Cardinal Health Senior Project Specialist, Clinical Research Associate in Minnesota
Your safety is our top priority. We regularly consult with medical professionals on best practices in COVID-19 prevention to protect our employees. We train our employees on these best practices and regularly clean our sites in accordance with CDC guidelines. Please note: all individuals entering our facilities are required to complete a self-health check, wear a mask, and follow all posted guidelines.
This role has the ability to sit remotely
What Clinical Operations Project Management contributes to Cardinal Health:
Clinical Operations Management is responsible for strategic oversight and leadership direction within the Clinical Operations function.
- Support Project Managers in charge of medical device clinical trials
- Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
- Performs remote and onsite monitoring visits as needed and according to Clinical Monitoring Plan.
- Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
- Creates and assists with maintenance of project files, handles project correspondence
- Participates in file audits
- Prepares and maintains site manuals, reference tools and other documents
- Maintains, updates, and inputs clinical tracking information into databases
- Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
- Manages shared mailbox, processes site requests and routes correspondence appropriately
- Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
- Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
- Routinely anticipates, identifies and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues
- Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training.
- Bachelor's degree preferred or equivalent experience
- Experience in clinical research/pharma/biotech or related field
- Good knowledge of medical terminology, clinical data, and ICH/GCP/EU MDR preferred
- Ability to successfully prioritize and work on multiple tasks
- Strong attention to detail, accuracy and organizational skills
- Excellent communication, presentation, and interpersonal skills
- Ability to embrace new technologies
- Minimal travel up to 10% may be required
What is expected of you and others at this level:
- Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
- Works on projects of moderate scope and complexity
- Identifies possible solutions to a variety of technical problems and takes actions to resolve
- Applies judgment within defined parameters
- Receives general guidance may receive more detailed instruction on new projects
- Work reviewed for sound reasoning and accuracy
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
To read and review this privacy notice click here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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