What are the responsibilities and job description for the Sn Clinical Trial Associate position at Actalent?

Description

We are seeking a Senior Clinical Trial Associate to support clinical studies for mitral and tricuspid valve products and to provide interim clinical support for the Versa Vascular tricuspid repair products. As a vital part of the Clinical Affairs team, you will collaborate with key stakeholders to execute clinical studies with minimal supervision. Close cooperation with research sites, engineering, regulatory teams, biostatisticians, and other departments will be essential for this role. The role is fast-paced and evolving, requiring excellent organizational and project management skills.

• Support clinical research activities to ensure effective management of clinical studies.

• Maintain and track clinical study data, assist in investigator qualification and selection activities, monitor patient recruitment, and oversee study progress.

• Manage clinical research organizations (CRO) involved with the study.

• Oversee site start-up/activation processes, including preparing study documents such as protocols, CRFs/eCRFs, informed consent forms, and clinical monitoring plans.

• Organize IRB/EC submissions and ensure regulatory compliance for successful outcomes.

• Amend clinical study documents as needed and assist clinical sites with institutional review board submissions.

• Support on-site and remote site qualification, initiation, monitoring, and close-out visits.

• Serve as the main liaison for participating clinical trial sites, focusing on data entry, query resolution, investigational device tracking, and accountability.

• Schedule safety event reviews and develop necessary narratives and reports. Support management of CEC and DSMB if applicable.

• Manage trial master file, maintain study documentation, and clinical trial management systems.

• Track and process site payments, develop tracking tools as necessary, and assist in study financial tracking.

• Develop, administer, track and archive pre-study questionnaires.

• A minimum of 5 years of medical device clinical trials experience.

• Bachelor’s degree; preferred clinical research/clinical trial management certification/education.

• Previous experience in managing and implementing cardiac medical device trials; 1-3 years of monitoring experience is preferred.

• In-depth knowledge of clinical research study design and medical terminology.

• Advanced knowledge of Clinical investigation of medical devices for human subjects, including ISO 14155, 21 CFR Part 11, 50, 54, 812, ICH/GCP guidelines, and other relevant regulations.

• Strong ability to interact with physicians and professionals inside and outside the company.

• Experience in protocol and ICF development, writing clinical sections for regulatory submissions.

• Ability to manage CROs and provide relevant study updates to management.

• Experience with negotiating clinical research contracts and budgets.

• Experience with supporting or managing a clinical events committee and data safety monitoring board.

• Experience with electronic data capture (EDC) systems.

• Knowledge of statistics and statistical methods.

• Ability to work effectively on cross-functional teams and manage multiple projects and priorities.

• Excellent communication, presentation, and organizational skills with high attention to detail.

• Ability to learn quickly and self-educate on various surgical specialties applicable to clinical projects.

• Strong work ethic to meet tight timelines or manage multiple projects with a problem-solving mindset.

• Proficiency in Microsoft Office Suite and PDF applications.

• Ability to work onsite in Santa Cruz as needed - 3 days a week

Skills

Clinical research, pharmaceutical, site start up, eTMF, medical device, regulatory binders, sharepoint

Additional Skills & Qualifications