Manager Project
Resume:
LENORA HAYES
ac6zx2@r.postjobfree.com
SUMMARY
Experienced Clinical Trial Assistant. Assist regulatory services with regulatory guidelines and procedures; perform essential document collection, review, maintenance and close-out activities, enter and abstract data. Ensure that sponsor and investigator obligations are being met and are in compliance with the local regulatory requirements and with ICH/GCP guidelines. Trial Master File (TMF) Manager; setup TMF; perform QC checks, and perform FDA audits. Strong sense of urgency, with attention to detail. Demonstrate ability to work in a fast paced deadline driven environment. Excellent interpersonal skills when dealing with internal and external clients; excellent customer service skills; as well as excellent written skills. Work well independently as well as in a team environment.
CAREER HISTORY
From 3/2017 – present Independent Contractor/Auditor (part-time)
Quiktrak, Oregon
Responsibilities include: contacting businesses and scheduling inspections within given timeframe; travelling varying distances to conduct inspections utilizing Revoquest software to enter data to complete reports; identifying equipment, locating serial numbers and documenting any damage; photographing equipment, the business and any serial numbers; interviewing the business contact individual following the inspection; submitting completed reports within given timeframe.
From 4/2016 – 11/2016 Outreach Coordinator/Patient Recruitment(contract)
Wake Research Associates – Raleigh, NC
Assist research site with patient recruitment to identify potential study candidates from a media campaign. As Enrollment Assistant / Outreach Coordinator travel to medical facilities and other specified areas of region to communicate with individuals regarding the studies and provide them study research information through flyers and brochures. Communicate effectively and professionally to corporate offices to obtain permission to allow distribution of recruiting materials. Use laptop to enter potential patient data into patient portal and download data collected. Participate in research study protocol training. Follow-up on potential patients via phone call who have expressed an interest in the study as well as administrative responsibilities. Create Patient Recruitment Questionnaires.
From 1/2015 to 12/2015 TMF Manager
Chiltern International – Cary, NC
QUALIFICATIONS & TRAINING
As Trial Master File Manager; setup up the TMF according to client specific document list; serve as a point of contact for the Study Team and Project Managers; follow the company training instructions and reference documents for accurate filing of trial documents into the company Trial Master File; serve as a key user and expert for electronic master file system; track filing activities and ensure quality, checking results using the company standards and SOPS; actively identify problems and make improvements; review metrics with Manger to ensure deliverables are being met; serve as a liaison with study teams; serve as a point of contact for external and internal audits; ensure that regulatory documents were setup and maintained according to regulatory requirements.
Key areas of Responsibility
Prepare for internal and sponsor audits.
Scan and set up the paper General Files, and Centre Specific Files.
Perform QC checks of docs, and transfers paper and electronic Sponsor Files.
Meticulous attention to detail, reviewing regulatory documents such as Investigator Brochure, Financial Disclosure Forms, PI credentials, and lab credentials.
Track filing activities, follow the company training, instructions, and reference documents for accurate filing of trial documents into the company Trial Master File.
Good interpersonal and communication skills when dealing with internal and external clients and providers.
From 4/ 2013 – 3/ 2014: Medical Recruiter (remotely)
L & E Research, Raleigh, NC
QUALIFICATIONS & TRAINING
Recruit qualified candidate using data in the database in order to meet criteria for specific client focus groups. Scope of recruiting could include off site locations nationally. Determine qualified or not qualified candidates for the group based on client screening instrument.
Key areas of Responsibility
Call patients, medical doctors and other type of recruits to explain the study and see if they are interested in discussing their health issues.
Update the Facilities Manager Plus database for any changes.
End of day communications to project managers about project status.
Attend training meeting and monthly recruiter meetings at base office.
Act as a team member to achieve the team goals and team responsibilities.
From 10/ 2011 – 1/ 2012: Clinical Research Coordinator (contractor)
Becton Dickinson, Durham, NC
QUALIFICATIONS & TRAINING
Perform administrative responsibilities for the clinical team. Perform quality control checks of filed documents according to the company SOPs. Ship clinical supplies to appropriate sites; review and track receipt of clinical supplies. Assist Data Coordinators with entering data and data management.
Key areas of Responsibility:
Served as the key team member for receiving all site documents from the CRAs and assisting the entire research project team as a whole.
Verifying PI credentials and lab directors credentials.
Maintain project files and tracked them into a database.
Establish tracking procedures for projects while under minimal direction of supervisor; maintained and updated project tracking tools, metrics, and computer databases.
Attend teleconferences and meetings when necessary and take minutes.
Print and archive all memos and documents, and project related correspondence.
Compile, review, and track protocol deviation logs, including return of completed forms to clinical trial study site, review documents to verify the credentials of PIs by reviewing their CVs.
Perform quality control functions under the direction of the CTM or TMF as required and ensure necessary corrections are made.
Perform audit of study files and data management files and listings reviews to make sure they were in compliant with FDA guidelines.
