Clinical Research Coordinator: Protocols & Compliance Lead

Alliance for Multispecialty Research LLC; Lexington (KY); On-site; USD 45,000 - 60,000; Full time

Job summary

Alliance for Multispecialty Research LLC in Lexington, KY seeks a Clinical Research Coordinator to support and manage tasks critical to clinical studies. You will ensure compliance with federal regulations, monitor participants, and identify issues proactively throughout the study.

The role reports to the Site Manager/Team Lead and requires a non-exempt classification with potential overtime. The ideal candidate has 1 year of clinical research experience and a background in medical terminology

Qualifications

• 1 year 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 lead study-related tasks.
• Ability to multi-task in a high-paced evolving environment.
• Exceptional listening, written, and verbal communication skills as well.
• Demonstrate proficiency in office equipment and software programs.
• Excellent organizational and task management skills.
• Ability to be ambulatory most of the workday.
• Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.

Responsibilities

• Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent.
• Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols.
• Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution.
• Establish understanding of SOP’s and implement the SOP’s
• Gain understanding of the pharmaceutical drug per clinical trial.
• Develop detailed knowledge of protocol and procedures per clinical research study.
• Communicate effectively with study sponsors, CROs, monitors/CRA’s, IRBs, laboratories, and clinical personnel within the research industry.
• 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.
• Specimen collection, processing, and storage
• Transporting clinical specimens to the laboratory.
• Educate subjects on diaries and oversees compliance with diary completion.
• 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
• Position may require occasional weekend and/or overtime hours.
• Other duties as assigned

Skills

Clinical research experience

Medical terminology

Independent work

Multi-tasking

Communication skills

Office software

Organizational skills

Ambulatory work

Equipment handling

Education

Medical training or healthcare education

Job description

Alliance for Multispecialty Research LLC in Lexington, KY seeks a Clinical Research Coordinator to support and manage tasks critical to clinical studies. You will ensure compliance with federal regulations, monitor participants, and identify issues proactively throughout the study.

The role reports to the Site Manager/Team Lead and requires a non-exempt classification with potential overtime. The ideal candidate has 1 year of clinical research experience and a background in medical terminology