Clin Process Spec 1

Job Overview

Provide project related assistance for assigned project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.

Essential Functions
- Draft and update the study monitoring Plan for Sponsor studies/protocols.
- Preparing, handling, distributing, filing, and archiving of study related logs and form.
- Assist with periodic review of study files for accuracy and completeness.
- Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Develop, Prepare, & Maintain the Global study performance dashboard by acquiring data from primary or secondary data sources.
- Assist the Study team in various phases such as planning, maintenance and close out activities by providing detail analysis of the data as per the requirement in the form of report.
- Assist the project team to mitigate the risk for a trial which is under high risk by giving detailed analysis report.
- Support the project team and various stakeholders by accurately updating and maintaining the required data in the systems/tools within provided timelines.
- Work with various stakeholders to prioritize business and information needs.
- Responding to information requests from different stakeholders.
- Resolving discrepancies in the data and obtaining further details for incomplete information.
- Identify, analyze, and interpret trends or patterns for various metrics.
- Analyze future and current end user requirements to improve clinical operations.
- Engage in on the job training, quality improvement initiatives and departmental orientation.
- Track monthly retrospective quality issues for the internal team members
- Collaborate with Information Technology and clinical staff to support defined business needs.
- Design clinical and administrative reports.
- Develop and analyze systems to obtain necessary output for specific requirements.
- Perform administrative tasks to support team members with clinical trial execution as needed.
- Advocate compliance with all standard operating procedures.
- Assist with tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
- Meeting the Sponsor representatives/Trail Managers and proving support on study related activities
- Assit in eTMF activity
- filing/initial QC and classification of documents into TMF, Perform detailed quality checks of documents uploaded into the TMFs
- May be assigned role of systems expert - guiding teams on using of systems, creating guidance documents, updating trainings relevant to the systems and any new updates available in the systems. relaying the trainings to the team and be available to address the quesries for the teams.
- Provide SME support/Training and development

**Qualifications**:

- Bachelor's Degree Bachelor's degree in a healthcare or other scientific discipline or educational equivalent

Req
- 3 years of Clinical Research experience, including a minimum of 2 years on-site monitoring experience.
- r equivalent combination of education, training and experience.
- "Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.

3 years overall experience
- Equivalent combination of education, training and experience"

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