Study Start Up Associate II – Medical Device

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

📋 Description

• Execute site start-up activities for clinical trials concerning the preparation and approval of regulatory documents.

• Work autonomously and take the initiative to coordinate all essential activities for site regulatory submissions.

• Oversee multiple sets of critical regulatory documents across various studies and division portfolios.

• Collaborate with clinical sites to aid in the negotiation and customization of the Informed Consent Form (ICF).

• Cultivate and enhance relationships with clinical research sites to establish expertise in the field.

• Ensure target timelines for IRB/EC are met by assisting clinical research sites with the application submission process.

• Address and resolve site start-up challenges to minimize impact on service level agreements and study objectives.

• Develop, prepare, complete, and track all necessary regulatory, ICF, and legal documentation.

• Assist with internal quality audits and regulatory inspections as needed.

• Provide leadership with updates on site start-up activities, investigator readiness, regulatory submissions, approval statuses, and more.

⛳️ Requirements

• Bachelor’s Degree or an equivalent blend of experience and education.

• Over 3 years of experience in clinical/scientific research and medical device fields, particularly in clinical study site start-up within the US.

• Experience in the medical device industry is preferred but not mandatory.

• Relevant clinical research certifications (e.g., CCRP, SOCRA) may be accepted in place of direct medical device experience.

• Experience executing the core functions of a Trial Operations CRA in the pharmaceutical, biotechnology, or related clinical research sectors is advantageous.

• Capacity to handle multiple tasks: support various studies and/or personnel simultaneously, working in a highly dynamic environment.

• Ability to collaborate in a team setting and exhibit clear, concise communication and presentation skills—both written and verbal.

• Must be comfortable engaging with clinical research site personnel via phone and email.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.