Clinical Research Coordinator II

Headlands Research, Inc.; Escondido (CA); On-site; USD 73,000 - 80,000; Full time

Job summary

Headlands Research AMCR Institute in Escondido, CA is seeking an experienced Clinical Research Coordinator to join our onsite team. You will oversee study activities, ensure protocol adherence, and deliver high-quality participant care across metabolic and immunologic trials.

This full-time role emphasizes collaboration, data integrity, and regulatory compliance, with SOPs, GCP, and FDA guidelines guiding everyday work.

Qualifications

• Experience managing multiple phase 2-4 industry-sponsored trials as primary coordinator.
• Education in health-related field or equivalent clinical research training.
• Strong knowledge of FDA regulations and ICH-GCP.
• Experience with EDC, IVRS, and clinical research platforms.
• Proficient medical terminology and clinical documentation.
• Excellent organizational and multitasking abilities.
• Clear, professional verbal and written communication.
• Willingness to work onsite in a collaborative environment.

Responsibilities

• Provide high-quality care for study patients.
• Coordinate all aspects of assigned clinical trials from initiation to close-out.
• Ensure accurate, timely documentation per protocol.
• Maintain compliance with FDA regulations, GCP guidelines, IRB, and SOPs.
• Manage recruitment, informed consent, and retention.
• Support data entry and resolve queries in EDC.
• Collaborate with investigators, sponsors/CROs, labs, and teams.
• Assist in monitoring visits, audits, and inspections.
• Maintain regulatory documentation and training compliance.

Skills

Clinical trial coordination

FDA & ICH-GCP knowledge

Communication skills

Organizational skills

Onsite work capability

Education in health field

EDC/IVRS experience

Clinical documentation

Education

Bachelor's degree

Health-related coursework/experience

Tools

EDC systems

IVRS

Job description

At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion.

Escondido, CA

AMCR Institute (a Headlands Research site)

Full-time | Onsite (no opportunities for hybrid or remote)

For CRCs looking for stability, collaboration, and meaningful work

If you’re an experienced Clinical Research Coordinator who values strong operations, multidisciplinary collaboration, and a schedule that actually supports work–life balance, AMCR Institute may be the right next step in your career.

Our Escondido site is known for its depth of experience, thoughtful study execution, and team-based approach to clinical research—particularly in metabolic studies.

About AMCR Institute

Headlands Research AMCR Institute, located in Escondido, California, is dedicated to advancing metabolic and immunologic research through patient-centered, high-quality clinical trials. The site conducts studies focused on pre-diabetes, type 1 and type 2 diabetes, obesity, NAFLD/MASH, and vaccines. With a passionate and experienced team, AMCR Institute partners with sponsors and CROs to deliver meticulous research while prioritizing the care, safety, and confidentiality of every participant. By accelerating access to innovative therapies, the site makes a meaningful difference in the lives of the many affected by metabolic and immunologic conditions.

Why Experienced CRCs Choose AMCR

• Multi-disciplinary collaboration with seasoned investigators and clinical staff
• Strong operational support and clear SOPs
• Exposure to complex, meaningful studies—not just high-volume turnover
• Backing of a growing research network with resources and stability

Responsibilities

• Provide the highest level of care for study patients
• Deliver excellent customer service to pharmaceutical clients
• Coordinate all aspects of assigned clinical trials from site initiation through close-out
• Conduct subject visits and ensure accurate, timely documentation in compliance with protocol and standards
• Maintain compliance with protocols, GCP/ICH guidelines, FDA regulations, IRB requirements, and SOPs
• Manage subject recruitment, informed consent, and retention activities
• Ensure timely EDC data entry and resolution of queries
• Report and follow up on AEs, SAEs, and protocol deviations
• Collaborate with investigators, sponsors/CROs, labs, and internal teams
• Prepare for and participate in monitoring visits, audits, and inspections
• Maintain regulatory documentation and ensure training compliance for amendments and systems
• Perform study procedures such as phlebotomy, ECGs, and sample processing (as trained)
• Attend investigator meetings and provide cross-functional support as needed
• Maintain working knowledge of protocols, lab manuals, equipment calibration, and inventory

Requirements

• At least one year of experience managing multiple phase 2-4 industry-sponsored clinical trial studies as the primary coordinator required
• Bachelor's degree OR 2 years of college in a health-related program OR experience and training in conducting clinical trials with knowledge of ICH GCP required.
• Strong understanding of FDA regulations, ICH-GCP, and clinical trial operations
• Experience with EDC, IVRS, and clinical research platforms
• Proficiency in medical terminology and clinical documentation
• Strong organizational skills with the ability to manage multiple studies
• Clear, professional verbal and written communication skills
• Comfortable working onsite in a collaborative, clinical environment

Who Thrives In This Role

• CRCs who want structure, support, and accountability
• Those interested in taking the next step in managing people
• Professionals who value teamwork over silos
• Coordinators who care about data quality, patient experience, and compliance
• Those ready to grow within a stable, well-established research site

California Pay Range

$73,000 - $80,000 USD

Headlands Research will never ask a candidate for personal identifiable information (date of birth, social security number, driver’s license information, etc) via email or messenger tools, or for a financial deposit of any kind.

Headlands Research is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, age, sex, national origin, disability status, genetic information, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Need Assistance?

Headlands Research is committed to providing access and reasonable accommodation in its employment for individuals with disabilities. To request disability accommodation in the application process, contact [e-mail] for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.