Joyce Brooks Email & Phone Number

Billerica, Massachusetts, United States

• Managed and functioned as Parexel's direct point of contact with assigned sites & deadline deliverables. • Ensure CDAs are in place, distribute regulatory packets, collected, reviewed, processed, and tracked study specific site regulatory documents (IBs, PSPs, 1572s, FDFs, CVs, MLs, GCP Certs), including ICF review to ensure accurate subject budgets and travel reimbursements received from participating research sites in accordance with applicable SOPs, ICH Guidelines, GCPs and ED Review Plan & supported translations for ICFs, patient recruitment materials per internal SOP/s.• • Prepare the initial site related IRB application and associated documents required prior to SIV delegated by the CRA and reviewing/approving all essential documents. Post SIV the iCRA would review/approve the documents as determined by Parexel SOPs. • Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF) for HIPPA compliance, translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.• Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (eTMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.• Identify, use judgement and knowledge to address and resolve or escalate site questions or issues, including but not limited to potential issues or risks with site activation timelines, patient recruitment, training deficiencies, data quality or integrity, study non-compliance, etc.• This is not an all-inclusive list of accountabilities and supporting activities for the iCRA role.

Billerica, Massachusetts, United States

• Managed the review of ICFs for multiple studies to customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF) to ensure ICH Guidelines, GCPs, SOPs are followed and HIPPA Compliant, translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments. Uploaded redlined versions of all sites ICFs to the eTMF.• This is not an all-inclusive list of accountabilities and supporting activities for the In-House CRA role.

Raleigh, Nc

• Managed sites to ensure all regulatory documents were collected and filed appropriately at both the site and in the Trial Master File (eTMF). Conduct routine file audits and maintain audit ready eTMF. • Review and monitor regulatory file development and ensure completion in advance of Site Initiation Visits. • Ensure regulatory documents are current according to SOPs, ICH Guidelines, GCPs via Excel spreadsheet tracking. • Maintain field CRA visit schedule and visit calendar. Collaborate with Clinical Team to support continuous evaluation of sufficient site monitoring coverage. • Monitor quality of site data and performance and implement action plans for sites not meeting expectations, in conjunction with the clinical study team. • Assist field CRAs with preparation of on-site visits, including running data reports, QC of files and resolving outstanding action items and respond to requests from CRAs during their on-site visits. • Conduct first review of monitoring visit reports including required documentation. Ensure all follow-up letters were prepared and all follow-up action items from on-site visits were tracked and closed, as required. • Work closely with field CRAs to track and resolve EDC queries on discrepant data. • Conduct regular review of data including adverse events and device usage entered on electronic Case Report Forms (eCRFs). Request source documentation in support of adverse events and device issues. Assist in writing safety narratives, if required. • Assist in the development of study documents and tools, including Informed Consent Form (ICF) templates are HIPPA Compliant (for both local and central IRBs), site binder packets have all contents, newsletters, etc.• This is not an all-inclusive list of accountabilities and supporting activities for the In-House CRA role.

Boston, Massachusetts, United States

• Managed the review of sites lab reports and present them to the PI for review and determination of clinical significance and notify Study Manager if a retest was required and/or needed.• Notify patient, the patient PCP, and the facility director of positive COVID results as delegated by the PI.• Uploading completed regulatory documents & signed lab reports to Study Hub database.• Ensure CDAs are in place, distribute regulatory packets, collect sites completed PSPs, 1572s, FDFs, CVs, MLs, GCP training certs of study personnel, review for accuracy and upload to eTMF and ensure applicable SOPs, ICH Guidelines, GCPs and the ED Review Plan are followed.• Remind site PIs of sign-off deadlines in EDC system with patient CRFs to ensure it was completed.• Review the sites DOA forms received from Study Manager to ensure PI sign-off was completed in a timely manner.• Attend remote monitoring visits and assist in resolution of queries.• Assist with data entry of source documents from Study Hub to Veeva EDC.• Assist the Study Manager in the completion of SAEs ensuring they are reported within 24 hours of awareness.• Assist with the timely completion of Adverse Events forms and respond to sponsor/CRA inquiries in 48 hours.

Morrisville, North Carolina Area

• Managed and built sites in Clinical Trial Management System and update required activity fields related to site activation.• Distributed CDAs, Essential Document packets, Essential Document eBinders, Study Specific Site Questionnaires to sites and review completed essential documents and assemble packets.• Consulted with cross-functional teams to prioritize collection/review of essential regulatory SSU documents, reported to SSU Leads/Managers, Project Managers and assisted CRAs, Contract Leads and Data Management as needed.• • Ensure CDAs are in place, distributed regulatory packets, collected, reviewed, processed, and tracked study specific site regulatory documents (IBs, PSPs, 1572s, FDFs, CVs, MLs, GCP Certs), including ICF review and negotiation of subject budgets/travel reimbursements received from participating research sites were accurate and in accordance with applicable SOPs, ICH Guidelines, GCPs and ED Review Plan & supported translations for ICFs and patient recruitment materials.• Managed IRB submission(s) and followed up on all approvals received from the Central Institutional Review Board (IRB). Submit draft (redline version) Central IRB/Local IRB ICFs to Site Management & Monitoring ICF team for review.• Coordinated and/or completed distribution of mass mailings as needed during start up and maintenance of studies (i.e., updated Investigator Brochures, Protocol Amendments).• Conducted quality checks of the Central eTMF to ensure required site essential regulatory documents, regulatory packet checklists were coded, uploaded to the eTMF system to ensure it is always audit ready.• Managed ICF Reviews for HIPPA Compliance for 11 neurology studies to build, edit and review ICFs and completed ICF Checklist required to ensure all FDA, ICH and GCP required regulatory elements were present, biomarker/HIPPA laws, Injury language/patient compensation are accurate prior to clinical sites submitting to their Local/Central Ethics Committee (LEC/CEC).

