Clinical Research Associate

ROBIN MCCOY

**** ****** **** ***, ******* NC ****4 · 919-***-****

************@*****.***

Flexible, efficient, proactive, and highly motivated. Also, able to create and re-set priorities in a fast-paced environment without sacrificing my attention to detail. I work well within a team, both in a leadership role and as a contributor. I am a confident communicator, love a challenge, and can independently create solutions to complex issues.

EXPERIENCE

JUNE 2023 -CURRENT

IN HOUSE CRA- SANOFI

LIAISES WITH INTERNAL AND EXTERNAL CUSTOMERS TO MEET PROJECT SPECIFIC GOALS INCLUDING PARTICIPATION IN SPONSOR AND PROJECT

RELATED MEETINGS

ACTS AS A LIAISON WITH CLINICAL SUPPLY/SERVICE VENDORS AND OTHER FUNCTIONAL AREA TEAM MEMBERS TO MEET PROJECT TEAM

GOALS.

IDENTIFIES, MONITORS, DOCUMENTS, AND TRACKS OUT-OF-SCOPE ACTIVITIES.

SUPPORTS CLINICAL TEAM MANAGER (CTM)/START UP LEAD (SUL) AND CLINICAL RESEARCH ASSOCIATE (CRA) IN THE MANAGEMENT

OF INVESTIGATIONAL SITES TO ENSURE COMPLIANCE WITH STUDY TIMELINES, THE TRIAL PROTOCOL, ICH/GCP AND APPLICABLE REGULATIONS.

ASSISTS WITH INVESTIGATIONAL PRODUCT ACCOUNTABILITY, SUBJECT SCREENING/ENROLLMENT, CASE REPORT FORM RETRIEVAL AND QUERY

DISTRIBUTION TO/FROM INVESTIGATIONAL SITES.

PROFICIENT IN THE DEVELOPMENT AND REVIEW OF INFORMED CONSENT FORM TEMPLATES.

MAY SERVE AS AN INDEPENDENT ESSENTIAL DOCUMENT REVIEWER AND/OR PERFORM SECOND REVIEW OF ESSENTIAL DOCUMENTS .

ASSISTS IN THE CREATION AND MAINTENANCE OF CLINICAL PROJECT DOCUMENTS INCLUDING, BUT NOT LIMITED TO CLINICAL MANAGEMENT

PLANS, MONITORING GUIDELINES, SITE OPERATIONS MANUALS, MONITORING VISIT LETTER TEMPLATES AND PROJECT START-UP PLANS

UNDER THE GUIDANCE OF THE SUL/CTM.

SUPPORTS THE CTM/SUL/CRA TO RESOLVE INTERNAL AND EXTERNAL CLINICAL ISSUES FOR CLIENT RESEARCH PROJECTS MANAGED BY PRA.

INTERACTS WITH SITE, CLIENTS, VENDORS AND PRA FUNCTIONAL AREAS AS SECONDARY PROJECT CONTACT FOR SITE ISSUES AND QUESTIONS.

SUPPORTS CTM/SUL/CRA IN THE MANAGEMENT OF CLINICAL BUDGET AND EVALUATION OF STUDY PROCESSES.

EVALUATES METRIC DATA TO IDENTIFY PROCESS IMPROVEMENTS.

ASSISTS WITH MANAGING AND TRAINING STAFF.

MANAGES TIME AND PROJECT REQUIREMENTS BASED ON STUDY CONTRACT.

SEPTEMBER 2022-JUNE 2023

IN HOUSE CRA –DOCS GLOBAL (ICON)

PERFORMS INVESTIGATOR RECRUITMENT ACTIVITIES UTILIZING PHONE SCRIPTS, QUESTIONNAIRES, STUDY SITE MATERIALS AND OTHER TOOLS FOR

USE IN EVALUATING INVESTIGATIVE SITES.

UTILIZES THE CLINICAL TRIAL MANAGEMENT SYSTEM (THE CTMS) TO ENSURE INVESTIGATOR RECRUITMENT ACTIVITIES ARE ACCURATELY

TRACKED.

PERFORMS ESSENTIAL DOCUMENT COLLECTION, REVIEW, MAINTENANCE AND CLOSE-OUT ACTIVITIES, ENSURING THAT SPONSOR AND

INVESTIGATOR OBLIGATIONS ARE BEING MET AND ARE IN COMPLIANCE WITH APPLICABLE LOCAL REGULATORY REQUIREMENTS AND ICH/GCP

GUIDELINES.

SUPPORTS INVESTIGATORS AND INVESTIGATIVE STAFF IN FULFILLING OBLIGATIONS WITH REGARD TO LOCAL SUBMISSIONS ACCORDING TO LOCAL

REGULATORY AND INSTITUTION REVIEW BOARD (IRB)/INDEPENDENT ETHICS COMMITTEE (IEC) REQUIREMENTS.

