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Clinical Research Nurse

Kingston, New Hampshire, United States
August 04, 2011
Contact Info:

Tammie A Kelsey

(203) ***-****

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


• 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.


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


• 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


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


• 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.


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


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