Join a rapidly growing team that is a global leader in clinical trials! Re:Cognition Health, a leading provider of clinical trial research specializing in cognitive impairment, is looking for an ambitious, organized, and highly motivated Clinical Trials Start-Up Officer for its clinical trials team. Re:Cognition Health’s clinics are major centers for international trials of disease-modifying drugs for Alzheimer’s disease and other neurological conditions.

We have an opportunity across the organisation for a Clinical Trials Start-Up Officer to join a talented growing team. The position is a hybrid role, based in Chicago, IL.

The Clinical Trials Start-Up Officer will primarily be responsible for the start-up process for clinical trials delivered across all US Re:Cognition Health centers, with assistance given from our UK based Clinical Trials Start-Up Specialist. The role includes the feasibility and start-up processes for clinical trials, ensuring compliance with the International Conference on Harmonisation guidelines for Good Clinical Practice (ICH GCP, R2) and specific protocols as designated by the trial Sponsors and Clinical Research Organisations. A key performance indicator will be to ensure a rapid, high quality start-up process across all US Re:Cognition Health centres.

JOB RESPONSIBILITIES:

· Responsible for the management of the Clinical trials pipeline tracker on a day-to-day basis, ensuring that all feasibility and start-up tasks are up to date for all centers, and report on new clinical trials set up progress.

· Responsible for the completion of Confidentially Agreements (CDA), as required.

· Accountable for the completion and submission of site-specific feasibility and/or site pre-qualification processes, ensuring a rapid and consistent response to requests, with suitable feasibility presented.

· Responsible for the coordination of set up activities for all studies and provide assistance and support to Management with site set-up processes, in collaboration with the study CRO / Sponsor representatives.

· Responsible for the preparation of site-specific essential document packages including training documentation, from central electronic records for all centers.

· Responsible for ensuring the preparation of site-specific Informed Consent Forms (ICF) and other similar documents (e.g. source documents) and their amendments, are in place, in collaboration with the sponsor/CRO team.

· Ensure third party vendors required for the trial are working with the site team/CRO/sponsor to return all necessary documentation and approvals.

· Responsible for collection of protocol approval signatures for all centers.

· Ensure accurate data set up within the CTMS system.

Requirements:

• Bachelor’s Degree in a science, technical, health-related field
• Minimum 1 year of previous or current experience in clinical research experience, at site level
• IT Proficiency
• HIPAA and GCP trained
• Excellent verbal and written communication skills

Desirable:

• At least 6 months experience in CNS trials
• Experience of using electronic data capture systems, e.g., Medidata RAVE

Clinical Trials Assistant Benefits:

• 4 weeks PTO
• Excellent health/dental/vision insurance
• 401k retirement plan with employer match
• Employer-provided life and disability insurance
• Health Savings Account
• Continuous Professional Development

ABOUT RE:COGNITION HEALTH

Re:Cognition Health is a pioneering brain and mind clinic that specializes in the treatment and care of people showing symptoms of cognitive impairment. Utilizing the latest progressive medical research and evidence-based treatments, we are passionate about transforming and optimizing cognitive performance through education, clinical excellence and by providing access to emerging treatments.

We value people who are dedicated, hardworking and looking to contribute to the growth of our business at an exciting time. Our vision is to become the recognized worldwide leader in the diagnosis, treatment and care management of individuals experiencing cognitive impairment. Come join our team where everyone is valued and where critical and important work is being done!

To find out more about our company, please visit https://recognitionhealth.com

Job Type: Full-time

Pay: $55,000.00 - $65,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Health insurance
• Health savings account
• Paid time off
• Professional development assistance
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Clinical research: 1 year (Required)

Work Location: In person