Clinical Research On-Site

John C. Sealock, CCRA

Clinical Research Professional

**** ***** *********, ***** *** York 10452

Tel: +1-212-***-****

Employment History

PPD - A Division of Thermo Fisher Scientific Home Based, Bronx, NY, USA

Senior Clinical Research Associate-I April 2023 – February 2024

•Responsible for all aspects of study site management including but not limited to:

•Study site management including site qualification, site initiation, routine monitoring, and close-out of clinical sites

•Maintenance of study files

•Scheduling and conduct of study site visits

•Liaise with sponsors and vendors

•Other duties, as assigned

•General On-Site and Remote Monitoring Responsibilities:

•Responsible for on-site tasks as required and according to training goals (e.g. review of Case Report Forms (CRFs), Study File Notebook, Drug Accountability, and Site Training Logs)

•Initiated, monitored, and closed out clinical investigative sites

•Ensured the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects into the study

•Ensured the protection of study subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

•Ensured the integrity of the data submitted via paper and/or electronic CRFs or other data collection tools by careful source document review

•Monitored data for missing or implausible data

•Prepared accurate and timely trip/monitoring reports

•Performed CRF review, query generation, and resolution against established data review guidelines on PPD or client data management systems

•Assisted with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management

•Provided coverage for clinical contact telephone lines

•Updated, tracked, and maintained study-specific trial management tools/systems

•Generated and tracked drug shipments and supplies

•Tracked and followed-up on serious adverse events

•Implement study-specific communication plan

•Attended investigators’ meetings, project team meetings and teleconferences

Becton Dickinson, & Co., Franklin Lakes, NJ, USA

Clinical Research Associate - Global Clinical Development (Permanent) June 2019 – August 2020

Clinical Research Associate - Global Clinical Development (Contract –

SRG Wolfe Group) May 2018 – June 2019

•Supported the day-to-day operations associated with the execution of clinical trials for both internal and external study sites – studies included hematology, serology, and oncology centered testing of blood samples collected in marketed and pre-marketed blood collection tubes

•Served as Study Manager/Monitor performing on-site and in-house monitoring activities

•Responsible for the planning and implementation of remote and on-site study initiation, interim monitoring, and close-out Visits for assigned studies

•Provided support to clinical project teams, with on-site and remote review of site documentation and study data to ensure the overall quality of clinical trials

•Responsible for regulatory document collection, tracking screening and enrollment, supporting safety reviews and reporting

•Created study specific documentation

• Assisted with development and implementation of studies from initial concept to final database lock

•Reviewed clinical data working directly with internal and external/vendor laboratories to determine the parameters needed for device storage, sample collection, sample processing, and device operation that would optimize consistent and accurate results

•Developed training and reference materials for use at the study sites from initiation to close-out

•Assisted in the training of new staff

•Reviewed and adjusted training and reference materials as needed

•Contributed to the development and improvement of company procedures, processes, and templates in support of Global Clinical Development efforts towards continuous quality improvement

Syneos Health (Formerly INC Research/InVentiv Health), Home-Based, Bronx, NY, USA

Clinical Research Associate-II/eTMF Project Lead August 2017 – May 2018

•Managed effort to obtain, review, and submit all site level essential documents following closeout visits (COVs)

•Created, implemented, and trained teams on new procedures for the collection and review of all site level essential documents

•Lead and supported study team on client’s eTMF processes and procedures

•Liaised with study team, client and sites regarding necessary pre- and post-COV activities

•Assisted client eTMF document reviewers in resolving site-level and project-level essential document issues

•Provided support and coaching to CTA and CRA teams

•Worked with client and management to identify process improvements and efficiencies

•Ad-Hoc duties as needed to further the project goals

Covance Clinical Development Services, Home Based, Bronx, NY, USA

Clinical Research Associate I July 2016 – May 2017

•Assigned to one urinary incontinence trial with one sponsor and two salvage treatment studies for metastatic breast cancer subjects for another sponsor

•Responsible for all aspects of study site management including but not limited to:

•Study site management including site qualification, site initiation, routine monitoring, and close-out of clinical sites

•Maintenance of study files

•Scheduling and conduct of study site visits

•Liaise with sponsors and vendors

•Other duties, as assigned

•General On-Site and Remote Monitoring Responsibilities:

•Responsible for on-site tasks as required and according to training goals (e.g. review of CRFs, Study File Notebook, Drug Accountability, and Site Training Logs)

•Initiated, monitored, and closed out clinical investigative sites

•Ensured the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects into the study

•Ensured the protection of study subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

•Ensured the integrity of the data submitted via paper and/or electronic CRFs or other data collection tools by careful source document review

