Clinical Trials Management Associate jobs in United States
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Unicon Pharma Inc ยท 1 day ago

Clinical Trials Management Associate

Unicon Pharma Inc is involved in the pharmaceutical industry, and they are seeking a Clinical Trials Management Associate. The role involves conducting site evaluations, ensuring compliance with protocols, and assisting in the coordination of CROs or vendors for clinical trials.

BiotechnologyMedicalPharmaceutical
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Satish Reddy
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Responsibilities

Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas. With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required:
Assures site compliance with the routine protocol and regulatory requirements and quality of data. Assists in the setting and updating of study timelines
Assists in CRO or vendor selection
With guidance from supervisor coordinates CROs or vendors
Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans
Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
Participate or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams (May participate in abstract presentations, oral presentations and manuscript development)
Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials

Qualification

Clinical Research AssociateSite evaluationsFDA RegulationsICH GuidelinesGCPsData analysisProtocol draftingSoft skills

Required

Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas
With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required
Assures site compliance with the routine protocol and regulatory requirements and quality of data
Assists in the setting and updating of study timelines
Assists in CRO or vendor selection
With guidance from supervisor coordinates CROs or vendors
Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans
Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
Participate or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams
Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials

Company

Unicon Pharma Inc

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Unicon Pharma provides customized workforce solutions for life sciences companies, bringing innovative treatments from concept to reality.

H1B Sponsorship

Unicon Pharma Inc has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (71)
2024 (58)
2023 (71)
2022 (80)
2021 (91)
2020 (87)

Funding

Current Stage
Growth Stage

Leadership Team

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Ravi Kollipara
CEO
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Company data provided by crunchbase