Clinical Writer Resume Example Company Name

CLINICAL WRITER

Summary

Over 20 years clinical research experience in medical device and pharmaceutical studies. *Proficient in Feasibility (animal and human studies) through Marketing studies in medical device. *Experienced in Phase I through Phase IV pharmaceutical studies. *Exceptional knowledge of GCP, GMP, GLP, ICH, FDA 21 CFR, ISO 14155:2011, ISO 80601-2-61:2011 MDD 93/42/EEC. *Experienced and proficient in site/investigator qualification, study/site initiation, monitoring, and closeout visits. *Experienced and proficient in writing protocols, informed consents, clinical study reports, and PMA/IDE annual reports. *Managed clinical projects in life support systems - respiratory/anesthesia and cardiovascular systems; diagnostic imaging (Molecular Imaging and Computed Tomography); ophthalmology; hypercholesterolemia; breast cancer; migraine; septic shock; euvolemic hyponatremia; hyponatremia on subjects with CHF; analgesia study on subjects that undergone total knee arthroplasty; cardiovascular surgery; and electrophysiology. *Dependable, self-motivated, self-reliant, meticulous, organized, and detail oriented. *Exceptional verbal and written communication. *Ability to work as a strong individual contributor within a team environment across multiple business segments and cross functional teams. *A quick learner with strong, diverse product knowledge and able to function as a subject matter expert.

Experience

Company NameMay 2013 to CurrentClinical Writer
City, State

Partners and collaborates with global Clinical Affairs Project Managers (CAPMs), Business Research Manager (RMs), Subject Matter Expertise (SME), Data Managers, Biostatisticians, Product Regulatory Affairs Leader, and Medical Directors to ensure compliance with GCP, ICH, FDA 21 CFR, ISO 14155:2011, ISO 80601-2-61:2011, Medical Device Directive (MDD-93-42-EEC), GEHC Clinical Affairs Human and Animal Trial Procedures (HAT), and GEHC QMS.
Collaborate with the Business Research Team to ensure efficient and timely submissions of new clinical study protocols, informed consent, and clinical study reports in the research management workflow to support New Product Introduction (NPI) and Advance Technology Development (ATD).
Participated in Investigator Meeting.
Developed and designed CRF, SIV Presentation, and form templates.
Compile clinical study protocol from overall contribution of information from the Research Team.
Write informed consent forms for the clinical study on the basis of the protocol requirements.
Compile clinical study report from the statistically analyzed data.
Assist in the design of case report forms, and writing of monitoring plan.

Company NameOctober 2010 to May 2013Sr. Clinical Research Associate
City, State

Managed investigational sites to ensure Investigators and study staff complied with the protocol, GCP, and other regulatory requirements.
Partnered with CAPM, RMs, and Medical Director to ensure research is conducted in compliance with GCP, ICH, FDA 21 CFR, ISO 14155, GEHC MACA - RMP, and GEHC Quality Management System (QMS).
Collaborated with Business Research Team to ensure efficient and timely submissions of new clinical studies in the research management workflow to support NPI.
Composed and developed CRA handbook; wrote and reviewed protocols; wrote informed consent forms; and designed CRFs, CRA report templates, logs, and forms.
Performed qualification, initiation, monitoring, and closeout visits.
Performed source data verification (SDV) of data on CRFs, data clarification, and device accountability.
Maintained regulatory documents in the Clinical History File and at the clinical site.
Collaborated with investigators, site management organizations, and clinical research coordinators.
Collaborated with MACA CRA, Medical Directors, Data Management, and Biostatisticians.

Company NameFebruary 2010 to September 2010Sr. Clinical Research Associate, Consultant
City, State

Managed Phase I clinical studies in the Clinical Pharmacology and Quantitative Sciences department of Allergan.
Met study timelines for Global Drug Development (GDD).
Performed qualification, initiation, monitoring and closeout visits.
Performed source document verification against case report forms, process queries, and drug accountability.
Maintained regulatory documents in-house and at the clinical site.
Collaborated with investigators, site management organizations, and clinical research coordinators.
Collaborated with team members and clinical data management.

