Clinical Research Associate
6 days ago
We are seeking a highly skilled Clinical Research Assistant to join our team at Medix. As a Clinical Research Assistant, you will be responsible for assisting with the collection, documentation, and maintenance of clinical data.
Key Responsibilities:
- Assist with the conduct of clinical trials in accordance with study protocols, GCP, ICH Guidelines, and SOPs.
- Perform venipuncture, capillary puncture, and other fluid collections within the scope of the protocol and local regulations.
- With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc.) within the scope of the protocol, local regulations, and laws.
- 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 the 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 via phone or in person.
- Maintain confidentiality of patient protected health information, sponsor confidential information, and company 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 a minimum of 1 year of relevant experience in the 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 the daily schedule may change rapidly.
Required Physical Abilities:
- Sit or stand for long periods of time.
- Communicate in person and by telephone.
- Limited walking required.
- Limited to lifting up to 30 pounds.
About Medix:
We are dedicated to providing workforce solutions to clients throughout multiple industries. We have been named among the Best and Brightest Companies to Work For in the Nation for two consecutive years. Medix has also been ranked as one of the fastest-growing companies by Inc. Magazine.
Our commitment to our core purpose of positively impacting 20,000 lives affects not only the way we interact with our clients and talent, but also with our coworkers.
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