Research Assistant

How This Role Makes a Difference

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) in combination to be able to educate patients and their families on what participating in the study means for the patient
  • Speak about studies with patients in a manner they can understand
  • Interpret patient reported medical history and medication use to determine pre-screening qualification for a study
  • Assess if a patient is ready to be scheduled for a screening visit for a study or if more time is needed for them to become informed about the study, including a potential discussion with the study doctor
  • Review next required study visits for patients and the timeline in the protocol to ensure they are scheduled within protocol window
  • Work closely with the Central Study Coordinator to understand all aspects of the study to which each patient consented, and ensure they are being scheduled for all applicable protocol mandated activities
  • Proactively contact patients to collect information, remind them of upcoming appointments, and engage in other patient retention activities
  • Verify completion of study visits through systems checks and then process patient stipend payments accordingly
  • Communicate PI decisions on study eligibility to patients
  • Communicate via various mediums such as phone, email, and video conference
  • Document all patient interaction 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 use good judgement prioritize data entry, clean-up work, and addressing queries according to study needs and requirements
  • Enter data in the correct systems within the required time frames per site per study
• Site Interaction
  • Attend regularly scheduled meetings with PIs and their site teams
  • Review work done since previous meeting and prepare the site meeting agenda accordingly
  • Present progress information, escalations, and items for clarification to PI during calls alongside the CSC
  • Communicate with study sites between regularly scheduled calls to resolve issues and questions
• MRI Facility Set-up
  • Identify potential facilities for patients to go for study imaging requirements
  • Explain the 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 for the duration of the study
• Other Responsibilities
  • Analyze and understand study protocols
  • Support the preparation of regulatory documents, obtain signatures from required and appropriate personnel as required
  • Help troubleshoot technical issues that may arise
  • Assist with other study related administrative activities as needed

The Expertise Required

• Highly proficient at using a variety of technologies used for clinical research including recruitment platforms, IWRS, EDC, and other clinical trial software, and able to work across multiple platforms at the same time
• 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 customer service abilities
• Proficient in research terminology and basic medical terminology
• Understand the overall clinical development paradigm and 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 (at minimum: 100MB up and 15 MB down, 5 GHz router)

Certifications/Licenses, Education, and Experience

• Minimum Experience:
  • A minimum of 2 years of relevant clinical research experience
  • Spanish fluency is a bonus

How We Work Together

• Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
• Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
• Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.

The expected pay range for this role is $65,000 - $75,000 USD per year for full time team members.

Benefits & Perks (US Full Time Employees)

• 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