Sr. Clinical Research Associate

Job Responsibilities and Essential Duties

• Provides data coordination and data management for randomized clinical studies.
• Manages investigative site activity for multiple protocols.
• Creates and implements subject enrollment strategies for assigned investigative sites.
• Ensures clinical trials are managed and executed following ICH GCP, regulations, the protocol, and company-specific SOPs.
• Designs CRFs and eCRFs for data acquisition and data entry.
• Works closely with sites to train and support data capture and cleaning, coordinating efficient corrections to the database, assisting with troubleshooting and site challenges.
• Defines necessary validations or reports to ensure quality and timeliness of data collection.
• Makes sure study metrics and site performance are monitored using standard study management tools.
• Collaborates with the study team to prepare abstracts, manuscripts, and other materials for internal and external audiences.
• Participates in meetings with multidisciplinary teams both internally and externally to ensure successful and timely completion of deliverables.
• Supports reporting to clinicaltrials.gov including data review, quality control checks, and interim and final analysis.

Required Knowledge & Skills

• Minimum requirement of a Bachelor's Degree, preferably in health sciences or a related field.
• Minimum of 6+ years of clinical research associate experience, in particular in supporting randomized clinical trials in either the medical device or pharmaceutical industry is required.
• Experience in cardiothoracic clinical trials preferred.
• Experience with data collection and project management tools.
• Critical attention to detail and accuracy.
• Ability to communicate appropriately and effectively both orally and in writing.

About us

Paragonix Technologies develops and markets organ transportation and preservation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time.

Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Pay and Schedule

US BASED SALARY - The minimum base salary for this position is $110,000 and the maximum salary is $125,000 plus 10% in annual bonus