Clinical Research Associate

Job Title:

Clinical Research Associate

Job Description

The Clinical Research Associate (Sr. CRA) plays a crucial role in planning and developing high-quality clinical activities to support various projects. This position requires clinical research experience, as well as an understanding of research methodology, regulations, and guidelines. The Sr. CRA is responsible for assisting with clinical strategies, protocol development and execution, monitoring, and data quality management of clinical studies. Collaboration with CROs, vendors, study investigators, and study staff members is essential.

The Sr. CRA will monitor clinical research sites in accordance with FDA regulations, global regulatory bodies, GCP and ISO compliance, and company SOPs.

Responsibilities

+ Support clinical trials in collaboration with other clinical team members, focusing on site qualification, initiation, site management, data management, and other tasks to support 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 tools.

+ Assist with data management activities, query generation, and resolution.

+ Review informed consent forms and site activation documentation.

+ Assist in planning and preparing materials for investigator and coordinator meetings.

+ Assist with reporting study metrics, including subject screening and enrollment, data collection, and documentation of adverse events.

+ Assist with the 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.

+ Conduct pre-study, initiation, routine, and close-out site visits to ensure protocol compliance.

+ Train study coordinators and investigators on protocol, including study procedures, CRF completion, enrollment, and informed consent.

+ Work with staff at study sites to resolve data discrepancies.

+ Obtain, review, and process regulatory and study-specific documents from investigative sites.

+ Maintain investigational product accountability and monitor IRB requirements.

Essential Skills

+ Bachelor's degree, preferably in a medical/scientific field.

+ 4+ years of experience supporting clinical research or similar experience in a medical and/or scientific area.

+ Master's degree can substitute for 1 year of experience.

+ Proficient knowledge of FDA regulations and ICH/GCP guidelines.

+ Ability to anticipate and meet deadlines, prioritize work, and maintain strong attention to detail.

+ Proficiency in MS Office, including PowerPoint, Excel, and Word.

+ Customer service-oriented with strong interpersonal skills.

+ Excellent organizational, written, and verbal communication skills.

+ Ability to effectively build and maintain positive relationships with physicians, peers, and colleagues across all organizational levels.

+ Ability to multitask effectively while maintaining high-quality outputs.

Additional

Skills & Qualifications

+ Proven experience working within an FDA IDE pre-market clinical study.

+ Strong knowledge and understanding of prostate anatomy.

Work Environment

The position is based in a small office environment within a start-up medical device community. The team enjoys a monthly budget for team activities, fostering a collaborative and engaging work culture.

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.

Final date to receive applications

This position is anticipated to close on Jun 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 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…