Clinical Research Assistant (32624) in Lone Tree, Colorado at GI Alliance

Clinical Research Assistant (32624)
Job DetailsJob Location: Urology Denver Lone Tree - Lone Tree, CO 80124
Position Type: Full Time
Job Shift: Day
Description

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.

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

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:

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