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| Desired Industry: Biotech |
SpiderID: 18828 |
| Desired Job Location: Austin, Texas |
Date Posted: 2/7/2008 |
| Type of Position: Contractor |
Availability Date: Available now |
| Desired Wage: negotiable |
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U.S. Work Authorization: Yes |
| Job Level: Experienced with over 2 years experience |
Willing to Travel: Yes, 25-50% |
| Highest Degree Attained: Bachelors |
Willing to Relocate: No |
Objective:
12 years experience in clinical research in clinical operations, data management and training. Outstanding interpersonal skills with a track record of establishing positive relationships with clients, co-workers, and direct reports. Respected leader, effective communicator and problem solver. Ability to manage diverse personalities.
Seeking home-based, part-time (approximately 60%) contract CRA position with travel limited to Texas or to states bordering Texas. I am a 1099 contractor.
Experience:
Research Experience
PPD, Austin, TX Senior Clinical Team Manager May 2006-November 2007
Clinical Team Manager March 2005-April 2006
CTM/Sr. CTM: Managed an Expanded Access Program with 68 sites in US and Canada as part of a global study in 40 countries. The North America clinical team consisted of 8 CRAs and 1 administrative staff member. 100 percent of sites utilized local IRBs.
Assumed duties when study had been ongoing for greater then a year; was assigned to study due to reputation as CRA advocate.
Responsible for all clinical deliverables and majority of project management deliverables as PM gradually reduced hours to 0.1 FTE on study.
Responsible for identifying and resolving quality issues.
Managed payments to sites.
Oversaw execution of site monitoring, CRF retrieval and site management through detailed review of monitoring visit reports.
Tracked and analyzed regulatory document collection, enrollment rates, CRF retrieval rates and query metrics.
Presented monitoring plan training and study-specific team training to new team members.
Responsible for the coordination, management, training and development of CRAs. Approval of expense reports for proper reimbursement and time sheets.
Conducted performance evaluations for CRAs.
CTM: Managed a Phase III trial with 50 sites in the US and Canada. The project team consisted of 6 CRAs and 1 administrative staff member. Seventy-eight percent of the sites utilized local IRBs.
Accountable for achieving the final clinical deliverable within the time period specified in the contract.
Oversaw execution of site monitoring, CRF retrieval and site management through detailed review of MVRs. Tracked and analyzed regulatory document collection, enrollment rates, CRF retrieval rates and query rates. Prepared and presented therapeutic training, monitoring plan training, study-specific team training, initiation training and investigator meeting presentation.
Responsible for the coordination, management, training and development of CRAs. Approved expense reports for proper reimbursement and time sheets.
Conducted conference calls to update CRAs, Sponsor and PPD management on the status of the study.
Conducted accompanied field visits and performance evaluations for CRAs.
Line management of CRAs.
Quintiles, Inc. Clinical Team Leader 2004-2005
Senior Clinical Research Associate 2002-2005
CTL: Provided clinical research expertise, site monitor leadership and management of clinical monitoring activities for all types of clinical trials.
Responsible for the planning and delivery of the clinical component of the project in accordance with the scope of work and contracted timelines, and for managing the clinical portion of the study budget.
Monthly statistical reports.
Development of the Clinical Management plan.
CRA training.
Site management of 30 sites in US and Bermuda.
Sr. CRA (11 studies):
Responsible for monitoring clinical trials and assuring adherence to Good Clinical Practices, investigator integrity and compliance with all study procedures.
Prepared and submitted timely project deliverables such as detailed trip reports and telephone contact reports.
Performed evaluation, initiation, interim and close out visits.
Developed the Study Site Reference Manual.
Facilitated EDC (electronic data capture) training at Investigator meeting.
Responsible for database lock activities for US and South African data for study including: reviewing of multiple listings for clinical relevancy/data accuracy, phone contact with sites for clarification of data entries, interaction with data management and sponsor for resolution of discrepancies for 80 sites and 240 subjects.
Responsible for query resolution for all sites on a 49 site 740 subject trial for database closure.
Manager of Education, School of Applied Science/Quintiles University
Data Management Training Manager/Data Management Trainer,
Clinical Data Management 1999-2002
Designed and delivered training to principal investigators, sponsors, study coordinators, data managers and clinical research associates on a new technology, InForm, an electronic data capture system from PhaseForward, which utilizes web-based technology.
Managed educational programs primarily for clinical data management employees both in person and through distance learning.
Provided expertise in the creation/conversion of curriculum to Technology-Based Training (TBT) modalities.
Served on multi-disciplinary service groups/teams to contribute to the development of educational materials.
Worked with CDM managers, identified, prioritized, and documented completion of the necessary training for associates.
Data Coordination Specialist / Senior Data Coordination Analyst (Hoechst Marion Roussel) 1995 - 1999
Data Project Manager on global project with three Phase III trials running concurrently.
Responsible for all aspects of data management delivery and the integrity of the data bases in clinical trials.
Presented at Investigator Meetings regarding case report forms and data collection.
Data analyst on phase I and II trials. Responsible for case report form design and data cleaning.
Wrote database validations; coded medical adverse events; audited end-of-study data bases.
