Talencio's client, Cardialen, is an early stage medical device company based in Minneapolis. Our client is developing a novel application of low energy cardiac defibrillation therapy. The new device is expected to provide a better quality of life for patients. Cardialen is continuing clinical testing of the technology in humans as well as continuing development of the implantable device to deliver the therapy.
Cardialen is looking to hire a contract Senior Clinical Research Associate for a long-term, 12 – 24 months, engagement with a potential to convert to a direct hire. This is a key role for the company.
The Senior Clinical Research Associate works in close collaboration with management for the execution of clinical trials according to GCP, FDA regulations and SOPs, and acts as a pivotal point of contact and communication between department staff, outside contractors and clinical site personnel. They also assist with the preparation of regulatory submissions.
Analyzes and evaluates clinical data gathered during research.
Ensures compliance with protocol and overall clinical objectives.
Supports clinical trial execution and provides oversight of the CRO.
Helps with the development and implementation of clinical processes, procedures, and programs.
Help with development of SOPs.
Responsible for overseeing all activities of the clinical trial including study initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation in accordance with Federal Regulations, Good Clinical Practices, ICH Guidelines and company Standard Operating Procedures.
Establishes professional rapport and frequent communication with investigational site personnel and contracted vendors.
Works with CRO to ensure quality of data submitted from study sites and assure timely submission of data.
Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH and/or FDA GCP Guidelines.
Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.
Ensures documented follow-up to all outstanding issues, within the scope of this position profile.
Appropriately escalates serious or outstanding issues to management.
Facilitates the Regulatory Compliance audit process, as needed.
Bachelor's degree in a scientific discipline or equivalent.
At least 5 years of clinical research experience.
Demonstrated experience in all aspects of a clinical trial including, but not limited to, protocol development, study visits, and drafting study-specific documents.
Knowledge of FDA regulations/ICH required.
Must have demonstrated knowledge of industry standards in managing clinical data for studies.
Minimal travel required (less than 10%).
Clear evidence of a proactive and results driven approach.
Excellent verbal and written communications skills.
Intermediate skills in Microsoft Office, Word, and Power Point.
ACRP or SOCRA certification preferred.
Ability to work independently.
Experience in cardiac rhythm management is highly desired.
This is not a remote position. The Sr. CRA will be on-site in Minneapolis, MN.
Qualified candidates send resumes to AMehlhoff@talencio.com