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JOB DESCRIPTION/POSITION SUMMARY: The Quality Assurance, Mgr. will be responsible for compliance oversight with studies and supporting suppliers (i.e., Phase 1 Units, Labs, CROs, Research Sites, etc.) within the Pharma Segment. The oversight will include vendor qualifications, audits, CRO and site oversight and site monitors assigned to studies.
Audit Responsibilities:
- Proactively anticipate the horizon of regulations and make sure that current GCP/Clinical Trial practices reflect current and future industry practice.
- Independently performs Clinical site audits, vendor (such as central labs, bioanalytical labs, clinical trial supplies packaging and retention facilities etc.) audits and internal audits as required ensuring adherence to audit schedules.
- Determine if there is a site compliance issue and take appropriate action (i.e., for cause audit, co-monitor trip, etc.)
- Serves as interface for inspections and audits relating to GCP compliance.
- Open and manage Supplier Corrective Action Report (SCAR) as needed.
- Open and manage Non-Conformance (NCR) as needed.
Monitoring Oversight Responsibilities:
- Oversee assigned site monitors to the study and ensure the following activities are being done as expected (i.e., complete, thorough, escalation as needed):
- Monitors activities conducted by clinical investigative sites as they relate to sponsor clinical studies to ensure successful execution of the protocol.
- Oversee the vendor monitoring activities as needed.
- Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Protocol/Amendment(s), Monitoring Plans, and to quality standards in conducting clinical research.
- Ensure subject safety and verify diligence in protecting the confidentiality and well-being of study subjects.
- Conducts site qualification, site initiation, interim monitoring and close out visits for Phase 1-4 studies or accompanies the CRO site monitor when performing these visits.
- Performs source data verification as defined in the monitoring plan (including ICF review)
- Verify completeness, accuracy, consistency, and compliance/quality of trial data collected at study sites; identify deficiencies and discrepancies and provides remedial training and/or corrective action as required; generate and resolve queries in between monitoring visits.
- Complete monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended action to secure compliance.
- Responsible for timely identification, escalation and resolution of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.
- Involved in review of study plans.
- Checks Investigator site file for completeness
- IP management and accountability
- Manages Key Performance Indicators assigned to monitoring activities as defined by the study team.
Qualifications
MINIMUM REQUIREMENTS: Education and Experience (in years):
• BA or BS with scientific discipline (Pharmacy, Nursing, Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), B Pharm or RN or BSc Nursing degree or equivalent. Minimum of 5 years of clinical research monitoring experience and auditing.
• Industry certification - SOCRA or ACRP, or equivalent preferred.
• Read, write, and speak fluent English
Knowledge and skills:
• There will be expectations of being in closet Baxter office, when work requires interactions with Pharma team members, and may be required to be on-site with CRO’s during the time studies are being executed
• Ability to travel preferred but flexible, maximum 40%
• Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable federal regulations.
• Experience in monitoring/auditing sites, ability to prioritize and multi-task in a fast-paced environment
• Detailed oriented, with strong time management and organizational skills
• Excellent communication and team skills
• Effective interpersonal skills
• Working knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
• Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc.
• Demonstrated business ethics and integrity.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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