Andrea Davis, PhD
Raleigh,NC
Summary
Clinical Trial Specialist with expertise in managing trial protocols and ensuring regulatory compliance. Adept at enhancing patient recruitment strategies and collaborating with cross-functional teams to streamline operations. Committed to maintaining data integrity and adhering to Good Clinical Practice guidelines throughout the trial process. Experienced Clinical Trial Specialist with background in overseeing all stages of clinical trials from protocol development to closeout. Proven track record in ensuring compliance with GCP, SOPs and regulatory requirements, while managing logistics, data collection and analysis. Strengths include exceptional organizational skills, strong analytical mindset and ability to handle multiple projects simultaneously. Previous roles have demonstrated significant contribution in increasing efficiency of trial operations and enhancing data quality.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Clinical Trial Specialist
Clinical Resource Network-Boehringher Ingelheim
Ridgefield, Connecticut
02.2023 - 02.2026
- Coordinated clinical trial protocols and ensured compliance with regulatory standards.
- Managed patient recruitment efforts to enhance trial participation and retention.
- Collaborated with cross-functional teams to streamline trial operations and reporting.
- Developed training materials and conducted sessions for clinical site staff.
- Monitored trial progress and addressed issues to maintain timeline integrity.
- Reviewed data collection processes for accuracy and consistency across sites.
- Assisted in preparing documentation for regulatory submissions and audits.
- Provided support during site visits and inspections by regulatory authorities.
- Created databases for tracking patient information gathered during clinical trials.
- Ensured compliance with Good Clinical Practice guidelines and all applicable regulations.
- Provided guidance on study design, protocol development and implementation strategies.
- Coordinated with research personnel to ensure accurate data collection during trials.
- Maintained effective communication between sponsors, investigators, research coordinators, clinicians and other members of the team throughout the duration of the trial.
- Drafted reports summarizing the results of clinical trials.
- Analyzed laboratory results from participants in order to monitor safety parameters.
- Conducted site visits to review procedures, assess risk factors, and ensure compliance with regulatory standards.
- Developed and implemented operational plans for clinical trial studies according to established protocol guidelines.
- Monitored recruitment efforts for clinical trials by working closely with physicians to identify potential subjects.
- Developed quality control systems to ensure accuracy of data collected during a trial.
- Resolved issues that arose during a study involving participants or personnel at multiple sites.
- Assisted in developing training programs for new staff members involved in clinical trial activities.
- Monitored subject enrollment and tracked dropout details.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Kept patient care protocols and clinical trial operations in compliance.
- Gathered and reviewed study data.
Site Study Manager ( Clinical Site Manager)
InSightec
Dallas , TX
10.2021 - 08.2022
- Managed clinical study protocols for innovative medical technologies.
- Coordinated cross-functional teams to ensure study compliance and timelines.
- Developed training materials for staff on regulatory requirements and procedures.
- Oversaw data collection processes to maintain study integrity and accuracy.
- Led risk assessment meetings to identify potential challenges in studies.
- Assisted in the preparation of presentations for regulatory submissions and audits.
- Provided training to staff on Good Clinical Practices guidelines and regulatory requirements.
- Organized and coordinated clinical trial activities, including data collection and analysis.
- Maintained accurate records of patient information in accordance with HIPAA regulations.
- Conducted regular meetings with project teams to review timelines, budgets, and deliverables.
- Developed procedures for organizing and filing clinical data to enhance workflow efficiency.
- Processed clinical data by entering records of receipt, verification and entry of information.
- Coordinated maintenance schedules for imaging systems and related tools.
- Mentored new employees on safety protocols, processes and procedures.
- Reviewed project plans regularly to ensure deadlines are met on time.
- Developed contingency plans to address unforeseen challenges, minimizing impact on project timeline.
- Conducted risk assessments, implementing mitigation strategies to minimize project delays.
- Facilitated team meetings to discuss project status, challenges, and strategies for improvement.
Initiation Clinical Research Associate II
PAREXEL International
Durham, US, US
06.2001 - 01.2020
- Conducts the clinical monitoring of specific study projects and facilitates specific start-up activities such as Site Regulatory Package (SRP) collection and Regulatory Site Management overseer.
