Job Opportunity
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.