Job Description

Clinical Research Specialist Clinical Trials

Job Location Type: Virtual / Hybrid

Location: Minnesota

Job Type: 24 Months Contract

Shift Schedule: Monday Friday, 40 hours per week

About the Role

We are seeking a Clinical Research Specialist to support the planning and execution of clinical research studies within a regulated medical device environment. This opportunity is ideal for an early-career clinical research professional with hands-on site management experience , familiarity with clinical systems, and a strong understanding of Good Clinical Practice (GCP) and clinical trial requirements.

Working under the direction of a Clinical Study Manager, you will support study operations from start-up through closeout, including site coordination, study documentation, data review, clinical system maintenance, and collaboration with internal and external stakeholders. The role offers an opportunity to contribute to meaningful clinical research while building experience across the clinical trial lifecycle.

Key Responsibilities

• Support the planning, execution, and oversight of clinical evaluation and research studies.
• Perform clinical site management activities , including site selection, coordination, monitoring support, and issue resolution.
• Support study start-up and closeout activities in accordance with study plans and company SOPs.
• Prepare, review, and maintain clinical study documentation, protocols, patient record forms, and related trial materials.
• Assist with clinical data review and interpretation of study results.
• Maintain and update clinical research systems and documentation, including CTMS, EDC, and TMF .
• Coordinate with clinical sites, vendors, investigators, project teams, and internal stakeholders to support study milestones.
• Help ensure clinical trials are conducted in compliance with GCP, SOPs, and applicable regulatory requirements .
• Support site and vendor selection activities and assist with clinical supply and operational planning as needed.
• Track study progress, identify operational issues, and communicate status, risks, and needs to project stakeholders.
• Build and maintain effective working relationships with internal teams and external clinical partners.
• Contribute to process improvements and recommend enhancements to improve study effectiveness and execution.
• Provide guidance and support to less-experienced team members when needed.

Required Qualifications

• Bachelor s degree in Clinical Research, Life Sciences, Healthcare, or a related discipline.
• 1 2+ years of relevant clinical research experience , with strong consideration given to hands-on site management experience.
• Experience working directly with clinical sites or within a sponsor/CRO environment.
• Working knowledge of Good Clinical Practice (GCP) and clinical trial regulatory requirements.
• Experience with clinical research systems such as CTMS, EDC, and TMF .
• Strong organizational skills with the ability to manage documentation, timelines, and multiple study activities.
• Effective written and verbal communication skills.
• Ability to work independently with general supervision while collaborating across cross-functional teams.

Preferred Qualifications

• Experience supporting medical device or regulated clinical research studies.
• Experience with clinical study start-up, site selection, study documentation, monitoring support, or closeout activities.
• Familiarity with country-specific or regional clinical research regulations.
• Experience coordinating with investigators, vendors, internal project teams, and other external stakeholders.
• Strong documentation, compliance, and audit-readiness mindset.

Job Tags

Contract work, Monday to Friday, Shift work

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