Quality Employee For A Quality Employer

Tuesday, December 8, 2009
I am currently looking to reenter the workforce. I resigned from a clinical research position in October of 2007. During my time off I have done personal travel, read, attended lectures, volunteered, worked in my garden and enjoyed other interests that stimulated my mind, body and spirit. Now it is time to get back to work.

The best job for me is a job where I can support a company, its leadership and team with what I do best and that is working hard to accomplish goals that lead to a job well done, with the ultimate goal of contributing to a company’s success. In today’s economy it is important for everyone to realize that no job is too small, everyone matters and that all of us must work together for the greater good.

I enjoy working and do it very well. I am very thorough about looking at all aspects of the decision making process. So when I agree to a job or project, I give it my all, and then some. I have never been a fair weathered employee. All of my jobs, regardless of the challenge, have been embraced with hard work, determination, discipline, dedication and devotion.

I have a diverse employment history that can be helpful to any company, performing any job. I am not limiting myself to the medical profession, or to any one area of the healthcare field. While I have spent a great deal of time learning, defining and parlaying clinical research into a career, I am experienced in many areas in and outside of the healthcare industry. At this point in my life I am looking for a job that speaks to me, which might lead me down a new career path. I am looking for full-time employment, but would also like to be considered for part-time positions, as well as volunteer work. I will consider relocating to another state or travel abroad depending on the circumstances.

Some may consider me overqualified for some of the positions for which I am responding. However, I hope you will see a conscientious employee with strong skills, and a proven track record, applying for jobs that he can do well, and do with pride.

I have a friendly personality. I appreciate laughter. Friends, coworkers and supervisors describe me as a team player, outgoing, creative, energetic, kind, considerate, practical, confident and self-motivated. I am highly organized and able to look at situations and determine my role and responsibilities. I work at a pace that is above average. I am a big fan of constructive criticism and encourage this type of conversation, as this leads to personal growth.

You can learn more about me by accessing the links at the top of this blog. Please access my "Main Blog" to learn more about me as it pertains to my creativity, organization and character.

In closing, I hope you will see a person that has a diverse set of skills that can be helpful to anyone in need of a quality employee. You can contact me via phone at 443.739.2518 or by email at paerki@aim.com. Thank you. - paerki
Read On

Professional Experience

Friday, November 6, 2009
Project Manager / CRC
International Research Center - Towson, MD.
May 2005 to October 2007

Q/A of Source Documents and CRFs; Maintaining Regulatory Documents and Investigator Binders; Implementing laboratory compliance, procedures and setup; Transcription of CRFs (computerized and paper); Creating study forms (source documents, CRFs, logs, etc.); Monitoring Drug Accountability; Consenting subjects; Interviewing potential new employees; Attending Investigator Meetings and preparing presentations for the Clinical Research Team; Resolving Study Queries; Preparing and reviewing recruitment scripts; Performing Vital Signs, ECGs, Phlebotomy; Responsible for reporting SAEs to Sponsors and IRB; Supervision of 2 study staff; Monitoring and Tracking Enrollment; Training subjects on use of take-home diaries, dosing with study drugs, etc.During the past year, coordinated 12 clinical research trials: adult schizophrenia (7), adult bipolar (1), adolescent schizophrenia (1), adolescent bipolar (1), hypertension (1) and osteo-arthritis (1). Also trained new research staff and managed day-to-day operations of a new CRU, from May to August, 2007.

Senior Clinical Research Coordinator
Innovative Medical Research / an Advance PCS Company - Towson, MD.
July 1999 to May 2003


Q/A of Source Documents and CRFs Maintaining Regulatory Documents and Investigator Binders; Implementing laboratory compliance, procedures and setup; Transcription of CRFs (computerized and paper); Performing clinical assessments, evaluations, and testing on study patients (including cognitive testing); Creating study forms (source documents, CRFs, logs, etc.); Monitoring Drug Accountability; Consenting subjects; Interviewing potential new employees; Attending Investigator Meetings and preparing presentations for the Clinical Research Team; Resolving Study Queries; Preparing and reviewing recruitment scripts; Performing Vital Signs, ECGs, Phlebotomy; Responsible for reporting SAEs to Sponsors and IRB; Supervision of 4 study staff; Monitoring and Tracking Enrollment; Training subjects on use of take-home diaries, dosing with study drugs, etc. During the past year, coordinated 6 clinical research trials; trained new research staff; edited recruitment scripts; developed FAQs for the general public; and prepared for an internal audit. Also developed tools for time management and for tracking employee performance. Involved in meetings with investigators to determine future research studies. Number of studies completed at IMR now total 20. Promoted twice since hired by IMR. Managed all site activities as IMR prepared to close, including the review and archiving of all prior studies (greater than 100); overseeing five current trials; and handling all regulatory affairs.

