Clinical Research Spec - Exempt

Advanced Clinical; Coon Rapids (MN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health coverage

Life insurance

Disability insurance

401k benefits

Job summary

Advanced Group is seeking a Clinical Research Specialist to support the execution and oversight of clinical studies in Minnesota. You will assist with site management, study documentation, clinical systems, and operational activities to ensure studies comply with GCP and regulatory requirements.

Responsibilities include coordinating site management and communications, maintaining trial records, and reviewing data and metrics to drive compliant deliverables.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, Nursing, or a related field.
• 1–2+ years of experience in clinical research, clinical operations, or site management.
• Experience with CTMS, EDC, TMF, or similar clinical systems.
• Knowledge of GCP guidelines and clinical trial regulations.

Responsibilities

• Support clinical studies from startup through closeout.
• Coordinate site management, study documentation, and stakeholder communications.
• Maintain clinical systems, study records, and trial documentation.
• Review study data, metrics, and operational deliverables.
• Support site, vendor, and investigator interactions.
• Identify and escalation study risks, issues, and compliance concerns.
• Ensure compliance with GCP, SOPs, and regulatory requirements.

Skills

Organizational skills

Communication skills

Cross-functional teamwork

Problem-solving

CTMS/EDC/TMF

Education

Bachelor's degree in Life Sciences or related field

Tools

CTMS

EDC

TMF

Job description

We are seeking a Clinical Research Specialist to support the execution and oversight of clinical studies. This role will assist with site management, study documentation, clinical systems, and operational activities to ensure studies are conducted in compliance with GCP and regulatory requirements.

Position Overview

We are seeking a Clinical Research Specialist to support the execution and oversight of clinical studies. This role will assist with site management, study documentation, clinical systems, and operational activities to ensure studies are conducted in compliance with GCP and regulatory requirements.

Key Responsibilities

• Support clinical studies from startup through closeout.
• Coordinate site management, study documentation, and stakeholder communications.
• Maintain clinical systems, study records, and trial documentation.
• Review study data, metrics, and operational deliverables.
• Support site, vendor, and investigator interactions.
• Identify and escalation study risks, issues, and compliance concerns.
• Ensure compliance with GCP, SOPs, and regulatory requirements.

Required Qualifications

• Bachelor's degree in Life Sciences, Healthcare, Nursing, or a related field.
• 1-2+ years of experience in clinical research, clinical operations, or site management.
• Experience with CTMS, EDC, TMF, or similar clinical systems.
• Knowledge of GCP guidelines and clinical trial regulations.
• Strong organizational, communication, and problem-solving skills.
• Ability to manage multiple priorities and work effectively with cross-functional teams.

Preferred Qualifications

• Experience at a clinical site, sponsor, CRO, or research organization.
• Experience supporting study startup, monitoring, or closeout activities.
• Experience supporting multicenter or global clinical studies.

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [e-mail].