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Clinical Research Nurse

Location:
Kingston, New Hampshire, United States
Posted:
August 04, 2011
Email:
e0wb49@r.postjobfree.com
Contact Info:
*********@*******.*** ***-***-****


Tammie A Kelsey

(203) ***-****

e0wb49@r.postjobfree.com

Extensive research career with recent focus on pharmacovigilance in the clinical trial and post marketing setting. Knowledge and skills in the following areas:

• Phase I, II, III, IV Studies • FDA Regulations/ICH Guidelines/GCP/HIPAA

• Pharmacovigilance Regulatory Requirements • Clinical Trial/Management

• Study Initiation/Closeout

• Clinical Study Reports/Tables/Listings

• Safety/Medical Monitoring Plans • Protocol/Study Procedures Manual

• Reports/Clinical Report Forms Monitoring

• Investigator Brochures

• FDA Audits • Quality Assurance Audits

SUMMARY OF QUALIFICATIONS

• Experienced in clinical trials, project leadership, clinical data management and pre/post marketing drug safety surveillance.

• Strong knowledge of pharmacovigilance in both the clinical trial and post marketing setting gained from 5 years of employment in the pharmaceutical industry and 10 years in the clinical research field.

• Certifications include ACRP Certified Clinical Research Coordinator (CCRC) with analytical and medical research experience.

• Significant training, continuing education and knowledge of Federal Regulations, Good Clinical Practices, ICH Guidelines and Standard Operating Procedures.

• Twenty five years of medical experience provides a strong medical foundation and a variety of transferable skills.

• Research experience includes expertise in producing, reviewing and collecting critical documents including Clinical Report Form’s (CRF/eCRF) and source documentation.

• Excellent qualifications in leadership and interpersonal communication skills. Comfortable speaking with a diverse audience.

• A team-oriented professional who works well under pressure, is goal oriented, with a commitment to patient safety and exacting research.

• Professional experience has provided exposure to: drug development process, clinical monitoring processes, collaborative opportunities, compliance, training, data collection, source documentation, validation, personnel management.

• Exercises judgment within generally defined practices and policies in selecting methods and techniques for problem solving and obtaining solutions.

• Successful interaction with sponsors, CRO’s, team members, and senior management members.

• Supervise and manage internal and external personnel to ensure timely initiation and completion of clinical studies and various clinical documents including those submitted to regulatory agencies.

PROFESSIONAL EXPERIENCE

Alexion Pharmaceuticals, Inc. 2009-Present

Pharmacovigilance Analyst/Specialist II

• Assesses events and effectively triages cases based on seriousness and expectedness.

• Responsible for providing quality documentation of safety data, particularly serious adverse events

(SAE’s), through direct contribution in a matrix environment.

• Ensures compliance with health authority regulations in all aspects of drug safety data processing

and reporting.

• Provides proactive safety surveillance across the lifecycle of Alexion products.

• Processes and assesses SAE’s from receipt to case closure in the safety database including query

generation and narrative writing.

• Conducts follow-up to complete needed adverse event (AE) information.

• Compilation of SAE Management Plan (SMP) covering SAE workflow between Clinical Research

Organization’s (CRO) and Alexion.

• Develops, reviews, and updates drug safety forms & templates for harmonization with relevant

clinical operation forms and templates (i.e. SAE data collection form and CRF).

• Collaborates with team members on the development and implementation of Pharmacovigilance

(PV) standard operating procedures (SOPs) and working processes (WPD).

• Drafts drug safety documents, including contributing to annual reports, and other periodic reports

• Oversees electronic and hard copy document management, retrieval, and archiving of PV

information including individual case summary reports to partners, CRO’s, and health authorities.

• Reviews and reconciles SAE data between clinical and safety databases.

• Interacts with clinical operations for assigned study protocols.

• Interacts regularly with medical information, regulatory affairs, commercial, and data

management groups on PV related issues.

• Remains informed of all appropriate current health authority regulations and guidance’s, including

those from ICH

• Relies on extensive experience and judgment to plan and accomplish goals.

• Acts independently to determine methods and new assignments

• Leads the continuous process improvement effort by developing, implementing, and documenting

all PV reporting conventions and training other team members and CRO’s with respect to Alexion

data collection conventions

• Drafts and performs first line review of Safety Monitoring Plan between CRO’s and Alexion.

• Contributes to the development of training courses for all study team members.

• Review Scope of Work (SOW) involving PV services from CRO’s.

Vion Pharmaceuticals, Inc.

Sr. Pharmacovigilance Coordinator 01/2007-10/2009

• Directly supported Vice President of Medical Affairs.

• Instrumental in creating Pharmacovigilance Department.

• Created and updated Pharmacovigilance standard operating procedures (SOP’s).

• Developed and reviewed all safety monitoring plans (SMP’s) and medical monitoring plans (MMP’s)

for all clinical trials.

• Assisted Clinical Affairs Department with development of clinical protocols, case report forms

(CRF’s) and informed consent forms (ICF’s).

• Received data from study sites and clinical research organizations (CRO’s) on all serious adverse

events (SAE’s) across all clinical trials conducted in both the United States and Internationally.

• Reviewed data from case report forms (CRF’s) and source documentation for medical content,

accuracy and completeness.

• Worked directly with CRO’s and clinical study sites to obtain all follow up information to complete

SAE reports.

• Obtained medical monitor assessment and notifies investigators and regulatory authorities

appropriately.

