Site Solutions Executive (PRI) – Premier Research | Mumbai (Parel) | Full-Time | Office-Based
Job ID: R5751
Work Type: Office-Based
Location: Mumbai – Parel, India
Employment Type: Full-Time, 1-Year Contract
Premier Research is hiring a Site Solutions Executive (PRI) to support our India Operations team. This role plays a critical part in enabling biotech, medtech, and specialty pharmaceutical organizations to transform innovative scientific ideas into advanced medicines, diagnostics, and medical devices. We believe in empowering our team members with growth opportunities, skill development, and a collaborative environment where every voice matters.
Join us to contribute to meaningful clinical research that directly impacts patient lives.
Key Responsibilities
Clinical Site Coordination
Manage and coordinate all clinical trial activities at the site in alignment with study protocols, GCP guidelines, and local regulatory requirements.
Support the Principal Investigator (PI) and site teams to ensure clinical trials meet sponsor and regulatory expectations.
Review site processes, identify gaps, and support implementation of improved workflows.
Data and Documentation Management
Perform timely and accurate data entry of CRFs/eCRFs in collaboration with the PI.
Maintain essential clinical trial documentation, including the Trial Master File.
Prepare for and support site initiation, monitoring, close-out visits, QA activities, sponsor visits, and regulatory inspections.
Ethics Committee and Regulatory Support
Coordinate ethics committee submissions, including protocol approvals, adverse events, and periodic study reports.
Ensure proper documentation for all EC communications.
Notify sponsor/CRO teams regarding external audits or inspections.
Patient and Study Operations
Assist in scheduling patient assessments and investigations as directed by the PI.
Ensure availability and proper storage of Investigational Products (IP), lab kits, and trial supplies, including maintaining temperature logs and IP accountability records.
Organize and coordinate biological sample pick-up and reporting.
Maintain communication with site monitors regarding patient enrolment, visit schedules, and dosing/dispensing.
Quality, Compliance, and Communication
Support timely resolution of data queries.
Facilitate effective communication between investigators, sponsors, and CRO representatives.
Assist in patient awareness, training programs, and community-based study activities.
Escalate systemic non-compliance or misconduct to the line manager as required.
Direct feasibility requests to the feasibility team.
Study Feasibility and Data Collection
Support collection of feasibility and epidemiological data.
Build and maintain a database of potential study participants per protocol criteria.
Identify operational challenges and collaborate with LM, TSM, and PI on mitigation plans.
Training and Audit Support
Complete all mandatory and ongoing training modules and SOPs.
Collaborate with PI to address audit findings and implement corrective actions.
Qualifications and Experience Required
Educational Requirements
Bachelor’s or Master’s degree in Clinical, Biological, or Mathematical Sciences, OR
Medical, Dental, or Nursing degree;
Candidates without the above qualifications must have a minimum of 4 years of experience working at clinical research sites.
Skills and Competencies
Strong verbal and written communication skills in English and at least one regional Indian language.
Excellent interpersonal, coordination, and organizational skills.
Strong analytical and problem-solving abilities.
High attention to detail with strong documentation accuracy.
Awareness of ethical, scientific, and patient-safety standards in clinical research.
Proficiency with computers, data entry systems, and office communication tools.
Why Join Premier Research?
Opportunity to contribute to global clinical research impacting patient lives.
Access to professional growth, skill development, and knowledge enhancement.
Work environment that values ideas, engagement, and collaboration.
Stability through a structured contract role with defined responsibilities.
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