Senior Clinical Research Associate, Contractor Senior Clinical Research Associate, Contractor role at Biorasi
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.
Manage 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 the project management team.
Organize delivery of investigational product, laboratory supplies, CRFs and other study-specific materials to and from clinical sites.
Perform investigational product inventory and ensure return of unused investigational product to designated location or verify destruction as required.
Assist with, prepare for, and attend 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 and escalate issues at site to project management.
Collect and review essential study documents from site for filing in eTMF.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate quality and integrity of study site practices related to proper conduct of the study and ensure adherence to applicable regulations.
Comply with international GCP guidelines/regulations and SOPs for executing clinical studies. Participate in quality assurance activities and coordinate resolution of audit findings.
Assist the Clinical Trial Manager with clinical operations activities by overseeing resource allocation, reviewing site performance, providing feedback to CRAs and CTAs, resolving issues, and reviewing/overseeing site visit reports.
May review protocols, eCRFs, study manuals and other study-related documents, as requested by the Clinical Trial Manager.
May conduct on-site evaluation visits and on-site training of CRAs.
Lead and participate in regular team meetings and teleconferences.
Assist with reporting site performance regarding timelines and deliverables during project team meetings and compile feedback for analysis of overall study performance.
May serve as a mentor to associates on job performance, trainings and professional growth.
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 of three years’ monitoring experience in clinical studies involving MASH, type 2 diabetes, metabolic disease, or dyslipidemia
Sound knowledge of medical terminology and advanced proficiency in clinical monitoring process
Ability to travel up to 70%, depending on project requirements
Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
Good leadership, planning, project management, verbal and written communication skills
Knowledge and experience with MS Office suite (at minimum Word, PowerPoint and Excel)
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 .
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.
Seniority level Associate
Employment type Contract
Job function Research
Industries Research Services
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