Clinical Research Associate-Research-Other

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 AdministrationRequired: 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

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:

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

Essential Responsibilities:

• Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations.
• Completes patient screening for eligibility to research protocol; records results in logs and Epic.
• Completes registration/randomization to protocol; schedules treatment, specimen collection, imaging studies and/or other tests/exams.
• Completes patient recruitment and follow-up.
• 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.
• Reports and communicates to the sponsor/CRA/monitor/IRB.
• Reports serious adverse events.
• Handles and maintains investigator files.
• Schedules meetings with physicians, creates agendas, and takes minutes.
• Sends letters and/or telephones/communicates with patients and physicians regarding study results.
• Performs other duties as assigned.

Essential Skils:

• Ability to organize information or data to facilitate easy retrieval and use
• Ability to create a welcoming environment for patients and visitors, demonstrating empathy and respect in all interactions
• Written and verbal communication skills
• 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