Clinical Research Assistant

Paycom; Lone Tree (CO); On-site; USD 42,000 - 65,000; Full time

Job summary

Paycom is seeking an Experienced Medical Assistant or Research Assistant to support a growing Urology research department. The role interfaces with study coordinators, PIs, and sponsors to recruit subjects, collect samples, and manage data in EMR and EDC systems.

Ideal candidates have 1+ year in MA or RA roles, familiarity with GCP and regulatory guidelines, and strong communication and organization skills to navigate complex trial workflows.

Qualifications

• Minimum 1 year of experience as a medical assistant or research assistant.
• Familiarity with Good Clinical Practices (GCP) and FDA/IRB rules.
• Excellent written and verbal communication; strong time management.

Responsibilities

• Screen potential candidates for eligibility and consent.
• Obtain and document informed consent with ethical standards.
• Collect and process laboratory specimens according to study protocols.
• Perform protocol-specific measurements and data collection (vital signs, ECG, urinalysis).
• Maintain source documents and conduct data entry in EDC systems.
• Coordinate with study coordinators, PI, and sponsors on visits and documentation.

Skills

Medical Assistant

Research Assistant

GCP knowledge

Communication

Time management

Tools

EMR

EDC

IRB systems

Practice Management

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.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 marketAble to collaborate with experienced patient navigators, IT, and data management teamsROLE 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 regulationsMust have > 1 year experience as a medical assistant or research assistant.Urology based clinical experience preferredShould possess or develop proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems, and study specific EDC and IVRS systemsEffective time management and the ability to prioritize workExcellent communication skills and the ability to interact with all levels of management, staff, and physicians in person, virtually, and in writingAbility to be flexible with the day-to-day job requirements to facilitate a successful workflow in clinicESSENTIAL JOB RESPONSIBLITIES:Review and follow Urology Alliance Standard Operating ProceduresRead and understand specific requirements of each study protocol and informed consent formWorks with study coordinators and other research team members to complete protocol specific procedures and documentationAssists in clinic and protocol administration duties including but not limited to:Explain the purpose, risks, and benefits of clinical trial participationScreen potential candidates in a timely and accurate mannerEnsure that study patients understand the information presented and agree to the protocol requirementsObtain and maintain consent of patients prior to any study-related procedures being performed and with the highest ethical standardsProvide instructions to patients to ensure proper protocol complianceDistribute study medications in compliance with protocol randomization requirementsLearn 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 requirementsPerform study-specific readings and measurements including but not limited to:Vital signsECGUrine Pregnancy TestUroflow, TRUS, urinalysis, cystoscopyPhotography and videographyReports irregular readings and measurements to Investigator and Lead Study CoordinatorPackage and ship laboratory specimens to study-specific destinationsComplete applicable training requirements and ongoing education as requiredMaintain 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 recordsEffectively communicate with potential candidates for trials and collect metrics to track progressMust have or gain knowledge of relevant software/programsWork closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and callsAssist with the development of source documents and phone screen toolsManage ancillary supply inventory and assist with drug accountabilityMaintain HIPAA compliant communication and confidentiality, at all timesParticipate in site visits (site initiation visits, interim monitoring visits, close-out visits, etc.Assist study coordinators with necessary study close-out procedures and documentationPerforms other duties as assigned