Education:
Associate of Science, Nursing
Johnson County Community College, Overland Park, KS
Bachelor of Science, Medical Record Administration
University of Kansas, College of Health Sciences and Hospital, Kansas City, KS
Completed 21 of 36 hours for Masters of Science in Community Health Administration and Wellness California College for Health Sciences, San Diego, CA
Affiliations:
Licenses and Certifications
Certified Targeted Selectionฎ Interviewer by Development Dimensions International (DDI)
Certified Clinical Research Professional (CCRP)
Registered Nurse (RN)
Registered Health Information Administrator (RHIA)
Professional Affiliations
Member, Society of Clinical Research Associates
Member, Society for Clinical Data Management
Member, Heartland Association of Research Professionals
Award
PPD CEO Performance Excellence Award for demonstration of world class service and quality
Skills:
Computer Skills
Proficient in: InForm Web-based EDC system from Phase Forward, MS Word, Excel, Power Point, Lotus Notes, Inntrax (Clinical Trial Management system), Integrated Review (database browser), InFormant (Lotus Notes based data base for Monitoring Reports); Siebel CTMS
Additional Information:
Therapeutic Experience
Circulatory: Cardiovascular morbidity and mortality
Respiratory: Asthma
Mental Disorders: Unipolar Depression, Schizophrenia
Endocrine/Metabolic: Diabetes
Immunology: Lupus Nephritis
Musculoskeletal: Osteoporosis
Oncology: Chronic Myeloid Leukemia
Other: Nausea; vaccine
Clinical Trials
Project Experience in Clinical Management:
Oncology: An open-label, multicenter, expanded access study of oral XXXX in adult patients with XXXX resistant or intolerant chronic myeloid leukemia in blast crisis, accelerated phase or chronic phase.
Immunology: A Randomized, Double-blind, Placebo controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of XXXX in Subjects with ISN/RPS 2003 Class III or IV Lupus Nephritis.
Immunology: Feasibility/Site Selection for: A Randomized, Double-blind, Placebo controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of XXXX in Subjects with ISN/RPS 2003 Class III or IV Lupus Nephritis.
Mental Disorders: Phase IV, Comparative efficacy of XXX and XXX in Achieving and Sustaining Remission in Patients with Recurrent Unipolar Depression.
Circulatory/Endocrine/Metabolic: Phase V, Evaluation of the effects of XXX and Omega-3 Fatty Acids in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose, Impaired Glucose Tolerance or Early Type 2 Diabetes Mellitus
Mental Disorders: Phase IV, A Multi-center, Open-label, Flexible-dose, Parallel-group Evaluation of the Cataractogenic Potentials of XXX and XXX in the Long-term Treatment of Patients with Schizophrenia or Schizoaffective Disorder.
Other Symptoms: Phase III, Prevention of Highly Active Antiretroviral Therapy-related Nausea and Vomiting, cannabinoid.
Infections/Parasitic Diseases: Phase I, An Open-label Study of the Safety of XXX (to treat complications of the smallpox vaccine) in Healthy, Normal Volunteers.
Other Symptoms: Phase III, Delayed Chemotherapy Induced Nausea and Vomiting, cannabinoid.
Respiratory: Phase III, Double Blind, Parallel, Multicenter Placebo Controlled Trial of Inhaled Corticoid Steroids To Reduce Oral Corticoid Steroid Use In Oral-corticoid Steroid Dependent Patients with Severe Persistent Asthma.
Endocrine/Metabolic: Phase III, Insulin treated diabetes, Insulin XXX, 26 week safety extension study.
Endocrine/Metabolic: Phase III, 26-week, Multinational, Multicenter, Controlled, Open, 1:1 Randomized, Parallel Clinical Trial Comparing XXX with Regular Human Insulin Injected Subcutaneously in Subjects with Type 2 Diabetes Mellitus Also Using NPH Insulin.
Endocrine/Metabolic: Phase III, Assess Noninferiority Between Pre- and Post-meal Administration of XXX and Pre-meal Regular Human Insulin in Subjects with Type 1 Diabetes Mellitus Receiving Insulin Glargine as the Basal Insulin Therapy.
Endocrine/Metabolic: Phase IV, Evaluation of Diabetic Retinopathy Progression in Subjects with Type 2 Diabetes Mellitus Treated with Insulin.
Musculoskeletal: Phase IIIB, A Multicenter, Randomized, Active-controlled, Single-blind, Parallel-group Comparison of XXXX 5 mg Flexible-dosing Instructions to Before-breakfast-dosing Instructions in
Postmenopausal Women with Osteoporosis.
Project Experience in Data Management:
Mental Disorders: Phase III, Schizophrenia, antipsychotic, 5HT2a inhibitor, Project Data Manager (3 phase III protocols).
Mental Disorders: Phase IIb, Schizophrenia antipsychotic, 5HT2a inhibitor,
Mental Disorders: Phase IIa, Schizophrenia antipsychotic, 5HT2a inhibitor
Mental Disorders: Phase I, Schizophrenia antipsychotic, 5HT2a inhibitor.
Endocrine/Metabolic: Phase II, Prevention of complications in Type 1 and Type 2 diabetics, aminoguanidine.
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