[Hiring] Clinical Research Associate @SOLVENTUM

Role Description

As a Clinical Research Associate, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Ensuring preparation, collection, and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigative site.
• Conducting pre-study site visits, collecting and reviewing site feasibility and operational processes information, and preparing reports; participating in the final selection of investigators and study sites.
• Conducting clinical study site initiation visits; advising and training site personnel on Sponsor and regulatory requirements for study conduct.
• Conducting site monitoring visits and following-up to identify significant problems and issues and ensuring that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies.
• Reviewing on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifying deficiencies and discrepancies, and providing remedial training and/or initiating corrective action as required.
• Reviewing case report form queries and problems, and clarifying and/or obtaining changes to data as appropriate.
• Collaborating closely with the Clinical Project Manager, cross functional study teams and all Research partners, internal and external to company.
• Assisting with device preparation, shipment coordination and maintaining appropriate accountability records.

Qualifications

• Bachelor’s degree or higher (completed and verified prior to start) from an accredited institution AND three (3) years of clinical research, biomedical, or medical device industry experience in a private, public, government or military environment, which must include two (2) years of direct Clinical Research Associate (CRA) experience conducting clinical study monitoring activities.
• OR High School Diploma/GED (completed and verified prior to start) AND seven (7) years of clinical research, biomedical, or medical device industry experience in a private, public, government or military environment, which must include five (5) years of direct Clinical Research Associate (CRA) experience conducting clinical study monitoring activities.
• Direct CRA monitoring experience monitoring medical device clinical studies.
• Experience working in hospital or clinical setting or medical laboratory.
• Uses Smartsheet, Microsoft Copilot, and Microsoft 365 applications to manage, track, analyze, and communicate work-related information.
• Background in preparing and delivering verbal, written, and presentation communications regarding project status, issues, and escalations to relevant stakeholders.
• Identifies problems, evaluates potential solutions, and supports resolution of business or project issues.
• Prioritizes, plans, tracks, and evaluates deliverables against established requirements and timelines.
• Manages multiple concurrent tasks and adjusts priorities based on changing business needs and deadlines.

Requirements

• Work location: Remote.
• Travel: May include up to 75%.
• Relocation Assistance: Is not authorized.
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Benefits

• Competitive pay and benefits.
• Medical, Dental & Vision.
• Health Savings Accounts.
• Health Care & Dependent Care Flexible Spending Accounts.
• Disability Benefits.
• Life Insurance.
• Voluntary Benefits.
• Paid Absences.
• Retirement Benefits.