Project Data

S.A. Wooten

EDUCATION

**** ********** ** *******, *******, AZ

MBA (Healthcare Management)

**** ***** ******** ******* **********, Durham, NC

BA (English Literature)

THERAPEUTIC EXPERIENCE

Gastroenterology (Irritable Bowel Syndrome, Crohn’s Disease, Opioid Induced Bowel Dysfunction)

Oncology (Bladder Cancer, Chemotherapy related anemia (Prostate and Colon)

Cardiovascular (Congestive Heart Failure)

Musculoskeletal (Rheumatoid Arthritis)

PROFESSIONAL EXPERIENCE

02/2012- current

KForce/Pfizer, Tampa FL (home-based)

Prompt Monitor (Contractor)

• Remote Monitoring for specified trials and sites

• Review inclusion/exclusion criteria for accuracy

• Review eligibility criteria

• Review and process safety data

• Notate Protocol Deviations

• Ensure dose adjustments match protocol specifications

07/2011- 02/2012

Mosley Manor PCH, Sylvania GA (home-based)

Clinical Coordinator (Contractor)

• Create meal plans and dietary restrictions based on subjects’ health charts

• Schedule and confirm medical appointments

• Create recreational charts and schedules for subjects according to state mandates

• Record changes and chart trends in behavior (physical and mental) of subjects

• Ensure proper recording of all medication administered to subjects

• Maintain records of subject care, condition, progress/problems and notate areas that require improvement

• Maintain spreadsheets and file documentation for employee mileage, fuel, and transporting of subjects

• Analyze monthly expenses for leisure activities, food, supplies, and vehicle maintenance

• Update company SOPs and handbook according to Lutheran guidelines

• Assist in preparation of quarterly audits

02/2011- 07/2011

Anchor Technical Staffing/Parexel, Durham, NC

CMA II (Contractor)

• Take responsibility for specific tasks on projects, or acts as the main CTS contact on individual projects

• Mentor and train new staff as appropriate

• Conduct country specific feasibility and/or site pre-qualification and/or or remote qualification visits and/or site selection activities

• Create country specific / site specific (if necessary) Informed Consent Form (ICF)

• Review and approve country specific ICFs

• Prepare and negotiate clinical site agreement at a site level

• Customize SRP Guidelines

• Audit electronic site files to ensure consistency with regulatory documents on site

• Collect and compile regulatory documents in collaborations with the CRA

• Conduct outbound and receive inbound calls daily

• Follow-up on appropriate site related questions

• Review and approve SRP

• Submit safety updates to IRB/IEC

06/2010- 02/2011

Aerotek/Quintiles, RTP, NC

iCRA (Contractor)

• Collect, track and review study site files and documents used to monitor interest for enrollment of investigative sites.

• Ensure compliance with protocol guidelines and requirements of regulatory agencies, including the provisions of the Anti-Kickback Statute (USA) and the False Claims Act (USA).

• Thoroughly document and track all communication (email, voice, fax, call reports) with all study site personnel and any client interaction in accordance with study plans.

• May assist in the development of site specific recruitment, retention and follow up plans / processes in line with the project strategy provided by Project Coordination Centre (PCC) Lead.

• Ensure the site is recording data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources in accordance with study plans.

• Follow established guidelines in the collection and tracking of clinical data and resolution of data queries in accordance with study plans and client preferences. Evaluate and assure quality of data collected; ensure that all data and study documents are handled consistently with the demands of regulatory agencies with respect to data protection.

• Identify problems and/or inconsistencies; monitor site and subject progress, including documentation and reporting of adverse events; recommend corrective action as appropriate; escalate to PCC Lead or line manager as appropriate

• Respond to questions on study procedures/protocol via the study hotline.

• Liaise and work in conjunction with CRAs monitoring on-site as needed. Perform on-site co-monitoring and remote monitoring activities as needed.

• Provide guidance to PCC Clinical Assistant staff as needed.

10/07 – 04/09

Covance, Princeton, NJ

Regional CRA II

• Completes project tasks associated with the CRA II role as well as the Lead CRA role

• Provides feedback to Project Managers and Line Managers regarding study timelines and CRA availability

• Completes monitoring visits to ensure the integrity of clinical data and appropriate follow up procedures, including source document verification and SAE reporting in accordance with the project plan

• Develops patient enrollment strategies with the project team and study sites

• Completes remote data review and issue site queries

• Assists in review and approval of monitoring visit reports

• Participates in site recruitment strategies

• Provides training to sites and study staff on protocol, procedures, drug accountability, and supplies.

• Completes co-monitoring visits and evaluation field visits for CRA trainees

• Review regulatory packets for new sites to ensure accuracy

• Communicate with sites regarding enrollment, patient data entry, and advertising options

01/06 - 10/07

Kendle, Cincinnati, OH

Regional CRA II

• Completes project activities associated with monitoring functions of Phase III-IV clinical research studies while developing an understanding of the drug development process, Good Clinical Practices, and relevant regulations

• Provide clinical and technical support for CRA I and administrative staff

• Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs)

• Performs clinical trial initiation, monitoring and close out activities while adhering to all applicable regulatory and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs)

• Develops and implements innovative approaches for site selection, and pre-study activities to identify and evaluate potential investigators

• Completes site evaluation and reports to Lead CRA / Project Leader as appropriate

• Completes submission of documents to the Ethics Committees, when required

• Assists with the development of study specific monitoring plan, annotated CRFs, contracts, monitoring conventions, tracking forms, and other study related documents

• Participates in study specific training

• Actively participates in the preparation and coordination of investigator meetings and attends when required

