Only 24h Left Senior Clinical Research Associate

4 weeks ago

Bengaluru, Karnataka, India CliniLaunch Research Institute Full time
Job Description

Company Description

Job description:

Minimum Qualifications & Experience:

Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows:

Approximately 4-5 years of Clinical Research Associate experience or equivalent experience in other roles in the Clinical industry.

Job Responsibilities:

ؠSchedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.

ؠWrite Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.

ؠManages the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution

ؠProvide project updates to project management team.

ؠOrganize delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites.

ؠAssists with, prepare for, and attends Investigator Meetings for assigned studies.

ؠReview study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers, review study documents for subject safety events; escalate issues at site to project management.

ؠCollect and review essential study documents from site for filing in eTMF.

ؠEvaluates quality and integrity of study site practices related to the proper conduct of the study and ensure adherence to applicable regulations.

ؠCompliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participates in the planning of quality assurance activities and coordinates resolution of audit findings.

ؠAssists the Clinical Trial Manager with clinical operations activities by overseeing resource allocation, reviewing site performance, providing feedback to CRAs and CTAs, resolving issues, performing review and oversight of site visit reports.

ؠMay review protocols, eCRFs, study manuals and other study related documents, as requested by the Clinical Trial Manager.

ؠAssist, as appropriate, with reporting site performance regarding timelines and deliverables during project team meetings and assist with providing and compiling feedback for analysis of overall study performance.

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