Sn Clinical Trial Associate

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

• 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.

Microsoft - excel, word, ppt, etc.

Experience Level

Intermediate Level

This is a Contract position based out of Santa Cruz, CA.

The pay range for this position is $45.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Santa Cruz,CA.

This position is anticipated to close on Jul 3, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.