Research Assistant

Summary

Care Access works to make the future of health better and more accessible by bringing clinical research and health services directly to communities. The Research Assistant provides virtual study support under the delegation of a Principal Investigator, supporting patient engagement, study delivery, data management, site interactions, imaging facility coordination, and administrative activities.

Responsibilities

• 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
• 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
• 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
• 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
• 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

Skills

• 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)
• A minimum of 2 years of relevant clinical research experience
• Remote within the United States. This role requires 100% of work to be performed in a remote office environment
• This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role
• The ability to use keyboards and other computer equipment
• Care Access is unable to sponsor work visas at this time
• Spanish fluency is a bonus

Qualifications

Must Haves

• 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)
• A minimum of 2 years of relevant clinical research experience
• Remote within the United States. This role requires 100% of work to be performed in a remote office environment
• This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role
• The ability to use keyboards and other computer equipment
• Care Access is unable to sponsor work visas at this time

Nice to Haves

• 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