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Job Description

OBJECTIVES: 

• Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and Takeda requirements

ACCOUNTABILITIES: 

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with study protocol and applicable regulatory requirements
• Work with CROs to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure site documents are available for filing in the Trial Master File (TMF) and verify that documents are maintained in accordance with GCP and local regulatory requirements
• Ensure 100% adherence to monitoring and study plan
• Support clinical quality in managing CAPAs and other study audit observations
• Support Clinical Operations Lead/ Clinical Operations Manager in performing CRO oversight as per agreed parameters
• Ensures adherence to study budget through constant monitoring for allocated study(ies)
• Ensures dissemination of study updates to relevant stakeholders as per agreed timelines

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• Master’s or Ph. D degree in scientific discipline or healthcare with >5 years’ experience in clinical trials industry as Clinical Research Associate
• Good working knowledge of GCP and local clinical trial rules and regulations
• Organizational and problem-solving skills
• Superior communication, strategic, interpersonal, and negotiating skill
• Proven/ stable performance records over past 2-3 years

TRAVEL REQUIREMENTS:

• Domestic travel may be required (20-30%), including some weekend commitments.
• Limited international travel (10-20%) may be required

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