• Tracked SAE data for trends requiring changes to the investigator’s brochure (IB).

• Assisted with annual IND safety report and updates to the investigator brochure (IB).

• Performed SAE reconciliation of clinical and safety database for all clinical studies and assisted study

sites on discrepancy resolution.

Clinical Project Leader

• Provided leadership in the development of study-related documents, including study protocols, informed

consent documents and investigator files.

• Established close working relationships with physicians, their research staff and outside consultants

through excellent communications on a regular basis.

• Provided review and approval of informed consent documents, monitoring reports and clinical study

agreements.

• Participated in and conducted visits and meetings with investigational sites, physicians and consultants as

needed.

• Achieved study objectives by working with team members in setting project priorities, milestones and

resolving project conflicts.

• Tracked the collection of all study related and essential regulatory documents including site CV’s, IRB

approvals, patient enrollment forms, drug accountability forms, deviation/violation forms.

• Reviewed all study data and worked directly with study sites, monitors and CRO to reconcile all data

issues in order to facilitate study database lock.

• Reviewed all study tables and listings for accuracy and completeness for final study report.

• Co-author of Final Study Report for A Phase I Study of VNP40101M and Temozolomide In Patients with

Hematologic Malignancies.

Clinical Research Associate

• Involved in protocol design, planning, implementation and evaluation of Phase I-III

oncology clinical trials conducted in both the United States and Internationally.

• Reviewed data generated from clinical trials for completeness, accuracy and appropriateness.

• Resolved all questions immediately from investigators or CRO’s concerning issues arising in trials.

• Ensured timelines of trials while maintaining good clinical judgment and compliance with GCP,

FDA and ICH guidelines.

• Developed and implemented SOPs.

• Performed study site audits to ensured accuracy of clinical data and provide guidance to study staff.

• Reviewed regulatory documents according to ICH/GCP guidelines and 21 CFR.

• Maintained protocol timelines to achieve target objectives.

• Interacted with internal and external working groups to evaluate needs and resources for studies.

• Assisted the data management groups and the project team in the processing of all clinical data by

ensuring the timely collection of other aspects of job-related responsibilities, data and query resolution.

• Worked as an integral team member with respect to quality, integrity and timeliness of projects.

• Motivated site to reach goals. Developed successful, professional rapport with site staff.

• Essential team member on New Drug Application submitted to the FDA.

Molecular Neuroimaging/Institute for Neurodegenerative Disorders 11/2002-1/2007

Certified Clinical Research Nurse Coordinator

• Recruitment, implementation and coordination of Phase I-IV clinical trials involving Parkinson’s,

Huntington’s and Alzheimer’s Disease.

• Project lead for all Huntington Disease clinical trials.

• Project lead for all Phase I Healthy Control clinical studies.

• Determined patient eligibility performed consenting process, responsible for drug accountability.

• Performed all diagnostic procedures including procuring safety labs via venipuncture as well as gaining

intravenous access to administer study drug per manufactures instructions.

• Accurately completed CRF’s both paper and electronic through EDC. Ensured compliance with protocol

by maintaining timelines and possessing a working knowledge of regulatory practices and procedures.

• Created source documents for all clinical studies.

• Documented and reported serious adverse events to both sponsors and IRB’s.

• Developed and implement standard operating procedures for research facility.

• Maintained an enjoyable working relationship with all monitors on all clinical studies.

• Attended investigator meetings in preparation for all clinical studies.

Midstate Medical Center, Emergency Department 12/2001-1/2003

Licensed Practical Nurse

• Assessed and administered emergency care to patients with a broad range of complaints from fractured

bones, patients suffering with asthma attacks to patients experiencing chest pain.

• Skilled in administering I.V. therapy, CPR, defibrillation, physical assessments, removing sutures and

staples and performing emergency medical treatment according to hospital protocol.

• Proficient in patient documentation per hospital guidelines.

Whitney Pediatrics 11/1998-5/2000

Licensed Practical Nurse

• Responsible for the care of pediatric patients and their families.

• Duties included performing triage via telephone, assessing patients on arrival at the office, administering

immunizations and medications and performing routine hearing and vision screening.

• Additional responsibilities including drawing blood, scheduling appointments, ordering all medical

supplies, insurance referrals and keeping the day running smoothly for five physicians.

Saint Raphael Hospital 6/1998-11/1998

Licensed Practical Nurse, Certified Critical Care Nurse

• Responsible for patient care and comfort on the post-operative orthopedic floor.

• Administered pain medication, maintained I.V access, and applied post-operative orthopedic equipment.

• Performed constant evaluation of post-op patients, provided frequent updates to physicians on patient

status, documented patient status per hospital guidelines.

New Haven Ambulance Service 5/1990-5/1992

Emergency Medical Technician

• Skilled in administering life-sustaining treatment to patients in emergency situations.

• Trained to administer I.V. fluids, perform CPR, defibrillation, physical assessment and determined the

appropriate emergency treatment according to medical protocols.

• Effectively relayed patient’s condition to emergency room personnel.

CONTINUING EDUCATION

Image Solutions Inc.-Electronic Common Technical Document (eCTD) Training

Drug Information Association (DIA)-Principles of Drug Safety Surveillance

Norton Training Institute-Clinical Research Associate Training Program

Barnett International-Monitoring Clinical Drug Studies

TECHNICAL SKILLS

PC, Mac, Excel, Word, Power Point, Visio, Starting Point, Inform, Oracle, Arisg, Argus, MedDRA