Paige Haney
Malvern
Summary
Results-driven Clinical Research Specialist with 7 years of progressive experience supporting and managing diverse clinical trials across multiple therapeutic areas. Proven expertise in study start-up activities, including regulatory submissions, site feasibility, essential document collection, and activation readiness for both sponsor-initiated and investigator-initiated studies. Adept at leading cross-functional teams, optimizing study workflows, and driving timelines to ensure efficient and compliant trial initiation. Skilled in navigating GCP/ICH guidelines, institutional policies, and global regulatory standards while fostering strong partnerships with investigators, site staff, and cross-functional stakeholders. Seeking to leverage advanced operational knowledge, project coordination leadership, and a strong regulatory foundation to excel in an Experienced Study Start-Up Project Manager role.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Lead Clinical Research Coordinator II
Elligo Health Research/ AMS Cardiology
Horsham, PA
10.2023 - Current
- Manage multiple concurrent trials
- Assist with mentoring and training study team members
- Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close-out activities
- Collect, process, and ship laboratory specimens
- Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and with clinical trial master filing systems.
Remote Quality Assurance Analyst
Care Access
Boston, MA
05.2022 - 10.2023
- Collaborated with cross-functional teams to ensure product quality and customer satisfaction
- Investigated customer complaints and developed corrective actions to prevent reoccurrence
- Developed and maintained quality assurance metrics to track and report performance
- Conducted audits to identify and document non-conformances and investigate root causes
- Provided training and guidance to personnel on quality assurance methods and processes
Remote Patient Screener
Care Access
Boston, MA
05.2022 - 10.2023
- Deliver education and manage study patient screening through informed consent
- Complete screening visits remotely for all assigned Clinical Trials
- Utilized multiple platforms for managing patient data
- Serve as liaison between patients, CRC's, and physicians
- Review and comprehend all active study protocols
- Educated patients on health maintenance, safety, and disease prevention
- Complete CRF's and enter data into EDC system's
- Schedule all study related visits
Clinical Research Coordinator
Mid Atlantic Retina/Wills Eye Hospital
Philadelphia, PA
10.2021 - 05.2022
- Coordinating all aspects of phase I through phase IV Clinical Trials
- Monitored and tracked participant progress throughout the course of clinical trials
- Coordinated the recruitment, scheduling, and enrollment of participants in clinical research studies
- Worked with sponsors and other stakeholders to ensure compliance with study protocols
- Analyzed and reported data to ensure compliance with regulatory standards
- Monitored and managed research budgets
- Assisted in the preparation of regulatory submissions
Clinical Research Coordinator
New Jersey Urology LLC
Voorhees, NJ
07.2019 - 10.2021
- Follow site SOP's and GCP guidelines
- Conduct informed consent
- Building and maintaining excellent communication with Principal Investigators
- Ensure efficient monitoring of all trials by ensuring that the data is clean and entered accurately into the sponsor EDC in timely fashion
- Create and submit Regulatory and associating documents as needed to start new clinical trials
- Revise IRB submissions in response to identified problems and resolve issues in a timely manner
- Create and maintain up to date Source Documents
- Track and obtain knowledge to observe and report adverse/serious adverse events, protocol violations/deviations in a timely and accurate manner
- Complete safety assessments such as labs, ekg's, and vitals
Patient Service Representative
New Jersey Urology LLC
Voorhees, NJ
03.2019 - 07.2021
- Conduct new patient intake interviews
- Schedule appointments
- Manage patient concerns
- Verify insurance and input billing
- Train new PSR employees
- Coordinate and speak with various medical departments
- Referred patients to appropriate medical departments and responded to over 40 calls with scheduling requests daily
- Assisted patients with billing concerns and guided their financial aid applications
- Resolved questions, concerns and patient conflicts while delivering the highest level of customer service
- Maintained ethical standards in the performance of duties and in interactions with patients, colleagues and health care professionals
Medical Records Coordinator
New Jersey Urology LLC
Mt Laurel, NJ
01.2018 - 07.2019
- Analyzed and processed medical records in a timely and accurate manner
- Ensured medical records were stored securely and handled with confidentiality
- Processed patient requests for medical records in accordance with HIPAA regulations
Education
Master - Cosmetology
Rizzieri Aveda School for Beauty and Wellness
Voorhees, NJ01-2016
High School Diploma -
Hammonton
Hammonton, NJ06-2015
Skills
- SSU Management: regulatory collection, submissions, feasibility, qualification, protocol review, and operational planning
- IRB/EC Strategy: submission planning, coordination, and regulatory binder/CTA development
- Site Activation: end-to-end lifecycle oversight, milestone tracking, timeline creation, and risk mitigation
- Cross-Functional Collaboration: Clinical Ops, Regulatory, Legal, Contracts, and vendors
- Vendor & Site Management: relationship building, negotiation, conflict resolution, and escalation handling
- Team Leadership: mentoring CRCs/site staff, delegation oversight, resource planning, and training development
- Process Excellence: SOP implementation, workflow optimization, and multi-study prioritization
- Systems Expertise: CTMS, eTMF, EDC, eISF, IRB portals, safety systems, Smartsheet, Excel, and other tracking tools
- Compliance Knowledge: strong understanding of GCP, ICH, FDA regulations
- Communication & Reporting: sponsor/CRO communication, KPI tracking, and presentation of activation timelines and metrics
- Phlebotomy
Certification
BLS, CITI, NIDA, Biological Substances, HSP, GCP E6 (R3), CTL
Timeline
Lead Clinical Research Coordinator II
Elligo Health Research/ AMS Cardiology
10.2023 - Current
Remote Quality Assurance Analyst
Care Access
05.2022 - 10.2023
Remote Patient Screener
Care Access
05.2022 - 10.2023
Clinical Research Coordinator
Mid Atlantic Retina/Wills Eye Hospital
10.2021 - 05.2022
Clinical Research Coordinator
New Jersey Urology LLC
07.2019 - 10.2021
Patient Service Representative
New Jersey Urology LLC
03.2019 - 07.2021
Medical Records Coordinator
New Jersey Urology LLC
01.2018 - 07.2019
Master - Cosmetology
Rizzieri Aveda School for Beauty and Wellness
High School Diploma -
Hammonton