Clinical Research Associate

Description The Senior Clinical Research Associate (Sr. CRA) assists with the planning and development of high-quality clinical activities to support Francis Medical projects. The Sr. CRA has clinical research experience, and an understanding of research methodology, regulations, and guidelines. The Sr. CRA has experience assisting with the development of clinical strategies and/or plans, protocol development and execution, monitoring, and ensuring data quality and management of clinical studies. The Sr. CRA collaborates with CROs and other vendors in the execution of clinical trials and interacts with study investigators and other study staff members. The Sr. CRA will monitor clinical research sites in accordance with FDA Regulations, other global regulatory bodies, GCP and ISO compliance, and company SOPs.

Principal Responsibilities:

• Support clinical trials in collaboration with other clinical team members pertaining to site qualification, initiation. site management, data management and other ongoing tasks to support for clinical trials.
• Perform site activities in compliance with GCP and FDA regulations for clinical trials
• Assist with the development of study related documents including case report forms, study manuals, and other study related tools.
• Assists with data management activities, query generation and resolution.
• Reviews informed consent forms and site activation documentation.
• Assists in planning and preparing materials for investigator and coordinator meetings.
• Assists with reporting study metrics, e.g. subject screening and enrollment, data collection, documentation of adverse events.
• Assists with preparation of study summary reports for presentations, publications and regulatory submissions.
• Provide input to the data management plan, monitoring plan, safety plan and other study-specific plans.
• Conducting pre-study, initiation, routine (as needed to ensure protocol compliance), and close-out site visits
• Training study coordinators/investigators on protocol including study procedures, CRF completion, enrollment, and informed consent, and study product
• Working with staff at study sites to resolve data discrepancies
• Obtaining/reviewing/processing of regulatory and study-specific documents from investigative sites
• Maintaining investigational product accountability
• Monitoring IRB requirements

Additional Skills & Qualifications Must Have:

• Bachelor's degree, preferably in a medical/scientific field
• 4+ years' experience supporting clinical research or similar experience in a medical and/or scientific area
• Master's degree will substitute for 1 year of experience.
• In-depth knowledge and proficient in FDA regulations and ICH/GCP guidelines
• Ability to anticipate and meet deadlines, prioritize work, strong attention to detail, and the ability to retain confidential information.
• Proficiency in MS Office, including PowerPoint, Excel and Word.
• Must be customer service oriented with strong interpersonal skills.
• Excellent organizational, written, and verbal communication skills
• Effectively build and maintain positive relationships with physicians, peers, and colleagues across all organizational levels
• Ability to multitask effectively while maintaining high quality outputs Nice to

Have:

• Proven experience working within an FDA IDE pre-market clinical study
• Strong knowledge and understanding of prostate anatomy Experience Level Intermediate Level Job Type & Location This is a Contract position based out of Maple Grove, MN.

Pay and Benefits The pay range for this position is $65.00 - $75.00/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) Workplace Type This is a hybrid position in Maple Grove,MN.

Application Deadline This position is anticipated to close on May 13, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. 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.