•Monitored data for missing or implausible data

•Prepared accurate and timely trip/monitoring reports

•Performed CRF review, query generation, and resolution against established data review guidelines on Covance or client data management systems

•Assisted with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management

•Provided coverage for clinical contact telephone lines

•Updated, tracked, and maintained study-specific trial management tools/systems

•Generated and tracked drug shipments and supplies

•Tracked and followed-up on serious adverse events

•Implement study-specific communication plan

•Attended investigators’ meetings, project team meetings and teleconferences

Columbia University/Columbia University Medical Center, New York, NY, USA

In-House Clinical Research Associate August 2015 – July 2016

•Performed compliance reviews/audits/internal monitoring

•Verified essential documents were current, complete, and accurate

•Verified informed consent and HIPAA documentation were current and complete

•Verified study conduct was in compliance with the protocol as well as all applicable university, federal, and state regulations as well as applicable international guidelines

•Reviewed and verified accuracy of clinical trial data

•Assessed and verified IP accountability, storage, dispensation, and compliance

•Reviewed reports of audit or quality assurance monitoring activities conducted by departments, centers, schools, or outside entities

•Gathered information from sources other than the research team when necessary that verified data, actions, or events related to the conduct of research

•Escalated site and trial related issues per University SOPs, until identified issues were resolved or closed

•Prepared accurate, comprehensive, and timely confirmation letters, monitoring reports, and follow-up letters

Mount Sinai – Beth Israel Comprehensive Cancer Center, New York, NY, USA

Regulatory Coordinator – Oncology Clinical Trials July 2013 – August 2015

•Acted as primary contact between study site and sponsors, CROs, hospital IRB, and vendors for 60+ oncology trials and secondary contact for 60+ additional oncology trials – study sponsors included: ECOG, ACRIN, SWOG, AbbVie, AstraZeneca, Celgene, Novartis, Hoffman-LaRoche, Eli Lilly, Bristol-Myers Squibb, Johnson & Johnson, Pfizer, Merck, and others

•Created and maintained all regulatory/essential documents for 60+ oncology trials

•Composed informed consent forms that conformed with sponsor, IRB, state, federal, and applicable international regulations and guidelines

•Prepared for sponsor and CRO site visits such as site qualification, initiation, monitoring, and closeout visits

•Prepared and provided education and training to research personnel, research administration staff, and any other individuals involved with human research

•Managed student interns/volunteers on clinical research basics to aid onsite studies

John Sealock - Consultant, New York, NY, USA

Clinical Research Consultant January 2009 – July 2013

•Performed remote/electronic monitoring of assigned site essential documents for trial master file reconciliation prior to FDA filings (6-month contract position)

•Consulted with prospective clinical trial sites prior to site qualification and initiation visits for pharmaceutical industry sponsored trials

•Built a clinical research program from the ground up for a privately-owned urgent care clinic

•Authored complete set of SOPs for day-to-day operations

•Managed multiple clinical trials site qualification and initiation visits – four studies, two sponsors

•Created and maintained all essential documents/study binders for al clinical trials

•Trained investigators and clinic staff in all aspects of clinical research site operations

•Processed SAE reports for pharmaceutical company post-marketing studies (6-month contract position)

Amarex Clinical Research, Germantown, MD, USA

Clinical Research Associate/Safety/Pharmacovigilance Specialist May 2008 – January 2009

•Monitored assigned study sites

•Verified and collected essential documents

•Verified informed consent documentation was current and complete

•Verified study conduct complied with the protocol as well as all applicable local, federal, and state regulations and applicable international guidelines

•Reviewed and verified accuracy of clinical trial data

•Developed Medical Monitoring Plans/SAE Reporting Plans and designed SAE Report Forms for domestic and international clinical research projects

•Provided supervision and training for project teams, study sites, and vendors for the documentation and reporting of SAEs

•Reviewed SAE reports for internal consistency, completeness, and congruity of clinical and demographic information

•Contacted domestic and international reporting sites that confirmed receipt of SAE reports and that obtained further clinical information if needed

•Supported corporate partnering efforts and business development activities by providing SAE and clinical trial expertise and participated in partnership committees

Technical Resources International, Bethesda, MD, USA

Safety/Pharmacovigilance Specialist August 2006 – November 2007

•Reviewed SAE reports for internal consistency, completeness, and congruity of clinical and demographic information

•Contacted domestic and international reporting sites that confirmed receipt of SAE reports and that obtained further clinical information if needed

•Supervised and trained for project teams, study sites, and vendors for the documentation and reporting of SAEs

•Tracked the safety reporting and regulatory review process for domestic and international protocols

•Compiled Safety and Regulatory Team findings and reported to DAIDS scientific review committees

