Clinical Research Assistant (32624)

GI Alliance; Lone Tree (CO); On-site; USD 28,000 - 41,000; Full time

Job summary

GI Alliance in Lone Tree, Colorado is seeking an Experienced Medical Assistant or Research Assistant to contribute to the growing Urology research department. You will support the clinical research team with subject recruitment, diagnostic testing, specimen collection, and patient communication.

The role involves exposure to FDA compliance, GCP, and IRB regulations, with opportunities to advance to Clinical Research Coordinator roles.

Qualifications

• Must have >1 year experience as a medical assistant or research assistant.
• Develop an understanding of and demonstrate Good Clinical Practices (GCPs).
• Follow FDA clinical trial and IRB rules and regulations.

Responsibilities

• Review and follow Urology Alliance Standard Operating Procedures.
• Read and understand study protocol requirements and informed consent forms.
• Work with study coordinators to complete protocol procedures and documentation.
• Assist in clinic and protocol administration duties including obtaining informed consent.
• Learn lab procedures and process lab specimens per manuals.
• Maintain source documents and case report forms in accordance with regulations.

Skills

Communication skills

Time management

Flexibility

Patient interaction

Tools

EMR

Practice Management systems

EDC

Job description

Position Summary

Experienced Medical Assistant or Research Assistant needed to contribute to Urology 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.

Position Summary

Experienced Medical Assistant or Research Assistant needed to contribute to Urology 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 Manager, Principal Investigators (PI) and Sub-Investigators (Sub-Is) on various clinical research studies.

Job Relationships

• Reports to the Regional Manager, Clinical Operations Leads and all physicians at the local market
• 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 Alliance 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