Summary
Overview
Work History
Education
Skills
Accomplishments
References
Timeline
Generic

Maryssa McPherson

Raleigh,North Carolina

Summary

A Senior Clinical Research Associate with over 7 years of experience working in the clinical research industry, of which 3 years are Clinical Research Coordinator experience. Proven track record of successfully coordinating participants throughout clinical trials Phase II-III, ensuring studies are executed in accordance with the protocol, ICH/GCP guidelines, FDA regulations, and SOPs. Experienced working on trials from start-up to close-out as well as participating in PSSVs, SIVs, IMVs (remote and onsite), and COVs. Proficient in site management, informed consent collection, source documentation, inclusion/exclusion, Inform/Oracle Clinical and Medidata Rave, AE/SAE reporting, as well as eCOA and eTMF. Has served 2 years as a site leader as well as a trainer/mentor for co-workers and currently maintains Senior CRA responsibilities. In depth experience with site monitoring processes, study metrics tracking, patient recruitment/retention and working with investigators.

Overview

8
8
years of professional experience

Work History

Clinical Research Associate II

ICON
09.2024 - Current
  • Participates in audit preparation and follow-up activities as needed
  • Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation
  • Manages essential documents as required by local regulations and ICH-GCP guidelines before, during and after a clinical study; assists with resolution of investigational site/data queries
  • Writes and submits reports of investigational site findings and updates applicable tracking systems
  • Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate
  • Verifies proper management and accountability of Investigational Product (IP)
  • Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables
  • Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs
  • Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations
  • Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes
  • Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel and study close out
  • Gathers and reviews information for assigned sites and identifies inconsistencies
  • With limited guidance from project and functional management, assesses risk and escalates as appropriate
  • Independently performs a variety of onsite and offsite monitoring visit types

Clinical Research Associate I

ICON
12.2022 - 09.2024
  • Ensured the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs
  • Managed the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables
  • Verified proper management and accountability of Investigational Product (IP)
  • Managed essential documents as required by local regulations and ICH-GCP guidelines before, during and after a clinical study as well as assisted with resolution of investigational site/data queries
  • Wrote and submitted reports of investigational site findings and updated applicable tracking systems
  • Escalated observed deficiencies, issues, and corrective and preventative action plans as appropriate
  • Performed key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation
  • Participated in audit preparation and follow-up activities as needed
  • Verified the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations
  • Completed onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes
  • Activities included qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel and study close out
  • Monitored the progress of clinical studies at investigative sites onsite or remotely, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization Good Clinical Practices (ICH-GCP) and all applicable regulatory requirements
  • Independently performed a limited range of onsite and offsite monitoring visit types
  • Gathered and reviewed information for assigned sites and identified inconsistencies
  • With guidance from project and functional management, assessed risks and escalated as appropriate
  • Completion of CRA Bridge Academy, November 2022: Successful completion of the CRA Bridge Academy which consisted of approximately 30 hours of live, instructor-led training followed by hard and soft skills online course assignments surrounding the conduct, and management of clinical trials
  • The initial training in the program concludes with a robust final exam
  • Through ongoing mentorship and managerial support, participants then complete onsite observation and performance visits until fully operational in all aspects of the CRA role

Clinical Research Coordinator II

ICON
12.2019 - 12.2022
  • Promoted after 1 year from Clinical Research Coordinator Level 1 to Clinical Research Coordinator Level 2
  • Participated in pre-study site visits, site selection visits, site initiation visits, close out visits, and investigator meetings with site staff, PI/Sub-I's and CRA
  • Built strong relationships and provided ongoing communication to Manager of Clinical Operations, Regulatory Coordinators, Clinical Research Coordinators, Medical Writers, Clinical Research Associates, Project Managers, Clinical Team Leads, Clinical Trial Associates, Study Start Up Associates, Medical Monitors, Registered Nurses, Principal Investigators and Sub Investigators to facilitate daily trial activities and comply with research protocols
  • Prepared study documentation in the event of an Accellacare, Sponsor, or FDA audit or Inspection
  • Entered visit data in a variety of EDC systems and CRF's as well as addressing all queries or data clarifications in a timely manner or to prepare for database lock
  • Dispensed study IP at the direction of the investigator and educated patients on study IP administration as well as maintained continuous study IP inventory and accountability at the site
  • Implemented Informed Consent processes and continuous review of inclusion/exclusion for each study participant
  • Continuous review and documentation of AE's and SAE's and provided this information to Investigators, Sponsors and Central IRB in a timely manner
  • Documented and reported protocol violations and significant deviations to the Institutional Review Board, Principal Investigator, Manager of Clinical Operations, Clinical Research Associate and Project Managers
  • Gathered, processed and shipped lab specimens to Central lab facilities as well as review and documentation of patient laboratory results
  • Performed technical requirements of the study protocol including phlebotomy, intramuscular injections, nasopharyngeal swabs, vitals and blood pressure, EKG's, and urine pregnancy testing
  • Created and updated source documents and progress notes as required by protocol
  • Managed hundreds of active study participants across several enrolling clinical trials at any given time ensuring patient safety while maintaining knowledge of associated protocol requirements
  • Effectively communicated with CRA's from the Sponsoring company through telephone contact, written communication, and scheduled remote or onsite monitoring visits
  • Utilized CTMS systems to maintain progress of trial participants, schedule and complete onsite and telephone study visits, complete participant reimbursement, capture referral source of participants, and promote patient recruitment
  • Established relationships with study participants and provided patient education of clinical trial processes according to protocol requirements
  • Performed study start up duties including completion of regulatory documents, recruitment plans and identifying/screening participants
  • Accountable for completing clinical trials assignments in an accurate and timely manner in accordance with SOP's, GCP and ICH guidelines and FDA regulations
  • Helped organize and facilitate ICON/Accellacare onsite and offsite events to increase public knowledge of clinical trials, recruitment and retention of study participants and promote awareness of clinical trials
  • Enrollment of 250+ participants over a 2 month period during global pandemic for COVID-19 Vaccine Trial that ultimately led to EUA approval
  • Has served 2+ years as a site leader as well as a trainer/mentor for co-workers

