TERRI L. RHOADES

Raleigh, North Carolina ***** acvnam@r.postjobfree.com

919-***-**** www.linkedin.com/in/terrilrhoades

SUMMARY

Highly experienced scientist with noteworthy record of performance, including making substantial contributions to annual revenue increases of between $43M and $1.7B; and expertise in:

Product Lifecycle Development

Clinical Matrix Team-Building

Audit Participation

Regulatory & IND Submissions

Clinical Documents Review

Query Resolution

Safety Plan Development

MedRa WHO Dictionary Coding

Narrative Writing

Investigator Recruitment

Training & Mentorship

Vendor Management

Areas of Therapeutic Expertise:

Virology

Neurology

Oncology

Immunology

Endocrinology

Muscular Skeletal

Metabolism

Inflammation

Psychiatry

Respiratory

Gastroenterology

Radiopharmaceuticals

Technology skills include: Software: Microsoft Office (Word, Excel, PowerPoint); Databases: Oceans, Oracle Argus II, CTMS, Ramos, Coding Memo, EDC, Inform, Medidata, RAVE

CAREER HIGHLIGHTS

Played instrumental role in increasing annual revenues by $1.35B and $79M as sole Safety Scientist for Tykerb and Requip, respectively; and $43M/year increase by submitting Requip XL for Parkinson’s disease; the latter two while working with complex vendors.

On team credited with $100M/year Votrient revenue increase by delivering clinical aggregate reports.

Performed safety adverse events, reconciliations, clinical narratives, signal evaluation risk management and IND report submissions for Lamictal XR, which increased revenue of $300M/year.

Contributed IND safety aggregate reports, reconciliations, narratives, and safety data submissions in clinical report for final submission on Paxil CR, which generated $1B in annual revenue.

Achieved IND for Treximet with annual revenue of 1.12B.

Monitored pediatric clinical trials of Bristol Myers Squibb Metformin, extending patent for three years for product generating an annual revenue of $1.7B.

Compiled record of “no findings” from various agencies for all monitored clinical trial sites and regulatory audits. Created aggregate reports for all studies in clinical trials.

Achieved approval on all 38 local Investigative Review Board (IRB) informed consents for Bristol Myers Squibb pediatrics within tight deadline.

EXPERIENCE

CRO, Research Triangle Park, North Carolina July 2015- January 2016

Safety Specialist/Associate Manager

Specialist on several pharmaceutical projects for complex Phase II oncology, cardiovascular and cystic fibrosis protocols.

Trained on post marketing protocols as a quality reviewer and quality auditor.

Worked with another CRO on EDC database access and training with sponsor pharmaceutical company.

Corresponded with pharmaceutical companies over submissions of regulatory reports and critical impact on study.

GLAXOSMITHKLINE Research Triangle Park, North Carolina February 2002- November 2014

Principal Clinical Safety Scientist

Sole safety scientist for all oncology products.

Managed more than 30 compounds from drug development, preclinical, pharmacokinetics through Phase I-IV.

Served as sole safety scientist on enrollment of 3,000-6,000 patients in large Tykerb clinical trial(s); and credited with obtaining new drug applications (NDAs) for it, as well as for: Paxil CR, Arannon, Votrient, Lamictal XR, Requip for restless leg syndrome, and Requip XL for Parkinson’s disease.

Given multiple products and therapeutic areas from preclinical, pharmacokinetics, Phase I-IV; and produced and implemented safety data for investigational new drug (IND) study, periodic safety update, (PSUR), and end of study reports narrative writing and NDA submissions.

Collected and analyzed clinical trial safety data, including working with: multiple vendors on lifecycle phases from II-III for Requip; and complex sharing agreements of study responsibilities for Requip XL.

Investigated and located Federal Drug Administration (FDA) written agreement to submit reports on listed events for Requip that required notification to hundreds of global sites.

Evaluated precursor to Inform database, Remote Data Access, for Paxil CR studies and reconciliations.

Created and presented PowerPoint slides on safety information at more than 25 investigator meetings, each with 400-800 physicians and nurses, who were going to be running the trials, in attendance.

Performed regulatory and IND query searches for regulators and medical monitors producing aggregate reports for submission.

Reviewed and approved clinical developmental plans (CDPs), risk management plans, adjudication board charters, pharmacovigilance plans (PVPs), serious adverse event (SAE) forms, protocols, laboratory reference manuals, and investigator brochures for compliance on safety information.

Created clinical narrative of SAEs and reviewed and approved others’ narratives for final submission.

Generated over 25 clinical trial final reconciliations and globally unblinded data; and trained others to do so.

Provided and supported information to clinical and contract research personnel dealing with safety.

Processed SAEs and pregnancy, IND’s, litigation and literature reports; and entered them into Ocean/Argus database within timelines specified by FDA and worldwide regulatory authorities.

Applied knowledge of coded federal regulations (CFRs) to safety reporting based on and international committee of harmonization (ICH) guidelines using MedRA WHO dictionary coding.

Produced over 22 IND reports in one day for Tykerb, along with other assigned oncology products.

Met different worldwide reporting timelines for entering safety data into database for 30 plus assigned products.

Performed reconciliations on National Cancer Institute’s old clinical trial data, resulting in an NDA.

Assisted team members on IND submissions, data entry, and narratives aggregate reports within tight reporting timelines.

Expert in post marketing, consumer health, and medical devices for all GSK products and all therapeutic areas.

Identified, investigated, and reported on call center employees’ lack of training on change in reporting issued in corrective and preventive plan action (CAPA) based on regulatory audit and six years overdue.

Acted as a liaison to Brazil site by assisting with safety issues and database queries.