PERFORMS STUDY TRACKING VIA THE CTMS OR SPONSOR DESIGNATED SYSTEM TO ENSURE THAT THE STUDY FILES ARE CURRENT, ACCURATE

AND COMPLETE.

DOCUMENTS SITE AND SPONSOR CONTACT AND STUDY INTERACTIONS IN A TIMELY AND PROFESSIONAL MANNER.

ASSISTS WITH RESOLUTION OF INVESTIGATIONAL SITE/DATA QUERIES.

LIAISES WITH PROJECT TEAM MEMBERS REGARDING STUDY SITE ISSUES.

PROVIDES QUALITY REVIEW OF THE INFORMED CONSENT TEMPLATE.

NOVEMBER 2021-SEPTEMBER 2022

MEDICAL ADVISOR CLINICAL PROJECT ASSISTANT II –DOCS GLOBAL (ICON)

CPA TO FOLLOW SUBMISSION AND TRACKING PROCESS FOR ANY MASS COMMUNICATIONS THEY ARE TASKED WITH DISTRIBUTING TO THE SITES.CHECK IF A SHAREPOINT HAS BEEN SET UP FOR THE STUDY, SET-UP STUDY AND FOLDERS ON SHAREPOINT,MDA/MAR TO PROVIDE CPA A LIST OF POTENTIAL SITES TO COMPLETE THE NECESSARY FEASIBILITY TASKS WITHIN A TIMELY MANNER.

Generation or request of LOI/CDA

Distribution of LOI/CDA

Follow up with sites and or Sanofi legal for negotiation process

Continued tracking of LOIs until full execution

Distribution of FQs through the Zs platform

APRIL 2020-NOVEMBER 2021

Project associate-Docs global (icon)

Coordinates with the clinical project team the distribution, retrieval and review of regulatory documents required for initiation of a clinical trial.

Assures the accuracy of required clinical trial documents maintained within LSF

Throughout the clinical trial.

Generates grant payments requests, maintains tracking tool for each study and resolves payment inquiries from investigator sites.

Prepares necessary study supplies for clinical trials and processes site requests for shipping supplies, as needed. Maintenance of clinical trial tracking systems.

Maintaining technology skills to meet the challenges of the evolving electronic documentation era solved by obtaining training on systems updates. Assisting the

study teams in meeting timelines. Solved by working closely with the study team.

FEBRUARY 2019-APRIL 2020

TMF Operations specialist- syneos- Morrisville NC

Performs support tasks related to the set-up, maintenance and close out of the Trial Master File.

Process study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study specific TMF Plans. Support the set-up, maintenance, and closure of TMF repositories. Support documentation collection activities, including: o Document scanning and indexing for trial using an electronic TMF o Document filing for trials using a paper TMF Perform quality review of documents submitted for entry into the TMF and liaise with project teamsto resolve any issues identified Maintain compliance with departmental quality, performance and utilization targets Complete administrative tasks (e.g., status reports) as requested Maintain compliance with company requirements (e.g., timetracking, training) Participates in preparation/reconciliation of TMF documentation related to audits, inspections and shipments. Participates in study specific training as required. For Paper documents, responds promptly to each request received for a project document or project file, ensures timely and appropriate delivery to the requestor, and timely and accurate refiling upon return. Ensures that all applicable paperwork is completed upon release and return of each project document and/or project filefrom the Document Control Room Ensures the security and compliance of all documents related toactive and archived projects Performs other work-related duties as assigned

DECEMBER 2018 – FEBRUARY 2019

MEDICAL INFORMATION SPECIALIST-PPD Morrisville NC

PROVIDES MEDICAL AND TECHNICAL INFORMATION WITH HIGH QUALITY CUSTOMER SERVICE. DOCUMENTS INTERACTIONS ACCORDING TO CLIENT GUIDELINES. IDENTIFIES AND RECORDS ADVERSE EVENTS AND PRODUCT COMPLAINTS. PROCESSES FULFILLMENT (E.G., MAIL, FAX, E-MAIL) AND ADMINISTRATIVE RESPONSIBILITIES AS NEEDED.

PROVIDES MEDICAL AND TECHNICAL INFORMATION WITH HIGH QUALITY CUSTOMER SERVICE.

DOCUMENTS INTERACTIONS ACCORDING TO CLIENT GUIDELINES. IDENTIFIES AND RECORDS ADVERSE EVENTS AND PRODUCT COMPLAINTS.

WORKS CLOSELY WITH INTERNAL AND EXTERNAL CLIENT CONTACTS (UP TO AND INCLUDING MEMBERS OF CLIENT MANAGEMENT) TO RESOLVE COMPLEX CUSTOMER AND HCP ISSUES.

