Clinical Research Associate

1-5 years

Not Disclosed

Mumbai

15 June 6, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.

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.

Your role:

Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
Manages the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment, and enrolment, CRF completion and submission, and data query generation and resolution
Provide project updates to project management team.
Organize delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites.
Perform investigational product inventory, ensuring return of unused investigational product to designated location or verifies destruction as required.
Assists with, and attends, Investigator Meetings for assigned studies.
Review study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers, review study documents for subject safety events; escalate Issues at site to project management.
Collect and review essential study documents from site for filing in eTMF.
Administer protocol and study related training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate quality and integrity of study site practices related to the proper study conduct, ensuring adherence to applicable regulations.
Compliances: 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.
To lead and partake in regular team meeting / teleconferences.
Assist, as appropriate, with reporting site performance regarding timelines and deliverables to the project team during team meetings and assist with providing feedback for analysis of overall study performance.
Other duties as assigned.

Your Profile:

Bachelor’s Degree in biomedical sciences or related scientific discipline
Fluent English (oral and written) and applicable local business language.
Minimum one-year monitoring experience, more experience would be preferred, along with combination of clinical research coordinator and or other relevant clinical research experience.
Sound knowledge of medical terminologies and clinical monitoring process.
Sound knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
Excellent verbal, written communication, and presentation skills.
Knowledge and experience with MS Office suite (at a minimum Word, PowerPoint, and Excel).
Effective business skills for interactive situations with peers, sites, and clients.

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com or email us at careers@biorasi.com.

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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