In-House Clinical Research Associate (Biotech - REMOTE)

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 We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer. Apply tot his job Apply To this Job