Please note - This position will be located in Minnesota. Remote work is not available for this role.
We are looking for a Senior Clinical Research Associate (CRA) to join our clinical team. This person will lead the planning, development and execution of clinical research projects under only general supervision, in accordance with applicable regulatory requirements and company policy. Coordinates the scientific and logistical aspects of clinical studies through collaboration with cross-functional partners and/or clinical vendors (if applicable). This position is the primary point of contact for their assigned clinical study (or studies) and is responsible for aligning the extended team members to deliver on study milestones and project deliverables.
We are looking for a candidate with the ability to manage timelines, is self- motivated, and be a part of a creative and collaborative team. In this role, your work will include activities such as;
Responsible for compliance with applicable organizational policies and procedures.
Serves as a direct liaison between organization and investigators/institutions participating in clinical trials.
Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, performing monitoring visits and follow-up of corrective actions.
Participates in the site qualification, activation and initiation process, including review of site activation documentation
Contributes to developing and writing clinical protocols, case report forms, and other study aids.
Maintains expertise in regulations for applicable geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.). Serves as a resource related to clinical trial regulations.
Ensures timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations.
Assists with critical data review and query resolution at a site level.
Contributes to development and maintenance of departmental standard operating procedures (SOPs).
Effectively and professionally interacts with Primary Investigators, Research Coordinators, and other site staff to ensure efficient site management throughout the study.
Ensures the study is “audit ready” at all times (study team training records, central files, system validation, etc.).
Prepares and conducts site visits as needed, including site qualification, study initiation, interim monitoring, and close-out visits.
Prepares and assists in regulatory reports and submissions (if applicable).
Continually monitors study compliance and implements corrective action plans at individual sites and across study, as needed.
Bachelor's degree (engineering/life sciences/medical/scientific field preferred)
Minimum of 6 years of experience in medical device clinical research or advanced degree with a minimum of 4 years working in clinical research demonstrating progressive experience in conduct of clinical research
Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates) preferred
Strong knowledge of clinical research operations
Strong knowledge of ISO, FDA, GCP, and MedDev regulations and guidance for trial related activities
Strong prioritization and organizational skills
Demonstrated strong problem-solving skills
Works effectively on cross-functional teams
Works effectively with all levels of professionals at clinical sites
Strong computer skills (MS Office products including Word, Excel, Project, Visio)
Experience working with a variety of Electronic Data Capture systems
High attention to detail and accuracy
Flexible and dependable
Able to manage multiple tasks
Advanced written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
Ability to travel 30%
Additional Salary Information: We offer a competitive benefits package that includes:
Long-Term Disability Coverage, Life Insurance, AD&D
Health Savings and Flexible Spending Accounts
401k with company match
PTO and Paid Holidays
About Osprey Medical, Inc.
Osprey Medical, Inc. specializes in the commercialization of proprietary technologies designed to protect CKD patients’ kidneys from the harmful effects of dye. Our proprietary technologies reduce the amount of contrast (dye) used during heart catheterization procedures without compromising X-ray image quality for the physician.
• Our Mission is to improve outcomes in patients with Chronic Kidney Disease by reducing contrast induced Acute Kidney Injury (AKI) and lowering hospital costs.
• Our Vision is to make heart imaging procedures safer for patients with poor kidney function.