Lauren Beach
Summary
Detail-oriented and highly organized Assistant Clinical Research Manager with proven experience in supporting comprehensive research operations. Skilled in regulatory compliance, ensuring data integrity, and collaborating effectively with principal investigators, sponsors, and clinical teams. Proficient in streamlining processes, managing documentation, and ensuring that timelines and quality standards are met throughout the study lifecycle. Recognized for proactive problem-solving, effective leadership, and a commitment to advancing knowledge in clinical research.
Overview
18
18
years of professional experience
Work History
ASSOC CLINICAL RESEARCH MGR | PROJECT ASSISTANT
PPD DEVELOPMENT, LP
05.2022 - Current
- Supervises multiple teams, Project Assistant and Clinical Data Associate
- Maintains critical document files and other study-related information
- Facilitates submission of documents to the Institutional Review Board (IRB) during study initiation activities
- Provides project-specific clerical support to Clinic Project Managers during the course of clinical research studies.
- Perform regulatory documentation review throughout study until final archival
- Reviews protocol and case report forms (CRFs) to determine study specific information required in Medidata RAVE
- Ensures data is entered accurately and have timely completion
- Plan and conduct internal Good Clinical Practice (GCP) audits (e.g., process, study conduct, study documentation, clinical study reports).
- Assist project managers in achieving timely completion of projects through diligent monitoring and data entry deadlines.
WAREHOUSE ASSOCIATE
PRIME NOW
02.2017 - 02.2023
- Selecting, packaging, and shipping customers' orders
- Sort packages into routes to ensure met the customer need and promised delivery time.
- Assist drivers with missing packages
- Stow/Receive items into proper locations
- Remove items that are damaged and/or expired.
- Collaborated with team members to achieve daily targets and complete tasks efficiently.
- Performed inventory control, such as counting, and stocking merchandise.
- Worked safely around moving machinery.
- Increased accuracy in order picking by utilizing electronic scanning devices and following established procedures.
QUALITY ASSURANCE ANALYST
NOVUM PHARMACEUTICAL RESEARCH SERVICES
08.2021 - 05.2022
- Plan and conduct internal Good Clinical Practice (GCP) audits (e.g., process, study conduct, study documentation, clinical study reports)
- Plan and conduct internal Quality Assurance (QA) audits (e.g., process, study conduct, study documentation)
- Write and issue QA audit reports to management for performing Novum internal and external QA audits
- Ensure responses to QA audit observational findings are appropriate and complete (closes observational corrections)
- Perform regulatory documentation review throughout study until final archival
- Assist QAM with preparing for and hosting Sponsor audits of Novum
- Assist QAM with Quality Review Board (QRB) preparation
- Archive Trial Master File documents for short and/or long-term storage
- Trainer of other QA personnel, clinic personnel, and others as needed.
Quality Control Associate
NOVUM PHARMACEUTICAL RESEARCH SERVICES
01.2017 - 08.2021
- Ensures data generated during studies are in compliance with protocol standards (case report form (CRF) vs protocol)
- Compares data in CRF and data collected in source documents for accuracy
- Identifies problems and informs clinical staff for proper notes, comments, and corrections
- Review of subject charts, study documentation and tables
- Review study documentation to ensure compliance to company Standard Operating Procedures (SOP).
- Maintained accurate documentation of all quality control activities, ensuring proper record-keeping for audit purposes.
- Trained new employees in quality control procedures, fostering a culture of excellence within the team.
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
- Edited, proofed and critiqued internal documents to improve clarity.
- Monitored dosing procedures and verified performance of procedures according to established item specifications and protocol.
- Participated in ongoing education and training programs, staying current with industry trends and best practices in quality control.
CUSTOMER SERVICE REPRESENTATIVE SR.
GALLAGHER BASSETT
01.2019 - 10.2019
- Responsible for professionally handling various inquiries regarding claims in a fast-paced environment
- Transfer data from paper or verbally provided directly from customers into claims system.
- Effectively mentor team members by facilitating knowledge acquisition through queries or one on one training situations
- Prepare and deliver training for new starters and experienced team members
- Point of contact for escalations and technical queries from within team
- Demonstrate superior listening skills while exhibiting excellent customer service, patience, and empathy to promote the company reputation of integrity.
- Create and update training material
- Participate in team action plans and ad hoc tasks.
CUSTOMER SERVICE REPRESENTATIVE
SYKES ENTERPRISES, INC
10.2016 - 01.2017
- Answers phones of inquiries regarding bills, service, and products
- Give accurate and appropriate information to answer questions, light troubleshoot issues and resolve complaints
- Provide input to assist in the selection of services and products
- Informs clients by explaining procedures; answering questions; providing information
- Determines eligibility by comparing client information to requirements
- Sells additional services by recognizing opportunities to up-sell accounts, explaining new features.
CUSTOMER SERVICE REPRESENTATIVE
USI INSURANCE SERVICES LLC
11.2007 - 09.2016
- Respond to email or fax inquiries and scans policies, endorsements, and audits
- Answers phones of inquiries
- Receives, sort and distribute mail
- Photocopy documents for department as requested
- Operates Xerox machine, IBM typewriter, Pitney Bowes DM400 series and GBC Docubind P200 binding system
- Create PDF or hard copy of policy books e(mailed) out to insured and/or producers
- Responsible for pulling loss run reports
- Generate monthly installment billings
- Update renewal spreadsheets
- Process endorsements and certificates of insurance
- Maintaining ID/PW logins for all staff for various carrier websites
- Daily administrative support to various account managers and producers
- Perform other duties, special assignments and projects as assigned
- Backup to receptionist.
Education
Biological Science
COLLEGE OF SOUTHERN NEVADA
05-2027
Skills
- Quality Control
- Staff Training
- Clinical Trial Experience
- Data Entry
- Manage Regulatory Documents
- Case Report Forms
- IRB Submissions
- Good Clinical Practices
- Documentation Audits
- Chart Audits
- Time management
- Adverse event reporting
Timeline
ASSOC CLINICAL RESEARCH MGR | PROJECT ASSISTANT
PPD DEVELOPMENT, LP
05.2022 - Current
QUALITY ASSURANCE ANALYST
NOVUM PHARMACEUTICAL RESEARCH SERVICES
08.2021 - 05.2022
CUSTOMER SERVICE REPRESENTATIVE SR.
GALLAGHER BASSETT
01.2019 - 10.2019
WAREHOUSE ASSOCIATE
PRIME NOW
02.2017 - 02.2023
Quality Control Associate
NOVUM PHARMACEUTICAL RESEARCH SERVICES
01.2017 - 08.2021
CUSTOMER SERVICE REPRESENTATIVE
SYKES ENTERPRISES, INC
10.2016 - 01.2017
CUSTOMER SERVICE REPRESENTATIVE
USI INSURANCE SERVICES LLC
11.2007 - 09.2016
Biological Science
COLLEGE OF SOUTHERN NEVADA
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