Central Monitor, Clinical

4 weeks ago

Mumbai, India BIORASI LLC Full time

We are Growing Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization, and we are unlike any CRO you’ve ever heard of.

Biorasi is looking for top performers who are as passionate about clinical research as we are - clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.

Start your career journey at Biorasi today with our newest opportunity
- **Centralized Monitor**

**Overview**
- We are international: Our headquarters is in Aventura, Florida. Other locations are Germany, India, Russia, and Ukraine.
- Our work culture includes: teamwork, hands-on mentality, flexibility, and open communication.
- Development and worklife balance: We want our employees to develop personally as well as professionally

**Your Responsibilities**
- Study Start-up: Support Clinical Trial Manager in site initiation, to include preparing and/or reviewing study-related documents (e.g., Monitoring Task Force Plan, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines, study logs and forms) and review of regulatory documents required for initiation of a clinical trial.
- Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.
- Follow Monitoring Task Force Plan as per the study requirements; perform eligibility review, remote evaluation of study data based on On-Study Analytics reports and provide actionable task to CRAs and Clinical Trial Manager.
- Reviews patient data listings and visualizations via analytical dashboards and/or reports to confirm eligibility, identify protocol deviations, patient safety concerns, data integrity issues and illogical/inaccurate/missing data.
- Assist in prioritizing of workflow for CRAs; assist in issuing SDV target and level changes for CRAs.
- Reviews action resolutions completed by CRAs and confirms that they adequately and completely resolve the issues raised.
- Escalate findings to the Manger Central Monitoring and CTM on studies assigned.
- Document and Supplies Management: assist project team in the collection, review and filing of site essential documents, and maintenance of the TMF. Assist in the tracking of clinical supplies at site in coordination with established systems such as IWRS, EDC and CTMS.
- Participates in project team meetings as applicable and attends clinical training sessions according to the project specific requirements.
- Compliance: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participates in the planning of quality assurance activities and coordinates resolution of audit findings.
- May serve as point of contact for any clinical queries from the investigators, nurses, and study coordinators and escalate to Medical Monitor in a timely manner.
- Other duties as assigned.
- Bachelor’s Degree in biomedical sciences or related scientific discipline; or sufficient work experience in related field
- Fluent English (oral and written) and applicable local business language.
- Minimum three years of monitoring experience or combination of clinical research coordinator and or other relevant clinical research experience. Experience with Risk based monitoring preferred.
- Sound knowledge of medical terminology and clinical monitoring process.
- Sound knowledge of medical terminology and clinical monitoring process.
- Excellent verbal, written communication skills.
- Knowledge and experience with MS Office suite (at a minimum Word, PowerPoint and Excel).

**About Our Company**

We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being. Our employees enjoy half-day Fridays, paid time off, paid holidays, extensive country specific benefits, employee bonus programs, career growth, training and development.

Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

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