Administrator
Scirex Corporation - Cockeysville, MD.
October 1998 to June 1999


Supervision of 12-employee team; managing office; developing and implementing office systems and procedures; coordination of communications between site and company headquarters in Austin, Texas; planning, implementing and tracking budget and expenses; creation and purchase of print and broadcast advertisements; interviewing and selecting laboratory and office staff; creation of forms, graphs and flow charts; conducting in-services on phlebotomy; formulating training programs for employees; reorganized staff and operations in order to gain better office and lab efficiency; created laboratory reference and policy/procedure manuals. Performed CRC functions as needed (recruitment/consenting, transcription, data entry, source document preparation, laboratory, phlebotomy, insert HepLocks for PK studies, etc.)


Laboratory Technician / Phlebotomist
Johns Hopkins Bayview Physicians/Ambulatory Care Laboratory - Baltimore, MD.
January 1996 to October 1998


Phlebotomy (adult and pediatric); performed laboratory tests; Accessioning Supervisor of five staff (as needed); reviewed laboratory results and answered client questions relating to tests and results; data entry using "HEX" system software; troubleshooting computer software problems; reviewed and maintained quality control records.


Front Desk Manager
St. Paul at Chase Condominium - Baltimore, MD.
November 1992 to December 1995


Responded to calls on a multi-line console for a 242-unit condominium tower (26 professional offices, 216 residential units); greeted and directed general public; typing correspondence; filing.


Manager
Midtown Tanning Salon - Baltimore, MD.
July 1994 to December 1995


Interviewed, hired and supervised two employees; created advertisements and marketing promotions; inventory maintenance; data entry using Breeze/Windows software; retail sales.


Laboratory Technician / Phlebotomist
Northwest Hospital Center - Baltimore, MD.
September 1989 to December 1991


Phlebotomy (adult/pediatric) in the following settings: emergency room, ICU, CCU, outpatient clinic, and routine patient floors; performed pre-admission/post OP testing in outpatient clinic; processed blood specimens and ordered laboratory tests with computer assistance.


Laboratory Technician
American Red Cross - Baltimore, MD.
June 1989 to September 1989


Processed blood specimens (coding, aliquoting and storage); reviewed, edited and entered laboratory data; maintaining Q/A records; performed reagent preparation; inventory maintenance.


Clinical Research Assistant
Johns Hopkins University, Center for Immunization Research - Baltimore, MD.
February 1986 to June 1989


Performed clinical and administrative duties for research studies; recruited, interviewed and consented volunteers for research studies; obtained medical histories, performed pre-admission testing (vital signs, ECGs, throat and nasal cultures); phlebotomy (adult/pediatric), processing and storage of blood specimens, operation of centrifuge/autoclave, maintained specimen/volunteer log books; performed laboratory tests, reagent preparation; data entry using Paradox/Lotus software; collected/analyzed laboratory data; maintenance of laboratory (sterilization of instruments, ordering supplies and equipment); assisted in protocol development, preparation of budgets and correspondence; development of forms and research study advertisements; supervision of phlebotomy team.


Clinical Assistant / Phlebotomist
Kimberly Quality Healthcare - Pasadena, MD.
June 1987 to September 1987


Project planning and development; coordinated employee/patient schedule; responsible for collecting, processing and storage of blood specimens from research participants; reviewed and edited all study data.


Assistant to Reading Coordinator / Receptionist
Essex Community College - Essex, MD.
June 1984 to December 1986


Implemented programs at college Reading Center, conducted reading placement tests; coordinated class schedules, prepared lesson plans and activity packets for students, maintained inventory of reading center study materials; typed correspondence. (Also served as receptionist for Human Development Division, responding to calls on a multi-line telephone console, communicated college course/program information to students; transcribed counseling sessions; typed correspondence, Summer 1995).

ADDITIONAL EXPERIENCE


Significant experience through on-the-job training, lectures, reading, seminars and conferences:

Management Conference
- Innovative Medical Research, Towson, MD. November 1999
Clinical Research Conference
- Innovative Medical Research, Towson, MD. November 1999
Management Conference
- SCIREX Corporation, Austin, TX. March 1999


ASSOCIATIONS / CERTIFICATIONS


Association of Clinical Research Professionals - No. 87214
American Society of Phlebotomy Technicians - No. 681023951068

CPR
American Heart Association - Expires: December 2009
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Selected Abilities

Thursday, November 5, 2009
Administrative: reviewing and editing data; writing and editing personal/business documents using Microsoft Word & Excel; performing web searches; data entry; training individuals on a variety of computer software programs/hardware devices; answering calls on a multi-line telephone console; advanced experience using a variety of office equipment; scheduling; retail sales.

Laboratory:
collecting, processing, coding, aliquoting and storage of blood specimens from research participants, as well as adult and pediatric phlebotomy in emergency rooms, ICU, CCU, outpatient clinics, and routine patient floors; collection, preparation and testing of throat and nasal cultures, pregnancy test, U/A and Urine cultures, as well as simple lab test: RPRs, Drug Screens, Cholesterol, A1C, CBCs, Glucose; IV insertion/HepLocks for PK studies; reagent preparation; data entry and analysis; maintenance of laboratory (sterilization of instruments, inventory, ordering supplies and equipment); maintenance of Q/A records; review of laboratory results and answering questions relating to tests and results
.