Worked with 100 SDE (licensing agreement) partners to clarify post-marketing reports.

Signal evaluation risk management on early clinical projects.

Sole safety scientist for epilepsy, pain, neuropathy, central nervous system, depression, arthritis and every oncology product.

Responsible for training CRA’s and sending them to sites for issues with SAE’s in clinical trials.

Controlled release of payments to sites that experienced SAE’s depending on resolution of events.

Performed more than 800 reconciliations in multiple therapeutic areas.

PHARMANET, INC., Cary, North Carolina October 2000- January 2002

Clinical Research Associate II

Monitored clinical trial studies, including site selection and initiation, interim monitoring, final closeout and drug closeout visits for multiple sponsors in therapeutic areas of virology, immunology, dermatology, cardiovascular events central nervous system and metabolic.

Completed monitoring of 15 sites on a Phase IIIB randomized double-blind clinical trial for Bristol Myers Squibb diabetes drug.

Designed monitoring conventions for a Takeda diabetes clinical trial.

Created study team tools for and monitored clinical trial of ankylosing spondylitis, contributing to Embrel receiving its related NDA.

Ensured adherence to protocol during monitoring visits, including: reporting violations to sponsors and resolving them in collaboration with medical monitor; and resolving case report form (CRF) discrepancies and other issues.

Performed drug accountability, return, and destruction, as well as regulatory binder audit.

Served as independent drug auditor for dermatology study cardiovascular study and ophthalmology.

Presented CRF’s at investigator meeting for ankylosing spondylitis.

PHARMACEUTICAL PRODUCT DEVELOPMENT (PPD RTP, NC August 1999-September 2000

Clinical Research Associate

Reviewed and approved over 38 local independent review board (IRB) informed consents in rescued pediatric clinical trial dealing with sponsors and legal for approval.

Monitored three Phase II-III rescued pediatric diabetes clinical trials for Bristol Myers Squibb for site selection, initiation, interim and closeout visits.

Monitored assigned sites for a Bristol Myers Squibb protocol on tight timelines of Phase II/III and helping to get Metformin NDA approved for pediatrics; and completed all closeout visits.

Coordinated regulatory training of employees from quality assurance.

Designed drug inventory spreadsheet for sponsor, which ensured all orders were submitted prior to its holiday shut down and resulted in considerable savings of both time and money.

Performed all site selection, initiation, interim monitoring, and closeout visits, and trained new clinical research associates (CRAs) in diabetes, immunology and virology studies.

Created table for screening blood glucose informed consents and documented 400+ screening consents for sponsor, Bristol Myers Squibb, in pediatric clinical trial for patent extension within tight deadlines.

Resolved case report forms discrepancies and protocol violations at site visit.

Monitored and unblinded all pediatric patients within 48 hrs of FDA approval of Metformin patent extension.

Collaborated with medical monitor to have pediatric patient experiencing suicidal ideation during the holidays and was seen by nutritionist. FDA later stated to the medical monitor how impressed he was by the diligence contact of the subject during weeks 8 through 12 study visits.

Trained and mentored new employees, taking them along on site visits and demonstrating auditing of files for completeness at PPD and the investigator site.

Monitored Phase IIIB Type 2 Diabetes randomized double-blind adult clinical trial for Takeda medical device study.

Therapeutic areas involved 3-4 plus central nervous system and cardiovascular AE/SAEs.

PHARMARESEARCH CORP., Morrisville, North Carolina May 1998- August1999

Clinical Research Associate

Performed site selection, initiation visits, interim visits and monitored nine sites in two pivotal Phase II and Phase III salvage protocols for HIV that contained 4 plus cardiovascular events, oncology events, ophthalmology events and 4 plus central nervous system events.

Monitored nine sites with two protocols in Phase II and Phase III HIV clinical trial with Grade 3 and Grade 4 adverse events for central nervous system symptoms.

Audited completed two-year Bristol Myers Squibb HIV study prior to FDA submission.

Participated in recruiting of 4,000 investigators for HIV study involving multiple countries.

Monitored hepatitis study and HIV study for Gilead for adefovir dipivoxil.

Monitored clinical trials, including study selection, study initiation, interim, closeout visits, drug accountability or drug destruction per SOPs in foreign country.

Collaborated with sponsor’s medical monitor to resolve protocol violations at site visit.

Clarified serious adverse events at site and provided additional information to sponsor

Monitored hepatitis study, infectious disease study with many serious adverse events.

EDUCATION / LICENSES & CERTIFICATIONS / ASSOCIATIONS

RADFORD UNIVERSITY, Radford, Virginia – Bachelor of Science in Biology with Chemistry Minor

REX HOSPITAL SCHOOL OF MEDICAL TECHNOLOGY, Raleigh, North Carolina

Earned Medical Technologist (MT) and Clinical Laboratory Scientist (CLS) certifications.

Completed Medical Technology Program Internship

WAKE COUNTY TECHNICAL COLLEGE, Raleigh, North Carolina

Completed Clinical Laboratory Assistant program

Passed higher Medical Laboratory Technician certification test due to having BS degree.

Reg. Medical Technologist (CLS; License # Available Upon Request), National Crediting Agency (NCA)

Reg. Medical Laboratory Technician (MLT; 014546), American Society for Clinical Pathology (ASCP)

Certified Clinical Research Associate (CCRA), American Crediting for Research Professionals (ACRP)

Association of Clinical Research Professionals (ACRP) Drug Information Association (DIA)

American Society for Clinical Pathology (ASCP) National Crediting Agency (NCA)

American Society of Medical Technologists (ASMT)

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