Research Medical Assistant
4 weeks ago
Must have:
- Drawing experience within the pediatric population
Summary:
The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities.
Responsibilities Role & Responsibilities:
- Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and SOPs
- Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
- With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations
- Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
- Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial
- Enter source data into the sponsor's and/or vendor's data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator
- Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team
- Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator
- Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects
- Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial
- Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person
- Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information
- Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team
- Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed
- Prepare source document charts, copy and/or file medical records and study related documents as required.
- Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems.
- Other duties as assigned
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