Clinical Research Coordinator

 

Location: Onsite in Durham, NC

Schedule: Full-Time | Monday – Friday (Regular Schedule)

Employment Type: Contract

 

Position Overview

Medix is seeking a detail-oriented, highly skilled Clinical Research Coordinator (CRC) to manage and conduct clinical trials from study startup through site closeout.

Operating under Good Clinical Practice (GCP), ICH Guidelines, ALCOA-C principles, and organizational SOPs, this role combines end-to-end trial coordination, regulatory oversight, data integrity, project management, and direct patient care. The CRC serves as a central operational liaison between trial participants, site leadership, sponsors, CROs, vendors, and regulatory bodies.

 

Key Responsibilities

Clinical Trial Operations & Protocol Management

• Implement and manage assigned protocols across the full study lifecycle, including study startup, vendor management, subject recruitment, protocol training, source development review, visit scheduling, and study closeout reporting.

• Evaluate and prescreen potential study subjects via phone and in person; participate in the Informed Consent Form (ICF) process per protocol, local regulations, and IRB standards.

• Develop, coordinate, and execute operational, research, and administrative strategies to manage assigned protocols effectively while incorporating key timelines, endpoints, vendors, and target patient populations.

• Apply project management concepts to assess risk, elevate study quality, and align trial operations with organizational financial performance and stakeholder value.

• Maintain a comprehensive understanding of the product development lifecycle, protocol design, critical data points, and disease processes under study.

Direct Patient Care & Clinical Procedures

• Perform hands-on clinical duties within licensed scope, including phlebotomy (venipuncture and capillary puncture), intravenous/intramuscular (IV/IM) dose preparation and administration, fibroscans, ECGs, and vital signs.

• Collect, process, package, and ship laboratory specimens in accordance with study protocols, local laws, and IATA regulations.

• Promote respect for cultural diversity and conventions in all interactions with subjects, coworkers, and trial partners.

Regulatory Compliance & Data Integrity

• Ensure strict data integrity by applying ALCOA-C principles when collecting, correcting, and transferring data into sponsor/CRO data capture systems and resolving EDC queries in a timely manner.

• Prepare, collect, and submit regulatory documentation to Sponsors, CROs, and IRBs per GCP/ICH guidelines and Clinical Trial Agreements.

• Monitor, document, and escalate Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and protocol deviations in accordance with protocols and Eximia SOPs.

• Develop Quality Control (QC) strategies, communication/escalation workflows, and training tools to prepare for and participate in site audits and inspections.

• Safeguard participant Protected Health Information (PHI) and protect confidential information across the study team.

Qualifications & Requirements

Education & Experience Options

• Bachelor’s Degree with 1+ years of experience as a Clinical Research Coordinator, OR

• Associate Degree with 3+ years of experience as a Clinical Research Coordinator, OR

• High School Diploma / Technical Degree with 5+ years of experience as a Clinical Research Coordinator.

Required Licenses & Certifications

• Active Phlebotomy certification (where applicable and required by state law).

• Intravenous (IV) / Intramuscular (IM) dose administration and preparation certification (where applicable and required by state law).

• Certified Clinical Research Coordinator (CCRC) certification through ACRP or SOCRA (required within 6 months of employment).

Preferred Skills & Competencies

• Domain Knowledge: Advanced knowledge of medical terminology, protocol design, and specimen processing standards.

• Technical Skills: Proficient in clinical trial software/EDC systems, Microsoft Office Suite, and standard office hardware.

• Operational Leadership: Proven ability to work independently, manage multiple deliverables, adapt to rapidly changing daily schedules, and develop team members.

• Core Strengths: Excellent verbal, written, and interpersonal communication skills; highly organized, detail-oriented, and proficient in strategic problem-solving.

^*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

^*As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.