- Serves as a liaison for Clinical Site Agreements (CSA) with budgets & performs Informed Consent Form (ICF) Customization for United States Country and Site Level assigned sites.
- Performs site engagement, problem solving, issue resolution with follow up for sites.
- Ensures excellent site communication, serves as a Clinical Research Organization (CRO) lead with Phase I-IV studies.
- Successfully performs SSU Feasibility tasks independently, Executes Feasibility Surveys to Sites prior to Site Activation, exemplifies role of iCRA Feasibility Lead, manages VEEVA Vault SSU regulatory documents, Trial Master File management, Remote Qualification Visits, Master CDA contracts and all supporting site management activities to ensure timely site initiation.
- Over 6.5 years of Late Phase experience managing sites with close-out activities, payment invoices, payment reconciliation, SAE & AE training site staff, reviewing EDC Queries, CRFs, DCFs, requesting regulatory documents from sites, reviewing IRB submissions, IRB Approvals also staying in line with ICH GCP,and keeping sites audit ready at all times.
- Vendor experience includes communicating study-related information to vendors as appropriate, ensuring Principal Investigators have drug shipment receipts for all patients as applicable.
- Assist in the management of CRO/Vendors to ensure deliverables are met with first time quality per scope of work and in compliance with ICH/GCP.
- Perform remote clinical monitoring tasks through the preparation, site initiation, management and termination of clinical study sites.
- Perform data integrity and verify safety report acknowledgements from clinical sites and follow up, maintain quality control adherence with remote visits, ensuring patient safety applying expertise, exemplifying independent judgment for designated projects in accordance with relevant regulations, SOPs, and study specific guidelines.
- Act as PAREXEL’s in-house key contact with assigned clinical sites, training site staff including physicians on study specific protocols, site registration, ensuring IRB compliance with Good Clinical Practice, and instructing central sites when to submit initial site application to Advarra IRB, or Western IRB (WIRB) appropriately, informs site approval, responds to any IRB site related concerns, and checks to ensure drug shipment orders are complete.
Initiation Clinical Site Manager II
PAREXEL International
Durham, NC
01.2018 - 01.2019
- Conduct the clinical monitoring of specific study projects and facilitate specific start-up activities such as Site Regulatory Package (SRP) collection, Clinical Site Agreement (CSA) & Informed Consent Form (ICF) negotiation, and all supporting site management activities to ensure timely site initiation.
- Perform remote clinical monitoring tasks through the preparation, site initiation, management and termination of clinical study sites.
- Perform data integrity and verify safety report acknowledgements from clinical sites and follow up, maintain quality control adherence with remote visits, ensuring patient safety applying expertise, exemplifying independent judgment for designated projects in accordance with relevant regulations, SOPs, and study specific guidelines.
- Act as PAREXEL’s in-house key contact with assigned clinical sites, training site staff including physicians on study specific protocols, site registration, ensuring IRB compliance with Good Clinical Practice, overseeing drug shipments inquiry and following up with the pharmacist to ensure accuracy of drug orders as appropriate to ensure patient safety, also reviewing, approving regulatory documentation independently to meet study deadlines.
- Perform the In House Clinical Research Associate Lead responsibility and report weekly clinical site updates, enrollment status to the Project Leader, Clinical Operations Leader.
- Medidata RAVE EDC 5.6 Certified.
Clinical Monitoring Associate II, Associate
PAREXEL International
Durham, US, US
11.2016 - 12.2017
- Conduct the clinical monitoring of specific study projects and facilitate specific start-up activities such as Site Regulatory Package (SRP) collection, Clinical Site Agreement (CSA) & Informed Consent Form (ICF) negotiation, and all supporting site management activities to ensure timely site initiation.
- Perform remote clinical monitoring tasks through the preparation, site initiation, management and termination of clinical study sites.
- Perform data integrity and verify safety report acknowledgements from clinical sites and follow up, maintain quality control adherence with remote visits, ensuring patient safety applying expertise, exemplifying independent judgment for designated projects in accordance with relevant regulations, SOPs, and study specific guidelines.
