Theresa Linus
Huntingdon Valley,PA
Summary
Results-driven leader with 14 years of progressive experience in global safety operations, compliance, quality assurance, and regulatory affairs, complemented by 11 years in clinical research and 6 years of direct patient care nursing. Recognized for solving complex problems, performing under pressure, and delivering compliant, high-quality outcomes in the pharmaceutical industry.
Overview
32
32
years of professional experience
1
1
Certification
Work History
Clinical Research Nurse
Drexel University-Clinical Research Center, College of Medicine
Philadelphia, PA
07.2016 - 12.2025
- Coordinated and oversaw daily operations for Infectious Disease and HIV clinical research trials
- Served as primary liaison between sponsors, investigators, and regulatory bodies (IRB, WIRB, IBC, DAIDS/NIH) to ensure study compliance
- Prepared and submitted regulatory documentation on schedule, including continuing reviews, protocol modifications, reportable events, and expedited adverse event reports
- Maintained complete and audit-ready regulatory binders; conducted quarterly QC reviews covering protocols, consent forms, approvals, training records, financial disclosures, laboratory certifications, and monitoring reports
- Collaborated with multidisciplinary research teams and participated in study meetings to ensure protocol adherence
- Developed and updated study-specific SOPs; contributed to the Quality Assurance Management Plan for the REPRIEVE Study
Research Quality Assurance Coordinator
Drexel University-Clinical Research Center, College of Medicine
Philadelphia, PA
09.2014 - 06.2016
- Led Quality Assurance activities for clinical research trials within the Infectious Diseases & HIV Medicine Division and Department of Medicine
- Conducted independent QA reviews of trial activities and documentation (CRFs, protocols, source documents, regulatory files) to ensure compliance with GCP, SOPs, protocols, and regulatory requirements
- Identified quality gaps and continuous improvement opportunities; communicated findings to management and study teams to maintain compliance
- Coordinated review and reporting of serious adverse events (SAEs) with medical staff; prepared and submitted adverse event reports to IRB and regulatory agencies
- Performed QA reviews of regulatory, source, and protocol documents in preparation for sponsor audits; documented and communicated findings to study staff
- Served as primary contact for sponsor audits; reviewed audit findings and developed Corrective and Preventive Action (CAPA) plans
- Maintained QA documentation and audit-ready files
- Contributed to the development and implementation of clinical research SOPs
- Performed data entry, CRF completion, query resolution, and data review to ensure database accuracy and integrity
- Participated in bi-weekly clinical research meetings
Senior Associate, Global Regulatory Affairs-Process Assurance
MERCK & CO. INC
West Point, PA
06.2012 - 11.2013
- Reviewed Global Regulatory Policy Newsletter (GRPN) to assess regulatory, clinical, and pharmacovigilance policy updates and their impact on business processes
- Performed initial screening and impact assessments of regulatory guidelines and procedures; partnered with business owners to finalize assessments and track outcomes
- Trained on and served as gatekeeper for the Non-Compliance Investigation Report (NCIR) process, guiding teams through identification, documentation, and resolution of process deviations and trends
- Facilitated annual internal PV and regulatory audits for global subsidiaries and headquarters, supporting 25–30 audits per year across systems, processes, and business partners
- Identified and prepared Subject Matter Experts (SMEs) for audit interviews; fulfilled HQ pre-audit and audit requests, including global system outputs and SOPs
- Acted as liaison between regulatory, clinical, safety, and medical teams to develop CAPA responses; collected supporting evidence and maintained audit documentation
- Participated in FDA Pharmacovigilance inspection (2013)
Senior Associate, Global Safety Quality
MERCK & CO. INC
West Point, PA
09.2010 - 05.2012
- Commended by Senior Associate, Pharmacovigilance (PV) Quality "ability to navigate between project responsibilities with ease, always prioritizing competing tasks in an efficient and appropriate manner allowed her to maintain an exemplary compliance rate in accordance with FDA regulations pertaining to adverse experience reporting."
- Recognized by Senior Associate PV Quality "for expertise in case quality and committed to the leader behaviors of fostering collaboration, speaking with courage and candor and a strong drive for positive results."
- Monitored global, subsidiary, business partner, and Banyu pharmacovigilance reporting compliance.
- Partnered with PV clinical teams to perform root cause analyses for late adverse event reports submitted to global health authorities and business partners
- Identified compliance trends and training gaps; investigated late-report notifications and delivered root cause analyses and corrective action plans in accordance with safety data exchange agreements
- Supported audits and inspections by providing metrics, documentation, and facilitation support
- Served as primary point of contact for NWAES MedDRA versioning and maintenance
- Participated in FDA Pharmacovigilance inspection (2011)
Senior Associate- Pharmacovigilance Quality
MERCK & CO. INC
West Point, PA
01.2010 - 09.2010
- Primary contact for the monitoring of Subsidiary/Banyu/business partner compliance.
- Attended and participated in monthly Global Safety Compliance meetings.
- Supported and maintained all NWAES Med DRA versioning responsibilities.
- Facilitated study unblindings; end of study unblinds for NWAES and non-Worldwide Product Safety (WPS) special requests for regulatory agencies or clinical research.
