Clinical Research Associate (CRA) - C
Experis, a ManpowerGroup company has an exciting contract opportunity for Clinical Research Associate . This position is a 12-month contract for one of our key clients, a global manufacturing company that is engaged in the discovery, development, and manufacturer of medical devices.
Job Title: Clinical Research Associate
Location: Des Plaines, IL
Duration: 12 Months (possibly extension)
- Complies with all policies, established procedures, regulations, and Good Clinical Practice (GCP).
- Acquires a basic understanding of the principles of the assay and/or instrument and "hands-on" knowledge and skills in performing assigned assays or operating instruments.
- Prepares clinical plans that meet product design goals, intended use, regulatory requirements, divisional operating procedures, and Clinical Research work instructions.
- Prepares clinical protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies.
- Identifies and qualifies clinical investigators and clinical sites.
- Initiates payments to clinical sites.
- Obtains and reviews all required essential documents necessary for study initiation.
- Collaborates with Statistical Support with the collection and statistical analyses of clinical data.
- Monitors clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines.
- Assures subject rights, safety, and welfare are protected; ensures data integrity through completeness, accuracy, and legibility.
- Conducts pre-study, initiation, interim, and closeout monitoring site visits and completes site visit reports.
- Maintains accurate and timely sponsor/site correspondence and communication.
- Review's data, prepares, and presents clinical data reviews and data summaries.
- Responds to audits and data queries.
- Prepares and presents project progress reports to keep management and team informed.
- Prepares the clinical sections of regulatory submissions and international registration packages.
- Functions independently in the field and interacts with all levels of medical and scientific professionals.
- Successful and timely completion of clinical studies directly impacts the ability to meet product market entry dates.
- Early identification of unsatisfactory results, operations, or specific problems allows immediate action to be taken by appropriate groups.
- Resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project.
- Accountable for the project scope and scheduled completion date.
- Works under the direction of the Clinical Project Manager
Kushagra Mohan I
Talent Acquisition Specialist
100 Manpower Place | Milwaukee, WI 53212