[Hiring] Research Assistant @Care Access

Role Description

Central Clinical Services enables decentralized and hybrid clinical trials by providing staff who virtually support patients and sites. The Research Assistant (RA) position delivers a strong customer experience for both sites and patients by providing virtual study support under the delegation of a PI. The RA is accountable for study delivery at the patient level and is expected to support the patient experience, data management, and other study administrative tasks with a quality-first approach. This is an early-to-mid experience position with the expectation that the RA has working knowledge of and experience in the clinical research industry. Candidates will be hired at the RA I or RA II level depending on experience.

How You'll Make An Impact

• Patient Engagement
  • Identify, recruit, educate, and pre-screen potential patients for a study.
  • Analyze, understand, and be knowledgeable of the study protocol and the associated disease(s) to educate patients and their families.
  • Speak about studies with patients in an understandable manner.
  • Interpret patient-reported medical history and medication use to determine pre-screening qualification.
  • Assess if a patient is ready for a screening visit or needs more time to become informed.
  • Review next required study visits for patients and ensure they are scheduled within protocol window.
  • Work closely with the Central Study Coordinator to ensure patients are scheduled for all applicable protocol mandated activities.
  • Proactively contact patients to collect information, remind them of upcoming appointments, and engage in retention activities.
  • Verify completion of study visits and process patient stipend payments accordingly.
  • Communicate PI decisions on study eligibility to patients.
  • Communicate via phone, email, and video conference.
  • Document all patient interactions appropriately and in accordance with GCP and ALCOA-C.
  • Help troubleshoot technology issues for patients as they arise.
• Systems Maintenance and Data Management
  • Maintain up-to-date information across multiple study portals.
  • Review data backlog and prioritize data entry, clean-up work, and addressing queries.
  • Enter data in the correct systems within required time frames.
• Site Interaction
  • Attend regularly scheduled meetings with PIs and their site teams.
  • Review work done since the previous meeting and prepare the site meeting agenda.
  • Present progress information, escalations, and items for clarification to PI during calls.
  • Communicate with study sites between scheduled calls to resolve issues and questions.
• MRI Facility Set-up
  • Identify potential facilities for study imaging requirements.
  • Explain imaging requirements to identified facilities per protocol.
  • Negotiate contracts with potential facilities.
  • Serve as the liaison between the facility and the central study imaging reader.
• Other Responsibilities
  • Analyze and understand study protocols.
  • Support the preparation of regulatory documents and obtain necessary signatures.
  • Help troubleshoot technical issues that may arise.
  • Assist with other study-related administrative activities as needed.

Qualifications

• Highly proficient at using a variety of technologies used for clinical research including recruitment platforms, IWRS, EDC, and other clinical trial software.
• Skillful with Microsoft Office applications (Word, Outlook, Teams, and Excel).
• Demonstrate professionalism in all situations and work effectively with a diverse group of individuals.
• Understand when issues require escalation.
• Strong communication and customer service abilities.
• Proficient in research terminology and basic medical terminology.
• Understand the overall clinical development paradigm and have excellent working knowledge of government regulations, GCP, and ALCOA-C.
• Strong organization and time management skills.
• High attention to detail.
• Ability to work in a fast-paced environment.
• Critical thinker and problem solver.
• Ability to work effectively in a remote environment.
• Proper home office set-up including a private space for participant communication and high-speed internet (minimum: 100MB up and 15 MB down, 5 GHz router).

Requirements

• A minimum of 2 years of relevant clinical research experience.
• Spanish fluency is a bonus.

Benefits

• Paid Time Off (PTO) and Company Paid Holidays.
• 100% Employer paid medical, dental, and vision insurance plan options.
• Health Savings Account and Flexible Spending Accounts.
• Bi-weekly HSA employer contribution.
• Company paid Short-Term Disability and Long-Term Disability.
• 401(k) Retirement Plan, with Company Match.