- Act as PAREXEL’s in-house key contact with assigned clinical sites, training site staff including physicians on study specific protocols, site registration, ensuring IRB compliance with Good Clinical Practice, overseeing drug shipments inquiry and following up with the pharmacist to ensure accuracy of drug orders as appropriate to ensure patient safety, also reviewing, approving regulatory documentation independently to meet study deadlines.
- Perform the In House Clinical Research Associate Lead responsibility and report weekly clinical site updates, enrollment status to the Project Leader, Clinical Operations Leader.
- Clinical Monitoring, I – (In-House CRA.
11.2014 - 11.2016
- Conduct the clinical monitoring of specific study projects and facilitate specific start-up activities such as Site Regulatory Package (SRP) collection, Clinical Site Agreement (CSA) & Informed Consent Form (ICF) negotiation, and all supporting site management activities to ensure timely site initiation.
- Perform remote clinical monitoring tasks through the preparation, site initiation, management and termination of clinical study sites.
- Perform data integrity and verify safety report acknowledgements from clinical sites and follow up, maintain quality control adherence with remote visits, ensuring patient safety applying expertise, exemplifying independent judgment for designated projects in accordance with relevant regulations, SOPs, and study specific guidelines.
- Act as PAREXEL’s in-house key contact with assigned clinical sites, training site staff including physicians on study specific protocols, site registration, ensuring IRB compliance with Good Clinical Practice, overseeing drug shipments inquiry and following up with the pharmacist to ensure accuracy of drug orders as appropriate to ensure patient safety, also reviewing, approving regulatory documentation independently to meet study deadlines.
- Perform the In House Clinical Research Associate Lead responsibility and report weekly clinical site updates, enrollment status to the Project Leader, Clinical Operations Leader.
Drug Safety Case Manager Consultant
Drug Safety Alliance
Durham, US, US
10.2013 - 08.2014
- Reviewed documents including medical records, reimbursements, financial statements, patient enrollment forms and insurance claims to determine whether or not the document contains an adverse event.
- Record retrieval and review of the document into Salesforce database.
- Assessed and triaged documents containing AE information, differentiating from those which do not contain or “might contain” AE information.
- Processed case narratives in the ARISG safety database daily.
- Processed IRT cases for Adverse Event Reporting in with Sponsor guided instructions.
- Triaged HCP letters for Serious Adverse documents in the ARISG safety database.
Data Technician
Duke Clinical Research Institute
Durham, US, US
04.2007 - 10.2013
- Interviewed patients on follow-up questionnaires for heart and stroke studies consisting of 3000-25,000 patients.
- Data entry in the tact master file database.
- Reviewed and evaluated accuracy of Case Report Forms, Rapid Report Forms, Confidential Patient Information Forms and translated Study Documents Forms from International Sites in a timely manner and independently.
- Communicated effectively and implemented problem-solving solutions about study specific issues with site coordinators and physicians.
- Provided quality feedback for Study Procedures Manuals in place.
- Familiarity with the EDC system, Microsoft Outlook, Lotus Notes Processes Serious Adverse Event (SAE), Adverse Event (AE) in clinical trials according to Standard Operating Procedures (SOPs) accurately and proficiently Review source documentation required by the protocol and Good Clinical Practice (GCP) Document safety events according to sponsor requirements and regulations Triage, reports and manage safety information appropriately in a timely sensitive manner consistently Maintain Regulatory and Compliance guidelines with workflow processes throughout clinical trials.
- Utilized Excel (V-Lookups) to research safety information, grouping data and managing patient information Knowledge of FDA, and IRB policy.
Clinical Research Assistant & Product Safety Specialist
PPD Pharmaceutical Company
Morrisville, US, US
02.2007 - 04.2007
- CARES Epidemiology Research Study, Bristol Myers Squibb Successfully completed 30 PPD Learning Management Systems Module Tests QC Audit of Clinical Trial Case information in to the CARES database daily Data entry tasks, file paperwork, work independently and cooperatively in a team.