Technical Resources International, Bethesda, MD, USA

Regulatory Compliance Associate I & II September 2004 – August 2006

•Performed and assigned draft sample informed consent reviews focusing on the required and additional elements and consistency with the protocol for all new NIH – NIAID – Department of AIDS (DAIDS) funded clinical research projects

•Managed junior regulatory compliance associates

•Conducted regulatory audit of domestic and international site-specific informed consent documents

•Consulted directly with domestic and international IRB/ERB’s that resolved conflicts between DAIDS, Federal, and local informed consent form guidelines

Mount Sinai School of Medicine, Department of Urology, New York, NY, USA

Clinical Research Coordinator September 2002 – May 2003

•Acted as primary contact between study site and sponsors, CROs, hospital IRB, and vendors for assigned studies and/or investigators

•Screened subjects for protocol suitability

•Discussed clinical trial participation with subjects and obtained informed consent

•Performed protocol specific clinical data collection/assessments

•Performed phlebotomy, specimen collection, processing, and preparation for shipping for assigned clinical trials

•Maintained study-specific training, delegation, consent, screening, drug accountability, and temperature logs

•Maintained paper and electronic CRF and AE/SAE forms

•Maintained all essential documents/study binders for all clinical trials

Astor Medical Group, New York, NY, USA

Clinical Research Program Coordinator August 2001 – September 2002

•Developed clinical research program and acted as primary contact between study site and sponsors, CROs, IRBs, and vendors for multiple-doctor, infectious disease private practice

•Screened subjects for protocol suitability

•Discussed clinical trial participation with subjects and obtained informed consent

•Performed protocol specific clinical data collection/assessments

•Performed phlebotomy, specimen collection, processing, and preparation for shipping for multiple clinical trials

•Maintained drug accountability and temperature logs

•Maintained paper and electronic CRF and AE/SAE forms

•Maintained all essential documents/study binders for all clinical trials

•Managed clinic medical support and laboratory staff

Metropolitan Gastroenterology Group, Washington, DC, USA

Clinical Research Coordinator October 2000 – August 2001

•Acted as primary contact between study site and sponsors, CROs, IRBs, and vendors for multiple-doctor, gastroenterology private practice

•Screened subjects for protocol suitability

•Discussed clinical trial participation with subjects and obtained informed consent

•Performed protocol specific clinical data collection/assessments

•Performed phlebotomy, specimen collection, processing, and preparation for shipping for multiple clinical trials

•Maintained drug accountability and temperature logs

•Maintained paper and electronic CRF and AE/SAE forms

•Maintained all essential documents/study binders for all clinical trials

Price Medical, Washington, DC, USA

Clinical Research Coordinator July 1998 – October 2000

•Acted as primary contact between study site and sponsors, CROs, IRBs, and vendors for multiple-doctor, infectious disease private practice

•Screened subjects for protocol suitability

•Discussed clinical trial participation with subjects and obtained informed consent

•Performed protocol specific clinical data collection/assessments

•Performed phlebotomy, specimen collection, processing, and preparation for shipping for multiple clinical trials

•Maintained drug accountability and temperature logs

•Maintained paper and electronic CRF and AE/SAE forms

•Maintained all essential documents/study binders for all clinical trials

AIDS Research Alliance Chicago, Chicago, IL, USA

Clinical Research Coordinator/In-House Clinical Research Associate May 1996 – June 1998

•Cross-monitored other study sites that included:

•Verified essential documents were current, complete, and accurate

•Verified informed consent documentation was current and complete

•Verified study conduct complied with the protocol as well as all applicable local, federal, and state regulations and applicable international guidelines

•Reviewed and verified accuracy of clinical trial data

•Screened subjects for protocol suitability

•Discussed clinical trial participation with subjects and obtained informed consent

•Performed protocol specific clinical data collection/assessments

•Performed phlebotomy, specimen collection, processing, and preparation for shipping for clinical trials

•Maintained drug accountability and temperature logs, paper and electronic CRF/AE/SAE forms

•Maintained all essential documents/study binders for all clinical trials

Dun and Bradstreet Healthcare Information, Chicago, IL, USA

Clinical Operations Specialist January 1995 – May 1996

•Recruited multiple site start-ups for a newly formed clinical research organization

•Prepared and attended site qualification and initiation visits

•Trained investigators and research coordinators

•Prepared and developed research site SOPs and source documents

•Monitored all sites that included:

•Verified and collected essential documents

•Verified informed consent documentation was current and complete

•Verified study conduct complied with the protocol as well as all applicable local, federal, and state regulations and applicable international guidelines

