Clinical Research Assistant
Behavioral Health Market Context
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Qualifications
- •Must be willing to gain a thorough knowledge and follow strict adherence of all clinical study protocols
- •Must have > 1 year experience as a medical assistant or research assistant
- •Should possess or develop proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems, and study specific EDC and IVRS systems
- •Effective time management and the ability to prioritize work
- •Excellent communication skills and the ability to interact with all levels of management, staff, and physicians in person, virtually, and in writing
- •Ability to be flexible with the day‑to‑day job requirements to facilitate a successful workflow in clinic
- •Urine Pregnancy Test;
- •Complete applicable training requirements and ongoing education as required
- •Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc
- •Must have or gain knowledge of relevant software/programs
- •Work closely with IRB and study sponsors, PIs and Sub‑Is
- •8 more items(s)
Responsibilities
- •Experienced Medical Assistant or Research Assistant needed to contribute to Urology Austin’s growing research department
- •Research Assistant (RA) roles often transition to Clinical Research Coordinator (CRC) roles and open the door to many other career opportunities within the industry
- •Research Assistants support the Clinical Research Team with subject recruitment, diagnostic testing, laboratory specimen collection, communications with patients, study sponsors, and investigators, and other interesting research related roles
- •You will work closely with our Study Coordinators, Clinical Research Director, Principal Investigators (PI) and Sub-Investigators (Sub-Is) on various clinical research studies
- •Reports to the Director of Clinical Research, VP of Clinical Research, Market President, and all the physicians at Urology Austin
- •Able to collaborate with experienced patient navigators, IT, and data management teams
- •Develop an understanding of and demonstrate Good Clinical Practices (GCPs), learn and comply with all FDA clinical trial and IRB rules and regulations
- •Review and follow Urology Austin Standard Operating Procedures
- •Read and understand specific requirements of each study protocol and informed consent form
- •Works with study coordinators and other research team members to complete protocol specific procedures and documentation
- •Assists in clinic and protocol administration duties including but not limited to:
- •Screen potential candidates in a timely and accurate manner;
- •Ensure that study patients understand the information presented and agree to the protocol requirements;
- •Obtain and maintain consent of patients prior to any study‑related procedures being performed with the highest ethical standards;
- •Provide instructions to patients to ensure proper protocol compliance;
- •Distribute study medications in compliance with protocol randomization requirements;
- •Learn and understand lab procedures and obtain and process study‑related lab specimens according to the study specific manuals;
- •Use approved source documents; obtain protocol‑specific data to complete and maintain source documents and case report forms (including electronic data capture – EDC) in accordance with applicable regulations and sponsor requirements
- •Perform study‑specific readings and measurements including but not limited to:
- •Vital signs; ECG;
- •Uroflow, TRUS, urinalysis, cystoscopy;
- •Photography and videography;
- •Report irregular readings and measurements to Investigator and Lead Study Coordinator;
- •Package and ship laboratory specimens to study‑specific destinations
- •Communicate with and support patients and their families as necessary
- •Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain records
- •Effectively communicate with potential candidates for trials and collect metrics to track progress
- •Attend necessary meetings and calls
- •Assist with the development of source documents and phone screen tools
- •Manage ancillary supply inventory and assist…
- •27 more items(s)
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