Colleen Lyttleton

267-***-**** or 267-***-**** • Skype: 267-***-**** • addhx8@r.postjobfree.com • linkedin/in/colleenlyttleton.com

Clinical Trial Management Graduate Level Certificate gained on February 10, 2020 from Sollers College

Bachelor of Arts in Psychology from Bucknell University

Associate Degree in Applied Science in Clinical Laboratory Science from Community College of Philadelphia

PROFILE: A career minded Clinical Research Assistant well trained in GCP, ICH E6 R2, FDA CFR regulations, Sponsor/CRO SOPs and IRB approved protocols. Using both a Medical Laboratory Science background and a Risk Based Monitoring perspective thereby ensuring precise protocol endpoint adherence. Willing to relocate and available for extensive business travel.

COMPUTER SOFTWARE SKILLS

Proficient Level in:

Microsoft Office 365: Excel, PowerPoint, Word with typing speed and accuracy 60wpm

SPSS • Clinical Conductor • Oracle RDC • MasterControl • Salesforce

CORE RELEVANT CLINICAL TRIAL MANAGEMENT SKILLS

Source Data Verification • GCP and ALCOA compliance application to site level and sponsor level workflow • Administrative support for Project Management Teams • IP Management and Laboratory procedures • Protocol endpoint management • FDA regulatory compliance • QA of essential documentation • Site Budgeting/CTA • EDC/CTMS/eCRFs/eTMF • Site/sponsor level SIV, INV to SCV monitoring • Implementation of multistage clinical trial protocols in several therapeutic areas • PHR coding and abstracting • ICF and Enrollment Processing • Managing global versioning and distribution of protocol amendments and other essential documentation • Development and maintenance of relationship with key players: FDA, Site Networks, IRB/IEB, Central and Reference laboratories • Excellent written and verbal skills applied to evidence based and personalized medical presentations in a professional manner • Protocol deviation reporting

Sollers College, Edison, NJ April 25, 2019 to February 10, 2020

Clinical Trial Management Intern (Protocol Therapeutic Areas: (Oncology, Immunology, Infectious Diseases, and Neurology)

Executed risk mitigating plan and critical data guidelines along with protocol implementation oversight duties.

Conducted Source Data Verification and Source Data Reviews using Oracle RDC.

Essential documents maintained as audit and inspection ready using MasterControl.

Reconciled data errors and posed queries as per eTMF, eCRF and source data documentation (site and sponsor level).

Managed site monitoring schedule and generated site visit reports with Clinical Conductor CTMS.

Presented and created Site level Power Point training and presentations defining product development, significant key research design features and risks involving primary and secondary endpoints.

Clinical Research Fastrack, Scottsdale, AZ October 19, 2018 to February 8, 2019

Clinical Research Intern

Maintained Regulatory Binder according to audit and inspection readiness SOP.

Participated in CAPA project implementation and resolution.

Demonstrated proficiency in issuing a timely query resolution report according to protocol timelines.

Performed ICH GCP and Common Law regulatory standard ICF processes.

Demonstrated proficiency to implement Phase I, II (a and b), III (a and b) and IV phase protocols according to protocol site visit schedules.

Performed and documented manual blood pressure; ECG; venipuncture; urinalysis; pregnancy test; centrifuging; pipetting and navigated the SOPs of laboratory manual.

Family Medical Associates, Levittown, PA January 7, 2019 to February 8, 2019

Clinical Research Coordinator Student Intern (Protocol Therapeutic Areas: Allergy, Endocrine System Diseases, Digestive Diseases)

Assisted Managing CRC in oversight of 5 different protocols; Subject recruitment processes; Laboratory specimen processing and shipping; Subject screening and prescreening; Protocol QA; Overviewed site’s data management systems; Conducted subject chart reviews and informed consent processes documentation reconciliations; Implementation of subject screening and prescreening; Completion and recording of subject vital signs; Subject source documents creation; Instructed on iMedidata data entry; Participated in SQV, SIV, MV and SCV monitoring reviews.

PROFESSIONAL CERTIFICATIONS

HIPPA certified on Aug. 19, 2019 • GCP certified by CITI on Feb. 12, 2019 • IATA certified on Jan. 29, 2019 • Clinical Research Fastrack Certificate of Completion in Jan. 2019 • ICD-9 and CPT Medical Record Coding and Abstracting certified by District 1199C

PROFESSIONAL MEMBERSHIPS

Association of Clinical Research Professional

Certified in Phlebotomy/Medical Laboratory Technician with the American Society for Clinical Pathologists (Cert. #25302080)

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