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Sunrise Systems is Hiring a Compliance Manager Near Gaithersburg, MD
Location: Gaithersburg, MD
Duration: 12 months (With high chance of possible extension)Position Type: Hourly contract Position (W2 only)DescriptionHuman Biological Samples (HBS) are fundamental to medical research in the discovery, development and implementation of new treatments and diagnostics. HBS are ethically sensitive materials and the collection, handling and access to HBS are subject to strict regulations, principles and ethical guidelines.
- The HBS Compliance Associate Director is responsible for ensuring the compliant use of samples for research.
- They are experienced in the review of informed consent and able to ensure samples are used in accordance with patient wishes, protecting our License to Operate.
- They will ensure HBS Compliance procedures are followed with regard to HBS specific policies and standards, and are able to advise stakeholders on use of samples, including decision making on approval of requests for their use in research.
- Review and advise on use of HBS in accordance with patient consent.
- Lead the identification and establishment of effective HBS compliance procedures to support review of samples as part of US inventories.
- Manage HBS processes to ensure standards are adhered to and compliance requirements are consistently applied for use of HBS in research for samples in the US for the Amnesty project.
- Support the business with compliant use of HBS through expert advice and decision making
- Ensure risks arising from HBS due diligence activities for US Inventory are identified and recorded.
- Maintain the documentation/SOPs associated with HBS due diligence activities for the US Amnesty project.
- Monitor the effectiveness of HBS due diligence processes and identify opportunities for improvement.
- Perform HBS due diligence reviews for client clinical sample use and re-use requests for HBS in the bio bank to support delivery of timely and effective decisions.
- Act as subject matter expert, reviewing informed consents and making recommendations on HBS use
Job Summary
Contractor
$93k-119k (estimate)
02/10/2024
06/26/2024
sunrisesystems.com
PEMBROKE, MA
50 - 100
Private
HENRY C APPLETON
$5M - $10M
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