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AMR Clinical · 2 months ago

Senior Clinical Research Coordinator

Myrtle Beach, SC, US

Full-time

Onsite

Mid, Senior Level

$28/hr - $32/hr

3+ years exp

AMR Clinical is a company focused on clinical research, and they are seeking a Senior Clinical Research Coordinator to perform and manage critical tasks for clinical research studies. This role involves ensuring compliance with regulations, overseeing junior staff, and managing complex clinical trials.

BiotechnologyHealth CarePharmaceutical

Responsibilities

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

Qualification

Clinical research experienceRegulatory complianceProtocol knowledgeMedical terminologyStudy managementMulti-taskingCommunication skillsOrganizational skillsProblem-solvingTeam leadership