Clinical Research Associate

Default Work Shift:

Varies (United States of America)

Hours:

40

Salary range:

$20.71 - $31.30

Schedule:

Full Time

Shift Hours:

8 Hour employee

Department:

Research-Other

Job Objective:

Assists in the running of Clinical Trials.

Job Description:

Education: Required: Bachelor’s degree or two (2) years’ research experience in lieu of degree; completion of CITI Good Clinical Practice (GCP) for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) course (www.CITIprogram.org) Preferred: Bachelor’s degree in Clinical Research, Nursing or Administration Licensure/Certification: Required: Certification from Society of Clinical Research Associate (SOCRA) as a Certified Clinical Research Professional (CCRP) or Certification from Association of Clinical Research Professionals (ACRP), such as, Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), ACRP Certified Professional (ACRP-CP) within two (2) years (full-time employee) or four (4) years (part-time employee) of hire Experience: Required: One (1) year of healthcare experience or successful completion of paid six (6) month Research Internship at Eisenhower Health

Reports To: Manager-Research and Clinical Trials Supervises: N/A Ages of Patients: Adult, Geriatric Blood Borne Pathogens: Moderate Potential

Skills, Knowledge, Abilities:

Ability to create a welcoming environment for patients and visitors, demonstrating empathy and respect in all interactions, Ability to organize information or data to facilitate easy retrieval and use, Ability to prioritize tasks and manage time efficiently to meet deadlines, Ability to use Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) and other relevant software applications, Written and verbal communication skills

Essential Responsibilities

1. Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations. 2. Completes patient screening for eligibility to research protocol; records results in logs and Epic. 3. Completes registration/randomization to protocol; schedules treatment, specimen collection, imaging studies and/or other tests/exams. 4. Completes patient recruitment and follow-up. 5. Completes case report forms (CRFs); ensures adequate source documentation in the medical record to support clinical trial; abstracts data from Epic (source data) and/or obtains medical records to complete CRFs; contacts patient, as needed, to collect data and documents in Epic; completes data entry in electronic data capture (EDC) or specified databases; resolves queries. 6. Reports and communicates to the sponsor/CRA/monitor/IRB. 7. Reports serious adverse events. 8. Handles and maintains investigator files. 9. Schedules meetings with physicians, creates agendas, and takes minutes. 10. Sends letters and/or telephones/communicates with patients and physicians regarding study results. 11. Performs other duties as assigned.