Offshore Compliance Team Support

The purpose of the Offshore Compliance Team Support role is to assist the entire offshore compliance team by serving as a floorwalker and subject matter expert (SME).

This role provides hands-on guidance to specialists, supports the Team Lead and Offshore Clinical Operations Supervisor in daily operations, and ensures that compliance activities are carried out effectively and in alignment with regulatory and protocol requirements.

Skills and Qualifications

Must-Have:

• Strong understanding of Source and EDC systems.
• Experience in Source Data Verification (SDV) and Clinical Research (CRA experience preferred).
• Exceptional attention to detail and consistency in process execution.
• Amenable to work ONSITE and on shifting schedule (following US time zone)

Soft Skills:

• Collaborative — able to follow existing processes initially without trying to change them immediately.
• Pleasant and professional communication style.
• Open to suggesting improvements after fully understanding the current systems.
• Open to improving efficiency later through constructive discussions.

Key Responsibilities

• Protocol and Process Compliance
  
  Ensure adherence to study protocols and site-specific processes while maintaining alignment with GCP standards and regulatory authorities (e.g., FDA, IRB).
• Protocol Review
  
  Support study builds in CRIO by reviewing protocols for operational clarity, compliance, and ethical considerations. Present findings and collaborate with the Offshore Compliance Team to ensure a unified understanding before implementation.
• Daily Quality Control of Audits
  
  Conduct daily quality control of visits audited by the Offshore Compliance Team to safeguard data integrity and alignment with compliance standards. When manpower is limited, directly audit visits to support operational continuity.
• Audit Process
  
  Carry out structured audit reviews within seven (7) days after the conclusion of site visits. This process involves:
  
  •    Following up and resolving addressed queries.
  
  •    Reaching out to site personnel for clarification when needed.
  
  •    Reviewing updates and newly uploaded source documents.
  
  •    Ensuring that outstanding queries are properly tracked and escalated if unresolved.
• Delegation Oversight
  
  Oversee and assist with the delegation process for the entire Offshore Compliance Team, ensuring balanced workload distribution and timely completion of tasks.
• Team Collaboration and Delegation
  
  Collaborate within the subunit and exercise self-delegation to ensure workload distribution, while coordinating with leads and supervisors to address compliance issues and share quality insights. Attend necessary meetings, trainings, and Focus Group Discussions.
• Project Support and Management
  
  Assist the Team Lead and Offshore Clinical Operations Supervisor in spearheading and managing projects aimed at process optimization, compliance improvement, and operational efficiency.
• Training and Coaching
  
  Provide ongoing training, mentoring, and coaching to Offshore Compliance Specialists to enhance knowledge, build competence, and reinforce adherence to compliance standards and best practices. Develop and update training materials when needed to align with evolving client and regulatory requirements.
• End-of-Month Reporting
  
  Prepare and deliver end-of-month reports in the absence of the Team Lead, highlighting any missed visits and ensuring transparency in audit coverage.
• Role Coverage During Absences
  
  Provide coverage for specific roles and responsibilities of the Team Lead and Offshore Clinical Operations Supervisor when they are absent or on leave, ensuring operational stability and uninterrupted workflow.

NOTE "Additional tasks, projects, and responsibilities may be assigned as needed to support and meet the needs, requirements and goals of the clients and the company."