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Regional Clinical Research Associate Resume Example

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REGIONAL CLINICAL RESEARCH ASSOCIATE
Professional Summary

Team-oriented Clinical Research Associate conducts site selection, site initiation, interim monitoring, and closure visits, at investigative sites. Ensures that clinical studies are conducted, data is accurately collected, and deviations from plan are reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.


Licenses

Certified Clinical Research Associate from the Academy of Clinical Research Professionals

Skill Highlights
  • Responsible for site management and performance including documentation. Site management includes all in-house and on-site monitoring for all visit types, adverse event reporting, conducting site initiation activities, investigator selection, CRF management and query resolution, study drug reconciliation, and final report and study closure activities.
  • Manages weekly site communication via telephone or email and on-site visit documentation, including trip reports, confirmation and follow-up letters and submission of expense reports.
  • Manages trial master file submissions and contents and archives communication with sites. Ensure compliance with the submission of required documents to sponsors and IRBs.
  • Performs source document verification (SDV) according to contractual requirements, assures timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP) and / or Data Management Plan (DMP).
  • Completes and submits visit reports according to SOP/WI or sponsor requirements and requiring minimal revisions.
  • Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.
  • Prepares for and attends investigator meetings as requested.
  • Maximizes return on travel time and expenses with effective use of looped visits.
Professional Experience
Regional Clinical Research Associate
May 2011 to Current
INC Research - Raleigh, North Carolina

Following an extensive internal clinical monitoring training, began interim monitoring in June of 2011, at twelve sites for a large Phase 3 Women's Health program that had completed start-up activities. Learned close-out visits while monitoring this program. During a Phase 3 AOMT study, in 2012, learned site selection visits and site initiation visits. Also monitored and closed out four sites for a pediatric study for which I was the sole U.S. monitor, in order to achieve utilization goals and relieve a Senior CRA. Performed co-monitoring and solo monitoring for a diagnostic infectious disease study which utilized paper case report forms, paper DCFs, and manual data collection. Have enthusiastically shared workload during other CRA's sabbaticals, employment turnover, and enrollment surges. Currently monitoring over twenty sites for two identical protocols within a pediatric AOMT program.

Regulatory Specialist
October 2007 to April 2011
INC Research - Raleigh, North Carolina

- Reviewed Informed Consent Forms (ICF) and Assents, to ensure compliance with Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) Guidelines.

- Performed initial review and processing of Serious Adverse Events reports; prepared and compiled clinical study reports; assisted with regulatory application preparation for IND and NDA

submissions.

- Managed the timely collection, maintenance, and distribution of study

documentation.

- Reviewed and made edits to site-specific ICFs, based on clinical trial regulations, ICH Guidelines and CRO/Sponsor SOP's.

- Performed secondary Essential Regulatory Document review necessary for release of investigational product.

- Wrote study plans for the collection, review and approval of Essential Regulatory Documents.

- Attended and presented at Sponsor meetings.

- Expert in clinical laboratory documentation review required for protocol-specific safety analysis.

- Well-versed in multiple clinical trials involving controlled substances, including narcotic pain relievers, hypnotic sleep medications, benzodiazepines, and Schedule II stimulants.

- Well-versed in Health Canada Submissions and Essential Document review, including the Quebec Multi-centric review process.

Associate Project Manager
October 2006 to October 2007
Copernicus Group IRB - Research Triangle Park, North Carolina

Provided timely and professional IRB services for 40+ clinical studies and 900+ investigative sites, within the scope of corporate SOPs and Federal Regulations/ICH Guidelines.

- Maintained strict confidentiality and accuracy of client data via Access database.

- Pre-reviewed and processed the expedited review of subject recruitment materials, revisions to Form FDA 1572, revisions to Subject Information and Consent Forms and translated materials.

- Reviewed and requested modifications to proposed advertisements and subject recruitment/retention materials to ensure clarity, subject safety, and compliance with regulations and SOPs.

- Reviewed submissions for Protocol Amendments, revised Investigator Brochures, revised Package Inserts, Serious Adverse Events, IND Safety Reports, and Continuing Review.

- Reviewed and made edits to Informed Consent Forms (ICFs) templates for sponsored research studies, based on clinical study protocol, Investigator Brochure, ICH Guidelines and CRO/Sponsor SOP's.