MAINTAINS KNOWLEDGE OF POLICIES AND PROCEDURES INCLUDING CLIENT PRODUCTS, SOPS,

PROTOCOLS, GCPS, AND ALL APPLICABLE REGULATORY REQUIREMENTS.

TAKE INBOUND CALLS TO DISCUSS CERTAIN ASPECTS, SIDE EFFECTS AND ELIGIBILITY FOR PHARMACEUTICALS.

WORK WITH SMALL TEAM TO ENSURE ALL INFORMATION COMMUNICATED IS CORRECT.

JANUARY 2014 – SEPTEMBER 2018

CLINICAL SYSTEMS ADMINISTRATOR CHILTERN INC. CARY NC

Provide assistance in maintenance, management and support of clinical technologies

Provide ongoing support to internal and external users of clinical systems.

Conduct duties as required by the department in accordance with international SOPs

Manage user accounts and security access levels Assist in System upgrades and UAT

OCTOBER 2008 – OCTOBER 2013

ORDER ENTRY SPECIALIST PERGO, RALEIGH, NORTH CAROLINA

Entered orders into database for various local vendors

Answered product inquiries by internal and external customers

Maintained and updated tracker with product order information

Provided administrative assistance to office staff

MAY 2008 – SEPTEMBER 2008

CLINICAL TRIAL ASSISTANT/FEASIBILITY OCKHAM DEVELOPMENT GROUP, INC., CARY, NORTH CAROLINA

Contacted sites to identify their possible interest in participating in up coming clinical trials. Collected CDAs (Confidentiality Agreements) in order to release study related information to potential sites

Sent and obtained feasibility questionnaires to sites to determine their qualifications to participate in studies of various indications

Tracked documents into database essential to creating weekly reports that ultimately decided site selection

Distributed status updates to appropriate project team members

MAY 2007 – OCTOBER 2007

INVESTIGATOR INTELLIGENCE AND SITE SERVICES ASSOCIATE PAREXEL INTERNATIONAL CORPORATION, DURHAM, NORTH CAROLINA

Distributed questionnaires/surveys to potential sites to participate in clinical trials.

Collected and recorded all responses of questionnaires/surveys into dataset.

Retrieved and tracked CDAs to initiate study information release to potential sites

Performed research function to determine site eligibility to participate in clinical trials

Generated status reports of site contacts for the purpose of Site Selection and distributed to Clinical Team

JULY 2006 – MAY 2007

STUDY START-UP ASSOCIATE PAREXEL INTERNATIONAL CORPORATION, DURHAM, NORTH CAROLINA

Assisted in the preparation, copying, and distribution of study initiation documentation including confidentiality agreements, telephone surveys, study questionnaires, checklists, template regulatory documents and contracts

Followed up with sites to collect regulatory documents and signed contracts

Assured that project tracking through CTMS was updated accurately in order to meet the project related timelines and contractual obligations

Performed general administrative duties for the assigned project team such as central files coding and submission; photocopying, scanning; and processing mass mailings

Maintained a working knowledge of applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and assured compliance with PAREXEL WSOPs

JANUARY 2006 – JULY 2006

CONTRACT DATA ASSISTANT DUKE CLINICAL RESEARCH INSTITUTE, DURHAM, NORTH CAROLINA

Generated and resolved queries from Case Report Forms

Entered data from paper forms into the project specific data entry system

Proofread data listings and other data display and compared to paper forms

SEPTEMBER 2005 – JANUARY 2006

CONTRACT DATA PROCESSOR DUKE CLINICAL RESEARCH INSTITUTE, DURHAM, NORTH CAROLINA

Conducted electronic and manual inventories of study materials

Performed data entry user testing and accurately recorded issues

Contacted sites to obtain data clarification to queries and reported back to project team

JANUARY 2001 – DECEMBER 2001

Project Associate QUINTILES, DURHAM NC

Set up and maintained project document files

Coordinated internal and external teleconferences

Arranged for catering of Project Team Meetings

Produced and distributed Monthly Financial Reports

Collected and tracked regulatory document

June 1999 – December 2000

Associate Project Supervisor QUINTILES, DURHAM NC

Collected and tracked regulatory documents

Updated daily reports and distributed to project team members

Ensured adequate telephone coverage for multiple studies

Managed a staff of ten Call Center Representative

EDUCATION

MAY 1986

High School Diploma BAYSIDE HIGH SCHOOL. BAYSIDE, NEW YORK

Some College courses

SKILLS

Proficient in MS Excel, MS Word, MS Power Point, MS Exchange, MS Access

Working knowledge of Data Entry and Query System

Comprehensive knowledge of Electronic Data Capture (EDC) system

Trial Master File

CTMS

Contact this candidate