Contracted Field Interviewer
Research Triangle Institute, RTI
Durham, US, US
08.2006 - 02.2007
- Environmental Epidemiology Exposure Factors Pilot Study (EPA) Operated the Case Management System to assist project management in efficiently assigning and monitoring cases.
- Conducted survey interviews; administer confidential paper work to participants Trained participants on how to use an EKG heart monitor, scientific camera and laptop.
- Cooperatively met deadlines for RTI Survey Research Staff along with troubleshooting computer problems as needed.
- Travel as required.
Education
PhD - Public Health-Community Health Promotion & Health Education
Walden University
01-2014
MSPH - Public Health
01-2007
BA - Psychology
North Carolina Central University
01-1997
Project Management Certificate-Non Credit- 2017- Skills Success -
Skills
- Conducted Remote Clinical monitoring, Site Initiation_ Phase I (SSU) through Phase II, III and IV and followed data integrity
- Regulatory compliance and informed consent
- Site management and project oversight
- Trial master file expertise
- Veeva Vault and SharePoint proficiency
- Point of contact for ECG Machine with Clario systems and Labcorp system Laboratory kit supply management for US sites
- Executed Query Issue Resolution management for follow up with US investigative sites
- Risk-based quality management (RBQM)
- Good clinical practice (GCP) adherence
- Patient recruitment strategies
- Regulatory submissions for site approvals
- Clinical trial management system (eTMF)
- Feasibility assessments and sponsor acknowledgment
- Learning management systems expertise
- Subject tracking tools proficiency
- Trained principal investigators on SAE and AE processes
- Followed Compliance with study documents and FDA readiness
Affiliations
American Heart Association Advocate
American Diabetes Association Advocate
American Public Health Association Member
Beta Kappa Chi Honorary Member
Psi Chi National Honorary Member
Alpha Kappa Alpha Sorority Incorporated Member
PUBLICATION:
Davis, A.D., 2014. Relationship of Age and Geographic Location to Heart Disease Health Beliefs of African American Women, ProQuest, UMI Dissertations Publishing 2014, pp. 127
Certification
Indication
Phase
# Patients
# Sites
Countries
Services Involved
Asthma
IV
6,200
561
US,ROW
Remote Site Management
Asthma
IV
11,664
849
US,ROW
Remote Site Management
Cardiac
IV
31,000
UNK
US,CAN
Data Management, QC
Cardiac
IV
12,000
UNK
US,ROW
Data Management, QC
Cardiac
IV
10,000
UNK
US,ROW
Data Management, QC
Cardiac
IV
4,000
UNK
US,ROW
Data Management, QC
Stroke
IV
10,000
UNK
US,ROW
Data Management, QC
Stroke
IV
8,000
UNK
US,ROW
Data Management, QC
Oncology
III
NA
UNK
US,ROW
Remote Site Management
AKS, PArthritis
III-IV
NA
UNK
US, CAN
Remote Site Management
Pediatric Crohn’s Disease
I
Languages
English: fluent
Timeline
Clinical Trial Specialist
Clinical Resource Network-Boehringher Ingelheim
02.2023 - 02.2026
Site Study Manager ( Clinical Site Manager)
InSightec
10.2021 - 08.2022
Initiation Clinical Site Manager II
PAREXEL International
01.2018 - 01.2019
Clinical Monitoring Associate II, Associate
PAREXEL International
11.2016 - 12.2017
11.2014 - 11.2016
Drug Safety Case Manager Consultant
Drug Safety Alliance
10.2013 - 08.2014
Data Technician
Duke Clinical Research Institute
04.2007 - 10.2013
Clinical Research Assistant & Product Safety Specialist
PPD Pharmaceutical Company
02.2007 - 04.2007
Contracted Field Interviewer
Research Triangle Institute, RTI
08.2006 - 02.2007
Initiation Clinical Research Associate II
PAREXEL International
06.2001 - 01.2020
PhD - Public Health-Community Health Promotion & Health Education
Walden University
MSPH - Public Health
BA - Psychology
North Carolina Central University