Talent Acquisition Specialist, Clinical Trials

CLINICAL SOLUTIONS GROUP, INC (Acquired by IQVIA)
02.2017 - 12.2019
  • Represented the recruiting team and CSG, Inc
  • Brand during internal meetings, external meetings, networking events, and nationwide conferences
  • Provided administrative management and oversight of clinical research professionals throughout the duration of their assignments
  • Ensured all new hire and onboarding forms, including contracts for selected candidates and clients, are fully executed in a timely manner
  • Arranged interviews and agreeable start dates with clients and candidates
  • Negotiated candidate hiring salaries to preserve equity within each department
  • Worked directly with hiring managers to attain feedback on candidates and determine hiring needs
  • Maintained knowledge of clinical trials process from Pre-Clinical, Phases I-III, FDA Submissions and Post Approval within Oncology, Respiratory, Infectious Disease, Neurology, and Cardiovascular therapeutic areas
  • Identified and screened, either in person or by telephone, new and existing clinical trials professionals on an ongoing basis, matching current or future openings
  • Sourced and hired various clinical trial positions including: Clinical Research Associates, Clinical Research Coordinators, Clinical Trial Assistants, Regulatory Coordinators, Medical Writers, Project Managers, Data Managers, Associate Directors, Directors, Statistical/SAS Programmers, Biostatisticians, and Bioinformaticians
  • Professional Recruiter for a niche staffing, consulting, and solutions provider specializing in the clinical trial industry, with a strong 20 year track record of supporting the top pharmaceutical, biotech, and CRO's in the country

Education

Bachelor of Science - Nutrition and Dietetics

East Carolina University
Greenville, North Carolina

Skills

  • Therapeutic Areas: NASH, Migraine, Obesity, Vaccine (COVID-19, RSV, Pneumonia, Avian Flu, Clostridium difficile), Pediatrics Vaccine, Colon Cancer Screening, Medical Device, Women's Health/Hot Flashes and Constipation
  • Subject Populations: Adults, Pediatrics, Geriatrics, Obese subjects, Female only, Diabetics, Healthy volunteers, Immunocompromised,
  • Clinical Trial Management Systems: Predictivv Study Operations (PSO), Client Proprietary System
  • IRB: Advarra/CIRBI, WCG
  • Reporting & Analysis: Tableau
  • Risk Based Monitoring: Medidata RAVE RBM
  • TMF: PhlexEview eTMF
  • EDC: Medidata RAVE, Oracle Inform
  • EKG/ECG: Biocinica/Clario/SmartStart, Banook
  • Lab Services: ACM Labratories, Covance/Labcorp, ICON, Okta/Cerba Research
  • IVRS/IWRS: 4g Clinical, Impala, Verasity Logic, Endpoint
  • eCOA: Medidata RAVE, Inform, Signant Health, TrialMax, YPrime, Medidata Patient Cloud, IQVIA eCOA, Mobile Health Platform
  • Other: PsiXchange, Firecrest, Clinical Conductor, CRIO (eSource), eConsent Platforms (Pfizer Secure Consent, IQVIA eConsent), Greenphire, FlexAdvantage, Florence Research Binders, Prepaid Technologies, Scout Clinical, ZioSuite/iRhythm Technologies, BioFire FilmArray BioSurveillance System

Accomplishments

  • Completion of CRA Bridge Academy, 11/01/22
  • Enrollment of 250+ participants over a 2 month period during global pandemic for COVID-19 Vaccine Trial that ultimately led to EUA approval.
  • Promoted after 1 year from Clinical Research Coordinator Level 1 to Clinical Research Coordinator Level 2.
  • Has served 6+ years as a site leader as well as a trainer/mentor for co-workers.

References

Available upon request

Timeline

Clinical Research Associate II

ICON
09.2024 - Current

Clinical Research Associate I

ICON
12.2022 - 09.2024

Clinical Research Coordinator II

ICON
12.2019 - 12.2022

Talent Acquisition Specialist, Clinical Trials

CLINICAL SOLUTIONS GROUP, INC (Acquired by IQVIA)
02.2017 - 12.2019

Bachelor of Science - Nutrition and Dietetics

East Carolina University

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Maryssa McPherson