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Are you a Medical Assistant looking for growth? Look no further! This is the PERFECT opportunity for an MA to transition into the Clinical Research industry and set their roots down with a dynamic and growing company. Apply today!
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 company 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
Qualifications
Education/Experience:
High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry
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