Cynthia Priester

832-***-**** advfne@r.postjobfree.com Palm Bay, FL 32907

SUMMARY

Clinical Research Professional proficient at coordinating and tracking project deliverables at CRO, SMO and Site level. Successful at managing a trial from feasibility to closeout. Capable of understanding and communicating effectively. Proficient in MS Programs, Excel, Power Point, Office 365 and multiple CTMS. Experience with Veeva Vault and Florence e-Binders. Over 17 years of experience that includes Pharma, Medical Device and Academia research.

Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.

SKILLS

Client communications

Multi-tasking skills

Managing unexpected obstacles

Project coordination

Process development

Efficient work breakdown structure

EXPERIENCE

ASSOCIATE PROJECT LEADER, DUKE CLINICAL RESEARCH INSTITUTE, August 2021-Current

Durham, NC (Remote)

Coordinate with Project Managers and Leaders to understand project needs and provide needed support to meet targets.

Maintain close connection with project team to quickly identify and resolve problems.

Assist Project Managers by identifying gaps and establishing best practices for existing and upcoming project initiatives.

Schedule team meetings and collaborate with internal and external teams to develop agendas and meeting materials.

Local IRB submissions including initial, continuing review and study closures.

Instrumental in developing Project Management Plans, completion of Project Management Workbooks and project management tracking.

Document review for content, grammar and accuracy: protocols, ICF/IAF’s, MOP’s, TSR’s, NPD’s and other documents as required.

Initial drafting of study specific Informed Consents and Assents.

Collaborating with team members to create process flow documents and diagrams.

CLINICAL OPERATIONS COORDINATOR, CARE ACCESS RESEARCH, April 2021-July 2021

BOSTON, MASSACHUSETES (Remote)

Streamline communications and simplify changes so the mobile “jump” team could efficiently and accurately complete study visits per protocol.

Establish and maintain excellent lines of communication with staff, internal teams, and client contacts.

Manage the constant change within the team onsite and offsite.

Daily planning and creating processes to support the research site workflow.

Orienting and training new hires, coordinating team assignment and travel.

CRA II/CRC, Covid, 19, Team, IQVIA October 2020-March 2021

DURHAM, NC

Acted as Liaison between CRO, SMO and Facility Administrators.

Reviewed site regulatory binder to check collection procedures and completeness of paperwork.

Adhered to good clinical practices, operating procedures and regulatory requirements.

Maintained strict confidentiality to keep personal information and collected data private.

Achieved project objectives by working closely with internal and external teammates.

Performed all study related tasks and completed patient visits per protocol.

Completed paper CRF’s and data entry into eCRF and for this hybrid data collection trial.

Data verification for data base locks.

Good working knowledge of the Phase III protocol and GCP/ICH guidelines helpful to educate other CRC's and follow up nurses upon arrival at the site.

Provided CRC's and follow up nurse's overview of Good Clinical Documentation including data collection processes and data management

Performed Quality Review of subject binders for completeness and accuracy prior to reconciling CRF's with EDC

Support prioritization of project related tasks and recommend improvements to processes leading to accuracy and efficiency

ELLIGO HEALTH RESEARCH, INC, May 2019- September 2020

AUSTIN, TX

VACCINE MANAGER July 2020- September 2020

Integral part of Phase III Randomized Covid SSU team.

Instrumental in identifying pertinent study staff needed to conduct the trial.

Act as facilitator between client and CRO to ensure accuracy and timeliness of required documents.

Verify study equipment was on site and in working order, verify receipt of lab kits and all other expected supplies prior to SSU.

Train new project personnel on the protocol, study visits and data collection.

Ensure that all study delegations were assigned per scope of work and all required training was completed prior to SSU and documented appropriately.

Contribute to process development for efficient, accurate and verifiable data collection.

REGULATORY SPECIALIST, May 2019-July 2020 (Contract, Remote)

Set up of Florence e-ISF for each assigned protocol, preparation and maintenance of document core dossiers and submission to proper regulatory agencies.

Liase between PI’s, sites, CRA’s and vendors.

Complete tracking documentation.

Ensure that all personnel responsible for conducting any study related activities completed the required training.

Instrumental in identifying the need for process development and training.

Created process training documentation for Regulatory team.

Provided input and helped draft SOPs for the Regulatory Department.

CLINICAL TRIAL RECRUITER, CENTEX STUDIES, INC, March 2019-May 2019

Houston, TX

Instrumental in increasing clinical trial patient enrollment for Phase III/IV Crohn's, GERD and other GI trials utilizing recruitment tools such as StudyKik and Image Bloom, closely monitoring social media and online sources for industry trends, utilizing CTMS Crio for managing and reporting purposes.

CLINICAL TRIAL DOCUMENT SPECIALIST, LEXICON PHARMACEUTICALS, INC, July 2018-January 2019, THE WOODLANDS, TX

Review and manage e-TMF's in Veeva Vault at the site and sponsor level.

Reconcile received documents with expected document list.

Perform QC checks of clinical trial master file(s) at the site, sponsor and country level to help ensure inspection readiness (this involves becoming familiar with sponsor level documents, country level documents and the submission processes, details of documents and even translating different country documents when applicable using a document translating application)

Support the needs of Clinical Operations with skill and efficiency.

RESEARCH COORDINATOR III, LOMA LINDA UNIVERSITY HEALTH, July 2016-January 2018

LOMA LINDA, CA

Project Management; Strategically plan and implement research protocols per guidelines from study start-up to closeout.

Instrumental in determining feasibility of Industry sponsored trials in Academic setting and implementation of those trials once awarded.

Assist Rheumatology Fellows with feasibility of protocol design, local IRB submission, and implementation of protocols in the clinic setting.

Search and apply for grants/funding of Investigator Initiated Research.

Support needs of Rheumatology Division with skill and efficiency, resolve clinic workflow problems, improve operations and provide exceptional client support.

RESEARCH COORDINATOR, DM CLINICAL RESEARCH, September 2015-May 2016

TOMBALL, TX

Site feasibility assessments.

Develop recruitment strategies and study management plans with Principal Investigator and coordinate study monitoring visits with the study team.

Screen EMR’s, databases and physician referrals to identify prospective candidates for each study.

Schedule and coordinate PSV’s, SIV’s, IMV’s and COV’s.

Assist with regulatory document submissions.

Evaluate congruence of data collection tools (i.e., case report forms, electronic data capture) with the study protocol, create case report forms and other documents as needed.

Work with principal investigator and sponsors to facilitate daily trial activities and ensure compliance with research protocols.

SENIOR RESEARCH COORDINATOR, BAYLOR COLLEGE OF MEDICINE, August 2013-June 2015

HOUSTON, TX

Study Management: plan and organize research protocols from study start-up to closeout.

Assist Postdoctoral Research Fellows with writing, review, feasibility, IRB submissions, and implementation of newly approved protocols.

Participate in designing surveys used in Investigator initiated study protocols.

Prepare regulatory submissions for initial and continuing IRB approval, maintenance of FDA IDE approvals and amendments.

Instrumental in determining feasibility and implementation of Industry Sponsored trials in an academic environment. Work with Principal Investigators.to identify necessary resources to conduct the trial, develop workflow and secure adequate space in clinics to conduct study visits.

EDUCATION AND TRAINING

Bachelor of Science

Management, UNIVERSITY OF PHOENIX, January 2012

Associate of Arts

Health Services Administration, KEISER UNIVERSITY, January 1999

Associate of Science

Medical Assisting, KEISER UNIVERSITY, January 1997

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