Morrisville, North Carolina Area

• Managed and main point of contact for site activation, including feasibility, site selection, and per FDA/ICH/GCP/HIPAA laws and regulations and study-specific requirements.• Lead and participated in weekly sponsor & internal meetings to report site status updates.• Collaborated with assigned Clinical Research Associates (CRAs) for maintenance of study sites through the life of the studies from start-up to close-out per the internal work instructions and SOPs processes.• Collected country and site level intelligence to support Site Identification activities including the negotiation and collection of CDAs and the collection and analysis of Site Identification Questionnaires.• Provided relevant study teams to the study project with weekly reports for follow up and updates on the status of CDAs negotiation and finalization, local EC submissions and expected IRB Approvals dates as well as site performance metrics and project specific deliverables when completed.• Ensure CDAs are in place, distribute regulatory packets, collected, reviewed, processed, and tracked study specific site regulatory documents (IBs, PSPs, 1572s, FDFs, CVs, MLs, GCP Certs), including ICF review/translation to ensure proper subject budgets/travel reimbursements received from participating research sites in accordance with applicable SOPs, ICH Guidelines, GCPs and ED Review Plan and patient recruitment materials.• Developed and adapted global, regional, country, and site-specific ICFs to ensure HIPPA Compliant per protocol requirements.• Ensured regulatory documents were reviewed and curate, Local/Central/CA Ethics Committee approved, contracts fully executed, Investigational Product (IP) Release authorized, project specific deliverables completed, coded, and uploaded to the eTMF system to ensure it is audit ready at all times. • Liaised with cross-functional teams with SSU Leads/Managers, Project Managers and assisted CRAs, Contract Leads and Data Management as needed.

Raleigh-Durham, North Carolina Area

Performed qualification, initiations, interim, and close-out visits.Traveled on average 60-80% nationwide.Developed working practices for training record maintenance.Provide study coordinators with feedback from inform consent review, site status, deficiencies, corrective action plans, and managed follow-up procedures to ensure protocol adherence.Identified and escalated the reporting of adverse events (AE), serious adverse events (SAE) and protocol deviations as well as retrained site personnel on proper procedures.Reviewed investigational drug expiration dates.Tracked all site documentation and requested updated documents as needed.Maintained 100% compliance with trip report turnaround.Reviewed eCRF data entry to ensure accuracy and accountability.Provided sites with ongoing education and training with study procedures, enrollment, patient retention, and regulatory compliance.

Raleigh-Durham, North Carolina Area

 Managed the daily activities of investigational sites for assigned clinical trial studies, including the facilitation of data entry into the EDC, review of regulatory documents, ICF review to ensure FDA/ICH/GCP compliance prior to sites Local IRB Submissons, Clinical Trial Agreements (CTA), budgets, payments, IVRS/IWRS, site status, deficiencies, corrective action plan, when needed and follow-up to ensure deficiencies were resolved. Participate in weekly sponsor and/or internal meetings to report site status updates. Developed positive working relationships with study coordinators who were difficult for other co-workers to manage. Assist CRAs with on-site visits and remote monitoring activities to ensure FDA/ICH/GCP and monitoring guidelines were met according to the study-specific protocol and SOPs.  Assist with the on-boarding and training of new staff to get them acclimated to their job responsibilities and ensure company SOPs were reviewed and followed. Coordinated and assessed the feasibility of potential investigative sites through telephone screening, regulatory document review, and ensuring investigator commitment. Maintained the clinical trial management system (CTMS) to ensure it is up-to-date. Attended off-site investigator and study coordinator meetings. Conducted remote SDV review of the electronic case report form (eCRF) system and trained site personnel to accurately answer protocol related questions to ensure data base lock deadline was met. Implemented site deficiencies and initiated the execution of corrective action plans.  Assist with managing the Trial Master File (eTMF) to ensure filing was update within the provided timelines and audit ready at all times. Coordinated investigational product readiness and availability, working cross-functionally with manufacturing, QA, and supply chain management to ensure readiness and product availability prior to patient treatment and dosing.

Raleigh-Durham, North Carolina Area

Mentored and trained new Clinical Trial Assistants (CTAs).Conducted remote site close-outs and completed monitoring reports for 32 sites for an Acute Myocardial, Phase III study.Developed notification and tracking systems for the collection of CEC documents assure sites maintained the confidentiality of patient information.Developed trial processes, patient transfers, regulatory processes for document transfer for non-US coordinating centers, and site status definitions.

Associate Of Arts And Science (Aas), Science, 3.4

Pharmacy Technology Certification, Science, 3.4