Maryssa McPherson
Raleigh
Summary
Senior Clinical Research Professional with over nine years of experience working in the clinical research industry. Prior experience as a methodical Clinical Research Coordinator and a proven track record of successfully monitoring and managing clinical trials with precision and integrity from start-up to close-out Phases I-IV, ensuring studies are executed in accordance with the protocol, ICH-GCP R3 guidelines, FDA regulations, and SOPs. Proficient in informed consent collection, AE/SAE/AESI reporting, regulatory and IRB processes, identifying data trends, audit preparation, patient recruitment and retention, and working with investigators. Proven track record of significant contributions toward improving study processes and driving project success across cross-functional teams, with data analysis and study metrics tracking.
Overview
9
9
years of professional experience
Work History
Senior Clinical Research Associate
IQVIA
Raleigh
11.2025 - Current
- Manages and monitors multiple enrolling clinical trials ensuring patient safety while maintaining knowledge of associated protocol requirements, ICH GCP guidelines and ALCOA++ standards.
- Performs remote and onsite monitoring visits across multiple protocols (SQV, SIV, IMV, COV) in accordance with site monitoring plan and GCPs.
- Works with multiple sites and dozens of study team members to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluates the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations and escalates quality issues until resolution.
- Manages progress of multiple assigned studies by tracking regulatory submissions/approvals, recruitment and enrollment, case report form (CRF) completion as well as data query generation and resolution.
- Continuous collection and verification that essential documents are available and/or filed in the TMF, CTMS and ISF and that all are maintained in accordance with GCP and local regulatory requirements.
- Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting and escalating detailed visit reports, issues and protocol deviations.
- Collaborates and liaises with study team members for project execution support and escalation as appropriate.
Clinical Research Associate II
ICON PLC
Raleigh
11.2022 - 11.2025
- Served as a Study Team Lead as well as an appointed Mentor and Trainer to new Clinical Research Associate employees and junior colleagues.
- Independently monitored the progress of multiple study protocols, both onsite or remotely, ensuring clinical trials are conducted, recorded, and reported with integrity in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization Good Clinical Practices (ICH-GCP), ALCOA++ standards and all applicable regulatory requirements.
- Verified the protection of study participants by confirming subject eligibility prior to enrollment, as well as that informed consent procedures and protocol requirements have been performed in accordance with ICH-GCP and applicable regulations.
- Managed, collected and filed essential documents across multiple TMF and CTMS systems as required by local regulations and ICH-GCP guidelines before, during and after a clinical study.
- 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.
- Verified proper management and accountability of subject enrollment, data deliverables, and Investigational Product (IP).
- Independently completed onsite and remote monitoring activities including qualifying potential investigative sites, initiating clinical trials, maintaining study start up documentation, providing instructions to site personnel and study close out procedures.
- Proactively identified site risks, inconsistencies as well as data trends and escalated issues and as appropriate.
- Ensured the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs.
- Managed investigative site staff across dozens of sites to continue facilitating enrollment and data deliverables.
- Verified proper management and accountability of Investigational Product (IP).
- Wrote and submitted reports of investigational site findings and updated applicable tracking systems.
- Independently identified and managed site inconsistencies, deficiencies, issues, and root causes as well as corrective and preventative action plans for both study teams and site staff.
- Performed key risk assessment and management responsibilities including key risk indicators and site health analysis, site process evaluation, and project escalation.
- Participated in audit preparation and follow-up activities as needed.
Clinical Research Coordinator II
Accellacare (ICON PLC)
Raleigh
12.2019 - 11.2022
- Managed hundreds of active study participants across multiple enrolling clinical trials at any given time, ensuring patient safety and data integrity while maintaining knowledge of associated protocol requirements, ICH GCP guidelines and ALCOA++ standards.
- Participated in pre-study site visits, site selection visits, site initiation visits, close-out visits, and investigator meetings with study team members, PIs/Sub-Is, and CRAs.
- Built and maintained strong relationships and provided ongoing communication about trial status and participants to the Principal Investigators, Sub-Investigators, Manager of Clinical Operations, Regulatory Coordinators, Clinical Research Coordinators, Medical Writers, Clinical Research Associates, Clinical Trial Managers, Project Managers, Clinical Team Leads, Clinical Trial Associates, Study Start-Up Associates, Medical Monitors, Registered Nurses, to facilitate daily trial activities and comply with research protocols.
