Clinical Trial Data Management
Resume:
Skills
Work History
Diane Marsh
Lab Manager/MAPC Phlebotomist
Spokane, WA, 99218
*****.*****@*****.***
ICH/Good Clinical Practice
Laboratory management
Clinical Trial process
Standard operating procedures
Data management
Instrument Calibration
Research coordination
Biological sample processing
Chemical handling
2010-01 - Current Independent Phlebotomy Contractor Eastgate Medical Services, WA
Perform venipuncture and other methods of blood collection at various locations, including homes, clinics, and laboratories.
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Ensure all samples are accurately labeled, documented, and handled according to standard procedures and client-specific requirements.
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Safely transport samples to designated laboratories or drop-off points, ensuring timely delivery and maintaining sample integrity.
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Provide a professional, courteous, and empathetic experience for clients, ensuring their comfort and understanding of the procedure.
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Obtain necessary informed consent and medical history when required, ensuring all interactions are documented appropriately.
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Address any concerns or questions from clients regarding the phlebotomy process.
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Adhere to all relevant healthcare regulations, including OSHA standards and HIPAA requirements, to ensure client safety and confidentiality.
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Maintain a clean and organized workspace, whether at home visits, clinics, or mobile setups, following all safety protocols.
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Properly dispose of biohazardous waste and maintain the sterility of phlebotomy equipment.
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Accurately document all sample collections, including date, time, and client information, ensuring records are maintained according to client or regulatory requirements.
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Provide necessary reports to contracting entities, including any deviations or issues encountered during sample collection.
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Manage and maintain an inventory of phlebotomy supplies, ensuring all necessary equipment is available, properly sterilized, and in working order.
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Order supplies as needed and manage costs to maintain a profitable operation.
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Develop and maintain relationships with healthcare providers, laboratories, and other clients to secure and manage contracts.
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Negotiate contract terms, set service fees, and ensure timely payment for services rendered.
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Market services to potential clients, including private individuals, to expand the business.
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2010-01 - Current Phlebotomy Team Lead Contractor
Quest Diagnostics
Lead and supervise a team of laboratory technicians and scientists, providing direction, support, and mentorship.
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Assign tasks and manage the daily workflow to ensure that laboratory testing is performed timely and efficiently.
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Conduct regular team meetings to communicate goals, updates, and address any concerns or challenges.
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Oversee the day-to-day operations of the clinical laboratory, ensuring all procedures are followed according to standard operating procedures (SOPs) and regulatory guidelines.
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Monitor laboratory processes to ensure accuracy, reliability, and efficiency in testing and analysis.
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Manage laboratory resources, including equipment, supplies, and reagents, ensuring they are available and in good working condition.
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Implement and maintain quality control programs to ensure that all laboratory tests meet the required standards.
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Ensure compliance with all regulatory requirements, including those set by CAP, CLIA, and other relevant accrediting bodies.
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Investigate and resolve any quality issues, including non-conformities, and implement corrective actions as necessary.
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Provide training and ongoing development opportunities for laboratory staff to enhance their skills and knowledge.
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Ensure that all team members are trained on new equipment, technologies, and procedures.
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Conduct performance evaluations and provide constructive feedback to support staff growth and development.
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Oversee the accurate entry, management, and analysis of laboratory data, ensuring data integrity and compliance with laboratory information management systems (LIMS).
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Prepare and present reports on laboratory performance, including productivity, quality, and compliance metrics.
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Work closely with clinical staff, researchers, and other stakeholders to support their needs and ensure laboratory services align with organizational goals.
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2017-01 - Current Clinical Trial Laboratory Manager Inland Northwest Research, Spokane, WA
• Supervise and coordinate daily activities within the clinical trial laboratory. Ensure that all laboratory processes, including sample collection, processing, analysis, and storage, are performed according to standard operating procedures (SOPs) and trial protocols.
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Maintain laboratory equipment, ensuring regular calibration, maintenance, and troubleshooting as needed.
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Manage a team of laboratory technicians and assistants, providing leadership, training, and performance evaluations.
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Ensure that all lab personnel are trained in SOPs, safety procedures, and trial- specific protocols.
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Ensure that laboratory practices adhere to Good Clinical Laboratory Practice
(GCLP) guidelines, regulatory standards, and ethical requirements.
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Oversee quality control and quality assurance activities, including the development and implementation of corrective actions when necessary.
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Maintain accurate and up-to-date documentation, including laboratory records, reports, and logs.
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Liaise with clinical research coordinators, principal investigators, and other stakeholders to ensure seamless integration of laboratory activities with clinical trial timelines.
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Communicate effectively with sponsors, regulatory bodies, and auditors during inspections and audits.
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Oversee the collection, labeling, processing, storage, and shipment of biological samples in accordance with trial protocols and regulatory requirements.
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Ensure the integrity and traceability of samples throughout the clinical trial process.
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Develop and manage the laboratory budget, ensuring cost-effective use of resources.
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• Order and maintain adequate inventory of laboratory supplies and reagents. Ensure the accurate and timely entry of laboratory data into electronic databases or laboratory information management systems (LIMS).
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Collaborate with data management teams to support data cleaning, validation, and analysis.
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2015-01 - Current Clinical Trial Phlebotomist
Oregon Health Sciences University, WA
Perform venipuncture and other methods of blood collection from clinical trial participants following standard operating procedures (SOPs) and trial protocols.
