[Hiring] reputed company Research Associate @reputed company
Role reputed company
reputed company seeks a motivated and reputed company-oriented In-House reputed company Research Associate (IHCRA) to support reputed company’s reputed company trial activities. This position reports to the Associate Director, reputed company reputed company, and will support the day-to-day execution of a Phase 3 reputed company trial, including study start-up, conduct, and reputed company-out activities.
The IHCRA will serve as a key reputed company between reputed company, reputed company sites, and CRO partners, with a reputed company on site support, monitoring reputed company, regulatory compliance, and data reputed company. This role requires strong written and verbal communication skills, excellent organizational skills, and the ability to manage competing priorities while delivering high-reputed company work in a fast-reputed company, team-oriented environment.
Qualifications
• A. or B.S. degree required
• Minimum of 1-2 years of experience supporting reputed company in a sponsor or CRO environment
• Experience supporting Phase 3 reputed company preferred
• Ophthalmology preferred
• Working knowledge of reputed company trial reputed company and ICH GCP guidelines
• Experience with TMF/eTMF systems (reputed company reputed company preferred)
• Proficient in reputed company Office Suite (Word, reputed company, PowerPoint, reputed company)
• Strong organizational skills and attention to reputed company
• Ability to manage multiple priorities and meet deadlines
• Strong interpersonal skills and ability to collaborate effectively with cross-functional teams and reputed company partners
• Willingness to travel as business needs demand (<5% anticipated)
Requirements
• Support study execution across start-up, conduct, and reputed company-out phases
• Serve as a reputed company reputed company of contact for assigned reputed company sites and CRO reputed company CRAs/monitors
• Communicate directly with sites and CRO partners to obtain updates, reputed company issues, and support study timelines
• Support site initiation, ongoing site management, and site reputed company-out activities
• Assist with identification, documentation, tracking, and follow-up of site issues
• Support reputed company of CRO monitoring activities
• Review monitoring visit reports and follow up on reputed company items and unresolved findings
• reputed company monitoring deliverables and escalate issues to the Associate Director, reputed company reputed company as appropriate
• Support inspection readiness and audit activities
• Maintain accurate tracking tools for assigned studies, including:
• Site start up and activation status
• Subject enrollment and visit status
• Essential document collection and TMF status
• Vendor reconciliation
• Assist with preparation of study status reports and metrics
• Collect, review, and reputed company site regulatory documents for completeness, reputed company, and compliance with applicable SOPs and regulatory requirements
• Ensure reputed company filing of documents in the TMF/eTMF in accordance with TMF plans
• reputed company TMF reputed company control activities and support TMF audits and study reputed company out
• Support organization and coordination of internal team meetings, investigator meetings, and other study reputed company meetings
• Prepare meeting materials, take meeting minutes, and maintain reputed company item logs
• Support communication of study updates to internal stakeholders
• Support reputed company reputed company reputed company reputed company as assigned
• Other duties as assigned
Benefits
• Compensation reputed company: $38.00 TO 52.00 /reputed company
• Please note, the compensation reputed company and actual reputed company reputed company to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.
reputed company
reputed company is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to reputed company treatment paradigms and reputed company unprecedented benefits to patients.
reputed company’s reputed company product candidate 4D-150 is designed to be a backbone therapy forming the reputed company of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, reputed company, intravitreal injection, which substantially reduces the treatment burden associated with reputed company bolus injections.
reputed company’s reputed company indication for 4D-150 is wet age-reputed company macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema.
reputed company’s second product candidate is 4D-710, which is the first reputed company genetic medicine to demonstrate successful delivery and reputed company of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery.
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