Company NameSeptember 2006 to January 2010Clinical Research Consultant
City, State

Managed projects in cardiovascular surgery (heart valve repair and replacement), breast cancer, migraine, septic shock, euvolemic hyponatremia, hyponatremia on subjects with congestive heart failure (NYHA Class III/IV), and prolonged analgesia on subjects undergoing total knee arthroplasty.
Prepared Pre-market Approval Application (PMA), monthly interim reports, and other annual clinical study submissions to the FDA and other government agencies.
Collaborated with biostatisticians and data management on database design, review of clinical data, and data discrepancies/correction.
Trained and mentored junior clinical research associates.
Performed qualification/pre-study, site initiation, interim monitoring, and closeout visits at investigational sites in US and Canada.
Audited case report forms, processed adverse and serious adverse events, and processed queries for clinical studies.
Maintained regulatory documents in-house and at the sites for the clinical studies.
Prepared/designed study protocol, case report forms, report of prior investigations, investigator's brochure, and other materials required for clinical study.
Collaborated with investigators and clinical research coordinators at clinical sites.

Company NameMarch 2006 to August 2006ProjectLeader
City, State

Managed a 40 site pharmaceutical clinical study on hypercholesterolemia under the supervision of the Director of Project Management in accordance to contractual services.
Ensured that customer service, quality, timelines, and financial targets were met.
Lead and motivated cross-functional project team for assigned project.
Tracked projected milestones.
Maintained contact and reported study status to the sponsor and internally on a weekly basis.
Collaborated with other project leaders involved in the project.
Reviewed and submitted site visit reports to the sponsor in accordance to the timelines agreed upon contractually.
Managed project budget and internal/external invoicing in accordance to the contract.
Processed and approved laboratory alerts and deviation waiver requests, and visit reports.

Company NameJuly 1999 to February 2006Senior Clinical Research Specialist
City, State

Supervised and mentored junior clinical research associates.
Appeared before the Japanese MHLW for the GCP audit of an IDE clinical study that gained approval.
Managed 10 clinical studies in heart valve therapy that were under an IDE/PMA and post-market approval studies with multiple sites and long term follow-up for submission to the Japanese and Canadian Ministry of Health.
Liaison to the Principal Investigators on clinical data for manuscript publication.
Clinical project leader of a product development team for a medical device project for use in minimally invasive procedures in Heart Valve Therapy.
Prepared clinical report for PMA annual report that was submitted to the FDA and the Japanese Ministry of Health, Labor, and Welfare (MHLW); and gained approval.
Performed "mock audits" at investigational sites in preparation for a potential audit by the FDA/MHLW.
Designed a database to automate the payment process for clinical grant payments to investigative sites.
Performed pre-study/site qualification, site initiation, monitoring visits, and closeout visits at investigational sites in US and Canada.
Observed open heart surgeries, TEE, and stress test to ensure site personnel were performing the procedures according to clinical study procedures.
Collaborated with European Clinical Specialists in maintaining the clinical studies in Europe.
Collaborated with Biostatistics and Data Management on database design, review of clinical data, and data discrepancies/correction.
Prepared/designed study protocol, case report forms, informed consent forms, HIPAA Authorization forms, report of prior investigations, investigator's brochure, and other materials required for an IDE study.

Company NameJuly 1995 to July 1999Clinical Affairs Coordinator
City, State

Worked in electrophysiology and transmyocardial revascularization (TMR) clinical studies.
Designed and implemented the return kit for the return of contaminated sharp and non-sharp devices.
Developed and implemented the procedure for Return Goods Authorization System (RGA).
Processed IDE device returns and complaints with Quality Engineers.
Member and coordinator of the Safety Committee.
Processed and reported adverse device events to Regulatory Affairs.
Responsible for accountability of device inventories in house and at investigational sites.
Audited case report forms and processed queries for clinical studies.
Designed Case Report Forms and additional clinical study forms as indicated in the study protocols.
Coordinated and prepared materials for Investigator and Study Coordinator meetings.
Processed grant payments for clinical studies.
Wrote and processed Standard Operating Procedure and Engineering Change Order.

Education and Training

California State Polytechnic UniversityMarch 1997Bachelor of Science Degree: Foods and NutritionStateFoods and Nutrition

Mount San Antonio CollegeJune 1985Associate Arts Degree: Computer ScienceComputer Science

2016FDA BIMO Compliance and Enforcement of Drugs and Device

2016- Diverse Women in Clinical Trials Webinar Series - Part I: Planning for Diversity

2016- Diverse Women in Clinical Trials Webinar Series - Part II: Recruitment & Retention

2015- Presenting with Impact and Clarity

2015- Thriving in a Matrixed Organization

2014- Effective Protocol Design-Quality Risk Management

2013- Clinical Quality Assurance (FDA)

