Sr. Clinical Research Associate
Purpose of this position will oversee the clinical trial process from startup activities to site close out including onsite
monitoring across a range of therapeutic areas.
The incumbent should have 3 - 4 years relevant experience, preferably with a CRO. Understanding of clinical research process, the
drug development process and ICH GCP is a must.
The Core Responsibilities for the position would be:
- To ensure all assigned studies follow SIRO/applicable SOPs, GCP and local regulations.
- To do all regulatory/ethics submission as per timelines and to ensure regulatory documents are available, complete and current.
- In coordination with the project manager and/or medical monitor, perform study site qualification visits. Also to participate in/conduct investigator's meeting and site initiation visits.
- To identify, define, coordinate and conduct site study training.
- In coordination with the project manager, provide oversight of all study-related activities.
- To perform regular monitoring visits to site.
- To ensure the compliance to ICH-GCP guidelines, local & international regulations (i.e. DCGI, FDA) and applicable SOPs.
- To verify the case report forms and source data according to the monitoring plan.
- To ensure complete and accurate drug accountability.
- To prepare monitoring reports.
- To maintain audit readiness at the site level.
- To ensure that the clinical trial supplies are appropriately handled and adequately maintained at the site as per the project requirements.
- To ensure site level metrics (i.e. 100% IP accountability, 100% informed consent documentation etc.) are tracked and communicated as appropriate.
- To evaluate the speed of recruitment and propose alternative solutions if the predefined objectives are not met, either in the terms of patient number or timelines.
- To resolve all data queries or other study related queries from the site within timeframe.
- To conduct site close out and assure appropriate archival of controlled documents.
- To review research protocols and amendments, informed consent documents, case report form and/or other applicable business and project related documents to provide the feedback for modification/altercations if any.
- To provide input into development of Informed Consent Form.
- To maintain contacts outside the regular onsite visits, by appropriate communication means, to regulate and motivate work to be performed by investigators or their staff. These contacts are always recorded and regularly transmitted to the project manager/project team.
- To organize travel and movements to the best cost efficiency and in respect of the general rules and procedures of the company.
- To resolve issues as they affect clinical plan timelines and quality to ensure achievement of goals and objectives at the site level.
- To ensure proper escalation of site/project related issues.