Clinical Research Coordinator

Clinical Research Coordinator

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, 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

Duties/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.

Other Responsibilities:

• Represent the site at Investigator Meetings and external conferences, providing post-meeting updates to the team.
• Perform other leadership duties as assigned.

Required Skills/Abilities:

• 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.
• Other Qualifications:
• Strong knowledge of GCP, FDA, and IRB regulatory requirements.
• Proven ability to lead and motivate teams in a clinical research setting.
• Excellent problem-solving, organizational, and communication skills.
• Proficiency in CTMS and electronic regulatory systems (any vendor, preferred)
• Phlebotomy experience

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.

Performance Requirements:

• Advanced knowledge of clinical trial operations, compliance, and documentation.
• Demonstrated leadership, with the ability to mentor and oversee multiple team members.
• Strong analytical skills for identifying and resolving study challenges.
• Proficiency in Microsoft Office, CTMS, and other clinical trial software.
• Ability to manage multiple priorities under tight deadlines.

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

EEO Statement:

The Remedy Mental Health is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, or any other protected status.

Disclaimer:

This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the position. Duties may change based on business needs.

Work Authorization Requirement: All candidates must be legally authorized to work in the United States. The company does not currently sponsor employment visas.