- Performed continuous review of subject eligibility using inclusion/exclusion during the screening period and subsequent visits.
- Documented laboratory data and adverse reactions and immediately notified investigators, the Institutional Review Board and sponsor of any serious adverse events.
- Accurately collected and entered study source data in a variety of EDC systems and CRFs within 48 hours of visit completion, and addressed all queries or data clarifications issued in vendor systems within 48 hours or receipt.
- Dispensed IP at the direction of the investigator, educated patients on study IP administration, and maintained continuous study IP inventory and accountability at the site.
- Implemented informed consent processes, and continuous review and verification of patient eligibility.
- Continuous review, documentation, and communication of protocol deviations and AE/SAE/AESIs to Investigators, CRAs and Sponsors and IRB in a timely manner.
- Performed technical requirements of the study protocol including lab work (phlebotomy and processing), vitals, blood pressure, intramuscular injections, subcutaneous injections, nasopharyngeal swabs, ECG/EKGs, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by the protocol.
- 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.
- Performed study start up duties including completion of regulatory documents, source documents, recruitment plans and tools, as well as identifying/screening participants via patient database and EMR systems.
- Established and maintained relationships with study participants to ensure patient retention, and continuously provided patient education of clinical trial processes according to ICH GCP and protocol requirements.
- Gathered, processed, and shipped lab specimens to central lab facilities per IATA requirements, and reviewed patient laboratory results.
- Dispensed study medication at the direction of the Investigator and continuously educated study participates of proper IP administration, per protocol.
- Maintained weekly communication with the CRA monitor across multiple protocols through telephone contact, written communication, and on-site visits.
- Prepared study documentation in the event of an ICON, Sponsor, or FDA audit.
- Organized and facilitated onsite and offsite marketing events to promote public knowledge of clinical trials, recruitment and retention of study participants.
- Enrollment of 250+ participants over a 2 month period during global pandemic for COVID-19 Vaccine Trial that ultimately led to EUA approval.
- Served 2+ years as a site leader as well as a CRC trainer and CRC mentor for co-workers and new study coordinators.
Talent Acquisition Specialist, Clinical Trials
Clinical Solutions Group, Inc.
Raleigh
02.2017 - 11.2019
- 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.
- 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, SMEs, Biostatisticians, and Bioinformaticians.
- 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 Sponsor hiring needs.
- 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.
- Acquired by IQVIA in 2020
Education
Bachelor’s of Science - Nutrition & Dietetics
East Carolina University
Greenville, NC05.2013
Skills
◆ Therapeutic Areas:
Rare Disease, Immunology, NASH/Metabolic, Migraine/Neurology, Cardiovascular, Obesity, Vaccines, Pediatrics, Type II Diabetes, Colon Cancer Screening, Medical Device, Women's Health/Hot Flashes, Gastrointestinal/Constipation, Dermatology
◆ Study Populations: Immunocompromised, Rare Disease, Pediatrics, Geriatrics, Diabetics/Obese, Female only, Healthy volunteers, Adults
◆ Client Systems:
Veeva Vault CTMS, Predictivv Study Operations (PSO), Veeva eTMF, CRIO, BOX, SiteConnect, Clinergize, Tableau, PhlexEview eTMF, Clinical Conductor, Clinically, Vestigo, EMR, RealTime,
◆ Vendor Systems:
Veeva CDMS, Medidata RAVE, Medidata Patient Cloud, Oracle Inform, Labcorp, Clario, Banook, Endpoint, Okta/Cerba, Perceptive, Almac, Impala, Verasity Logic, StudyHub, Impala, Trialmax, YPrime, Signant Health, ACM Laboratories, ICON Laboratories, Mobile Health Platform eCOA, PsiXchange, Firecrest, Bluesky, Verified Clinical Trials, Greenphire, Scout, FlexAdvantage, eConsent, Florence, Prepaid Technologies, BioFire, Ziosuite/iRhythm Technologies
◆ IRB (Central & Local): Sabai, Advarra/CIRBI, WCG
Timeline
Senior Clinical Research Associate
IQVIA
11.2025 - Current
Clinical Research Associate II
ICON PLC
11.2022 - 11.2025
Clinical Research Coordinator II
Accellacare (ICON PLC)
12.2019 - 11.2022
Talent Acquisition Specialist, Clinical Trials
Clinical Solutions Group, Inc.
02.2017 - 11.2019
Bachelor’s of Science - Nutrition & Dietetics
East Carolina University