Senior Associate Education and Quality Control (EQC)
MERCK & CO. INC
West Point, PA
08.2002 - 01.2010
- Conducted daily reviews of expedited safety reports submitted to the FDA; uploaded investigator letters and IND Safety Reports to internal systems for research associate access
- Generated and distributed Serious Adverse Event (SAE) investigator notifications to global subsidiaries in compliance with ICH-GCP requirements
- Performed quarterly reviews of subsidiary pharmacovigilance compliance
- Delivered PV training and tutorials to departments, subsidiaries, and contingent staff; coordinated regional teleconferences and ad hoc training sessions as needed
- Managed MHRA/EU regulatory package inquiries and resolution requests
- Processed EQC requests, including downgrades, data corrections, U.S. clinical voids, and company causality assessments for domestic and international cases
- Performed quality reviews of Product Safety Update Reports (PSURs) and bridging documents
- Supported and maintained NWAES MedDRA versioning activities
- Facilitated study and end-of-study unblinding requests for NWAES, Worldwide Product Safety, regulatory agencies, and clinical research teams
Adverse Experience Coordinator
MERCK & CO. INC
West Point, PA
10.1998 - 08.2002
- Prepared and submitted Adverse Drug Reaction reports for marketed and investigational products to the FDA, including expedited and periodic submissions
- Reviewed and processed litigation-related safety reports
- Compiled safety data for IND and NDA periodic FDA submissions
- Collaborated daily with Clinical, Clinical Risk Management, and Safety Surveillance teams to ensure data accuracy and regulatory compliance
- Advanced from temporary to permanent full-time role within one year based on performance
Registered Nurse Cardiac Care Telemetry Step Down Unit
ALBERT EINSTEIN MEDICAL CENTER
Philadelphia, PA
01.1995 - 01.2000
- Provided direct nursing care to pre- and post-operative patients, including those with complex cardiac conditions
- Administered medications, performed physical assessments, interpreted laboratory results, and documented care accurately
- Educated and supported patients and families on medications, disease processes, procedures, and discharge planning
- Collaborated effectively with multidisciplinary healthcare teams; selected as preceptor for new graduate and newly hired RNs
Psychiatric Aid, Pediatric Unit
EASTERN PENNSYLVANIA PSYCHIATRIC INSTITUTE
Philadelphia, PA
01.1994 - 01.1995
- Provided one-on-one direct care in a 13-bed pediatric unit for children ages 3–13
- Supported patients with developmental delays, behavioral disorders, learning disabilities, trauma histories, and acute mental health needs
- Recognized with a Commendation for rapid and effective intervention in a pediatric choking emergency.
Education
Bachelor of Science - Nursing
Thomas Jefferson University School of Nursing
Philadelphia, PA05-1995
Prerequisites for Nursing -
Holy Family College
Philadelphia, PA01.1993
Skills
- Electronic CRFs (eCRFs)
- Oracle Clinical-Remote Data Capture (OC-RDC)
- EPIC
- OpenClinica
- ECOS (eClinical OS)
- Excel
- Allscripts
- Coeus Lite
- RedCAP
- Microsoft Office
- SharePoint
Certification
• Certified Professional Registered Nurse
• CPR Certified
• CITI (Collaborative Institutional Training Initiative)Certified:
• Good Clinical Practice (GCP)- Medical GCP-Current
• Human Subject Research (HSR)-Current
• Health information Privacy and Security (HIPS)-Current
• Responsible Conduct of Research (RCR)- Current
• HIPAA and medical Research certified- 10/01/14
• Title 9 Certificate- Current
• CPR Certified
• CITI (Collaborative Institutional Training Initiative)Certified:
• Good Clinical Practice (GCP)- Medical GCP-Current
• Human Subject Research (HSR)-Current
• Health information Privacy and Security (HIPS)-Current
• Responsible Conduct of Research (RCR)- Current
• HIPAA and medical Research certified- 10/01/14
• Title 9 Certificate- Current
Professional Development
- Adult Critical Care Course (AEMC) Philadelphia, PA 1995
- Basic Dysrhythmia Course, 1995
- Critical Care Pharmacology Course, 1995
- Certificate of Achievement in IV Venipuncture by the Pervascular Nurse Consultants, 1995
- Attended Heart Centers Cardiology Conference by Accucore Cardiac Monitors, 1995
- Worldwide Pharmacovigilance Meeting, 05/01/00
Timeline
Clinical Research Nurse
Drexel University-Clinical Research Center, College of Medicine
07.2016 - 12.2025
Research Quality Assurance Coordinator
Drexel University-Clinical Research Center, College of Medicine
09.2014 - 06.2016
Senior Associate, Global Regulatory Affairs-Process Assurance
MERCK & CO. INC
06.2012 - 11.2013
Senior Associate, Global Safety Quality
MERCK & CO. INC
09.2010 - 05.2012
Senior Associate- Pharmacovigilance Quality
MERCK & CO. INC
01.2010 - 09.2010
Senior Associate Education and Quality Control (EQC)
MERCK & CO. INC
08.2002 - 01.2010
Adverse Experience Coordinator
MERCK & CO. INC
10.1998 - 08.2002
Registered Nurse Cardiac Care Telemetry Step Down Unit
ALBERT EINSTEIN MEDICAL CENTER
01.1995 - 01.2000
Psychiatric Aid, Pediatric Unit
EASTERN PENNSYLVANIA PSYCHIATRIC INSTITUTE
01.1994 - 01.1995
Bachelor of Science - Nursing
Thomas Jefferson University School of Nursing
Prerequisites for Nursing -
Holy Family College