2012- Project Management at GE

2012- Project Leadership Course

2011Medical Writer Certificate-AMWA [Oct-2011] 2011 - Influencing Skills at GE

2011- CAP Coaches Workshop

2011- CITI Training

2011- GEHC MACA Leadership Skills

2010- Intro to Life Support Solutions Products

2010- Phase Forward InForm (CRA, CRC, PI)

2010- FirstDoc System

2010- IMPACT and IMPACT/Mysites

2010- MS Sharepoint

2010- ICH E6 - Good Clinical Practices (review)

2006- Project ManagementAdvanced Echocardiography

2001- OCRA, Conducting Successful Clinical Trials under GCP Regulations

2001- Association of Clinical Research Professionals Annual Meeting

2001- Writing courses thru American Medical Writers Association for Certification

2001- Conducting Successful Clinical Trials under GCP Regulations to Facilitate the Product Approval Process

2000- CE Marking Process

2000- Comprehensive Review of Intraoperative Echo & Transesophageal Echo

2000- Comprehensive Monitoring through Barnett International

1999- Heart Valve Therapy Clinical Research Training

1999- Transmyocardial Revascularization (TMR) Training

1999- Comprehensive Monitoring

1999- Good Documentation Practices under GP1012

1997- Good Clinical Practices

1997- Electrophysiology Training

1996- CE Marking Process

Certifications

Medical Writing Certificate (EW/Chore), October 2011, AMWA

Activities and Honors

Association of Clinical Research Professionals (ACRP) American Medical Writers Association (AMWA)

Publications

Johnson, A.; Lauer, C.K.; Cadogan, C. (2016) "How Did You Get Here? Stories of Bench Research, Bollywood, and Stormy Epiphanies." AMWA Journal. 31(3):118-119 PRESENTATION: Presenter, "Transitioning Intro Medical Writing for Diverse Professionals," AMWA's 75th Annual Conference: Quest toward Brilliance, September 30-October 3, 2015, San Antonio, TX Presenter, "From R&D to Clinical Trials: Medical Writing Strategies for Global Teams," AMWA's 74th Annual Conference: Shake, Rattle, and RollWrite, October 8-11, 2014, Memphis, TN

Skills

Microsoft Word, Excel, Access, Internet Explorer, Outlook, Powerpoint, and Visio

Resume Overview

School Attended

California State Polytechnic University
Mount San Antonio College

Job Titles Held:

Clinical Writer
Sr. Clinical Research Associate
Sr. Clinical Research Associate, Consultant
Clinical Research Consultant
Project Leader
Senior Clinical Research Specialist
Clinical Affairs Coordinator

Degrees

Bachelor of Science Degree : Foods and Nutrition
Associate Arts Degree : Computer Science
FDA BIMO Compliance and Enforcement of Drugs and Device
- Diverse Women in Clinical Trials Webinar Series - Part I: Planning for Diversity
- Diverse Women in Clinical Trials Webinar Series - Part II: Recruitment & Retention
- Presenting with Impact and Clarity
- Thriving in a Matrixed Organization
- Effective Protocol Design-Quality Risk Management
- Clinical Quality Assurance (FDA)
- Project Management at GE
- Project Leadership Course
Medical Writer Certificate-AMWA [Oct-2011] 2011 - Influencing Skills at GE
- CAP Coaches Workshop
- CITI Training
- GEHC MACA Leadership Skills
- Intro to Life Support Solutions Products
- Phase Forward InForm (CRA, CRC, PI)
- FirstDoc System
- IMPACT and IMPACT/Mysites
- MS Sharepoint
- ICH E6 - Good Clinical Practices (review)
- Project Management
- OCRA, Conducting Successful Clinical Trials under GCP Regulations
- Association of Clinical Research Professionals Annual Meeting
- Writing courses thru American Medical Writers Association for Certification
- Conducting Successful Clinical Trials under GCP Regulations to Facilitate the Product Approval Process
- CE Marking Process
- Comprehensive Review of Intraoperative Echo & Transesophageal Echo
- Comprehensive Monitoring through Barnett International
- Heart Valve Therapy Clinical Research Training
- Transmyocardial Revascularization (TMR) Training
- Comprehensive Monitoring
- Good Documentation Practices under GP1012
- Good Clinical Practices
- Electrophysiology Training
- CE Marking Process

Clinical Writer Resume Example

Resume Score: 90%

DISCLAIMER

Resume Overview

Create a job alert for [job role title] at [location].

Similar Resumes