Collaboration with Sponsor affiliates, medical science liaisons and local country staff
• The SMA II may be requested to train junior staff
• Identify and communicate out-of-scope activities to the Lead CRA/Project Manager
•  Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations

Required Qualifications

• Minimum Experience: At least 4 years in clinical research, with a preference for oncology and cardiovascular experience.
• Educational Background: Bachelor’s degree in Life Sciences (Biotechnology, Microbiology, Biochemistry, Genetics, Molecular Biology), Nursing (BSc Nursing, MSc Nursing), Pharmacy (BPharm, MPharm, PharmD), or an equivalent field such as Clinical Research, Public Health, or Medical Laboratory Sciences.
• Technical Skills: Knowledge of ICH-GCP, regulatory requirements, and electronic data capture systems.
• Soft Skills: Strong communication, problem-solving, and analytical abilities.
• Flexibility: Willingness to travel up to 75% as per project requirements.

How to Apply

If you meet the qualifications and are ready to advance your career in clinical research, apply now! Lick the  link below to submit your application:

Apply Now