Ipca is a fully integrated, rapidly growing Indian pharmaceutical company with a strong thrust on exports. Ipca's APIs and Formulations produced at worldclass manufacturing facilities are approved by leading drug regulatory authorities including the US-Food and Drug Administration (FDA), UK-Medicines and Healthcare products Regulatory Agency (MHRA), South Africa-Medicines Control Council (MCC), Brazil-Brazilian National Health Vigilance Agency (ANVISA) and Australia-Therapeutic Goods Administration (TGA). With operations in over 100 countries, exports account for over 52% of the company's income.
Positions: Clinical Research Associate
Job Description:
* Developing and drafting study protocol, CRF, IB, PIS, ICF, financial agreements and patient diary and other CT documents.
* Identification and selection of study Investigators.
* Doing ethics committee submissions to seek EC approval
* Coordinate with vendors like courier services, translation agencies, printing agencies, diagnostic kit suppliers, central pathology laboratory etc.
* Ensuring CT supplies are maintained at all the sites till completion of assigned studies.
* Administer protocol and related study training to assigned sites.
* Perform monitoring visits, SDV as per the protocol and applicable regulations.
* To Track the progress of assigned studies wrt regulatory submissions and approvals, recruitment and enrolment rates, CRF completion and submission, and data query generation and resolution.
* Prepare monitoring reports and action plans regarding site management.
* Filing and collating trial documentation and reports.
* Report site issue (i.e, non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction) to head of the department
* Face internal quality audits
* Preparing clinical study reports and manuscripts for publication.
* To establish and maintain effective cordial working relationships with colleagues, managers and internal as well as external clients.
Candidate Profile:
Graduate and post graduate in pharmaceutical sciences or any other life-science with PGDCR/ MSc in clinical research. Individuals with excellent organizational and problem solving skills with good ability to manage competing priorities effectively. Strong verbal and written communication skills. Sound knowledge of Microsoft word, Excel, and Power Point. Effective skills on time management and business etiquettes. Willing to travel 10-12 days a month.
Additional Information:
Experience: 0-3 years
Location: Mumbai
Education: B.Pharm, M.Pharm, M.Sc, B.Sc
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: CR
Mail your CV to: sunitaf@ipca.co.in, nitinchandurkar@ipca.co.in
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