Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Mason B. Nichols

Home-Based

Summary

Dynamic Sr. Clinical Research Associate with extensive experience at Syneos Health, excelling in clinical trial monitoring and regulatory compliance. Demonstrated expertise in training and mentoring Clinical Research Associates, fostering collaboration with sponsors and vendors, and optimizing data and essential document management processes. Acknowledged for meticulous report writing and thorough review, ensuring strict adherence to protocols, and enhancing project success and efficiency.

Overview

12
12
years of professional experience
1
1
Certification

Work History

Sr. Clinical Research Associate II (Lead CRA)

Syneos Health
Home-Based
06.2023 - Current
  • Performed monitoring while leading additional tasks requiring expert time management and logistics.
  • Trained and mentored Syneos study assigned CRAs, JIT CRAs, and sponsor CRAs on study-specific monitoring responsibilities.
  • Conducted observation training visits for newly hired CRAs and completed CRA sign-off evaluations.
  • Developed tools and generated reports to enhance trial team efficiency, including TMF tools and data cleaning reports.
  • Updated essential documents for sponsor approval and distribution to study teams.
  • Participated in periodic conference calls with Sponsor, Vendor, and Syneos teams to meet critical deadlines for TMF, startup, closeout, and block data.
  • Maintained sponsor-facing documents and logs to ensure accurate record-keeping.
  • Reviewed and approved monitoring reports and SCAN action plans, exceeding company standards for timely review and approval.

Sr. Clinical Research Associate I

Syneos Health
Home-Based
02.2022 - 06.2023
  • Monitored clinical trials to ensure compliance with Good Clinical Practice and study procedures.
  • Managed site performance, including documentation and oversight of all monitoring activities.
  • Mentored junior-level CRAs, fostering professional growth and skill development.
  • Collaborated with Central Monitors on RBM activities for clinical research projects.

Clinical Research Associate II

Syneos Health
Home-Based
10.2020 - 02.2022
  • Executed site qualification, initiation, monitoring, management, and close-out visits to ensure regulatory compliance.
  • Utilized judgment to evaluate site performance and communicated serious issues to project teams.
  • Verified informed consent processes for subjects/patients were performed and documented adequately.
  • Assessed safety factors affecting subject/patient integrity at investigator sites, identifying protocol violations.
  • Conducted Source Document Reviews and verified accuracy of clinical data in case report forms.
  • Reviewed Investigator Site File for completeness and reconciled with Trial Master File contents.
  • Documented activities through monitoring letters, trip reports, and logs following SOPs.

Clinical Research Associate I

Syneos Health
Home-Based
03.2019 - 10.2020
  • Conducted site qualification, initiation, monitoring, management, and close-out visits to ensure compliance with regulations and protocols.
  • Evaluated overall site performance and staff effectiveness, recommending site-specific actions and escalating serious issues promptly.
  • Maintained comprehensive knowledge of ICH/GCP guidelines, relevant regulations, and company SOPs.
  • Verified informed consent processes for each subject/patient, ensuring adequate documentation.
  • Protected confidentiality of subjects/patients while assessing safety factors affecting clinical data integrity.
  • Reviewed Investigator Site File for accuracy, reconciling contents with Trial Master File requirements.
  • Documented activities through monitoring letters, and trip reports per SOPs and Clinical Monitoring Plan.
  • Supported recruitment and retention strategies while managing project scope, budgets, timelines, and site-level communications.

Staff Development Consultant

Synexus Research
04.2018 - 03.2019
  • Consulted with Synexus global development lead to refine developmental training based on psychology and neuroscience principles.
  • Provided insights to harmonize European and USA developmental processes for improved consistency.
  • Developed and delivered performance psychology curriculum in an online format for global employees.

Clinical Research Coordinator II

Synexus Research
Salt Lake City
12.2017 - 03.2019
  • Supported primary investigators by collecting quality data per GCP guidelines. Documented corrective actions and implemented preventative measures to mitigate future errors.
  • Protected human subject rights throughout research processes.
  • Executed pharmaceutical research in accordance with sponsor protocols.
  • Assessed feasibility of potential study protocols for alignment with project goals.
  • Conducted routine quality assurance checks of peer activities.

Clinical Research Coordinator

PRA Health Sciences
Salt Lake City
07.2013 - 07.2015
  • Supported primary investigators by ensuring all study procedures were conducted accurately, completely, and with integrity.
  • Executed pharmaceutical and medical technology companies research protocols.
  • Consulted with study sponsors to create and develop research protocols.
  • Maintained up to date data entry in multiple versions of electronic case report form software.
  • Scheduled and facilitated meetings between investigators and research sponsors.
  • Hosted visiting client representatives during onsite visits and provided them with requested subject and site information.
  • Verified dosage, reconciliated dispensing logs of, and dispensed IP.
  • Oversaw support staff training and coordinated the duties of the investigator, regulatory department, data entry department, recruiting department, screening procedures, psychological and physiological measurements, and lab.
  • Administered an array psychological and physiological measurements.
  • Recorded and followed-up on adverse events and protocol deviations.
  • Maintained up to date training in all ethical, procedural, and good clinical practice domains.
  • Consented research participants.
  • Hosted and worked with auditors and IRBs to ensure ethical and accurate study procedures were being conducted.
  • Awarded the 2nd performance bonus the history of PRA's outpatient research department.

Education

Master of Science - Sport and Exercise Psychology

Western Washington University (WWU)
Bellingham, WA
06.2017

Bachelor of Science - Psychology w/ Minor in Health

University of Utah
Salt Lake City, UT
05.2013

Associate of Science - Psychology

Salt Lake Community College
Salt Lake City, UT
05.2011

Skills

  • Clinical trial monitoring
  • Regulatory compliance
  • Data management
  • Site management
  • Protocol adherence
  • Training and mentoring
  • Vendor management expert
  • Report writing and review

Certification

International Academy of Clinical Research CRA accreditation

Timeline

Sr. Clinical Research Associate II (Lead CRA)

Syneos Health
06.2023 - Current

Sr. Clinical Research Associate I

Syneos Health
02.2022 - 06.2023

Clinical Research Associate II

Syneos Health
10.2020 - 02.2022

Clinical Research Associate I

Syneos Health
03.2019 - 10.2020

Staff Development Consultant

Synexus Research
04.2018 - 03.2019

Clinical Research Coordinator II

Synexus Research
12.2017 - 03.2019

Clinical Research Coordinator

PRA Health Sciences
07.2013 - 07.2015

Master of Science - Sport and Exercise Psychology

Western Washington University (WWU)

Bachelor of Science - Psychology w/ Minor in Health

University of Utah

Associate of Science - Psychology

Salt Lake Community College

Similar Profiles

CREATE PROFILE
Mason B. Nichols
Want your own profile? Build for free at Resume-Now.com