paerkiatwork: Clinical Research: Trials Coordinated (2 of 2)

A randomized, double blind, placebo controlled, parallel group trial to assess the efficacy and safety of an anti-epileptic in the prophylaxis of migraine. 2001

A multi-center, randomized, double blind placebo controlled parallel group trial to assess the efficacy of a triptan in the acute treatment of a migraine during the mild intensity phase of an attack in patients highly disabled by migraine. 2001

A double blind, placebo controlled, two attack cross-over study to assess the efficacy of a triptan in the acute treatment for mild migraine headache. 2001

An open-label evaluation of the long-term safety of a 5HT, receptor agonist as short-term prophylactic treatment for menstrually associated migraine. 2001

A randomized, double blind, placebo controlled single, crossover study to compare effects of two medications used to treat overactive bladder and placebo on cognitive function in healthy elderly subjects. 2001

A multi-center, randomized, double-blind, parallel group, single dose, placebo controlled study of the efficacy and safety of a combination medication in subjects with acute migraine attacks. 2001

An OTC plus sinus medication vs. OTC vs. triptan in migraine headache study. 2001

A double blind, placebo-controlled study to evaluate the efficacy of Amantadine in the prevention and treatment of Influenza A. 1988

A four-year study sponsored by the National Institutes of Health on the safety and efficacy of an influenza vaccine in the form on Nose Drops in Children and Adults. 1987 –1989

A four-year study sponsored by the National Institutes of Health on the safety and efficacy of a rotavirus vaccine in children and adults. 1987 –1989

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Work Ethic

There is always an opportunity to be the best, especially when at work. The way to achieve such greatness is by always being present in the moment. We must be diligent about dressing professionally, communicating effectively, and choosing timeliness over tardiness. All assignments must be completed with quality as a guide, never losing focus of the true objective. We must carefully buffer our steps with perceptive judgment. Most importantly, we must always be open to the possibility of learning, implementing and exchanging new information and ideas with our colleagues and coworkers. No one benefits if we’re not willing to share information collectively.

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Project Manager / CRC
International Research Center

I was hired as a Senior Clinical Research Coordinator, and promoted to Project Manager after one year. I was responsible for the coordination of several trials; phase I-IV in the areas of Psychiatry (Schizophrenia & Bipolar Disorder in adults and adolescents), Neurology (Alzheimer’s & Dementia), as well as two trials for Hypertension and one for Osteoarthritis of the knee. As a coordinator I performed all required study related procedures beginning with site selection, to the initiation visit, to the visit-to-visit care of each patient/volunteer (consenting, obtaining medical histories, phlebotomy, etc.), and finally trial closeout, which included post query resolution. As a Project Manager, I supervised, educated and followed up with staff on compliance, regulatory and quality assurance directives. My principal focus was quality data management. I set the precedent for internal audits (performing random inspections of charts, drug, etc.) of all staff coordinating trials, and I was lead contact for sponsor-related audits, as well as those conducted by the FDA. I managed a newly opened clinical research unit for 5 months prior to my departure. I exceeded my goals and achieved a high level of quality as demonstrated by my strong organizational skills and my yearly evaluations. (Please select the following link to see a detailed description of my specific abilities: Skills)

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Clinical Research: Trials Coordinated (2 of 2)

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