Alkem Laboratories Released Job Openings On 13/08/2022.With an illustrious journey which stands at striking distance of completing 5 decades, Alkem Laboratories manufacturing and marketing companies from India
Vacancy Details:
Alkem Laboratories Recruiting B.Pharma,M.Pharma,MBA Graduates with minimum 05-10 years Experience for Clinical Reseach Associate Position.Complete Details for the Clinical Reseach Associate as follows.
Important Details :
- Job Location: Mumbai
- No of Vacancies:NA
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 13/08/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
- To support the Medical Affairs teams with ongoing conduct of studies.
- Clinical trial coordination with various stakeholders including Regulatory team, Drug depot, Accounts, Packaging & labeling, CRO, Vendors, and courier services
- To provide general project and administrative support to the Medical Affairs team for identified studies including Phase IV, PMS, studies, etc.
- To be familiar with ICH GCP, appropriate regulations, relevant SOPs, and internal tracking systems.
- Responsible for organizing and maintaining the complete documentation for the studies assigned to you with the aim of ensuring complete and correct study administration in accordance with the SOPs (Standard Operating Procedures), as well as the ICH-GCP guidelines, including preparation for internal/external audits, final reconciliation and archival.
- Participating in the preparation, review, updating, and training of SOPs
- You will have an important task in study start-up, (digital) sending, tracing, and administration as well as saving of essential documents (e.g. CRFs, CVs, study protocols, investigator brochures, informed consent forms, and study supplies such as study medication and laboratory supplies).
- To be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate, performs site qualification, site initiation, interim monitoring, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP, and protocol compliance
- To process Data Collection Forms i.e. log-in, tracking, quality control as appropriate for the study.
- To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
- To coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary, lab supplies, drug supplies) as appropriate.
- To assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
- To assist in the coordination of CRO, Investigator payments, etc
- Identifying needs, bottlenecks, and deviations within your own study team
- To contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
- To assist in the tracking and distribution of safety reports.
- To coordinate document translation, if required.
- To assist the Medical Advisor and project team with project team meetings, Investigator Meeting coordination, activities preparation, and generating meeting minutes.
