Clinical Research Associate
3 months ago
**Title**:Clinical Research Associate**:
- Date: Sep 3, 2024- Location: Sun House - Corporate Office- Company: Sun Pharma Laboratories Ltd**In-House Managed Studies**
- Site feasibility, potential investigator identification and development of study budgets for each study
- Finalization of investigators, sites and execution of CDA and study related contracts
- Plan and conduct Investigator’s Meeting if needed
- Preparation and submission of study documents for EC permission for respective study across centers
- Work with R&D teams and facilitate IP procurement and ensuring streamlined auditable trial supplies to respective sites
- Overseeing & documenting IP dispensing, inventory management & reconciliation
- Site initiation, site monitoring and site close-out activities
- Investigator and site personnel training on Study protocol, procedures and GCP principles
- Ensure timely recruitment of trial participants and subsequent efficient and effective data management
- Ensure regular site monitoring visits as per plan, source data verification, informed consent form review, case report form review, investigational drug accountability, and adverse event review for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required
- Ensure timely reporting of SAEs, SUSARs and reporting of SAEs to all sites and investigators in alignment with regulations and Sun’s PV policies
- Coordinate project meetings and preparation of monitoring visit reports
- Risk identification, analysis and CAPA for sites not meeting expectations as per plan
- Co-ordinate with in-house or CRO partners for data management, statistical analysis & statistical analysis report
- Lead & guide data query resolutions in coordination with sites and data management team - Management of the trial budget(s) and maintenance of the accounts
RELATED EXPERIENCE REQUIREMENT
- 4-5 years’ experience in a CRO/Pharma/Biotech organization in clinical operations
- Experience in handling large clinical trials with multiple sites for different therapeutic areas
- Thorough Knowledge & experience of remote and risk-based monitoring will be of added value
- Must have experience in handling audits & inspections
- Training in clinical trial methodologies, research design and ICH - GCP
- Thorough knowledge of GCP guidelines, ICMR guidelines 2017 and Drugs and Cosmetic Act regulations pertaining to clinical trials
- Strong academic record with strength in research with knowledge of research methodologies
- Experience of working in matrix business environments preferred - Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards
**COMPETENCY REQUIREMENT**
- Integrity driven decision making skills
- Sound functional knowledge in clinical research and operations
- Collaboration and teaming with ability to work in a matrix environment
- Strategic thinking & sound analytical skills
- Big picture orientation with attention to detail
- Sense of urgency & desire to excel
- Intellectual curiosity
- Self-awareness and adaptability to work in a matrix environment
- Result oriented and performance driven
- Excellent interpersonal & communication skills to effectively interact with a broad range of audience
PHYSICAL REQUIREMENTS/WORKING CONDITIONS The role is majority office based but will involve an average 8 to 10 days of travel outside Mumbai.
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