• Provides status updates of pre-study and initiation activities to Lead CRA / Project Leader

• Completes initiation visits with study staff through training, reviewing regulatory requirements, collecting, tracking, and reviewing documents, reviewing patient screening/randomization procedures, reviewing SAE reporting requirements, and reviewing drug storage and accountability procedures

• Develops patient enrollment strategies with the project team and study sites

• Ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials

06/04 – 01/06

PharmalinkFHI, RTP, NC

In-House Clinical Research Associate I

• Participates in the investigator recruitment process and performs study monitoring visits per PharmalinkFHI standard operation procedures to ensure that FDA regulations, good clinical practices, and protocol requirements are being followed at the investigative site

• Complete site file audits for assigned sites and reconcile outstanding regulatory issues

• Obtain and review documentation (regulatory) for successful implementation, monitoring, and evaluation of clinical trials; works with the sites to obtain regulatory (IRB/EC) approval of study specific documents

• Perform study initiation and close out activities, reviewing with the site personnel the protocol, regulatory issues, the study procedures and conduct training on completion of the CRF/eCRF

• Document accountability, stability and storage conditions of clinical trial materials as required by the client

• Review case report forms for completeness, clarity, legibility, conformity to available source documentation, and adherence to the protocol

• Assist in preparation of protocols, case report forms, study manuals, etc

Sr. Project Coordinator 11/02 - 06/04

• Perform project related tasks which include remote data entry, reviewing and summarizing data reports, create study files, supporting Data management in systems testing, and developing and distributing study newsletters

• Assist in Database Lock and study closeout procedures and processes

• Create and maintain initial budget, timeline, and projections throughout the study

• Develop and maintain tracking reports related to progress of studies, communicate regularly with PM and team on status of trial activities

• Present changes in scope to client as needed for modification of initial processes

• Collect, track, and maintain regulatory documents

• Participate in master file audits for database lock and client/FDA visits

• Submit regulatory documentation to sites, client, and FDA

• Generate monthly reports of study achievements, challenges, and target deliverables

• Design powerpoint presentations for custom and standard reports

• Participate in the investigator recruitment process and site selection process

• Create and maintain spreadsheets as additional tracking sources for site contracts, data transfers, IRB renewal and expiration status

• Create process guidelines and SOP’s for working practices and documentation

• Provide administrative support to projects as needed (i.e. taking minutes, tracking/posting, filing, mass faxing/mailing, scheduling)

12/01 – 11/02

Clinical Trial Services, Durham, NC

Project Coordinator

• Act as a liaison between Project Managers, Production, Quality Control, and Shipping to ensure timeliness of drug kit production and shipping. Suggest changes to production schedule to maximize efficiency

• Create shipping guidelines, assembly guidelines, and packaging diagrams for PM’s approval; coordinate label ordering, creation, revision, translation, and approval

• Complete site visits to ensure proper storage and handling of investigational product

• Coordinate ordering and shipping of study drug supplies with company vendors

• Communicate with study site coordinators on drug supply, patient status, and obtain regulatory information

• Generate monthly reports and follow-up on incomplete, inaccurate, or missing drug accountability documents

• Provide administrative support to PM as needed (i.e. taking minutes, tracking/posting, filing, mass faxing/mailing, scheduling)

05/01- 09/01

Quintiles, RTP, NC

Sr. Clinical Assistant

• Prepare and manage clinical documentation such as IRB submissions, contracts, clinical trial agreements, form 1572s, and FDFs. Responsible for collecting and obtaining any revised documents such as CVs, laboratory ranges, study site general information, etc.

• Prepare study materials for Investigator Meetings

• Coordinate and attend Investigator Meetings as necessary for study trials

• Assist CRAs with designated in-house activities (tracking database, trip reports, study site information log)

• Create files for study sites and maintain all regulatory documents in Central Clinical Study Files (CCSF)

• Complete trial specific site file audits for FDA visit

• Enter all investigator and site information into InnTrax Applications

Project Associate 06/00 - 05/01

• Assist PM and study team with activities such as database lock, study close-out, and query resolution.

• Coordinate project-related communications and correspondence

• Coordinate study close-out activities and prepare documentation to be submitted to clients

• Communicate with study sites to resolve manual queries and DCFs

• Assist PM with preparation of monthly reports (PRM and budget)

• Update and maintain changes in project timelines (staffing, deliverables, etc.)

• Review and compile patient laboratory results during study close-out procedures

• Provide administrative support to projects as needed

Accelerated Clinical Technology Associate 06/99 – 06/00

• Verification of data from patient case reports forms reviewed through a web collect system

• Perform data review of CRFs – data entry and data cleaning

• Generate queries for illegible site entries and submit to sites for resolution

• Generate weekly DCF report and distribute to study sites

• Assist in Database Locks (mock, interim, and study close-out)

• Assist in preparation of test data (tabulation order, numeric fields, AEs, Con Meds, etc.)

• Transcribe patient information from study sites onto paper case report forms to be scanned

SKILLS/TRAINING:

• Proficient in Microsoft Office Applications, Oracle Clinical, Teleform Designer Applications

• Fundamentals of Clinical Support, Fraud and Scientific Misconduct, Site Support Services, and Clinical Drug Development training

• Project Management Communication Skills (2004)

• Electronic Data Capture Systems: ClinPhone, Inspire, Inform, OCRDC, Medidata RAVE, eDiaries

• Serious Adverse Event Systems: ARGUS, ClinTrace, MedDRA

• Clinical Trial Management Systems- Inntrax Applications, Infolink, Impala, Impact Harmony, ClinPhone, PMED

Contact this candidate