Job Description
The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The 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.
To consistently embody AMR Clinical's Core Values:
- 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
Primary Responsibilities: - Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures.
- 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.
- Phlebotomy
- Specimen collection, processing, and storage
- Transporting clinical specimens to the 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
- Position may require occasional weekend and/or overtime hours.
- Other duties as assigned
Desired Skills and 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.
- Must be fluent in English.
AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
** This is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.
Job Tags
Full time, Contract work, Work at office, Flexible hours,