Clinical Research Associate
About the Opportunity
We are currently seeking a Clinical Research Associate responsible for working creatively with research sites to facilitate and supervise the conduct of clinical trials, build relationships, and effectively communicate ideas and results, along with managing a high volume of data with multiple modalities.
Reports to Chief Scientific Officer with dotted line responsibilities to the Clinical Studies Project Manager
Is a full time position based in our corporate office, located in Bethesda, Maryland or works remotely
Requires travel, approximately 30% of the time
Maintains a customer focus, a commitment to excellence, and adherence to compliance policy and medical device regulation in all work decisions to uphold BrainScope’s “Culture of Quality”
We offer a competitive salary, strong benefits and stock options to complete the package
Along with Clinical Project Manager, perform clinical site initiation, conduct and close-out activities to execution within established timelines.
Perform site monitoring visits and follow-ups to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with applicable regulations, guidelines and policies.
Monitor and review existing and incoming data to support data handling processes ensuring data integrity is maintained by performing regular quality checks, query management and resolution.
Review and audit on-site files and records, clinical report forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies and discrepancies; provide remedial training and/or initiate corrective action as required.
Conduct re-training and provide clarification on protocol and regulatory requirements for study conduct; arrange, participate in and/or conduct site meetings and multi-center investigator meetings.
Ensure all clinical aspects of studies are being carried out in accordance with Good Clinical Practice (GCP), regulatory agency guidelines, company SOPS, and overall protocol clinical objectives for all phases of clinical trials.
Assist with company’s QMS activities in accordance with Good Documentation Practices (GDP).
Bachelor’s degree (minimum), preferably in Life Sciences
CRA certification preferred
4 years of total experience in a clinical research setting required, with a strong preference for experience with medical devices
Minimum of 1-3 years specific monitoring experience with CRO or sponsor company preferred
Must be able to work weekends when necessary to meet the needs of our clinical sites
Experience and skill in writing of technical clinical study documentation
Strong relationship management skills and the ability to influence others
Strong computer skills: ability to learn new technology and electronic data center systems
Demonstrated exceptional written and oral communication skills
Outstanding organizational skills, attention to detail, planning and prioritizing, efficient time management, concern for quality, common sense and flexibility
Operate effectively in a multi-disciplinary, team-oriented culture that emphasizes professional development
Experience with Microsoft Office Suite
Qualified applicants are encouraged to send their resume and a cover letter including availability to firstname.lastname@example.org.
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