临床试验协调员 - (FSP )

Job Title: Clinical Trial Coordinator - (FSP )
Job Location: Mumbai, Mahārāshtra, India
Job Location Type: Remote
Job Contract Type: Full time
Job Seniority Level:
Environmental Conditions: Office
Work Schedule: Standard (Mon-Fri)
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coord, you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing CRG personnel, you may utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. Additionally, you may act as a buddy during the onboarding phase and provide training to new staff as needed.

What You’ll Do:

• Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the Functional Service Provider (FSP) Manager and in collaboration with Client Management

• Collaborate with Clinical Operations/Study Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.

• Review of study documentation, including essential document packets, study plans, informed consent forms, etc.

• Supporting/oversight of risk-based monitoring.

• Attendance of key team meetings as required, including Minutes for selected studies

• Supporting regulatory inspection readiness (e.g. SOP Lists, storyboard collation.)

• Support clinical trial systems (e.g. CTMS/TMF associated activities for selected studies

• Supporting vendor contract administration as required.

• Support study close-out activities, e.g. financial reconciliation

• Supporting additional ad-hoc activities as needed, as agreed with Manager(s).

Education and Experience Requirements:

• • Bachelor's degree preferred.

• 2+ years’ experience in global clinical trial support as a CTC / CTC / Project Coordinator

• Experience in Phase 2 and 3 studies and global/international studies is advantageous.

• Experience working across multiple therapeutic areas (including oncology) is advantageous

• Have experience in Veeva Vault, Hands on experience in eTMF life cycle

Knowledge, Skills and Abilities:
• Ability to work in a team or independently as required
• Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Flexibility to reprioritize workload to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
• Good English language and grammar skills and proficient local language skills as needed
• Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
• Ability to successfully complete the organizations clinical training program
• Self-motivated, positive attitude and good interpersonal skills
• Effective oral and written communication skills
• Good interpersonal skills
• Essential judgment and decision-making skills
• Capable of accurately following project work instructions
• Good negotiation skills
• Independent thinker
• Ability to manage risk and perform risk escalation appropriately

Working Conditions and Environment:
• Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential Occasional travel required.

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Originally posted on Himalayas