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certified clinical research coordinator data entry qa resume example with 16 years of experience

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
  • :
Summary

Over 15 years as a multi-talented Clinical Research Professional managing Phase II-IV clinical trials in different therapeutic areas. Responsible for comprehensive project development and management. Experience also includes compliance according to ICH/GCPs and other regulatory agency guidelines. As well as dedicated experience in complying with study protocols, standard operating procedures. Practiced problem-solver with strong attention to detail. Proficient in handling patient information, laboratory samples, and compliance procedures for different clinical trials. Well-organized and hardworking with excellent communication and planning skills. Prepared to offer extensive experience in the field and take on a fast-paced position.

Therapeutic Areas

Vaccines, GI (Crohn's Disease, Ulcerative Colitis, IBS-D, IBS-C, GERD, Lactose Intolerance), Cardiovascular (Cholesterol, AFIB, HRVD), Neurology (Migraine, Parkinson's Disease), Respiratory (Asthma, COPD),

Other (Osteoarthritis, Rheumatoid Arthritis, Overactive Bladder, Insomnia), Endocrinology (Diabetes, Diabetic Neuropathy), Nephrology (CKD, Metabolic Acidosis, Dialysis).

Experience
Certified Clinical Research Coordinator/ Data Entry/ QA, 09/2012 - Current
Fresenius Medical Care Bozeman, MT,
  • Coordinated phases II-IV of clinical trials from study start up to study closure.
  • Acted as liaison between the physician and sponsor.
  • Conduct Quality Assurance and Quality Control, working under FDA, GCP, ICH Guidelines.
  • Responsible for Subject recruitment and retention, IP administration for blinded and unblinded trial.
  • Designed source documents for each clinical research study thereby optimizing the correct data is captured and study procedures are not missed.at specific subject visits.
  • Update drug accountability logs and design other drug and data collection forms as necessary.
  • Prepared for and participated in audits conducted by sponsors and other entities.
  • Provide guidance to lower level personnel involved in planning, implementation and evaluation of clinical studies.
  • Assists in training new personnel.
  • Oversee adherence to study protocol, subject evaluations, treatment administration, and collection, processing, and shipping of biological specimens.
  • Effectively met deadlines and consistently exceeded expectation for timely data collection and submission.
Clinical Operations Supervisor/ Lead Clinical Research Coordinator/ QA & QC, 03/2011 - 09/2012
Miami Clinical Research -MCR City, STATE,
  • Responsible for managing, coordinating, and ensuring overall integrity of research projects.
  • Supervised clinical studies in accordance with institutional and ICH/GCP guidelines, SOP's.
  • ICF Administration Conducted study visits in accordance with protocol requirements and assure accurate documentation.
  • Responsible for maintaining source documents and subject accountability records.
  • Maintained communications and solid working relationships with subjects and team members throughout entire trial.
  • Complete eCRF's in timely manner, analyzed study data and prepare study reports for sponsors.
  • Served as clinical liaison between sponsor and project teams to increase effective study coordination, directing research activities to ensure project milestones and corporate objectives are achieved.
  • Maintained IRB compliance and track submissions.
Clinical Operations Manager, 10/2009 - 03/2011
Suncoast Research Group, LLC City, STATE,
  • Supervised and assisted Clinical Research Coordinators.
  • Conduct Quality Assurance and Quality Control, provided support and timely follow-up for quality assurance activities.
  • Finalized IRB documentation, patient tracing sheets and protocol deviation's log.
  • Verified subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines.
Clinical Research Coordinator/Regulatory Specialist, 04/2005 - 10/2009
University Clinical Research, Inc City, STATE,
  • Assured compliance with ICH/GCP guidelines and sponsors SOP's.
  • Maintained regulatory documentation according to Essential Regulatory guidelines and TMF plan.
  • Clinical Trial Initiation, Attendance at Site Visits, subject recruitment, drug dispensation and accountability, data entry.
  • Record keeping and documentation, scheduling appointments for subjects, monitors, and auditors.
  • Assisted with Ambulatory Blood Pressure Monitor, vitals, laboratory procedures, and ECG's, pulmonary function test.
  • Attended investigator and site staff meetings to discuss ICF process, protocol review, safety issues, AE reporting.
Education and Training
: , Expected in 1994
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Betty Owen School - , New York
GPA:
Status -
: Business Administration, Expected in 1992
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La Guardia Community College - New York,
GPA:
Status -
High School Diploma: , Expected in 1990
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New York, Long Island City High School - ,
GPA:
Status -
Protocol Experience

• A 66-Week Extension to A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control
• A Phase IIb Randomized, Placebo and Active Comparator (Tolterodine) Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients with Overactive Bladder
• A Phase II Randomized, Placebo-controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adults with Autoimmune Disease
• A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Assess the Efficacy and Safety of Budesonide Foam (2MG/25ML BID for 2 Weeks, Followed by 2MG/25ML QD for 4 Weeks) Versus Placebo in Subjects with Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
• A Phase III Randomized, Double-blind, Placebo-controlled Multi-center Study of Subcutaneous Secukinumab in Pre-filled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long-Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNF Agents
• A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis
• DM199-2019-001, “A Multi-Center Open-label Investigation to Assess the Safety and Efficacy of Multiple Doses of DM199 in Patients with Chronic Kidney Disease (Stage II or III)”

Languages
  • Fluent in English and Spanish both verbal and written, open and clear communication

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Resume Overview

School Attended

  • Betty Owen School
  • La Guardia Community College
  • New York, Long Island City High School

Job Titles Held:

  • Certified Clinical Research Coordinator/ Data Entry/ QA
  • Clinical Operations Supervisor/ Lead Clinical Research Coordinator/ QA & QC
  • Clinical Operations Manager
  • Clinical Research Coordinator/Regulatory Specialist

Degrees

  • High School Diploma

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