- Coordinate, oversee, and complete functions on assigned trial activities as detailed on the task matrix.
- Perform department, Internal, Country, and Investigator file reviews, documenting findings in appropriate systems.
- Ensure tasks are performed on time, within budget, and to a high-quality standard; communicate risks to project leads.
- Provide system support (e.g., Activate & eTMF) and ensure system databases are current.
- Perform administrative tasks, including processing documents, performing (e)TMF reviews, distributing communications, and providing documents/reports to internal team members.
- Analyze and reconcile study metrics and findings reports; assist with clarification and resolution of findings.
- Assist with the coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assist with study-specific translation materials and translation QC.
- Maintain knowledge of SOPs, client SOPs/directives, and regulatory guidelines.
- Conduct on-site feasibility visits (Asia Pac only) as applicable.
- Support scheduling of client/internal meetings and review/track local regulatory documents.
- Provide system support and support RBM activities.
- Maintain study-specific documentation and systems, including team lists, tracking project-specific training requirements, system access management, and tracking project-level activity plans.
- Transmit documents to clients and centralized IRB/IEC.
- Maintain vendor trackers.
- Support start-up team in regulatory submissions and work with sites to obtain documents related to site selection.
- Assist with the preparation of regulatory compliance review packages and coordinate with internal departments to ensure site start-up activities are aligned.
- Complete the ‘Site Interest Plan’ in CTMS and collect/deliver associated documents from investigators and site personnel.
- Document all communication and follow-up associated with site contact and survey responses.
- Support the review of survey data for logical, complete, and reflective responses.
- Collaborate with teammates to meet project deadlines and communicate site issues and risks.
- Ensure efficient site contact and follow-up plans, compliance, and escalate concerns to management.
- Act as a local expert regarding site capacity and experience, gathering knowledge base, and recommending additional sites.
- Liaise with Global Investigator Services to resolve investigator queries and maintain ‘accounts and contact’ information.
- Contribute to the development and roll-out of global strategic feasibility processes and best practices.
- Train new personnel in processes and systems and utilize local knowledge to contribute to the identification and development of new sites.
Knowledge, Skills, and Abilities:
- Education: Bachelor’s Degree in Life Science preferred.
- Experience: 1-3 years in CRC or CTC role.
- Skills:
- Excellent business communication skills.
- Good knowledge of eTMF and ICH GCP-related activities.
- Ability to work independently or in a team.
- Strong organizational skills and attention to detail.
- Proven ability to handle multiple tasks efficiently.
- Strong customer focus and flexibility to reprioritize workload.
- Good English language and grammar skills; proficient local language skills as needed.
- Good computer skills (MS Office) and ability to master clinical trial database systems.
- Self-motivated with a positive attitude and good interpersonal skills.
- Effective communication, judgment, and decision-making skills.
- Good negotiation skills and ability to manage risk appropriately.
Preferred Candidates:
- Candidates preferably from Mumbai and nearby locations.
- Should be able to join immediately.
