Job description
Ensure study start up, conduct, close out and archival
• IEC administration work for our IEC
• Lead the team with daily calls, work allocation and ensure TAT, SLAs
• Facilitate Pre-study, Site qualification and feasibility, Study initiation
• Co-ordinates all required activities between Sponsor / CRO/ Investigator / EC
• EC submissions, review and approvals
• Co-ordinates Protocol related research procedures, study visits, and follow-up care Screen, recruit and enroll patients/research participants
• Collect, process and ship laboratory specimens Schedule subject visits and procedures
• GCP compliant study conduction and documentation and e CRF data entry for delegated trials
• Manage all logistics and co-ordinate with internal or external stakeholders
• Facilitate sponsor/CRO visits at sites, monitoring visits, audits and inspections
• Safety reporting: SAE and Adverse event monitoring, documentation and regulatory compliance
• Training and supervision of trial team at site / research staff
• Facilitate study close out activities
• Coordinate research/project team meetings
• Retain records/archive documents after study close out Facilitate Pre-study, site qualification and feasibility, study initiation.
• Clinical data outcomes, compliance for allocated centers, clinical summary, follow up on data validations and upload functions.
• Prescription data, Clinical reports, Baseline report, Adverse event reports etc. from the BO along with the follow up on allocated centers. Clinical outcome and validations of upload image functions. Follow up with allocated number of centers.
• Extensive work on excel and tools for data evaluation.
Job Specification
• Qualification: Bachelors degree - Life Sciences background with Clinical Research course
• Knowledge on Phase of Clinical Trials and ICH GCP E6 guideline
• ICMR guidelines
• Training skills
Functional Competencies
• Communication skills
• ICH GCP E6
• SICMR guidelines
Behavioral Competencies
• Trust & Integrity
• Flexibility
• Quality & Excellence
Good team playe Role & responsibilities

Role: Healthcare & Life Sciences - Other
Industry Type: Clinical Research / Contract Research
Department: Healthcare & Life Sciences
Employment Type: Full Time, Permanent
Role Category: Healthcare & Life Sciences - Other

Education
UG: B.Sc in Nursing

Key Skills
ICMR Guidelines ICH GCP E6 Clinical Research Clinical Data Management Clinical Trials