Clinical Research Associate

Clyde A. Harris, Jr. Pittsburgh, PA

**********@******.*** 412-***-****

Summary

Self-motivated professional with exceptional experience in immunology and oncology. Possesses sound clinical, research and business acumen, and the ability to plan, conduct multi-variant analysis, and develop strategies resulting in strong, compliant, and ethical research conduct leading to successful execution of study protocols. Adept at delivering scientific and clinical information, and resources to key decision makers and stakeholders within an academic setting. Demonstrates outstanding ability to translate clinical acumen into a proven record of 3x Presidents Club winner and generating 12 peer reviewed published articles in medical journals. Experience

Sales and Marketing Liaison

Plexision

Sep 2024 – present

Acts as a bridge between the sales, marketing teams, and clinical staff within a Plexision, ensures smooth communication and alignment between the three departments by sharing critical information, coordinating promotional strategies, and facilitating the transition of leads from marketing to sales to maximize the effectiveness of clinical assay utilization, KOL development, training Doctors and Nurses on how to effectively utilize the tests in a individualized and longitudinal manner, lead product launches and market penetration.

Clinical Research Associate III

NSABP Foundation

Nov 2023 – Aug 2024

Actively participated in study start-up activities. Examples of frequent activities include participation

in partner meetings, study timeline start-up development, site selection, Principal Investigator review. Assisted with site activation including document collection, ICF review, site access to study platforms, facilitate site questions. Facilitated team huddles to assess, plan, review and prioritize activities to ensure timely site activation. Participated in study specific training as required. Developed relationships with site staff and NSABP monitors. Acted as a liaison among NSABP, site staff, external partners. Tracked study metrics developed by either NSABP or external partners. Assisted with identifying metrics that require additional focus and developing an action plan. Developed and implement recruitment strategies to ensure accrual targets are met.

Developed awareness of site visits by monitors. These include site initiation visits, interim monitoring visits, close out visits. Followed Standard Operating Procedures

(SOPs), Work Instructions (WIs), GCP and ICH guidelines. Function as a resource for specific Study Start-Up Plans, Clinical Monitoring Plan, Roles and Responsibilities grid and other study-specific documents

Collaborated with clinical research organizations and centralized services such as central laboratories. Collaborated with data management regarding CRF development. Acted as a resource to sites and investigators.

Performed other job-related duties as assigned.

Conducted tasks with the in-depth knowledge of randomized clinical trials principles and procedures. Experienced with federal and state regulations and guidelines pertaining to the conduct of clinical trials. Knowledge of the infrastructure and operational characteristics of successful patient accrual related to site and study management.

Clinical Research Associate II

Rho

Mar 2023 - Sep 2023 (7 months)

Conducted Clinical study according to Sponsor requirements based on excellent knowledge of Good Clinical Practice, Protocol and applicable regulations: Served as your country’s clinical research industry subject matter expert. Planned and perform Site visits (SIV, SMV and SCOV) and site management activities to ensure compliance with Project Management plan and Protocol. Tasked with the planning and performance evaluation of Country and Site Feasibility, including assessments of potential Risks and challenges, as well as select Study sites and perform pre-study visits. Assisted in selection of Study specific Vendors and perform Vendor assessments. Supported in negotiation and execution of Investigator/ Institution contracts. Assisted in the preparation of documents submission to Ethics Committee, Competent Authorities and other bodies (as applicable), including communication with Sponsor, EC/ CA and other involved parties. Provided input in supportive Study specific processes, e.g., Study supplies management, patient reimbursement management etc.

Clinical Research Associate I

Syneos Health

Feb 2022 - Feb 2023

Performed site qualification, site initiation, interim monitoring, site management activities and close-out visits, performed on-site or remotely) ensuring regulatory, ICH- GCP and/or Good Pharmacoepidemiologic Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site- specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance and regulations.

Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrated diligence in protecting the confidentiality of each subject/patient. Assessed factors that might affect subject/patients safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Conducted Source Document Review of appropriate site source documents and medical records Verified required clinical data entered in the case report form (CRF) is accurate and complete. Applied query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilized available hardware and software to support the effective conduct of the clinical project data review and capture. Verified site compliance with electronic data capture requirements. Performed investigational product (IP) inventory, reconciliation and reviews storage and security. Verified the IP has been dispensed and administered to subjects/patients according to the protocol. Verified issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately

(re)labelled, imported, and released/returned. Routinely reviewed the Investigator Site File (ISF) for accuracy, timeliness, and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensured the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.