•Reviewed and verified accuracy of clinical trial data

•Performed essential document site file reconciliation

Douglas J. Ward, MD, P.C., Washington, DC, USA

Medical Assistant/Clinical Research Coordinator September 1992 – January 1995

•Acted as primary contact between study site and sponsors, CROs, IRBs, and vendors for multiple-doctor, infectious disease private practice

•Screened subjects for protocol suitability

•Discussed clinical trial participation with subjects and obtained informed consent

•Performed protocol specific clinical data collection/assessments

•Performed phlebotomy, specimen collection, processing, and preparation for shipping for multiple clinical trials

•Maintained drug accountability and temperature logs

•Maintained paper and electronic CRF and AE/SAE forms

•Maintained all essential documents/study binders for all clinical trials

Washington Hospital Center, Washington, DC, USA

Practitioner Assistant—Respiratory Therapy May 1991 – September 1992

•Provided in-patient respiratory care under supervision of Respiratory Therapists that included:

•Nebulizer and Metered Dose Inhaler treatments

•Chest Physiotherapy

•Incentive Spirometry

•Measured and recorded pre- and post-treatment vital signs

•Set-up and made adjustments of mechanical ventilators in intensive care units

•Obtained arterial blood samples for ABG analysis in general and intensive care units as well as trauma units

Therapeutic Experience

•Immune Mediated Inflammatory Disease (IMID): Inflammatory Bowel, Crohn’s (Phase III), Ulcerative Colitis (Phase III), Irritable Bowel (Phase III) Rheumatoid Arthritis (Phase III) - 2 years

•CardioMetabolic: Metabolic and Cardiovascular Risk, Type II Diabetes (Phase II & III) - 2 years

•NeuroScience: Multiple Sclerosis (Phase III) - 1 year

•Infectious Disease: Anti-Viral Therapy, HIV/AIDS (Phase II & III) – 12 years

•Oncology: Solid Tumors, Breast (Phase II & III), Colorectal (Phase II & III), Lung Cancer (Small and Non-Small Cell Lung Cancer) (Phase II & III), Hematologic Malignancies, Leukemia (Phase II & III), Hodgkin’s or non-Hodgkin’s Lymphoma (Phase II and III), Myeloma (Phase II and III), Cancer Supportive Care, Anemia due to chemo (Phase III) – 3 years

Device Work

•Bayer

•A1C Now – 1 year

•Becton Dickinson – 2.5 years

oIn-house and external site studies to test and evaluate blood and tissue collection systems:

Needles

Adapters/interfaces

Safety features

A newly invented system that modernizes the process of performing finger-sticks and collecting blood samples for testing

oIn-house and external site studies to validate labeling changes for BD Vacutainer® Blood collection tubes for:

Trace Elements

Tumor Markers

Drugs of Abuse

Cardiac Markers

Chemistry/Metabolic Panels

EtOH

Hematology/Oncology Related Testing

CBC Panels

oExternal study site study to evaluate an upgraded vacuum-assisted overnight urinary leakage collection system

Language Capabilities

•English

Electronic Systems

MS Office Suite – Word, Excel, Outlook, Power Point

•Medidata/Rave

•Veeva Vault

•ARGUS and other Oracle based clinical research systems

•Various Clinical Trial Management Systems - CTMS

•Various Electronic Medical Record systems

•Various Electronic Data Collection systems

Education

Bachelor of Science, George Mason University, Fairfax, VA, USA, January-1991

Certification

•Certified Clinical Research Associate, CCRA, Association of Clinical Research Professionals, April 2023

•Certified Clinical Research Project Manager, ACRP-PM, Association of Clinical Research Professionals, December-2018

•CITI Program Certification in Good Clinical Practice expires May-2026

Other

•Statement of Credit – 30-Hour Clinical Research Auditing Certification Program, Barnett Educational Services, Universal Activity Number: 077*-****-**-***-L01-P - November 5, 2015 to February 4, 2016

•Certificate of Completion, New York State Course for Pre/Post-HIV Test Counseling, October 2001

•Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals - 2000 to 2006

•Certificate of Completion, U.S. Department of Transportation Approved Course for the Handling, Packing, and Shipping of Hazardous Materials

Appendix 1

Publications, manuscripts, abstracts, and/ or presentations

Publications

•Penetar, D., Sing, H., Thorne, D., Thomas, M., Fertig, J., Schelling, A., Sealock, J.,Newhouse, P.A., and Belenky, G. (1991) Amphetamine effects on recovery sleep following total sleep deprivation. Human Psychopharmacol. 6: 319-323

Presentations

•Guest Lecturer – Clinical Research Ethics, Good Clinical Practice, and Human Subject Protection, American University, Washington D.C. June 2006

References

•Available upon request

Contact this candidate