Clinical Research Coordinator 3

Atlas Family • Columbia, MD

1d • Onsite

About The Position

The Clinical Research Coordinator III (CRC III) independently manages and coordinates daily clinical trial activities at the site level. This role ensures compliance with Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements. The CRC III leads participant recruitment, mitigates protocol non-compliance risk, manages study data entry, and oversees study operations. The ideal candidate is highly adaptable, goal-oriented with sound reasoning skills and able to lead site staff in the absence of the Site Manager.

Requirements

• Bachelor’s degree in a clinical or scientific field, or equivalent relevant experience.
• Certification as a Clinical Research Coordinator (CCRC), or 3–5 years of on-site clinical research experience.
• Proficient in electronic data capture (EDC) and clinical trial management systems (CTMS).
• Strong working knowledge of Microsoft Office (Outlook, Word, Excel).
• Deep understanding of clinical research terminology and documentation (e.g., 1572, ICF, SAE reports).
• Demonstrated ability to manage multiple tasks and meet deadlines in a fast-paced environment.
• Exceptional organizational, problem-solving, and communication skills (both verbal and written).
• Proficiency with Electronic Data Capture platforms (e.g., iMedidata, Medrio, ClinTrak, Zelta).
• Experience with CTMS (preferably Real-Time CTMS), Microsoft Office Suite, Teams, DocuSign, PDF editing tools.
• Completion of required certifications within two weeks of hire (training provided): GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC.

Nice To Haves

• Nursing or equivalent clinical background.
• Expert knowledge in HIPAA and applicable federal/state regulations regarding clinical research and patient privacy.
• Experience collaborating across cross-functional research departments.
• Ability to work independently while contributing effectively to team goals.

Responsibilities

• Conduct simple to complex clinical trials in alignment with study protocols, FDA GCP/ICH guidelines, and KUR SOPs.
• Serve as liaison to PIs, Sub-Investigators, KUR staff, participants, sponsors, and CROs.
• Ensure compliance with FDA, GCP/ICH guidelines, study protocols, and KUR SOPs.
• Recruit and screen potential study participants; maintain recruitment documentation.
• Collaborate in the development and execution of participant recruitment strategies to achieve enrollment targets.
• Assist the Site Manager and Protocol Manager with site feasibility assessments.
• Obtain informed consent under PI oversight using current IRB-approved forms.
• Verify eligibility criteria and ensure proper documentation before enrollment.
• Schedule and manage participant visits throughout the study lifecycle.
• Maintain accurate and audit-ready documentation including source notes, case report forms, and drug logs.
• Timely completion of case report forms and resolution of queries.
• Oversee investigational product management: receipt, storage, accountability, and documentation.
• Initiate and lead study start-up, participant recruitment, scheduling, informed consent, data entry, query resolution, protocol compliance, and study close-out.
• Proactively identify any audit risks and develop strategies to ensure compliance.
• Facilitate sponsor visits, audits, and regulatory inspections (SIVs, IMVs, RMVs, COVs).
• Complete all required training (e.g., GCP, IATA, SOPs) within set timelines and maintain current certification annually.
• Uphold confidentiality and regulatory requirements (e.g., IRB compliance, informed consent, HIPAA, privacy regulations).
• Maintain clear and consistent communication with all stakeholders (IRBs, sponsors, vendors).
• Participate in team calls and provide site-specific updates or remote support.
• Monitor study progress and ensure adherence to data retention policies.
• Provide training and guidance to study staff on protocol execution and compliance standards
• Support proper closure of studies, including return or destruction of study materials.
• Serve as liaison with study sponsors, CROs, vendors, and internal KUR departments (Regulatory, QA, Legal, Operations, Finance, BD).
• Monitor and respond to study-related alerts, such as temperature excursions; maintain and calibrate equipment.
• Respond promptly to emails from sponsors, CRAs, and KUR team members.
• Ensure timely resolution of internal and external queries and maintain responsive communication throughout the study lifecycle.
• Coordinate with cross-functional departments including Regulatory, QA, Legal, Finance, and BD.
• Manage third-party vendor relationships (e.g., couriers, dry ice suppliers).
• Maintain adequate stock of site and sponsor-specific supplies.
• Maintain organized workspace and site supply inventory, including sponsor-specific materials and paycards.
• Foster a positive and collaborative work environment with KUR and clinic staff.
• Track industry trends and communicate insights to the Business Development team.
• Serve in the role of site supervisor in the absence of the Site Manager.
• Perform additional duties as assigned.
• Perform clinical procedures (e.g., vital signs, phlebotomy, swab collection, ECG) in accordance with protocol and regulatory requirements.
• Collect, process, and ship biological specimens per protocol.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level