Clinical Research Coordinator at The Remedy Mental Health in Vadnais Heights, Minnesota

Job description

• We are seeking an experienced and dynamic individual to join our team as a Clinical Research Coordinator. This advanced-level position is ideal for candidates with a proven track record in clinical research coordination, leadership capabilities, and a passion for mentoring and oversight within a clinical research setting.
• The Clinical Research Coordinator is a senior research professional who not only manages study operations but also serves as a leader and resource for the clinical research team. Working under the direction of the Principal Investigator (PI)if applicable, the Lead CRC ensures compliance, quality, and operational efficiency across all clinical trials conducted at the site.
• Schedule: Monday - Friday, 8:00 AM - 5:00 PM, On-Site in Vadnais Heights, MN

Responsibilities

• Conduct clinical trial activities per protocol and FDA, ICH, GCP, GDP standards.
• Serve as the primary point of contact for day-to-day clinical trial operations.
• Oversee the delegation of study tasks to ensure even distribution of workload and adherence to timelines.
• Coordinate cross-functional teams to ensure all pre-study, initiation, and ongoing trial activities meet sponsor and regulatory requirements.
• Develop and implement site-specific workflows and protocols to optimize efficiency and compliance.
• Independently manage complex trials, including those involving investigational products, high volumes, or unique challenges.
• Ensure adherence to Good Clinical Practice (GCP), FDA regulations, IRB guidelines, and sponsor protocols.
• Conduct routine quality assurance reviews of documentation, source data, and regulatory files, providing feedback for corrections or improvements.
• Facilitate site audits and sponsor monitoring visits, serving as the lead point of contact.
• Act as the primary liaison for sponsors, CROs, and regulatory bodies regarding study updates, issues, and corrective actions.
• Ensure study participants are supported and informed throughout the research process, addressing escalated concerns as needed.
• Monitor site performance metrics and propose improvements to enhance operational efficiency.
• Oversee inventory management for investigational products, study supplies, and equipment.
• Coordinate training and preparedness of staff for emergency unblinding or adverse event protocols.

Requirements

• Education: Bachelor’s degree preferred
• Experience: Minimum 3 years of clinical research coordination experience, including 1-2 years in a leadership or mentoring role. Extensive experience managing multiple, complex trials with minimal supervision.
• Certifications: Certified Clinical Research Coordinator (CCRC) or equivalent credential preferred.

Skills

Required

• Phlebotomy experience

Benefits

• Paid Time Off
• Holiday Pay
• Medical Insurance
• Health Savings Account
• Dental Insurance
• Vision Insurance
• 401(k) with Employer Match
• Life Insurance and AD&D
• Short-Term Disability
• $30-$40/hour