Pharmaceutical Research Coordinator/Project Manager/Study Director

Profile

Pre-clinical pharmaceutical professional with experience studying the effects of toxicological, immunological, irritation and pharmacokinetic factors using in-vivo and in-vitro studies. Involved in drafting and assisting in the design of studies that focused on determining and interpolating effects of large and small molecule compounds in a pre-clinical contract research organization. Provides support to Study Directors and Scientists by creating or procuring study specific data required by FDA and regulatory agencies. Key functions have been maintaining the operational schedule for the immunology laboratory, monitoring department specific financial metrics, and assisting Study Directors with a variety of activities including, but not limited to, preparing proposal outlines, study pricing, drafting protocols and study specific amendments, and assisting the Study Director in obtaining data required by sponsors in their quest to fulfill the Investigatory New Drug (IND) submissions.

Qualifications

• Communicates and coordinates effectively with scientists, administrators, and pharmaceutical sponsored liaisons. Ability to interact with people and institutions at all levels.

• Excellent organizational skills employed in proposal and pricing creation, study scheduling, data mining and metric tracking

• Constantly seeks new ways to improve efficiencies, simplify processes, and lower costs while maintaining high quality work and products

• Key research experience areas include: immunotoxicology, pharmacokinetics, acute studies, dermal and ocular irritation studies, developmental and reproductive toxicology, and ISO 10993 series studies

Experience

MPI Research, Mattawan, Michigan April 2010 to present

Study Coordinator/Laboratory Operations (Immunology)

Worked closely with Study Directors providing support in preparation of outlines, study proposals, pricing and draft study protocols which were based on FDA, ICH and other regulatory guidelines. I also worked closely with the immunology laboratory, creating and maintaining the laboratory schedule, monitoring financial metrics, receiving reagents, reviewing data, and leading efforts to improve efficiency.

• Added QC role to position, completed annual archival of data two weeks prior to deadline

• Added operations role including laboratory scheduling, study creation in a validated system, reagent receipt, inventory, sample storage, and process improvement

• Reduced time spent maintaining the operational schedule for the immunology laboratory by 80%

• Reduced time spent on pricing immunological portions of studies, including de novo assays, sample analysis and validation by 90%, quotes sent to sponsors 2-3 days faster

• Spearheaded QA responses, literature searches, meeting coordination and website maintenance

• Key communication link between Immunology lab and Scheduling, Sales/Marketing, Study Directors, Pricing, Human Resources, IACUC, Veterinary Staff and Clinical Pathology

• Participated in a multi-departmental effort to improve costing and proposal creation

• Collaborated on and was process owner of a Lean Six Sigma team tasked to improve scheduling processes

MPI Research, Mattawan, Michigan April 2008 to April 2010

Research Associate II (Acute Toxicology)

Participated in novel compound testing focusing on irritation, maximum tolerated dose, PK/PD, ISO 10993, and other short-term studies in canine, rabbit, guinea pig and rodent species. Assisted and maintained research goals and time lines.

• Served as primary technician on over 20 studies, with duties including protocol review, equipment and food orders, planning meeting participation, study book set up, QAO response and study data review

• Administered test and control articles by many routes to laboratory species including dermal, intradermal, subcutaneous, intramuscular, intraperitoneal, oral, vaginal, intravaneous, perivaneous and ocular routes

• Collected study data using validated systems including, but not limited to, food and body weights, clinical observations, functional observational battery testing, ECG, blood pressure, and intraocular pressure data

• Irritation scoring including Draize and Beuhler dermal methods and primary eye irritation

• Blood samples collected for clinical pathology, PK/PD, and immunological testing via many routes including cardiac puncture, jugular vein, tail vein, ear vein, maxillary vein, sublingual vein, retro-orbital, saphenous vein, and cephalic vein

• Trained fellow technicians on various technical functions

• Completed all tasks in full GLP compliance

Ailurophile Cat Clinic, Lansing, Michigan April 2007 – December 2007

Veterinary Assistant

Worked interdependently with the veterinarian/owner to provide high quality, compassionate care to felines. Assisted on all major procedures and was entrusted to give much primary care with minimal supervision under the direction of the veterinarian.

• Provided assistance to clients in scheduling appointments, admitted boarders and surgery patients and followed up with owners of hospitalized patients

• Educated clients, explained medications and medical instructions, and went over estimates

• Delivered primary medical care including administration of medications, IV catheter and tracheal tube placement, surgery set-up, monitored anesthesia, vitals and IV fluids, took and developed x-rays, collected blood, fecal and urine samples, and prepared microscope slides

• Lived on-site, providing overnight care to hospitalized patients and boarders

Animal Emergency Hospital, Grand Rapids, Michigan May 2007 – April 2007

Veterinary Assistant

Assisted multiple veterinarians in a fast-paced veterinary setting, administering urgent care to critical patients in a high-pressure environment.

• Received emergency phone calls and recommended appropriate courses of action

• Delivered primary medical care to dogs, cats, rabbits, birds, snakes, and other pets including administration of medications, surgery set-up, vitals and IV fluid monitoring, x-rays, collection of blood, fecal and urine samples, sample analysis, and microscope slide preparation

Undergraduate Research

Michigan State University, East Lansing, Michigan September 2003 – August 2005

Media Interface and Network Design (MIND) Laboratory

Dr. Frank Biocca

The MIND lab focuses on behavioral and interactive research investigating how humans interact with virtual and augmented reality environments. The aim is to build intuitive and effective interfaces to improve the human ability to gather information through integration with an augmented overlay of the normal environment. My work primarily centered on conducting experiments on human subjects, collecting and preparing data for analysis, literature searches, copy editing, writing grant proposals, and managing the lab’s financial ledgers. Coordinated internationally with research experts allied with the MIND lab globally.

Education

Michigan State University, East Lansing, Michigan May 2005

B.S. Psychology with pre-medical tracking (graduated with honors)

Michigan State University, East Lansing, Michigan May 2007

B.S. Zoology

Michigan State University, East Lansing, Michigan May 2011

M.S., Pharmacology and Toxicology

Thesis topic - Controversial drugs commonly ingested during pregnancy: caffeine and aspartame

Affiliations

American Association for Laboratory Animal Science, member, 2009 to present

Kalamazoo Animal Rescue, volunteer, 2008 to present

Certifications

Laboratory Animal Technologist, American Association for Laboratory Animal Science, 2010. Certifies research facility employees responsible for management of operational groups and breeding programs. The third level of AALAS certification.

Laboratory Animal Technician, American Association for Laboratory Animal Science, 2009. Certifies research facility employees to perform animal care functions critical to the maintenance of healthy animals. The second level of AALAS certification

White Belt, Lean Six Sigma, 2010. Lean Six Sigma seeks to improve the quality of process outputs by identifying and removing the causes of defects (errors) and minimizing variability in business processes.

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