
Clinical Research Associate I
Austin, TXResearchSeen 4 days agoSeen in employer's feed 4 days ago
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Job overview
The Clinical Research Associate I supports clinical research studies by recruiting and consenting participants, coordinating study activities, and collecting and managing research data. The role also supports regulatory submissions, site monitoring, audits, and research documentation, while assisting the Principal Investigator and supervising or training research assistants. It requires careful, confidential handling of participant information and effective collaboration with research teams.
Skills & qualifications
Skills
Full job description
Identify, recruit, and consent research participants.Evaluate medical records and perform screenings to identify eligible study participants.Assist in screening and enrolling study participants.Administer assessments and conduct research experiment sessions.Call participants for follow-up as outlined within research protocols and maintain ongoing communication to support retention.Address participant questions and concerns throughout study participation.Collect, verify, and review research data from clinical sites.Ensure accurate and timely data entry into electronic data capture systems.Review, track, and resolve data queries.Ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.Facilitate Institutional Review Board (IRB) applications, submissions, renewals, and updates across multiple sites.Prepare, maintain, and organize regulatory documentation.Coordinate with ethics committees to safeguard participant rights.Conduct site initiation, monitoring, and close-out activities as needed.Monitor site performance and assist with issue resolution.Manage research administrative tasks, including maintaining supply inventories, ordering and maintaining equipment, and preparing participant payments.Assist in the supervision, coordination, and management of graduate and undergraduate research assistants supporting research projects.Assist the Principal Investigator with research-related activities, including preparation of manuscripts, progress reports, and grant submissions.Conduct literature reviews to support study design, protocol development, and reporting.Prepare study reports and maintain accurate documentation of study activities.Assist in training new site staff and research team members.Participate in internal and external audits.Support the development of study protocols and case report forms.Attend conferences and workshops to remain current on research and industry trends.Adhere to internal controls, reporting structures, and established procedures.Perform related duties as required.Double-check work for accuracy, maintain organized records, and follow detailed procedures.Write clear and concise reports, actively listen, and present information effectively.Analyze information, develop solutions, and implement corrective actions as needed.Collaborate effectively with team members and contribute to team success.Prioritize tasks, manage time efficiently, and meet deadlines.Demonstrate professionalism, discretion, and respect in all interactions.Handle sensitive information with confidentiality, sound judgment, and composure.Exhibit strong written, verbal, and interpersonal communication skills.Demonstrate excellent organizational and time-management abilities with strong attention to detail.Show critical thinking and problem-solving skills.Willingly train, mentor, and support undergraduate and graduate research assistants.
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