Study Start-up Associate I, II

🔥 43 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $60k - $105k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

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Theradex Oncology

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1982

🤝 B2B

🛍️ eCommerce

B2B • eCommerce • Marketing

Theradex Oncology is a comprehensive web design and development agency that specializes in providing a wide range of marketing services, including social media management, SEO, and inbound marketing strategies. The company focuses on delivering custom web solutions to businesses, with expertise in platforms like Hubspot and Shopify, and offers a variety of services such as advanced programming, graphic design, and professional video production. With a commitment to enhancing online presence and driving traffic, they serve clients locally in New Jersey and across the country.

📋 Description

• Serve as the primary point of contact to study sites during start-up • Work in a team setting managing multiple clinical study protocols • Responsible for all regulatory tasks pertaining to assigned studies • Reviews Sample and Site Informed Consent forms for compliance with the rules and regulations set forth by the FDA • Reviewing and approving site activation packages • Ensure that all assigned start up activities are on track and support study deliverables • Maintaining accurate, complete and current information in the appropriate databases • Organizes regulatory information and tracks study documents • Collecting and reviewing, of regulatory documents for completeness and compliance to the rules and regulations set forth by the FDA and the study sponsor • Filing in eTMF system and accurate Trial Master File Maintenance • Maintains Consistent site follow-up and ensure documents required are collected in a timely manner • Ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement • Researches regulatory issues and provides guidance and advice to colleagues • Participates in various start-up and Sponsor Kick-Off meetings • Escalate study issues appropriately and in a timely manner • Performs other duties as assigned

🎯 Requirements

• Bachelor’s degree required preferably in a life science field or equivalent • 1-4 years prior work experience required • Oncology clinical trials experience required • Randomized (larger trials) experience required • Prior experience in a CRO/pharmaceutical environment preferred • Prior Informed consent and Regulatory document review experience required • Proficient knowledge of Word and Excel • Detail oriented • Knowledge of eTMF preferred • Excellent verbal and written communication skills • Fluent knowledge of written and verbal English

🏖️ Benefits

• medical, dental and vision coverage • life insurance • disability insurance (STD/LTD) • company matched 401(k) • very competitive tuition reimbursement • generous vacation/sick plans • flexible work schedules • employee discounts and other company provided benefits