(facilities, vendor coordination, documentation) while ensuring compliance with
clinical research industry regulations
like
ICH-GCP, Schedule Y, and local labor laws
.
2. End-to-End Responsibilities
A. Human Resources Responsibilities
Recruitment & Onboarding
Preparing and posting job descriptions for clinical, regulatory, and operational roles.
Coordinating with department heads for manpower planning.
Screening resumes, conducting preliminary interviews, and scheduling further rounds.
Managing offer letters, appointment letters, and joining formalities.
Organizing induction programs to brief employees on CRO protocols, SOPs, and regulatory guidelines.
Employee Records & Compliance
Maintaining accurate HR files (digital & physical).
Tracking employee contracts, renewals, and role changes.
Ensuring all staff training and certification records (e.g., GCP training) are up to date.
Maintaining confidentiality of sensitive trial and personnel data.
Payroll & Benefits
Managing attendance, leave records, and shift schedules.
Coordinating payroll processing with accounts.
Handling statutory compliance - PF, ESI, gratuity, professional tax, and labor law requirements.
Administering health insurance and other benefits.
Employee Engagement & Performance
Coordinating internal events, recognition programs, and engagement activities.
Assisting with performance appraisal cycles, goal setting, and feedback sessions.
Managing grievance handling and disciplinary actions as per company policy.
B. Administrative Responsibilities
Office Operations
Overseeing office maintenance, cleanliness, and safety.
Ensuring availability of supplies (stationery, IT equipment, lab consumables).
Managing AMC contracts for office & lab equipment.
Supervising housekeeping, security, and facility management.
Vendor & Procurement Management
Coordinating with vendors for procurement of services and supplies.
Managing purchase orders, quotations, and vendor payments.
Negotiating costs and ensuring timely deliveries.
Travel & Logistics
Booking travel, accommodation, and transport for employees, especially for site monitoring visits or investigator meetings.
Managing logistics for clinical trial materials (ensuring temperature control, documentation).
Compliance & Documentation
Ensuring all administrative processes follow SOPs and regulatory compliance.
Coordinating audits (internal, sponsor, or regulatory inspections).
Maintaining visitor logs, access control, and safety protocols.
3. Skills & Competencies
Knowledge of Clinical Research Regulations
(ICH-GCP, Schedule Y, SOP adherence).
Strong
HR process knowledge
(recruitment, payroll, compliance).
Administrative & vendor management skills
.
Good communication and coordination skills.
Proficiency in MS Office, HRMS software, and documentation control systems.
Ability to maintain confidentiality and handle sensitive trial data.
4. Reporting Structure
Reports to:
HR Manager / Admin Manager / Director - Operations