Medical Data Specialist
5 hours ago
Job Description:
The Clinical Research Assistant plays a vital role in the success of our clinical trials. This individual will assist the Clinical Operations Team in collecting, documenting, and maintaining clinical data, including phlebotomy/laboratory, data entry, and administrative responsibilities.
Key Responsibilities:
- Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and standard operating procedures.
- Perform venipuncture, capillary puncture, and/or other fluid collection within the scope of the protocol and local laws and regulations.
- With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc.) within the scope of the protocol, local laws and regulations.
- Process, package, and ship laboratory specimens as required per protocol and International Air Transport Association 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, Contract Research Organizations, and vendors under the direction of the Clinical Research Team.
- Understand good documentation practices when collecting, transferring data to sponsor/Contract Research Organization 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 organization 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.
Required Skills and Qualifications:
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.
Benefits:
Our organization offers a comprehensive benefits package, including medical, dental, and vision insurance, paid time off, company holidays, 401(k) retirement plan with company match, and an annual incentive program.
Others:
As an employee of our organization, you will be part of a dynamic team that is dedicated to the success of our clinical trials. We offer opportunities for career advancement and professional growth in a collaborative and supportive environment.
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