Talentify
In-House Clinical Research Associate (Biotech - REMOTE)
This job is now closed
Job Description
- Req#: JP-005734109
Employer Industry: Biotechnology
Why consider this job opportunity:
- Salary up to $115,000 per year
- Discretionary bonus plan and stock option grants
- Comprehensive health benefits and a 401(k) with match
- Fully remote position with occasional travel (10-20%)
- Opportunity for career advancement within a growing Clinical Development team
- Engaging work environment in a dynamic start-up atmosphere
What to Expect (Job Responsibilities):
- Support the Trial Manager in tracking regulatory submissions and approvals, recruitment, and enrollment for assigned studies
- Assist in site start-up activities, including oversight of CRO start-up activities and participation in initiation visits
- Collaborate with the contracts team to review and negotiate site and vendor budgets/contracts
- Participate in CRO monitoring activities and co-monitoring visits to ensure compliance with protocol and regulatory requirements
- Adhere to Clinical Operations processes and maintain studies in an 'inspection ready' state
What is Required (Qualifications):
- Minimum of 4 years of relevant clinical operations experience
- Bachelor's degree in Life Sciences with at least 2 years in a pharmaceutical sponsor environment
- Proven monitoring oversight experience, including co-monitoring or remote monitoring
- Familiarity with TMF activities, including review of TMF index and document provision
- Excellent attention to detail and strong verbal, written, interpersonal, and presentation skills
How to Stand Out (Preferred Qualifications):
- Experience in vendor management and clinical research
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs
- Ability to participate in strategic initiatives under general supervision
- High energy, personal productivity, initiative, creativity, and commitment
- Team-player attitude, eager to work in a fast-moving, dynamic start-up environment
#Biotechnology #ClinicalResearch #RemoteWork #CareerGrowth #LifeSciences
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