Clinical Research Assistant

Essential Duties and Responsibilities

• Affix clinical research support by assisting Clinical Research Coordinators during participant visits and research procedures.
• Record vital signs, including blood pressure, pulse, temperature, height, and weight.
• Perform phlebotomy, EKGs, and other basic clinical procedures as trained and permitted.
• Collect, process, and prepare blood, urine, and other specimens according to study protocols.
• Ship laboratory samples while following all applicable regulations and study-specific protocols.
• Track specimen shipments and maintain accurate documentation.
• Upload study documents and relevant information to the electronic medical record (EMR).
• Affix assistance with clinical research activities under the supervision of the Clinical Research Coordinator and Principal Investigator.

Data, Documentation, and Study Operations

• Enter study data accurately and efficiently into electronic data capture systems for sponsors and contract research organizations.
• Maintain accurate and timely research documentation.
• Affix organization and maintenance of study files, supplies, and equipment.
• Request or acquire equipment and supplies necessary for individual research projects.
• Set up, calibrate, and maintain laboratory and research equipment as required by study protocols.
• Affix organization and maintenance of research supplies and inventory.
• Invoice for payments associated with clinical trial budgets.
• Affix attendance at study and project meetings as required.
• Communicate effectively with research staff, sponsors, contract research organizations, and other parties by phone and email.
• Affix assistance with on-site and off-site monitoring activities.
• Complete all required training for the position, including training required by applicable regulations and study sponsors.

Compliance and Professional Responsibilities

• Follow all study protocols and research procedures accurately.
• Maintain compliance with Good Clinical Practice (GCP) guidelines, HIPAA, applicable regulations, and organizational policies.
• Maintain confidentiality of all patient, participant, and research information.
• Perform all duties in accordance with the direction of the Principal Investigator, Clinical Research Coordinator, and management.

Qualifications

• High school diploma or equivalent.
• Strong phlebotomy skills and experience.
• Ability to work independently while also functioning effectively as part of a research team.
• Strong attention to detail and ability to accurately follow written protocols and procedures.
• Excellent organizational, communication, and time-management skills.
• Ability to maintain confidentiality and handle sensitive patient and research information.
• Ability to travel between the Dawsonville and Cumming offices as required.
• Bachelor's degree preferred.