Clinical Research Associate
Clinical Research Associate
-St. Louis Park, MN (Remote candidates will also be considered)
Position Summary:
We are seeking a Clinical Research Associate to join the Enterra team to assist with the management of clinical studies for our products to ensure compliance with protocols and applicable regulations including Good Clinical Practice (GCP). This role will serve as the point of contact between clinical sites and the Enterra team.
Job Responsibilities
- Responsible for patient accruals, subject stipends and tracking payments to sites for clinical study programs.
- Conduct site monitoring activities including monitoring visit preparation, onsite and remote co-monitoring, and monitoring visit follow-up.
- Completion of monitoring reports and tracking of action items.
- Perform data management activities.
- Assist with the writing and editing of study protocols, amendments, informed consents, committee charters, study reports, monitoring plans, and other related clinical and regulatory documents.
- Work with investigators and site personnel to quickly and effectively resolve discrepancies.
- Monitor ongoing compliance to study protocols in accordance with applicable regulations and GCP, work instructions, guidelines and/or policies.
- Assist with the management of investigational studies from start through study closure.
- Review source documentation to confirm subject eligibility for clinical trials.
- Update study dashboards, study trackers and other applicable study documents to provide regular updates to management.
- Engage in new study trial design with cross functional teams.
- Maintain, organize and update the trial master files for all clinical studies.
- Collect source documentation from sites related to adverse events and prepare material for adjudication by the clinical event committees.
- Assist in the creation and review of clinical trial documents.
- Assist with device accountability records for investigational products.
- Manage study supplies – track inventory and send to sites as needed.
- Support the regulatory submission process.
- Support investigator and coordinator meetings both in-person and online.
- Interact with study team, contract monitors, and the field sales team as needed.
- Assist with the review, editing, and compiling quality control documents.
- Any other job responsibilities as needed.
- 4+ years of experience in a clinical research role with at least 2 years in a CRA role of equivalent
- Ability to travel ~20%
- Previous experience with clinical trials and/or post-market registries in the U.S.
- Bachelors in a relevant field
- Current knowledge of medical device trials design and best practices.
- Strong project management skills and ability to act independently