WFH CRA Jobs at ICON Mumbai – BSc Life Sciences Apply Online
CRA II
Mumbai
2025-120404
Clinical Monitoring ICON Strategic Solutions Home-Based
About the role
Mumbai location. Remote setup
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Position overview:
The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Responsibilities:
- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
- Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
- Provides regular site status information to team members, trial management, and updates trial management tools
- Completes monitoring activity documents as required by PRA SOPs or other contractual obligations
- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
- Escalates site and trial related issues per SOPs, until identified issues are resolved or closed
- Performs essential document site file reconciliation
- Performs source document verification and query resolution
- Assesses IP accountability, dispensation, and compliance at the investigative sites
- Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
- Communicates with investigative sites
- Updates applicable tracking systems
- Ensures all required training is completed and documented
- Serves as observation visit leader
- Facilitates audits and audit resolution
- Mentors junior level CRAs and serves as a resource for new employees
- Serves as observation and performance visit leader
- May be assigned additional Clinical Operations tasks
- May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
- May be assigned clinical tasks where advanced negotiating skills are required
You are:
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field
- Minimum of 2 years of independent on-site monitoring experience in clinical trials
- Previous exposure to global oncology studies in Phase I, II, or III
- Strong knowledge of ICH-GCP guidelines and applicable regulatory requirements
- Excellent communication, organizational, and problem-solving skills
- Ability to manage multiple priorities and work independently
- Willingness to travel as required for site visits
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