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Ensure proper labeling, documentation, and handling of all collected samples to maintain their integrity.
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Safely transport and/or prepare samples for processing, storage, or shipment as required by the trial protocol.
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Provide a calm, professional, and empathetic environment for participants during sample collection, addressing any concerns or discomfort.
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Obtain informed consent when necessary and ensure that participants understand the procedures being performed.
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Adhere to all regulatory guidelines, including Good Clinical Practice (GCP) and institutional policies, to ensure compliance with ethical standards.
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Maintain a clean, safe, and organized work environment, following all safety protocols to prevent contamination or injury.
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Properly dispose of biohazardous waste and maintain sterilization of phlebotomy equipment.
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Accurately document all sample collections, including time, date, and any participant-specific information required by the clinical trial protocol.
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Report any issues or deviations from the protocol to the clinical trial coordinator or principal investigator.
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• Maintain accurate records of sample storage and shipment. Work closely with clinical trial coordinators, nurses, and laboratory staff to ensure timely and accurate collection and processing of samples.
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Monitor and manage the inventory of phlebotomy supplies, ensuring that all necessary equipment is available and in good working order.
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Experienced in various platforms for clinical trial lab management included but not limited to, ACM, Q2, Labcorp, Quest. Proficient in MS Office, Excel, Powerpoint, Teck View360, Hello Health, NextGen.
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2010-01 - 2020-06 Phlebotomy Team Lead/Wellness Coordinator Boston Heart
Lead and supervise a team of phlebotomists, providing guidance, support, and direction in daily operations.
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Coordinate staff schedules, ensuring adequate coverage and efficient workflow.
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Conduct regular team meetings to communicate goals, updates, and address any challenges or concerns.
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Oversee the day-to-day operations of the phlebotomy team, ensuring that all blood draws and specimen collections are performed according to standard operating procedures (SOPs) and best practices.
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Monitor the team's performance to ensure high standards of accuracy, safety, and patient care.
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Order supplies as needed to maintain continuous operations without interruptions.
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Work closely with other departments to coordinate specimen collection and processing, ensuring that laboratory and clinical needs are met.
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Ensure that all patients are treated with compassion, respect, and professionalism during their interactions with the phlebotomy team.
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Design, implement, and manage wellness programs tailored to the needs of the organization.
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Promote wellness programs through various communication channels, including newsletters, social media, and internal communications.
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Conduct surveys and assessments to gather feedback and measure employee interest and engagement.
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Encourage employee participation in wellness programs and provide ongoing support and motivation.
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Collaborate with HR, management, and external vendors to ensure wellness programs align with company goals and employee needs.
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• Track and report on the participation and effectiveness of wellness programs. Manage the budget for wellness programs, ensuring cost-effective use of resources.
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2010-01 - Current Phlebotomy Team Lead/Medical Examiner Summit Health
Lead and supervise a team of phlebotomists, providing guidance, support, and direction in daily operations.
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Coordinate staff schedules, ensuring adequate coverage and efficient workflow.
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Conduct regular team meetings to communicate goals, updates, and address any challenges or concerns.
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Oversee the day-to-day operations of the phlebotomy team, ensuring that all blood draws and specimen collections are performed according to standard operating procedures (SOPs) and best practices.
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Monitor the team's performance to ensure high standards of accuracy, safety, and patient care.
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Address and resolve any issues or challenges that arise during specimen collection, including patient concerns or equipment malfunctions.
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Ensure that all phlebotomy procedures comply with regulatory requirements, including those set by OSHA, CLIA, and other relevant accrediting bodies.
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Implement and monitor quality control measures to ensure the integrity of collected samples.
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Maintain accurate and up-to-date documentation, including logs, reports, and patient records.
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Provide training and ongoing development opportunities for phlebotomists to enhance their skills and knowledge.
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Ensure that all team members are trained on new equipment, techniques, and safety protocols.
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Education
Certifications
Clinical Trials
Conduct performance evaluations and provide constructive feedback to support staff growth and improvement.
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Ensure that all patients are treated with compassion, respect, and professionalism during their interactions with the phlebotomy team.
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• Address any patient concerns or complaints promptly and effectively. Promote a patient-centered approach within the team to enhance patient satisfaction.
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Monitor and manage the inventory of phlebotomy supplies, ensuring that all necessary equipment is available and in good working order.
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• Ensure proper maintenance and calibration of phlebotomy equipment. Act as a liaison between the phlebotomy team, laboratory staff, and management, ensuring effective communication and collaboration.
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Participate in cross-functional meetings and projects as a representative of the phlebotomy team.
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Phlebotomy - Active License
Spokane Community College - Spokane, WA
DOT 49 CFR Part 40 Urine Drug Screen Collector
CMI 400 Breath and Alcohol Technician
Cholestech/CardioChek
BLS/AED
IATA/HAZMAT Certified
CITI/Good Clinical Practice
IV Cannulation Certification
Registered Medical Assistant- WA State
Certified Pulmonary Function Test Technician
Certified ECG Technician
Experience in clinical trial phases I-IV in the areas of CNS, hematology, oncology, immunology and endocrinology. Subject matter expert in the area of clinical trial pathology, lab and data management.
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