Clinical Research Coordinator 2

Atlas Family • Centreville, AL

3d

About The Position

The Clinical Research Coordinator II (CRC II) manages and coordinates daily clinical trial activities at the site level with little direction. This role ensures compliance with Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements. The CRC II works autonomously towards participant recruitment, oversees protocol adherence and study data entry, and coordinates study operations, including investigational product handling and monitor visits. The ideal candidate is highly organized, detail-oriented, and excels in fostering collaboration with cross-functional teams at KUR and external stakeholders.

Requirements

• Bachelor’s degree in a clinical or scientific field, or equivalent relevant experience.
• Proficient in electronic data capture (EDC) and clinical trial management systems (CTMS).
• Knowledge of Microsoft Office (Outlook, Word, Excel).
• Strong 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).

Nice To Haves

• 2+ years of clinical research experience (Phase I–IV).
• Strong attention to detail, organization, and multitasking abilities.
• Knowledge of HIPAA regulations and informed consent laws.
• Familiarity with clinical trial documentation (e.g., 1572, SAE reports, ICFs).
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively across teams.
• Effective problem-solving and critical thinking skills.
• Previous experience using Real-Time CTMS is a plus.
• Nursing or equivalent clinical background.
• Familiarity with HIPAA and applicable federal/state regulations regarding clinical research and patient privacy.
• Experience collaborating across cross-functional research departments.
• Ability to work without minimal guidance 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.
• Collaborate with 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.
• 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.
• Manage investigational products including receipt, storage, and disposition.
• Lead study start-up, participant recruitment, scheduling, informed consent, data entry, query resolution, protocol compliance, and study close-out.
• 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.
• 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.
• 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.
• Other duties as assigned.

What This Job Offers

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