CTC I / II - FSP

Work Schedule

Environmental Conditions

Job Description

Summarized Purpose:

Assists the Project Team by providing administrative and technical support. Ensures files are reviewed according to schedule to support audit readiness. Supports site activation activities and aids in developing critical path. Represents CRG personnel and provides local input for site lists.

• According to the specific role (Central or Local), coordinates, oversees, and completes functions on assigned trial(s) activities as detailed on the task matrix.
• Performs department, internal, country, and investigator file reviews as assigned, and documents findings in appropriate system(s).
• Ensures allocated tasks are performed on time, within budget, and to a high-quality standard. Proactively communicates any risks to project leads.
• Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
• Completes administrative tasks for assigned trials, such as processing documents for the client's (e)TMF, conducting (e)TMF reviews, distributing mailings, and providing reports to the team.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• Assists with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study-specific translation materials and translation QC upon request.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Where applicable, conducts on-site feasibility visits (Asia Pac only).
• May support scheduling of client and/or internal meetings.
• May review and track local regulatory documents.
• May provide system support (i.e., Activate & eTMF). May support RBM activities.
• May support the maintenance of study-specific documentation and systems, including, but not limited to, study team lists, tracking of project-specific training requirements, system access management, and tracking of project level activity plans in appropriate system(s).
• Transmits documents to client and centralized IRB/IEC.
• Maintains vendor trackers.
• Supports start-up team in regulatory submissions.
• Works directly with sites to obtain documents related to site selection.
• Assists the project team with the preparation of regulatory compliance review packages.
• Provides support as needed to coordinate with internal departments, ensuring site start-up activities within the site activation critical path are aligned.
• May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel.
• Documents in real-time all communication, attempts, and follow-up associated with site contact and survey responses.
• Supports the review of survey data to ensure responses are logical, complete, and reflective of the question asked.
• Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicates with the team and appropriate clinical personnel regarding site issues and risks.
• Ensures an efficient and effective plan is in place for site contact and follow-up. Ensures compliance with the plan and brings up any concerns or non-compliance to management.
• May act as the local expert regarding site capacity and experience. Works with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites.
• Liaises with Global Investigator Services to resolve investigator queries in real-time and maintain ‘accounts and contact’ information.
• Contributes to the development and implementation of global strategic feasibility processes and standard methodologies.
• Trains new personnel in processes and systems.
• Applies local knowledge to contribute to identifying and developing new sites.

• Bachelor's Degree in Life Science is preferred
• Should have 1-3 years of experience in CRC or CTC role
• Should have excellent business communication skills
• Should have good knowledge of eTMF and ICH GCP related activities
• Should be able to join us immediately
• Preferably from Mumbai and nearby locations
• 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
• Must have proven ability to understand and follow country regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for 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 organization's 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
• Creative and analytical problem solver
• Skill in effectively handling risk and addressing critical issues when they arise