Sabrina Heidenga
Brighton,MI
Summary
Clinical research professional with comprehensive experience in managing clinical trial activities and ensuring compliance with regulatory standards. Known for strong collaboration and meeting project milestones efficiently. Exhibits excellent attention to detail and adaptability to dynamic environments.
Overview
9
9
years of professional experience
Work History
Clinical Trial Associate
Progenity
03.2019 - 12.2020
- Point of contact for operational activities relating to clinical sample management plans
- Be the point of contact between clinical study team, CRO, central and testing labs for communication regarding sample logistics and availability, batching and testing timelines, reanalysis and data reporting
- Track clinical samples from samples receipt to result, reporting to investigator sites
- Organize and plan meetings and provide agenda and meeting minutes to assist in purchase of clinical studies necessary for various studies
- Coordinated paperwork and purchasing of samples
- Researched and evaluated virtual clinical trial platforms
- Collected and managed clinical sample sources from various biobanks
- Update and manage project management timelines
Laboratory Office Manager
Stonebridge Coatings Laboratory, IC.
01.2019 - 06.2020
- Handled sensitive information with discretion, maintaining confidentiality of company documents and personnel records.
- Worked closely with different departments to gather information to ensure accuracy when creating Standard Operating Procedures
- Streamlined office operations by implementing efficient filing systems and organizational strategies.
- Maintained accurate financial records by reconciling accounts payable/receivable transactions regularly to ensure balanced budgets.
- Oversaw office inventory activities by ordering and requisitions and stocking and shipment receiving.
- Evaluated accuracy of existing quality assurance measurement techniques, implementing improvements to increase efficacy and reduce errors.
- Conducted regular audits to identify areas of improvement, leading to increased customer satisfaction levels.
- Served as a trusted advisor to senior management on matters related to quality assurance, contributing valuable insights that informed strategic decision-making processes.
Biorepository Supervisor
Progenity
06.2015 - 02.2018
- Manage all samples coming into laboratory
- Sourcing appropriate samples from biobanks and vendors
- Oversee, hiring, training and management of biorepository staff
- Fulfill sample requests received from various departments
- Manage remnant samples from commercial department
- Help plan and implement Project Validation including the planning of sample requirements, blinding and adjudication efforts
- Functioned as Study Coordinator for various studys including NIPT protocols and capsule endoscopy
- Monitoring of clinical sties along with team CRAs
- Aided in the implementation of new testing procedures, keeping the lab up-to-date with industry advancements.
- Supported colleagues in troubleshooting issues, fostering a collaborative team atmosphere.
- Assisted in maintaining a safe work environment through adherence to safety protocols and proper waste disposal methods.
- Contributed to the reduction of specimen rejection rates by adhering to strict handling procedures.
- Demonstrated strong attention to detail when entering patient demographic information into electronic systems, minimizing potential errors in records or billing processes.
- Maintained a high level of quality control with thorough specimen verification and proper labeling practices.
Clinical Trial Accessioning Technician
Progenity
06.2015 - 06.2016
- Management of all samples coming into laboratory
- Assisted clinical operations team with drafting and review of all SOPs for laboratory practices necessary for sample processing, clinical trial protocols, case report forms and any other study related documents
- Identified sample discrepancies and missing samples, request queries, track queries and assist in resolution
- Organized and implemented Freezerworks sample storage program to create and maintain proper sample storage organization for multiple studies
- Promoted an organized workspace through routine maintenance of equipment, storage areas, and documentation practices.
- Maintained a high level of quality control with thorough specimen verification and proper labeling practices.
- Enhanced laboratory turnaround time by accurately and efficiently accessioning specimens.
Polymer Laboratory Technician II
Stonebridge Coatings Laboratory, INC.
12.2014 - 06.2015
- Maintained a high level of accuracy in test results by following strict quality control procedures.
- Cleaned and sterilized tools and equipment to maximize purity of specimens.
- Operated basic laboratory equipment such as balances, pH meter, colorimeter, spectrophotometer, autoclave and evaporator.
- Performed testing and quality control using approved laboratory procedures and instrumentation.
- Documented information by maintaining daily logs and equipment record books.
- Calibrated and maintained instruments to keep equipment fully operational.
Polymer Laboratory Technician
Stonebridge Coatings Laboratory, INC.
08.2012 - 12.2014
- Maintained a high level of accuracy in test results by following strict quality control procedures.
- Cleaned and sterilized tools and equipment to maximize purity of specimens.
- Operated basic laboratory equipment such as balances, pH meter, colorimeter, spectrophotometer, autoclave and evaporator.
- Performed testing and quality control using approved laboratory procedures and instrumentation.
- Maintained documentation on tests performed in lab.
- Documented information by maintaining daily logs and equipment record books.
- Calibrated and maintained instruments to keep equipment fully operational.
- Contributed to a safe working environment by consistently following established safety procedures and guidelines within the lab setting.
Microbiology Intern
Pfizer Animal Health
05.2012 - 09.2012
- Supported staff members in their daily tasks, reducing workload burden and allowing for increased focus on higher-priority assignments.
- Gained valuable experience working within a specific industry, applying learned concepts directly into relevant work situations.
- Sorted and organized files, spreadsheets, and reports.
- Gained hands-on experience in various software programs, increasing proficiency and expanding technical skill set.
- Participated in workshops and presentations related to projects to gain knowledge.
- Contributed to a positive team environment by collaborating with fellow interns on group projects and presentations.
Education
Bachelor of Science - Biology
Madonna University
Livonia, MI12-2013
Skills
- Strong knowledge of clinical sample management
- Knowledge of GCP guidelines, FDA guidelines, medical terminology, and clinical trial processes
- Experience with Electronic Data Capture (EDC), eTMF software, and Freezerworks
- Ability to manage multiple projects, prioritize tasks and work remotely
- Ability to support project leads and drive the start-up process
- Can communicate effectively using Zoom chat/video, phone and Microsoft suite across function internally and externally
- Ability to work independently
Timeline
Clinical Trial Associate
Progenity
03.2019 - 12.2020
Laboratory Office Manager
Stonebridge Coatings Laboratory, IC.
01.2019 - 06.2020
Biorepository Supervisor
Progenity
06.2015 - 02.2018
Clinical Trial Accessioning Technician
Progenity
06.2015 - 06.2016
Polymer Laboratory Technician II
Stonebridge Coatings Laboratory, INC.
12.2014 - 06.2015
Polymer Laboratory Technician
Stonebridge Coatings Laboratory, INC.
08.2012 - 12.2014
Microbiology Intern
Pfizer Animal Health
05.2012 - 09.2012
Bachelor of Science - Biology
Madonna University
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