Posted: Friday, January 5, 2018 1:12 PM
Our client, a world leader in Pharmaceuticals and In:Vitro Diagnostics (IVD) tools, is seeking an Clinical Research Associate"
ESSENTIAL JOB FUNCTIONS
:Works under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects; May co:ordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
:Travels to field sites to monitor studies.
:Receives general instructions; plans and prepares studies.
:Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
:Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites.
:Collects and maintains legal and regulatory documentation, as applicable.
:Assumes responsibility for training and coordinating certification of study site personnel.
:Ensures accurate and complete study management/data collection and transfer to data management
:Ensures site compliance with regulations and study protocol.
:Monitors the sites and provides technical assistance, as necessary.
:Assists, prepares and manages study timelines
:Manages material logistics for the studies.
:Conducts reference material testing in:house.
:Organizes investigator meetings, as necessary.
:Participates in Project Team Meetings.
:Keeps informed of trends and developments in clinical research.
:Knows and effectively uses the broad concepts of a particular field or speicalization to resolve problems of limited scope and complexity.
:Analyzes alternative approaches to solve problems or devleop new perspectives n existing solutons.
:The essential job functions and major contributions listed above are not intended to be an exhaustive list of all responsibilities, duties and skills.
:Incumbents may be required to perform other duties as required.
Job Level Criteria:
Job Level Criteria defines additional responsibilities for this job, which includes such things as Strategic Focus, Leadership Responsibility and Impact of Work on the organization. To obtain appropriate Job Level Criteria, please go to the HR Intranet site under Job Descriptions and Levels.
Position Specific Qualifications (Training Requirements):
:Position specific job qualifications are maintained in the Clients Learning Solution within SAP.
:Managers and employees can contact their department's Learning Solutions Support Administrator (LSSA) to get a complete list of qualifications for a specific position.
Bachelors degree in a scientific discipline or related field, or equivalent combination of education and work experience. Masters Degree Peferred
Please respond with your updated resume and contact information to
• Location: East Bay
• Post ID: 92995262 eastbay