Summary :

The Clinical Research Assistant / Medical 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 front office 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 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

Education / Experience :

High School Graduate and / or technical degree with minimum of 1 year of relevant experience in life sciences industry

Required Licenses / Certifications :

• Phlebotomy if applicable and required by state law
• Intramuscular dose administration and preparation if applicable and required by state law

Required Skills :

• Demonstrated knowledge of medical terminology
• Demonstrated ability to use the following technology : Computers, Microsoft Office software, fax, copier, and multi-line telephone.
• Understanding of verbal, written, and organizational skills
• Demonstrated ability to work as a team player
• Demonstrated ability to read, write, and speak English
• Demonstrated ability to multi-task
• Demonstrated ability to follow written guidelines
• Demonstrated ability to be flexible / adapt as daily schedule may change rapidly

Required Physical Abilities :

• Sit or stand for long periods of time
• Communicate in person and by a telephone
• Limited walking required

Last updated : 2024-03-09