PHARMAFull-time
Sr. CRA I / CRA II
By Admin · Clinical Research & Clinical Operations
MUMBAI (IN)ONSITEPOSTED: 10/10/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE OVERVIEW
Syneos Health is hiring a Sr. CRA I / CRA II for its Mumbai office. The role requires at least four years of on-site CRA monitoring experience in core clinical trials and includes site monitoring, regulatory compliance, clinical data review, documentation, and site management.
ROLE DEFINITION & RESPONSIBILITIES
- •Conduct site qualification, initiation, interim monitoring, site management and close-out visits
- •evaluate site performance and escalate serious issues
- •verify informed consent and participant safety requirements
- •conduct source-document and medical-record reviews
- •verify clinical data and electronic data-capture compliance
- •manage clinical queries
- •review investigational product inventory, storage and administration where applicable
- •review and reconcile ISF and TMF documentation
- •prepare monitoring and project documentation
- •support recruitment and retention activities
- •manage site-level timelines and communications
- •train assigned site personnel
- •support investigator meetings and audit readiness
- •provide guidance or mentorship to junior CRAs where assigned
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Minimum 4 years of on-site monitoring experience as a CRA
- experience in core clinical trials
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements
- good computer skills
- ability to travel up to 75% regularly
- excellent communication, presentation and interpersonal skills
- basic critical-thinking skills
PREFERRED QUALIFICATIONS
- •FSP experience
- •experience in Oncology, Cardiology or Vaccines
REQUIRED VERIFIED SKILLS
Clinical trial monitoring
site qualification
site initiation
interim monitoring
site management
close-out visits
ICH-GCP
Good Clinical Practice
regulatory requirements
source document review
medical record review
clinical data review
query resolution
electronic data capture
investigational product management
Investigator Site File
Trial Master File
audit readiness
clinical documentation
communication
presentation
interpersonal skills
critical thinking
computer skills
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Career development and progression, supportive line management, technical and therapeutic area training, peer recognition and a total rewards program.
ORGANIZATION CONTEXT & CULTURE
Syneos Health is a life sciences services organisation working across drug development and commercialization.
TEAM SIZE: 25000+ colleagues
INDUSTRY: Biopharmaceutical / Healthcare Services
Culture: The posting describes a collaborative, agile, inclusive and changing work environment and highlights development, recognition and supportive line management.
EXPECTED CAREER ROADMAP
The posting states that Syneos Health supports career development and progression, technical and therapeutic area training, and structured line management support.
APPLICATION ADVISORY
Emphasize the minimum four years of on-site CRA monitoring experience and your work in core clinical trials. Highlight ICH-GCP and regulatory knowledge, source-document review, clinical data verification, query management, site-file oversight, and any FSP or Oncology, Cardiology, or Vaccines experience.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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