Key Responsibilities

A. Volunteer Registration and Intake

- Register volunteers for clinical research studies and verify their identification and required documents as per approved procedures.
- Maintain accurate volunteer records and support participant intake and reporting.
- Coordinate with the Clinical Operations team for study-related registration activities.

B. Informed Consent and Documentation

- Support the informed consent process in accordance with approved study documents, SOPs, and applicable ICH-GCP requirements.
- Ensure informed consent documentation is completed before any study-specific procedures, with consent obtained by appropriately authorized and trained personnel.
- Maintain confidentiality and proper filing of participant records.

C. Preliminary Screening Support

- Record baseline information, including height, weight, and BMI, as authorized by the study protocol and SOPs.
- Assist the clinical team in preliminary screening and documentation.
- Ensure that eligibility decisions and medical assessments are handled by appropriately qualified and authorized clinical personnel.

D. Database Management

- Enter and update volunteer demographic information and registration details in the designated database.
- Maintain accurate, complete, traceable, and confidential records.
- Identify discrepancies and report errors to the concerned supervisor for timely correction.

E. Study Coordination and Operational Support

- Coordinate with Clinical Operations, Medical, Nursing, and other relevant departments.
- Assist with study-related documentation, volunteer movement, meal distribution, and meal weighing, where applicable.
- Support preparation for study activities, inspections, and internal or external audits.
- Follow applicable SOPs, safety procedures, and data confidentiality requirements.

F. Compliance and Quality

- Follow applicable ICH-GCP principles, ethical requirements,



company SOPs, and relevant regulatory requirements.
- Maintain proper documentation and ensure data integrity.
- Immediately report deviations, documentation discrepancies, or confidentiality concerns to the reporting supervisor.

1. Educational Qualifications

- Any graduate, or an equivalent relevant qualification.
- Candidates with relevant clinical research or clinical pharmacology training will be preferred.

1. Experience

- Freshers may apply.
- Experience in clinical research, clinical pharmacology, volunteer registration, screening support, or database management will be an advantage.

1. Required Skills

- Good communication and interpersonal skills.
- Solid attention to detail and documentation accuracy.
- Basic to intermediate knowledge of MS Office, particularly Excel and Word.
- Ability to maintain confidentiality and handle participant records responsibly.
- Good coordination, time-management, and organizational skills.
- Willingness to work in a regulated clinical research environment.

1. Reporting Structure

Reports To: Registration Officer In-Charge / Clinical Operations Manager, as assigned by the company.

1. Key Performance Indicators (KPIs)

- Accuracy and completeness of volunteer registration records.
- Timely and accurate database updates.
- Compliance with approved SOPs and documentation requirements.
- Proper maintenance and confidentiality of participant records.
- Timely reporting and resolution of documentation discrepancies.
- Effective coordination with the Clinical Operations team.

1. General Responsibilities

The employee shall perform duties in accordance with company policies, applicable SOPs, study protocols, and instructions from the reporting manager. Additional related responsibilities may be assigned based on operational requirements. Pay: From ₹216,000.00 per year

Benefits

- Flexible schedule
- Provident Fund

Work Location: In person

📌 Registration Officer (Chandkheda)
🏢 Sycon clinical research private
📍 Chandkheda