Clinical Research Associate | Alkem | Mumbai

Job Description

• The CRA is responsible for supporting studies under Medical Affairs team including Phase III, IV studies, PMS, PASS, and Clinical drug research and administration support.
• You will work closely with CRO (Clinical Research Organizations), CTA’s, Regulatory and Pharmacovigilance team who monitor the progress of the study, along with Medical Advisors.
• You will work together with CRO, site coordinators, and occasionally with researchers and physicians (investigators) in clinics/hospitals where respective clinical trials are being conducted.

Job Functions/Responsibilities:

• 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.
• Review and approval of MSAs (agreements) in coordination with legal team
• Dossier preparation for Phase IV studies as per regulatory requirements
• Approvals of day to day invoices from CROs and vendors
• To assist in the production of slides, overheads, etc., as needed for the project, departmental, sponsor, and/or business development presentations.
• Providing project status reports to senior management on a timely basis
• Uses judgment and experience to evaluate the overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
• Proactively manage project-level operational aspects of the trial team, including management of trial timeline, budget, resources, and vendors, etc.
• Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner
• Involves in activities like contract review, budget allocation to sites, etc.
• Perform investigational product (IP) inventory, reconciliation, and review storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
• Other duties as assigned

Qualification/Experience Required:

• In addition to prior education, a completed pharmaceutical or administrative education or a higher level (Bachelor or Master) in Life Sciences;
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• Research or healthcare-related academic or work experience is preferable
• Good organizational skills, ability to manage multiple tasks, and meticulous attention to detail.
• Good written and verbal communication skills.
• Good written and spoken English.
• Knowledge of medical terminology;
• Knowledge of GCP
• Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook
• Willingness to travel for job-related activities if required (expected travel for this position is < 20%).

Qualification: B.Pharma, M.Pharma, MBA/PGDM, MS/M.Sc(Science)