07/10 Roxana Vazifdar
Specialist Recruiter at ApicalGo Consultancy

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Senior Clinical Research Associate (3-6 yrs)

Chennai/Delhi/Mumbai Job Code: 11982

PRIMARY PURPOSE:

The Sr. Clinical Research Associate (SrCRA) is responsible for monitoring clinical study sites to ensure compliance with clinical trial protocol, to check clinical study sites- activities, to make on-site visits, to review Case Report Forms (CRFs) and to communicate with Clinical Research Investigators. The SrCRA is also responsible for supporting the planning, coordination and management of clinical studies including investigator selection, site management, and preparation of clinical study documents in accordance with regulatory requirements.

RESPONSIBILITIES;

- Collaborates with clinical investigators to determine study design.

- Contribute to project-specific site initiation activities, track readiness status of sites for study initiation.

- Conduct monitoring activities including site initiations, monitoring and close-outs at clinical trial sites for low to medium risk/complexity studies.

- Responsible for writing and distributing time sensitive site visit reports, tracking resolutions of outstanding issues, and ensuring compliance with regulatory requirements, ICH guidelines, Standard Operating Procedures (SOPs), the study protocol and overall research objectives.

- Assists in preparation of clinical trial documentation, case report forms, protocols, monitoring report templates, and informed consent/assent documents etc. in accordance with project and regulatory requirements.

- Coordination with external vendors such as translation agencies, drug storage depot, central laboratories etc.

- Assists in development of project materials such as project Standard Operating Procedures (SOPs), Manual of Procedure (MOP), User Guides, etc.

- Identifies areas requiring follow-up and improvement at each clinical study site and reports findings to project leadership team.

- Collection and/or review of essential documents from participating sites for filing in Trial Master File during the study life cycle.

- Assists with maintenance and reconciliation of Trial Master File.

- Participates in protocol review calls with participating sites and prepares resulting summaries. Review includes assessment of completeness and compliance with regulatory requirements.

- Prepares and/or attends project team meetings and provides updates on project status and site-specific performance.

- Conduct training sessions if necessary, for new site personnel on GCP and study protocol requirements.

- Participate in corporate QA activities through Internal Quality Audit Team (IQAT), and internal/ external audits, as applicable.

- Attends and participates in project and functional area meetings and continuing education.

EXPERIENCE:

- Requires Graduate/Post Graduate in Life Sciences with 3-6 years- work experience in core monitoring services.

- Certified Research Professionals (preference).

- Familiarity in MS Word and Excel.

- Flexibility in time management.

- Should be able to work independently and as a team player.

- Attention to detail with good written and verbal communication skills.

- Possesses knowledge of GCP and local country regulatory requirements

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