Enter, update, abstract, and maintain data into a computerized system.
Archive data electronically and hard copy.
Track all regulatory documents such as: 1572, ICFs, financial disclosure forms, PI certifications such as licenses, CVs, in database.
Communicate with the study coordinators and monitors to ensure that supplies have been shipped.
Fax and electronically routed incoming scanned correspondence.
From 10/ 2010 – 12/ 2010: Regulatory Associate (contractor)
GlaxoSmithKline, RTP
QUALIFICATIONS & TRAINING
Work with Regulatory Services, prepare regulatory documents using varied information sources to ensure they were in compliant to guidelines. Edit technical documentation using supporting data processing technology.
Key areas of Responsibility:
Review safety documents to ensure they were in compliant with safety guidelines.
Assist in the authoring of company Material Safety Data Sheets, abstract and updating data into a database.
Conduct reviews of writing for understanding and logic. Liaise closely with other company personnel to ensure accuracy of such records.
From 5/ 2008 – July 2009: Site Identification Specialist (contractor)
Quintiles, Durham, NC
QUALIFICATIONS & TRAINING
Utilize historic site performance metrics, site relationships, feasibility data, and other sources to identify clinical sites. Submit investigators for quality assurance check as required by looking verifying the credentials of PIs who were being considering for participating in studies. Track all project activities in InnTrax, QSIMS, and Informatics for accurate filing of trial documents into the company Trial Master File.
Key areas of Responsibility:
Screen telephone calls, recorded and routed messages; answer routine questions.
Report on project progress to Clinical Team Leads, Project
Managers, Site Start-up, and Department Management.
Act as a team member to achieve the team goals and team responsibilities.
From 9/2007 – May 2008: Project Assistant
E-Merge, Durham, NC
QUALIFICATIONS & TRAINING
Maintain documentation as defined by company SOPs and guidelines. Develop and maintained study specific documentation. Issue site personnel system access to study electronically in compliance with 21 CRF Part 11 guidelines.
Key areas of Responsibility:
Ensure all customer contact is carried out in a high level of professionalism in order to develop and maintain good working relationships with each customer.
Fax, copy print forms and documents.
Work directly with Project Group Managers to provide support to the team.
Perform other administrative duties as assigned.
From 2/ 2006 – June 2007: Clinical Trial Assistant
RTI Health Solutions, Durham, NC
QUALIFICATIONS & TRAINING
Perform administrative responsibilities for the team. Review regulatory documents; prepare and send out regulatory binders to the sites; compiled documents for review to the IRB. Primarily responsible for maintaining TMF, perform quality control of clinical TMF, and ensure necessary corrections are made. Perform weekly contact with study coordinators on status of their subjects. Maintain central files; performed QC checks of file docs according to company standards and SOPs. Act as a team member to achieve the team goals and team responsibilities.
Key areas of Responsibility:
Prepare and reviewed regulatory documents; track site and subject information into a database.
Review and verify PI credentials and Lab Directors credentials.
Supervise work study student.
Made travel arrangements for Directors and other team members.
Setup and arranged food delivery for meetings, working with catering.
Arrange agenda for the Director.
Use Microsoft Outlook and Microsoft Office.
Reserve and setup conference rooms for meetings and take minutes.
Handling internal and external mail; including FedEx.
Assist in developing forms to be used in the study; working with the printers to have forms printed.
Manage database entering and abstracting data for tracking subjects’ progress in the study.
Research and verify PI participants to ensure they were qualified and if they had been debarred.
Perform inventory of supplies to be sent to study sites.
Receive and inspected incoming supplies.
Answer the 1-800 calls on the Helpline for the project, ensured all customer contact is carried out in a high level of professionalism in order to develop and maintain good working relationships with each customer.
Handle a large volume of phone calls and determining their priority.
Act as a key member for electronic master file system.
Assist with financial follow-up of the sites, making site payments.
Work with IVRS administrators on tracking subjects and entering data.
From 10/ 2004 – December 2004: Clinical Support Specialist (contractor)
GlaxoSmithKline, RTP, NC
QUALIFICATIONS & TRAINING
Provide support to team and Project Group Manager. Assist as a backup for several studies entering subject data into spreadsheet, preparing study material for shipment to site. Fax and sent mass mailings of site documents.
Key areas of Responsibility:
Screen telephone calls, recorded and routed messages, answered routine questions.
Follow the company training instructions and reference documents for accurate filing of trial documents into the company Trial Master File.
SPECIAL QUALIFICATIONS & TRAINING
Real-estate Broker Pre-licensing Durham Technical
Medical Coding Durham Technical
ICH-GCP Training RTI
Medical Terminology Continuing Education UNC-Chapel Hill
Communication Skills Durham Technical
Courses in Microcomputers Continuing Education Durham Technical
ADDITIONAL SKILLS
Microsoft Office, Microsoft Outlook, MS Excel, Access, and Power Point.
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