Job Description
Site Monitoring
• Regulatory/ethics submission of CT 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 selection visits. 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 and prepare monitoring reports
• 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 that the clinical trial supplies are appropriately handled and adequately maintained at the site as per the project requirements.
• Evaluates 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.
• Conduct site close out and assure appropriate archival of controlled documents.
• Maintain contacts outside the regular onsite visits, by appropriate communication means, to regulate or to motivate work to be performed by investigators or their staff. These contacts are always recorded and regularly transmitted to the project manager/project team.
• Organize travel and movements to the best cost efficiency and in respect of the general rules and procedures of the company.
Site Monitoring
• Regulatory/ethics submission of CT 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 selection visits. 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 and prepare monitoring reports
• 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 that the clinical trial supplies are appropriately handled and adequately maintained at the site as per the project requirements.
• Evaluates 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.
• Conduct site close out and assure appropriate archival of controlled documents.
• Maintain contacts outside the regular onsite visits, by appropriate communication means, to regulate or to motivate work to be performed by investigators or their staff. These contacts are always recorded and regularly transmitted to the project manager/project team.
• Organize travel and movements to the best cost efficiency and in respect of the general rules and procedures of the company.
Teamwork
• Proactively contributes to an atmosphere of teamwork,
• Meet or exceed the planned metrics and expectations of sponsors/team/project manager.
• Undertake the delegation of duties within the organization.
• Regular participation in project/departmental meetings.
• Proactively contributes to an atmosphere of teamwork,
• Meet or exceed the planned metrics and expectations of sponsors/team/project manager.
• Undertake the delegation of duties within the organization.
• Regular participation in project/departmental meetings.
Liaison with Other Departments
• Work in liaison with the finance department in the organization and administration of financial payments to the investigators or relevant local institutions.
• Work in liaison with the administration for the timely management of vendors and site related infrastructure support to the investigators or relevant local institutions.
• To liaise with other departments within the organization for timely achievement of the project milestones.
• Work in liaison with the finance department in the organization and administration of financial payments to the investigators or relevant local institutions.
• Work in liaison with the administration for the timely management of vendors and site related infrastructure support to the investigators or relevant local institutions.
• To liaise with other departments within the organization for timely achievement of the project milestones.
Candidate Profile
• Doctorate, Master’s or Bachelor’s Degree. Major course of study must be Science or Health-related. (i.e. M.Pharm, B.Pharm. MBBS, M.Tech (Biotech), M.Sc, B.Sc along with some diploma in clinical research etc)
• Understanding of clinical research process and ICH GCP
• Basic understanding of the drug development process
• Doctorate, Master’s or Bachelor’s Degree. Major course of study must be Science or Health-related. (i.e. M.Pharm, B.Pharm. MBBS, M.Tech (Biotech), M.Sc, B.Sc along with some diploma in clinical research etc)
• Understanding of clinical research process and ICH GCP
• Basic understanding of the drug development process
Additional Information:
Qualification : M.Pharm, B.Pharm. MBBS, M.Tech (Biotech), M.Sc, B.Sc
Location : Bangalore
Industry Type: Pharma / Healthcare / Clinical research
Functional Area: R&D
Last Date: 30th January, 2019
Qualification : M.Pharm, B.Pharm. MBBS, M.Tech (Biotech), M.Sc, B.Sc
Location : Bangalore
Industry Type: Pharma / Healthcare / Clinical research
Functional Area: R&D
Last Date: 30th January, 2019
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