Clinical Research Associate

Parexel International

Curriculum Vitae

TP-HR-WW-002-11.c CV Version Date: 10 Aug 22

Effective Date: 31 Jan 22 Clayton Fortes

Related to: SOP-HR-WW-001 Page 1 of 5

Developed from TP-BPM-WW-032; related to SOP-BPM-WW-001 Name: Clayton Fortes

Job title: Senior Clinical Research Associate

Summary of experience:

Accomplished Clinical Research Associate with 19 years' experience in the industry with working knowledge of drug development process, FDA regulatory requirements, Good Clinical Practices, ICH guidelines and HIPAA regulations. Detail-oriented clinical research expert with strong organizational and interpersonal skills. Excellent written and verbal communication skills. Experience in Early Phase Development through Phase IV trials. Therapeutic area expertise:

Indication Phase

Clinical phase

of the study.

Time on the

Project

Time you

personally

were

involved in

the project.

Countries

List only those

countries (not regions)

where you were directly

involved /accountable

Services Involved

The capacity in which you

worked on the trial/your

role on the study.

Oncology/

Hematology

I-IV 18 yrs. USA, Canada, India Sr. CRA

Infectious

Disease

I-IV 4 yrs. USA, South Africa Sr. CRA

Neurology II-IV 6 yrs. USA Sr. CRA

Immunotherapy:

CART-T

Lymphoma

I 9 yrs. USA Sr. CRA

Cardiovascular II/III 4 yrs. USA Sr. CRA

Ophthalmology II/III 5 yrs. USA Sr. CRA

Psychiatry II/III 5 yrs. USA Sr. CRA

Professional experience:

Senior Clinical Research Associate, Parexel International, Decentralized, Billerica August 2022 to present

Joined Parexel August 01, 2022

Parexel International

Curriculum Vitae

TP-HR-WW-002-11.c CV Version Date: 10 Aug 22

Effective Date: 31 Jan 22 Clayton Fortes

Related to: SOP-HR-WW-001 Page 2 of 5

Developed from TP-BPM-WW-032; related to SOP-BPM-WW-001 Clinical sites’ main point of contact, accountable for quality and delivery of sites from Initiation to Close out of the trial. Oversees the conduct of the trial at designated sites ensuring the rights and well-being of human subjects are protected, quality and integrity of the reported data and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s). Build relationships with investigators and site staff. Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.

Address and resolve issues at sites, including, questions, potential deficiencies in documentation, communication, and the need for additional training. Apply working knowledge and judgment to identify and evaluate potential data quality issues. Determine and implement appropriate follow-up action with the input of other / relevant parties and / or guidance provided, if applicable.

Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.

Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.

Review site recruitment plan in collaboration with the site staff on an ongoing basis. Perform and report on-site visits and remote contacts in accordance with the monitoring plan; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.

Assess & manage test article/study supply including supply, accountability and destruction/return status. Review & follow-up site payment status.

Follow-up on CRF data entry, query status, and SAEs. Conduct on-site study-specific training (if applicable). Perform site facilities assessments

Maintains sound working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL / Sponsor training requirements and study specific procedures, plans and training. Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required. Senior Clinical Research Associate II, Syneos Health, Decentralized, Morrisville, NC April 2013 - June 2022

Performed site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely. Reviewed completion of proper informed consent procedures. Parexel International

Curriculum Vitae

TP-HR-WW-002-11.c CV Version Date: 10 Aug 22

Effective Date: 31 Jan 22 Clayton Fortes

Related to: SOP-HR-WW-001 Page 3 of 5

Developed from TP-BPM-WW-032; related to SOP-BPM-WW-001 Ensured accurate data reporting via review of site source documents and medical records. Interpreted data to identify protocol deviations and risks to subject safety/data integrity; generated queries and manage resolutions with site personnel.

Performed investigational product accountability as per the protocol and Study Monitoring Plan. Evaluated execution of study protocol at the site level. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team. Senior Clinical Research Associate, Fortes Clinical, Decentralized, Woodbridge, CT March 2011 - March 2013

Obtained, reviewed, and processed essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance. Documented activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan. Understood project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing variables to achieve goals / targets. Enter data into tracking systems as required. Acted as primary liaison with study site personnel. Entered data into tracking systems as required.

Participated in the identification and selection of investigators and clinical sites. Senior Regional Clinical Associate, RPS, Decentralized, Blue Bell, PA October 2010 - March 2011

Performed site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely. Reviewed completion of proper informed consent procedures. Obtained, reviewed, and processed essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance. Documented activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan. Understood project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing variables to achieve goals / targets. Enter data into tracking systems as required. Acted as primary liaison with study site personnel. Parexel International

Curriculum Vitae

TP-HR-WW-002-11.c CV Version Date: 10 Aug 22

Effective Date: 31 Jan 22 Clayton Fortes

Related to: SOP-HR-WW-001 Page 4 of 5

Developed from TP-BPM-WW-032; related to SOP-BPM-WW-001 Senior Clinical Research Associate, Depuy Spine, Decentralized, Raynham MA January 2010-Oct 2010

Performed site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely. Reviewed completion of proper informed consent procedures. Obtained, reviewed, and processed essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance. Documented activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan. Understood project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing variables to achieve goals / targets. Enter data into tracking systems as required. Acted as primary liaison with study site personnel. Senior Clinical Research Associate, Fortes Clinical, Decentralized, India March 2009 - September 2010

Obtained, reviewed, and processed essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance. Documented activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan. Understood project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing variables to achieve goals / targets. Enter data into tracking systems as required. Acted as primary liaison with study site personnel. Entered data into tracking systems as required.

Participated in the identification and selection of investigators and clinical sites. Senior Clinical Research Associate, Covance, Decentralized, Durham, NC January 2004 - March 2009

Performed site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely. Reviewed completion of proper informed consent procedures. Obtained, reviewed, and processed essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance. Parexel International

Curriculum Vitae

TP-HR-WW-002-11.c CV Version Date: 10 Aug 22

Effective Date: 31 Jan 22 Clayton Fortes

Related to: SOP-HR-WW-001 Page 5 of 5

Developed from TP-BPM-WW-032; related to SOP-BPM-WW-001 Documented activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan. Understood project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing variables to achieve goals / targets. Enter data into tracking systems as required. Acted as primary liaison with study site personnel. Education:

Meerut University, Meerut, India, B.A. in Business, 1983 Language skills:

English - Fluent

Hindi - Fluent

Marathi- Fluent

Gujarati - Basic

Spanish - Basic

Professional associations:

American Clinical Research Professional (ACRP)

Regulatory Authority Professional Service (RAPS)

PAREXEL International Electronic Signature Page

This page is the manifestation of the electronic signature(s) used in compliance with PAREXEL International’s electronic signature policies and procedures and in compliance with applicable regulations. UserName: Fortes, Clayton (fortescl)

Title: Senior Clinical Research Associate, GCO

Date: Friday, 07 October 2022, 01:59 PM GMT Standard Time Meaning: Document contents approved.

Document ID: 697044374 - Name at Publication: 24026 Fortes_Clayton - CV.docx This document contains a total of 6 pages including any signature page/s.

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