Senior Clinical Research Coordinator

The Senior Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Senior Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study.

• United We Achieve
• Celebrate Diverse Perspectives
• Do the Right Thing
• Adapt and Persevere

The Clinical Research Coordinator reports to the Site Manager/Team Lead.

Classification:
Non-Exempt

• Expanded role in team management, mentorship, and training, which includes over-sight of level 1 CRC’s, Research Assistants and ancillary staff.
• Advanced Problem Solving & Decision-Making. Takes ownership of identifying, analyzing, and resolving complex study-related challenges, including protocol deviations, regulatory compliance issues, and operational inefficiencies. Proactively collaborates with QA and Site Manager to develop and implement corrective and preventive action plans to mitigate risks and improve study outcomes. Serves as a key resource for junior staff, providing guidance and training on problem-solving strategies while escalating critical issues to leadership as needed.
• Advanced knowledge of protocol and procedures.
• Greater responsibility for regulatory compliance, protocol deviations, and audits.
• Deeper involvement in recruitment strategy and study performance.
• Higher engagement with study sponsors, CROs, monitors/CRA’s, IRBs, laboratories, and clinical personnel within the research industry.
• Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols.
• Establish understanding of SOP’s and implement the SOP’s
• Gain understanding of the pharmaceutical drug per clinical trial.
• Advanced skills in study start-up and close-out procedures.
• Manage complex clinical trials, including those with challenging study designs and special patient populations.
• Work closely with Investigators to optimize site performance, improve study compliance, and facilitate better communication between research staff and investigators.
• Notify the correct personnel of any adverse events per the study protocol (PI, Sub-I, monitor/CRA, etc.)
• Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study.
• Establish and maintain patient rapport.
• Clinical data collection (vital signs, EKG recording, weight, height, etc.)
• Obtain medical records and review as required.
• Phlebotomy
• Specimen collection, processing, and storage
• Transporting clinical specimens to laboratory.
• Educate subjects on diaries and oversees compliance with diary completion.
• Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.)
• Responsible for completing patient phone call visits in accordance to the standard protocol period.
• Ensure documentation follows ALCOA standards and is completed in a timely manner.
• Ensure all necessary documents are completed, signed and dated.
• Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required.
• Manage study inventory and order supplies as needed.
• Prepare and assist study monitors during onsite visits.
• Maintain familiarity with all ongoing clinical research studies.
• Travel to Investigator meetings as needed.
• Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties
• Mentor team members to promote professional development
• Position may require occasional weekend and/or overtime hours.
• Other duties as assigned

• 3+ years of experience in clinical research.
• Completion of formal medical training, educational program, or healthcare experience
• Strong medical terminology
• Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.).
• Ability to work independently and…