In-House Clinical Research Associate

Madison, WI

Job Description


JOB OBJECTIVE: The In-House Clinical Research Associate (CRA) will assist with providing clinical trial coordination support and implementing clinical operational and clinical therapeutic plans and projects in accordance with organizational SOPs and ICH/GCP standards. The primary responsibilities of the CRA are to help develop, execute, and manage assigned aspects of the organization’s clinical trials in conjunction with the Clinical Operations and Clinical Therapeutics teams. The ideal candidate will have industry experience as a CTA or CRA with a Sponsor organization and demonstrate a drive and interest in bridging their clinical operations background with the unique demands of psychedelic research, which includes the work of clinical facilitation.


CORE DUTIES:


1. Supports the clinical study teams in the execution of clinical studies and clinical projects, ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.


2. Organizes, manages, and oversees the Trial Master Files (TMFs) to maintain up-to-date regulatory documentation in accordance with each study’s TMF Plan.


3. Organizes, manages and oversees the study working files on SharePoint (or similar platform) to maintain up-to-date study documentation in accordance with each study’s oversight plan.


4. Manages study trackers and reports, providing regular metric updates to the Clinical Operations and Clinical Therapeutics teams.


5. Assists with the coordination of study and project related meetings. Composes and distributes meeting agendas and minutes, and manages study team actions and decision items.


6. Manages the preparation, training, handling, distributing, and returns of clinical trial supplies as needed.


7. Acts as a central contact for the study team for designated project communications, correspondence, and associated documentation.


8. Liases with clinical study sites to assist the project team with training and on-site support of investigators, including co-monitoring or monitoring activities.


9. Ensures inspection-readiness and provides support to sites to prepare for clinical audits and inspections.


10. Liases with the central IRBs or Ethics Committees and other vendors, as needed.


11. Acts as a liaison between Clinical Site Staff and Clinical Facilitators involved in Usona’s clinical trials and the Clinical Operations and Clinical Therapeutics teams on topics pertaining to the conduct of studies and the thorough completion and certification of mandated trainings and adherence monitoring.


12. Works with the Clinical Therapeutics team to develop, operationalize, and execute systems for the qualification, tracking, and certification of Clinical Facilitator trainings and adherence monitoring.


13. Manages Clinical Facilitator access to training materials, such as training videos, assessments, and other documents.


14. Fully supports the Quality Policy by building quality into all aspects of the CRA’s work and by maintaining compliance to all quality requirements, including but not limited to maintaining and documenting all training requirements associated with the position.


15. Demonstrates inclusion through their words and actions and is accountable for maintaining a safe workspace. Acts with kindness, curiosity, and respect for others.


16. Embraces and is willing to incorporate the values and principles of self-knowledge, empathy, self-esteem, compassionate discernment, appreciation of diversity, and transparent communication in daily work.


17. Understands and complies with ethical, legal, and regulatory requirements applicable to our organization.


KEY QUALIFICATIONS:


1. At least 2+ years of relevant work experience and a Bachelor’s or higher degree in a relevant scientific discipline.


2. Must have a demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.


3. Well-organized and detail-oriented, with strong written and verbal communication skills.


4. Demonstrated skills in internal and external collaboration among cross-functional teams, vendors, and scientific and clinical advisors.


5. Demonstrated ability to work independently and in a team environment and exhibits initiative with a positive and proactive approach.


6. Able to prioritize and handle multiple tasks simultaneously.


7. Ability to proficiently use a computer and Microsoft Office applications and systems (such as Word, Excel, Outlook, SharePoint, Teams, etc), Adobe and other computer applications, as necessary.


8. Ability to travel 25% of the time.


PREFERRED QUALIFICATIONS:


1. Previous experience within a Sponsor organization in industry preferred.


2. Previous experience in a Clinical Operations role preferred.


3. Previous experience with electronic Trial Master File (eTMF) systems, Electronic Data Capture (EDC) systems, and/or Clinical Trial Management Systems (CTMS).


4. Experience with site monitoring preferred.


5. Experience with Central Nervous System (CNS) and/or psychedelic trials preferred.


6. In-house position preferred, remote possibility for ideal candidate.


PHYSICAL DEMANDS:


1. Ability to use a computer and Microsoft Office applications.

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