Clinical Research Coordinator Lead

Job Summary: The Clinical Research Coordinator Lead (CRC Lead) plays a pivotal leadership role in advancing clinical research at Pacific Sports and Spine. This position is responsible for end‑to‑end oversight of clinical trial performance, ensuring studies are conducted with the highest standards of quality, safety, and regulatory compliance.

The CRC Lead plans, coordinates, evaluates, and manages both participant care and study data across multiple device and drug trials focused on pain management. Working closely with Principal Investigators, clinic staff, sponsors, CROs, and internal research team members, the CRC Lead serves as the primary operational and regulatory authority for assigned trials and provides direct supervision and mentorship to Clinical Research Coordinator Assistant(s).

All duties are performed in accordance with company policies, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and all applicable local, state, and federal regulations.

Clinical research here at Pacific Sports and Spine is a strategic growth priority. The CRC Lead ensures:

• High‑quality study execution
• Strong sponsor and CRO partnerships
• Ethical, compliant, and patient‑centered research
• Sustainable research operations that scale with program growth

This role is ideal for a CRC ready to step into leadership, influence systems and workflows, and help drive clinical research to the next level.

Overview: Pacific Sports and Spine is dedicated to providing the highest level of medical treatment for its patients. This commitment is achieved through the continuous training of physicians and medical staff, fostering professional growth and achievement for every employee, and maintaining excellence in both medical practice and employment. With these principles combined with perseverance and dedication we strive to be a leading medical provider and employer in Lane and Douglas counties.

Key Responsibilities

Clinical Trial Leadership & Oversight

· Lead and coordinate device and drug clinical trials under the supervision of the Principal Investigator in accordance with FDA regulations, GCP, IRB requirements, and study protocols

· Serve as the primary operational liaison between Investigators, sponsors, CROs, monitors, auditors, and clinic leadership

· Identify potential issues, inconsistencies, or risks and take proactive corrective action

Participant & Clinical Responsibilities

· Oversee participant recruitment, screening, consent, enrollment, and retention

· Review subject medical records to determine protocol eligibility

· Educate participants and families regarding specific studies and clinical research participation

· Perform or oversee clinical tasks including vital signs, ECGs, phlebotomy, specimen processing, and investigational product handling

Data, Documentation & Regulatory Compliance

· Maintain accurate, timely source documentation and investigator site files

· Ensure completion of EDC data entry and resolution of sponsor and monitor queries

· Oversee adverse event reporting, protocol deviations, and safety monitoring

· Maintain study tracking metrics and performance dashboards

· Prepare for and support monitoring visits, audits, and inspections

Technology, Systems & Quality

· Lead study build, maintenance, and oversight within the eCTMS platform

· Perform Quality Control (QC) checks in accordance with SOPs and interface with Quality Assurance as needed

· Drive continuous improvement in research workflows and documentation standards

Team Leadership

· Supervise, mentor, and support Clinical Research Coordinator Assistant(s)

· Support onboarding, training, and performance development of research staff

· Foster collaboration across clinic, research, and administrative teams

Recruitment & Study Startup Support

· Participate in recruitment planning and startup meetings

· Coordinate advertising and recruitment materials with internal teams

· Maintain regular communication to maximize enrollment across studies

Experience & Education

· Clinical Research Coordinator experience required

· Prior lead or senior CRC experience strongly preferred

· Bachelor’s degree preferred

· Phlebotomy experience (certified) highly preferred

Other Duties as assigned

· Flexibility: Perform additional responsibilities as needed to support the mission and goals of Pacific Sports and Spine the organization.

Skills & Competencies

· Advanced knowledge of clinical research operations, GCP, and federal regulations

· Strong leadership, organizational, and prioritization skills

· Excellent interpersonal and communication skills (verbal and written)

· High‑level data management, quality control, and analytical skills

· Ability to manage multiple studies simultaneously in a fast‑paced environment

· Strong attention to detail with excellent critical thinking and problem‑solving skills

· Proficiency with digital research systems, including eCTMS and EDC platforms

· Knowledge of medical terminology, clinical practices, and interventional pain management preferred

Reporting Structure:

· The Clinical Research Coordinator Lead operates within the Research Department and reports directly to the Chief Operations Officer

Compensation and Benefits

· Wage range: TBD

· Position is eligible for employer-sponsored health benefits

· Schedule: Monday-Friday, 8am–5pm

Employment Status:

· Full-time, 40 hours per week, non-exempt position.

· Oregon is an at-will employer state and reserves the right to terminate employment at will.

Work environment and Physical Requirements:

· Clinical Setting-Work is primarily performed in a medical clinic environment with exposure to patients, healthcare equipment, and medical supplies.

· Confidentiality & HIPAA Compliance-Strict adherence to patient confidentiality and federal privacy regulations.

· Compliance & Safety Regulations-Adherence to OSHA, HIPAA, and other healthcare safety standards.

· Exposure to Illnesses-Potential exposure to infectious diseases, bloodborne pathogens, and bodily fluids; adherence to safety and sanitation protocols required

· Physical Demands-Frequent standing, walking, bending, and lifting are required

· Team-Oriented Environment-Collaboration with doctors, nurses, administrative staff, and other healthcare professionals.

· Relationships-Respectful productive relationships with co-workers, patience and outside professionals.

· Patient Interaction-Direct engagement with patients, including those in distress, requiring strong communication and empathy

· A CRC Lead at Pacific Sports and Spine will spend some of the day seated at a desk, working on a computer and/or handling paperwork. Prolonged computer use, along with frequent typing, can lead to discomfort in the back, neck, shoulders, or wrists if ergonomics are neglected. Eye strain may result from focusing on screens and small text, while filing and organizing records may require bending or reaching.

· The role may also involve using telephones or headsets, requiring high concentration to ensure accuracy and compliance. Although not physically demanding, the sedentary and repetitive nature of the role can cause strain. Taking breaks and maintaining good posture can help prevent discomfort and injury.

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

People with a criminal record are encouraged to apply

Work Location: In person