Study Start-up Associate I, II

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Act as the primary liaison for study sites during the initiation phase.

• Collaborate within a team to manage various clinical study protocols.

• Oversee all regulatory responsibilities associated with designated studies.

• Evaluate Sample and Site Informed Consent forms to ensure compliance with FDA regulations.

• Review and authorize site activation packages.

• Guarantee that all assigned start-up activities are progressing as planned and align with study objectives.

• Maintain accurate, complete, and up-to-date information in relevant databases.

• Organize regulatory information and monitor study documentation.

• Gather and assess regulatory documents for completeness and adherence to FDA rules and study sponsor requirements.

• Manage filing in the eTMF system and uphold accurate Trial Master File maintenance.

• Ensure consistent follow-up with sites and timely collection of necessary documents.

• Strive for maximum efficiency to minimize start-up timelines and identify areas for continuous improvement.

• Investigate regulatory issues and offer guidance and support to colleagues.

• Participate in various start-up and Sponsor Kick-Off meetings.

• Escalate study-related issues as necessary and in a timely fashion.

• Carry out additional responsibilities as assigned.

⛳️ Requirements

• A Bachelor’s degree is required, preferably in a life science discipline or its equivalent.

• 1-4 years of relevant work experience is required.

• Experience in oncology clinical trials is essential.

• Experience with randomized (larger trials) is required.

• Prior experience in a CRO/pharmaceutical setting is preferred.

• Experience with Informed Consent and regulatory document review is required.

• Proficient in Microsoft Word and Excel.

• Strong attention to detail is necessary.

• Familiarity with eTMF systems is preferred.

• Exceptional verbal and written communication skills are essential.

• Fluent in both written and spoken English.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Life insurance.

• Disability insurance (STD/LTD).

• Company-matched 401(k).

• Highly competitive tuition reimbursement.

• Generous vacation and sick leave policies.

• Flexible work schedules.

• Employee discounts and various other company-provided benefits.