| Job Purpose: This position will oversee the clinical trial process from startup activities to site close out including onsite monitoring across a range of therapeutic areas. |
| Core Principal Activities: 1. Site Monitoring · 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. · 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.
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| - 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.
- Provide input into development of Informed Consent Form.
- 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.
2. Issue Resolution - Resolve issues as they affect clinical plan timelines and quality to ensure achievement of goals and objectives at the site level.
- Ensure proper escalation of site/project related issues.
3. Intervention and Coaching To provide consultant value to personnel involved in a clinical trial team (i.e. site coordinator etc.): · Clinical trial and regulatory expertise in development and application of procedures, documents, training materials, communications, and/or tools. · Ongoing review of procedures and practices for maintenance. · Resolving queries (both internal and external) relative to current processes, regulatory guidelines, and/or quality (including policies and procedures, ICH-GCP and applicable regulations). · Delivery of education and training initiatives. · Ensuring regulatory compliance. 4. 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 with in the organization.
- Regular participation in project/departmental meetings.
5. Liaison with Other Departments - Work in liaison with the finance department at SIRO in the organization and administration of financial payments to the investigators or relevant local institutions.
- Work in liaison with the administration at SIRO for the timely management of vendors and site related infrastructure support to the investigators or relevant local institutions
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| - To liaise with other departments within the organization for timely achievement of the project milestones.
6. Assets Protection Appropriately manage discussions with internal and external personnel regarding the sharing of proprietary and confidential information. - Aware & adhere to protect company assets while traveling or during conversation.
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| Other Activities : - Responsible for monitoring the progress/performance of all projects to include quality of services provided timeliness of deliverables and compliance with regulatory requirements.
- Regular filling the movement details in the movement sheets in one week advance at least and updating the same on day to day basis.
- At any point of time 100% time should be reflected/accounted for in the timesheets.
- To participate in the departmental training activities and attendance level should be minimum 90% in all such in-house training programs.
- To participate in various on-going assessment programs for CRA's as per the departmental policies to documents performance and to provide feedback to address any deficiencies.
- To comply and abide by discipline, guidelines and policies of the organization.
- To comply and meet the timelines/policies/procedures of other support functions (i.e. finance, administration etc).
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| Qualifications and Skills: (List the education / training / certifications required) - Doctarate, Master's or Bachelors Degree. Major course of study must be Science or Health-related. (i.e. Ph.D, M.Pharm, B.Pharm., MBBS, M.Tech (Biotec), M.Sc, etc)
- Understanding of clinical research process and ICH GCP is must
- Basic understanding of the drug development process is must.
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| Experience: (No. of years and kind) - 2- 3 years relevant experience, preferably with a CRO (for a CRA)
- 4- 5 years relevant experience ,preferably with a CRO (for a Sr CRA)
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| Skills and Attitudes: (Technical & Soft skills – Which are over and above the standards given below) - Effective oral and written communication skills
- Must have the ability to work independently and collaboratively on a project.
- A thorough understanding of clinical trial design in various therapeutic areas, trial monitoring practices and all aspects of the drug development process is essential.
- A thorough knowledge of GCP and applicable regulatory guidelines and their impact on all areas of the clinical trial process is must.
- Highly quality conscious, with strong customer focus
· Highly systems & result oriented approach required - Performance with Integrity: Must deliver on clinical study milestones whilst operating according to SOPs and Good Clinical Practices.
- Quality/Performance Driver: Recognizes competing priorities and requests prioritization to meet deadlines when performance standards are in jeopardy.
- Problem Solving: Identifies problems and offers reasonable solutions
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David
Ida Solutions, Inc
david@idasolutions.net
Success…and why nothing succeeds like it.
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