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Senior Clinical Research Associate-Regional Home Based Resume Example

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SENIOR CLINICAL RESEARCH ASSOCIATE-REGIONAL HOME BASED
Professional Summary

Personable and committed health care professional with experience as a Registered Nurse, Clinical Research Associate (CRA), and Clinical Research Coordinator (CRC). Proficient in conducting clinical research utilizing nursing and management skills gained through education and experience. Competent in research site management with extensive knowledge obtained through work as a CRA and CRC. Committed to assuring quality clinical research is being done per all applicable guidelines while remaining vigilant about the safety and well being of all study participants. Emphatic about attention to detail and accuracy of information provided. Management experience in nursing and clinical research with a leadership style based on encouragement and support. Enthusiastic Clinical Research Professional with a track record of maintaining positive relationships with Study Sponsors, Principal Investigators, Study Coordinators and other research staff members, outside vendors, and other departments within the company.

Licenses

Registered Nurse-Arkansas

Skill Highlights
  • Knowledge of ICH GCP Guidelines
  • Effective monitoring skills
  • Knowledge of essential documents and regulatory requirements
  • Attentive to detail with focus on accuracy

  • Effectively influences others
  • Critical thinking proficiency
  • Staffing management ability
  • Personal and professional integrity

Professional Experience
PPDHot Springs, ARSenior Clinical Research Associate-Regional Home Based10/2011 to Current
  • Perform assigned aspects of the clinical monitoring process in accordance with ICH GCP guidelines, and company/site SOPs to assess the safety and efficacy of investigational products and/or medical devices.
  • Conduct site visits to determine protocol and regulatory compliance, source document verification, and study staff education/training
  • Serve as the primary contact with individual investigative sites, escalating issues as needed
  • Appropriate documentation of site communications
  • Track status of required information regarding site issues, deviations, and CRFs, and work with sites toward resolution
  • Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues
  • Serve as resource person for other team members in Renal therapeutic area
  • Provide direct support to the Clinical Team Manager by assisting with managerial tasks as needed
  • Develop study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data
  • Perform Serious Adverse Event reconciliation and work with study sites to resolve discrepancies
  • Preview outstanding data reports and work with sites to ensure data collection is met per contractual guidelines
  • Assist study sites with audit preparation/responses and quality issues
  • Maintain collaborative, effective relationship with study sites
Fresenius Medical CareLittle Rock, ARTreatment Options Specialist/Home Therapies Nurse08/2009 to 09/2011
  • Provided patient/family education on treatment options available for the treatment of end stage renal disease
  • Presented information on chronic kidney disease and treatment options in public and professional settings
  • Educated patients/families on performing hemo and peritoneal dialysis in the home setting
  • Provided ongoing education and support for patients receiving dialysis at home.
PRA InternationalHot Springs, ARClinical Research Associate I-Regional Home Based09/2007 to 08/2009
  • Performed all aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of the investigational product
  • Conducted site visits to determine protocol and regulatory compliance
  • Scrutinized essential documents for completion and current information
  • Provided ongoing education to study staff and principal investigators on proper conduction of the study
  • Maintained collaborative relationships with study coordinators to assure smooth progression of the study

Health First Physicians of ArkansasHot Springs, ARClinical Research Coordinator /Diabetes Education 02/2002 to 08/2007
  • Managed numerous drug studies for a large Internal Medicine practice
  • Directed multiple studies on diabetes mellitus II (oral and injections), osteoporosis, depression and general affective disorder, hypertension with focus on subject safety and well being
  • Participated in recruitment and screening of subjects
  • Managed patient interim visits with multiple ongoing studies
  • Performed all study procedures/assessments including collection and processing of lab specimens and EKGs
  • Dispensed Investigational Product and performed IP accountability
  • Maintained all source documents and patient CFR records , paper and electronic
  • Assured all studies were conducted according to GCP, federal regulations, and study protocol
  • Conducted diabetes education classes and assisted with other aspects of diabetes education in conjunction with the Diabetes Nurse Educator

Education and Training
Bachelor of Arts:Health Care Administration2000Graceland University, Lamoni, IA, USA
Diploma in Nursing:Nursing1975Baptist Memorial Hospital School of Nursing, Memphis, TN, USA
Computer Skills

Proficient with computer skills in:

  • Word
  • Excel
  • Powerpoint
  • CTMS
  • Cascade
  • eTMF
  • Electronic Data Capture (Oracle, Medidata)
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Resume Overview

Companies Worked For:

  • PPD
  • Fresenius Medical Care
  • PRA International
  • Health First Physicians of Arkansas

School Attended

  • Graceland University
  • Baptist Memorial Hospital School of Nursing

Job Titles Held:

  • Senior Clinical Research Associate-Regional Home Based
  • Treatment Options Specialist/Home Therapies Nurse
  • Clinical Research Associate I-Regional Home Based
  • Clinical Research Coordinator /Diabetes Education

Degrees

  • Bachelor of Arts : Health Care Administration 2000
    Diploma in Nursing : Nursing 1975

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