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Serve as the Principal Investigator for IRB-related activities associated with studies. Held accountable for all activities associated with internal blood draws. Supervise specimen bank personnel for human specimen procurement activities to enable successful design verification and validation studies; to support research phase activities at global R&D sites and Center of Excellence labs and support modified in-vitro diagnostic products.
Core Job Responsibilities
Responsible for implementing and maintaining the effectiveness of the quality system.
1. Principal Investigator responsibilities to meet IRB and study requirements. Support associated process audits associated with internal blood draws.
2. Facilitate timely and compliant blood draw study approvals. Compliance is with both division and corporate IRB-related policies; processes and procedures.
3. Ensure specimen collection needs are met to support ongoing projects and maintain a long range plan for sample procurement.
4. Actively support audit activities associated with specimen bank processes.
5. Interacts with Finance regularly regarding billing and coordinates charge-outs to non R&D functional areas purchasing from the Specimen Bank.
6. Identify new vendors and sources of sample acquisition to support ongoing project needs
Direct reports may vary with the project and the assignment. Direct reports may also include contract labor.
1. Identify subjects to participate in blood collections; and document verification of each subject's consent
2. Prepare; approve; and amend study documents
3. Conduct and/or oversee the clinical study in compliance with division procedure and the IRB/IEC approved protocol.
4 Prepare study records for retention according to site procedures
5. Maintain complete subject and specimen accountability records 6
. If clinically relevant results using a marketed product are generated that can be compared to a health related range; prepare an Out-of-range (OOR) agreement
7. Review study results against the approved OOR agreement. If OOR results are identified; contact the site designated licensed physician or qualified health care professional to notify the subject and protect subject confidentiality when communicating OOR information and document all activities related to management of OOR information and maintain in the study file.
8. Store confidential information in a secure area with limited access
9. Accountable for total project scope
10. Manage planning; collection and storage of human specimens needed for research; development and on-market in-vitro diagnostic activities. Ensure compliance to all applicable quality/regulatory requirements.
11. Establish long range plan for specimen needs and ensure needed strategic funding and focus.
12. Confirm that quality standards for accuracy and completeness are met by specimen bank personnel.
B.S. or B.A. Individual must be able to understand the scientific principles and the appropriate regulations and guidelines to effectively perform activities.
Minimum Experience/Training Required
Good communication, interpersonal, and team skills. Demonstrated ability to manage confidential information. Excellent written and oral communication skills. Superior attention to detail. Computer fluency in word processing and spreadsheets. Good working knowledge of personal computer software programs in Windows environment. An understanding of the clinical laboratory, the serology and disease processes desirable. EXPERIENCE: 1-2 years supervisory or management experience. Minimum of 5 years relevant professional experience in a related areas such as R&D, Quality, Technical Product Development or Clinical Research
CLS and MLT certification with 3-5 years clinical lab experience required.
Phlebotomy license and experience, preferred.
Medical & Scientific Affairs
United States > Santa Clara : 4551 Great America Parkway
Yes, 5 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
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