Clinical Liaison, Charlotte, North Carolina
March 2003 to September 2004
Publicis Touchpoint Selling Solutions, contract for Reckitt Benckiser Pharmaceuticals - Yardley, Pennsylvania

Marketed new treatment concept to psychiatry, pain management and addiction medicine specialists in four states.

- Executed special marketing projects, including exhibit planning and the facilitation of educational proposals for annual professional symposia.

- Liaised with substance abuse counselors, state controlled substance authorities and opioid treatment centers to educate the substance abuse community.

Medical Science Associate, Southeast Region
August 2000 to August 2002
Elan Pharmaceuticals - Research Triangle Park, California

Established productive, scientifically-based relationships with key Neuroscience Key Opinion Leaders (KOL's) throughout the Southeast and Mid-Atlantic states.

- Identified and prioritized sales growth initiatives with Zonegran™, a novel anti-convulsant and Diastat™, a rescue treatment for acute repetitive seizures.

- Analyzed physician practices and leveraged relationships for increased revenue and market share for District Managers in eight states.

- Managed an annual budget to cover educational programs, capstone projects, publications and independent investigator grants.

Neurology Sales Manager, Midwest
May 1999 to August 2000
Elan Pharmaceuticals - San Diego, California

- Coached and developed a regional sales network for 10 professional sales representatives.

- Planned territorial expansion and major market sales recruiting.

- Assisted marketing and product development teams with planning of effective national and regional advisory board meetings.

Neuroscience Specialty Representative
July 1997 to May 1999
Elan Pharmaceuticals - San Diego, California

Won President's Club Sales Award for 1998.

- Regional Trainer, 1997 – 1998. Conducted product and disease state training and mentored new sales representatives. Created study guides for sales representatives to augment corporate training materials for Parkinson's Disease, epilepsy and pain management.

- Completed “Coaching and Counseling” management development training.

- Attained national formulary approval for a new concept product on the Blue Cross Network.

Product Sales Representative, Cincinnati, Ohio
December 1995 to July 1997
Schwarz Pharma (acquired by UCB Pharma) - Atlanta, Georgia

- Promotion of prescription pharmaceutical products to primary care, Obstetrician-Gynecologists, Gastroenterologists, Cardiologists and Urologists.

Director of Marketing
July 1995 to December 1995
Option Care Home Infusion Pharmacy - Lexington, Kentucky

Led sales and marketing activities for a local home infusion provider to hospital discharge planners, oncologists, infectious disease specialists, orthopedic surgeons, and obstetricians.

Senior Sales Pharmaceutical Representative, Lexington, Kentucky
June 1988 to June 1995
Reed & Carnrick Pharmaceuticals (acquired by Schwarz Pharma, now UCB Pharma) - Atlanta, Georgia

Promoted prescription and over-the-counter products to primary care, gastroenterologists, cardiologists, obstetricians, and dermatologists.

Education and Training
Associate of Applied Science : Clinical Trials Research, 2006Durham Technical Community College - Durham, North Carolina, USA

Coursework included Anatomy and Physiology, Pathophysiology, Pharmacology, Clinical Research Regulations, Clinical Research Data Management, Clinical Research Monitoring, and Clinical Research Site Management

Bachelor of Science : Business Administration/Marketing Management, 1983Indiana University - Bloomington, Indiana, USA
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Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.

Resume Overview

Companies Worked For:

  • INC Research
  • Copernicus Group IRB
  • Publicis Touchpoint Selling Solutions, contract for Reckitt Benckiser Pharmaceuticals
  • Elan Pharmaceuticals
  • Schwarz Pharma (acquired by UCB Pharma)
  • Option Care Home Infusion Pharmacy
  • Reed & Carnrick Pharmaceuticals (acquired by Schwarz Pharma, now UCB Pharma)

School Attended

  • Durham Technical Community College
  • Indiana University

Job Titles Held:

  • Regional Clinical Research Associate
  • Regulatory Specialist
  • Associate Project Manager
  • Clinical Liaison, Charlotte, North Carolina
  • Medical Science Associate, Southeast Region
  • Neurology Sales Manager, Midwest
  • Neuroscience Specialty Representative
  • Product Sales Representative, Cincinnati, Ohio
  • Director of Marketing
  • Senior Sales Pharmaceutical Representative, Lexington, Kentucky

Degrees

  • Associate of Applied Science : Clinical Trials Research , 2006
    Bachelor of Science : Business Administration/Marketing Management , 1983

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