Clinical Research:
preparation and maintenance of regulatory documents; creating source and CRF documents, performing Q/A; transcription of CRFs (paper/database); performing clinical assessments (cognitive testing – CogFu, ADAS Cog, Mini Mental and computerized cognitive testing); evaluations and testing on research study participants (medical histories, vitals, EKGs, laboratory tests, neurological tests); lead coordinator of phase I – IV trials (beginning with the pre-site visit and ending with the closeout visit), as well as long-term storage of study documents; consenting and educating subjects on all aspects of research trials; writing recruitment scripts, FAQs, advertisements and public service announcements; documenting AEs and SAEs, as well as reporting to Investigators, Sponsors and IRB; tracking enrollment; recruitment; training individuals on take home diaries and medication usage; lead contact for internal, sponsor and FDA audits; tracking and completing queries.
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Clinical Research (Background)

Wednesday, November 4, 2009
My background in healthcare is very broad, beginning as a Clinical Research Assistant and reaching the level of Project Manager. I have managed multiple research trials, as well as people. My professional experience includes working with academic, government and medical institutions, as well as national private research firms.

My interests in research began at The Johns Hopkins University, assisting in the development of an immunization clinic. I later worked on a National Institutes of Health (NIH) - funded program at the Center for Immunization Research (CIR), coordinating phase I in-patient Influenza trials with a nasal- administered vaccine. I also worked on phase II and III drug studies. I acquired significant knowledge of regulatory procedures while working with multiple IRBs.

My focus on clinical experience and business included positions as a Laboratory Technician, Phlebotomist, and Clinical Assistant, as well as general business and sales/service opportunities, which provided valuable leadership and managerial skills.

While at The Johns Hopkins Bayview Ambulatory Care Laboratory, I began to center my career focus on research, while working on a two-month research grant, developing marketing plans and advertisements, forms and other administrative/clinical materials. I was soon hired by Scirex Corporation as an Administrator, where administrative and clinical areas coalesced, leading to an opportunity to join Innovative Medical Research (IMR) as a Senior Clinical Research Coordinator. I began by working on only one research trial, but the position soon grew to include coordination of multiple trials in several different disease areas, as well as management of the clinical research team.

A few years later I joined the International Research Center (IRC) as a Senior Clinical Research Coordinator. Shortly, after I was promoted to Project Manager. I was responsible for multiple projects (Phase I-IV). My main focus was Psychiatric Research.

I have had yearly training on HIPAA, OSHA and GCP guidelines, policies and procedures. I have served as the lead contact on 4 FDA audits and 12 internal sponsor audits, successfully responding to all inquiries.

I am a team player, recognized for superior organizations skills. I have coordinated multiple projects in a variety of different disease areas. I am a creative thinker, dependable with an energetic personality. I am successful at evaluating challenges, formulating solutions and implementing effective change.


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Clinical Research (Trials Coordinated)

Tuesday, November 3, 2009
A double blind, placebo-controlled, pilot investigation of an anti-seizure medication in the treatment of psychosis in subjects with dementia. 2005

A phase 3, randomized, double-blind, active controlled, multi-center trial to evaluate the safety and efficacy of a novel dual PPAR alpha/gamma agonist compared to a TSD in subjects with type 2 diabetes who have inadequate glycemic control. 2005

A randomized, double blind, placebo-controlled study to explore the efficacy and safety of a atypical antipsychotic, long acting intra-muscular injectible in the prevention of mood episodes in bipolar I disorder, with open-label extension. 2005

A randomized, double blind, placebo-controlled, parallel group, dose-response study to evaluate the efficacy and safety of 3 fixed doses of a novel atypical antipsychotic agent in subjects with schizophrenia. 2005

An open-label, parallel, randomized study to explore the in vitro / in vivo correlation of a novel atypical antipsychotic long-acting formulations and the comparability of two different formulations of varying particle size in subjects with schizophrenia. 2005

A randomized, double blind, placebo-controlled evaluation of the safety and efficacy of a triptan nasal spray in patients with moderate to severe migraine headache. 2002

A randomized, double blind, placebo-controlled evaluation of the safety and efficacy of a glutamate receptor antagonist in patients with mild to moderate dementia of Alzheimer’s Type. 2002

A randomized, placebo-controlled, double blind study to evaluate acetaminophen in the acute and pre-emptive treatment of headaches associated with aggrenox. 2002

A 20-week, multi-center, randomized, double-blind placebo controlled, preliminary study to evaluate the safety and efficacy of two fixed doses of a cholinesterase inhibitor in migraine prophylaxis. 2002

A randomized, double blind, placebo controlled trial to evaluate the safety and efficacy of a cholinesterase inhibitor in subjects with mild cognitive impairment (MCI) clinically at risk for development of probable Alzheimer’s disease. 2001

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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