Clinical Research Associate

Vizen Life Sciences Pvt Ltd; Hyderabad; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Vizen Life Sciences Pvt Ltd in Hyderabad seeks a Clinical Research professional to manage study start-up activities at investigational sites, assess feasibility, and coordinate regulatory submissions. The role covers site qualification, IP handling, training, and end-to-end site management.

The ideal candidate holds a Master’s in Pharmacy or related field and 2–5 years of research experience, with strong coordination and documentation skills to ensure quality data and compliance.

Qualifications

• Educational qualification: Master degree in pharmacy/ life science/Biology/Biotechnology/ Biochemistry/Diploma in Clinical Research
• Minimum work experience: 2 - 5 years of research experience

Responsibilities

• Facilitate Study Start up activities at Clinical Investigational Site
• Conduct Feasibility & assess the data
• Conduct site qualification visits to assess suitability of sites for study conduct including review of Investigator qualifications, site staff adequacy, site facilities, patient pool & share feedback to project team
• Collection of essential documents including validation records for site equipment from selected sites for regulatory and EC submissions
• Identify the training needs for the site to perform adequate conduct of trial
• Ensure supply of clinical trial material to sites before study initiation
• End to End clinical investigational site management:
• Initiate the study at clinical investigational sites
• Provide study protocol and related trainings
• Perform review of Informed Consent forms and narrative
• Perform review of source records, perform SDV
• Review of CRF data entry, data queries and coordinate with sites to resolve
• Ensure timely completion and review of site visit reports and addressing action items via follow up letters, tracking of action items till closure
• IP accountability and reconciliation
• Ensure adequate initial supply & re-supply of IP per study plan to clinical trial sites
• Provide adequate oversight to IP collection, storage, temperature monitoring including review of log, administration to study subjects
• Identification of any temperature excursions and suitability of IP for subject administration
• Ensure destruction of expired / used IP on site or return of such IP back to local depot, per study requirement & adequate documentation for same.
• Review of completion of logs, filing of relevant shipment etc. documentation in site / pharmacy file.
• Site Contracts and Site Payment Coordination
• Coordinate for CDA, Clinical trial agreements review and finalization and amendments, as applicable
• Ensure that site invoices are being generated as per clinical trial agreement
• Review and approval of site invoices and submission to payment processing team
• Coordinate for the payment release & confirm for site acknowledgements
• Perform ongoing reconciliation of payments against site activities including subject visits conduct etc.
• Liaising with safety lab for timely samples receipt, processing and release of reports & identify, resolve any issues / risks around same.

Skills

Clinical research coordination

Site management

IP accountability

Documentation

Regulatory submission

Education

Master degree in Pharmacy

Diploma in Clinical Research

Biology/Biotechnology/Biochemistry degree

Job description

Responsibilities

• Facilitate Study Start up activities at Clinical Investigational Site
• Conduct Feasibility & assess the data
• Conduct site qualification visits to assess suitability of sites for study conduct including review of Investigator qualifications, site staff adequacy, site facilities, patient pool & share feedback to project team
• Collection of essential documents including validation records for site equipment from selected sites for regulatory and EC submissions
• Identify the training needs for the site to perform adequate conduct of trial
• Ensure supply of clinical trial material to sites before study initiation
• End to End clinical investigational site management:
• Initiate the study at clinical investigational sites
• Provide study protocol and related trainings
• Perform review of Informed Consent forms and narrative
• Perform review of source records, perform SDV
• Review of CRF data entry, data queries and coordinate with sites to resolve
• Ensure timely completion and review of site visit reports and addressing action items via follow up letters, tracking of action items till closure
• IP accountability and reconciliation
• Ensure adequate initial supply & re-supply of IP per study plan to clinical trial sites
• Provide adequate oversight to IP collection, storage, temperature monitoring including review of log, administration to study subjects
• Identification of any temperature excursions and suitability of IP for subject administration
• Ensure destruction of expired / used IP on site or return of such IP back to local depot, per study requirement & adequate documentation for same.
• Review of completion of logs, filing of relevant shipment etc. documentation in site / pharmacy file.
• Site Contracts and Site Payment Coordination
• Coordinate for CDA, Clinical trial agreements review and finalization and amendments, as applicable
• Ensure that site invoices are being generated as per clinical trial agreement
• Review and approval of site invoices and submission to payment processing team
• Coordinate for the payment release & confirm for site acknowledgements
• Perform ongoing reconciliation of payments against site activities including subject visits conduct etc.
• Liaising with safety lab for timely samples receipt, processing and release of reports & identify, resolve any issues / risks around same.

Qualification & Experience

• Educational qualification: Master degree in pharmacy/ life science/Biology/Biotechnology/ Biochemistry/Diploma in Clinical Research
• Minimum work experience: 2 - 5 years of research experience