Clinical Research Assistant (30271)

Position Summary
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.
Job Relationships

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
ROLE QUALIFICATIONS: (experience, education, and skills)

Must be willing to gain a thorough knowledge and follow strict adherence of all clinical study protocols.
Develop an understanding of and demonstrate Good Clinical Practices (GCPs), learn and comply with all FDA clinical trial and IRB rules and regulations
Must have > 1 year experience as a medical assistant or research assistant.
Urology based clinical experience preferred
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
Essential Job Responsiblities

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:

Explain the purpose, risks, and benefits of clinical trial participation
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 and 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 (lab and procedural)
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
Urine Pregnancy Test
Uroflow, TRUS, urinalysis, cystoscopy
Photography and videography
Reports irregular readings and measurements to Investigator and Lead Study Coordinator
Package and ship laboratory specimens to study-specific destinations
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.
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
Must have or gain knowledge of relevant software/programs
Work closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and calls
Assist with the development of source documents and phone screen tools
Manage ancillary supply inventory and assist with drug accountability
Maintain HIPAA compliant communication and confidentiality, at all times
Participate in site visits (site initiation visits, interim monitoring visits, close-out visits, etc.
Assist study coordinators with necessary study close-out procedures and documentation
Performs other duties as assigned Performance Requirements
Knowledge

Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices, including clinical financial policies and reimbursement payment requirements.
Understanding of medical terminology.
Skills

Ability to use multi-line phone systems and basic computer systems.
Interpersonal and communication both with internal staff and external customers.
Skill in evaluating and implementing study protocols and budgets.
Skill in reading medical chart terminology.
Time Management.
Abilities

Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.
Elicit appropriate information for patients to clinic staff.
Ability to read and understand information and ideas presented in writing.
Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning.
Reporting to this position : No direct reports at this time, can change as department grows
Physical Demands And Work Environment
The physical demands and work environment characteristics described here are the representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions:

Physical demands: Involves sitting approximately 90 percent of the day, walking or standing for the remainder. Work may require stooping and bending to access files, supplies, mobility to complete errands, and lifting up to 20 pounds.
Work environment: Primarily office setting. Noise level in the work environment is usually moderate. Clean, well-lighted office environment.