Clinical Data Management

Manpreet Kaur

Laboratory Assistant Clinical Data Associate Clinical Research Associate

Fort Worth, Texas, United States ***********@*****.*** +1-469-***-**** Linkedin PROFESSIONAL PROFILE

• Medical Laboratory Assistant and Clinical Data Associate with over 5 years of experience in routine testing, planting microbiology specimens, preparing staining slides and recording testing data.

• Possess a Bachelor's in Medical Laboratory Science and professional training in Clinical Data Management.

• Hallmark skills include maintaining lab cleanliness and safety procedures, mitigating risk, and communicating test results efficiently.

• Expert in medical terminology, products, and services to effectively address and respond to public and personnel inquiries.

• Proven track record in performing electronic archival of CRFs, implementing clinical data management plans and performing data review in conjunction with medical and safety inspection. CORE COMPETENCIES

• Research & Analysis

• Cross-Team Collaboration

• Conflict Resolutions

• Negotiation Skills

• Interpersonal Skills

• Time Management

• Problem Solving

• Effective Communication

• Relationship Management

PROFESSIONAL EXPERIENCE

Quest Diagnostics Aug 2022 – Present

Laboratory Assistant

• Perform tests to identify bacteria and other microbes by growing cultures from samples in a microbiology Laboratory.

• Inoculating culture using different plates and introducing a new operating procedure for monitoring and shelving tissue culture supplies to increase efficiency by 15%.

• Maintained strict aseptic fields when collecting biological samples, minimizing staff and patient infection risks.

• Print labels, work on pending lists by the end of the shift, and finish the pending samples before the end of the change.

• Performed chemical analysis to determine their chemical makeup and susceptibility to certain medications.

• Utilized expertise in microbiology, chemistry and hematology to help diagnosis of medical issues of 20 patients daily.

• Prioritize a high volume of test requests to ensure all tests were completed by the end of the shift, multi-tasking procedures with varying time requirements to complete several projects concurrently. Punjab Health System Corporation Jun 2016 – Dec 2021 Medical Laboratory Technician

• Assisted hospital physicians in the diagnosis and treatment of illness, injuries and medical conditions by providing clinical testing and specimen analysis.

• Conducted Laboratory tests in the area of haematology, coagulation, urinalysis, serology, microbiology, and immunology. Performed urine drug screens along with calibrations and quality control once a week.

• Oversaw safety requirements in the department, followed HIPAA and universal safety precautions and wore proper protective equipment. Expedited critical testing results without compromising sample validity and quality assurance.

• Performed preventative maintenance on laboratory equipment and saved $10000 by implementing cost-saving initiatives. Stringently followed lab protocols, sanitation and testing procedures.

• Prepared detailed reports on experiments and tests and ran appropriate quality control; calculated and reported analysis results without supervision. Reviewed and prepared monthly QC and submitted it to the Medical Director.

• Performed various administrative duties, including data entry, document preparation and patient testing on analyzers values over $1000K while reporting results to clinical laboratory scientists. EDUCATION

Punjab Technical University Apr 2015 – Apr 2018

Bachelors In Medical Laboratory Science

TRAININGS

Eficens May 2022 – Aug 2022

Clinical Data Management Training

• Performed clinical data management functions, including data review, Protocol review, CRF design and creation, CRF review, database validation, query generation, and soft lock and hard lock.

• Updated, corrected, and reviewed the database based on resolved data queries. Performed QC auditing of the clinical trial database against the eCRF and resolved queries to establish accuracy.

• Performed SAE reconciliation between safety and clinical databases, and all other external data reconciliation like lab

(PK, biomarkers) etc. Learned comprehensive Knowledge of eCRF, edit check specification, eCRF page verification.

• Prepared data for independent readers, communicated effectively with site personnel and performed additional data management activities as required.

• Collaborated with the database administrator on the design of the clinical study database by following relevant procedures. Designed database setup, processed CRF and managed discrepancy to database lock.

• Involved in data review, data entry and query generation and updated the database to make corrections accordingly.

• Developed the data validation plan and managed clinical data cleaning and delivery activities, including database lock.

• Ensured data exchange services were on time according to the protocol timelines to ensure a smooth transition into the database.

• Reviewed SAS proc contents, CRF, eCRF Data, and tumor assessment forms for completeness, accuracy, and consistency.

SKILLS

• Database Management

• Medical Terminology

• Specimens Collection

• Clinical Data Management

• CRF Design

• SAE Reconciliation

• Clinical Data Cleaning

• Microsoft Office

• Aseptic Procedures

• Preventive Care

• Disease Diagnosis

• Test Data Analysis

• Google Suite

• Lab Equipment Maintenance

• Computer Skills

• Record Maintenance

• HIPAA

• Specimen Testing

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