Documented activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supported subject/patient recruitment, retention, and awareness strategies. Entered data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understood the project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Displayed ability to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets. Acted as a primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensured all assigned sites and project-specific site team members are trained and compliant with applicable requirements. Prepared for and attended Investigator Meetings and/or Sponsor face to face meetings. Participated in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provided guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Clinical Research Coordinator Crohn’s and Ulcerative Colitis Eli Lilly

Jun 2021 - Aug 2021 Contract

Performed site qualification, and study initiation at a private practice GI group in accordance with EL protocol guidelines. Managed the CRF, obtained informed consent from enrolled patients, study follow up, patient screening, EDC, Medidata Rave build out. Submitted AE as per protocol, conducted Crohn’s and Ulcerative Colitis disease state in-services to site staff.

Clinical Research Coordinator

City of Hope Hematological Malignancies

Apr 2021 - Jun 2021 contract

Managed the proper and timely completion of clinical trials while aligning all activities with regulatory compliance standards regarding human subject research. Works collaboratively with clinical staff to determine patient eligibility for clinical studies. Fully informed hospital personnel and all involved parties (patient and families) in the studies by providing in-service education. Gathered informed consent from patients and conducts follows up and attentive patient monitoring to comply with study protocol. Clinical Research Coordinator II

Esophageal and Lung Center of Allegheny General Hospital, Pittsburgh, PA May 2019 - Nov 2020

Managed the proper and timely completion of clinical trials while aligning all activities with regulatory compliance standards regarding human subject research. Works collaboratively with clinical staff to determine patient eligibility for clinical studies. Fully informs hospital personnel and all involved parties (patient and families) in the studies by providing in-service education. Gathers informed consent from patients and conducts follows up and attentive patient monitoring to comply with study protocol. Sales Training Consultant

LaJolla Pharmaceuticals Giapreza, San Diego, CA

Dec 2017 - Apr 2019

Drove training efforts by creating materials needed to supplement teachings. Penned modules to create pathophysiology of Septic or Distributive Shock. Conducted regional training sessions on Giapreza MOA, types of shock, inotropic interventions, and patient selection criteria.

Oncology Sales Specialist

Shire US, Lexington, MA

May 2015 - Nov 2017

Strategically promoted the Shire product Oncaspar® to generate sales to reach targets. Professionally represented Shire in all field activities and to drive high levels of field visibility. Spearheaded ancillary programs, patient advocacy, educational programs to reach objectives.

Senior Executive Representative I

Astellas Pharmaceuticals US

May 2010 - May 2013

Reached territory sales goals by promoting Astellas Products (Lexiscan®, Mycamine®, and Ambisome®, and Vaprisol for the treatment of patients with euvolemic and hypervolemic hypernatremia. Established and maintained relationships with key stakeholders and internal/external customers. Generated revenue and sales by educating customers advantages, uses and characteristics. Exceeded quarterly sales goals using a consultative sales approach and best sales practices.

Achieved top sales performance with awarded 2012 and 2013 President’s Club Recognized for improving and underperforming territory that was 143 out 156 in 2010 and grew to 10th Nationally in 2013

Senior Specialty Account Manager

Enzon Pharmaceuticals, Bridgewater, NJ

May 2005 - May 2010

Conceptualized and implemented business plans for targeted institutions to achieve assigned territory sales goals. Maintained strategic partnerships within the following medical subspecialties: Exercised an in-depth understanding of adult and pediatric cancer, Mantel Cell Lymphoma, Burkett’s Lymphoma, CNS metastatic processes, the Immunology of Cancer (solid and hematological malignancies), HSCT, Solid Organ Transplantation mechanisms of rejection, tolerance, and oncogenesis. Streamlined the enrollment of key institution in clinical trials from CALGB 10403 (Penn State Milton Hershey MC, West Penn Cancer Institute, Wilmot Cancer Center URMC, RPCI), and Dana-Faber Cancer Institute Consortium. Promoted from Specialty Account Representative to Senior Specialty Account Representative (2 levels higher) within 18 months. Winner of the 2005 Summit Cup Award

Recipient of the 2006 National Leadership Award

Awarded the Teamwork Award for 2006, 2007.

Education

University of Pittsburgh

Bachelors in Chemistry

Skills

Advanced knowledge in Immunology, Hematology, Oncology, Solid Organ Transplantation, Bone Marrow Transplantation, Infectious Disease, Nuclear Medicine, ECMO, LVAD, RVAD, SPSS

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