Project Data Manager in Clinical Research

Laboratory Professional and Data Manager

L. Paige Preece

**** ******* *****, **** **** City, UT 84108 801-***-**** abtst2@r.postjobfree.com

Direction and oversight of multiple study projects. Critical eye for quality and data discrepancies throughout study period.

Strategic thinker, able to adapt and adept at multi tasking. Quality and detail oriented to provide accurate results.

Dedicated to cultivating and maintaining professional relationships within the department and with customers, no matter

their location in the world. Attention to Quality Control is a trademark of my experience and is a necessity in my current

position.

• Experienced in Customer Relationship Management

• Experienced Employee Relationship Management

• Recognized for meeting difficult deadlines

• Will work hard for customers inside and outside of company

• Function well in multitasking environment

• Quality results oriented

• Proficient in Microsoft Office Suite programs, Oracle Clinical, Ancestry.com, Family Tree Maker, Ancestral

Quest

Education and Certification

Bachelor of Science in Sociology Utah State University, Logan, UT

Graduation Date: December 1991

Didactic Paramedic Course Hillsborough Community College, Tampa, FL

December 1993 August 1994; GPA: 4.0

Emergency Medical Technician Certificate Hillsborough Community College, Tampa, FL

August 1993; GPA 4.0

Society of Clinical Research Associates, Certified Clinical Research Professional (CCRP), Test Score:

94%

Professional Experience

05/2007 – Present, Clinical Research Data Manager

Clinical Research, Watson Laboratories

Salt Lake City, UT

Oversee clinical data projects from CRF creation, database creation, data validation plan, discrepancy management, and

data cleaning for presentation to Biostatistics. Responsibilities include utilization of Oracle Clinical computer program to

create study databases, create data validation logic plans and program them into Oracle. Perform database logic checks.

Perform Quality Control measures in the handling of study site discrepancies. Closing out those discrepancies to ensure

data has been corrected. This involves extensive and effective communication with customers within the company,

research sites, and other vendors. Work with cross functional team from beginning of a study protocol, through to

completion. This position also involves the continuous study and integration of new programming and data collection

skills.

01/2007 05/2007 – Research Associate

Alzheimer’s Research, Intermountain Healthcare

Salt Lake City, UT

Responsibilities include working directly with the principal investigator in developing and getting an Alzheimer’s Trial

started and functioning. Duties included making contacts with various Assisted Care Centers to present our program.

Working with potential study subjects in discussing the upcoming protocol, working with the Intermountain Institutional

Review Board to make sure all proper protocols were followed. Responsible for coordinating the services (ie physical

therapy, transportation to study site) for study subjects to participate in research protocol. Worked with subjects and their

families.

02/2005 – 01/2007 Study Coordinator 2

Clinical Trials, Huntsman Cancer Institute

University of Utah

Salt Lake City, UT

Job responsibilities included coordinating various studies for Gynecological and Neurological Oncological protocols. I

acted as a liaison between the pharmaceutical companies or sponsored groups and our regulatory department during the

study preparation process to be in compliance. It also includes interaction with the various Attending physician

investigators. I provide information and proper informed consent for the patients. I schedule protocol appropriate tests,

scans, infusions, office visits, specimen collection for the patients. It is also my responsibility to keep in contact with my

patients for proper monitoring. I also oversaw all of long term follow up for Southwest Oncology Group Trials. I was

involved with networking with other Institute and Hospital departments to facilitate the particular protocol requirements. I

have also prepared for major sponsored group audits, such as the Gynecological Oncology Group (GOG) 3 year Audit.

Participate in the Gyn Oncology and Neuri Oncology Tumor Case Presentation Boards.

10/2004 02/2005 Study Coordinator 1

Clinical Trials, Huntsman Cancer Institute

University of Utah

Salt Lake City, UT

Job responsibilities include coordinating various studies for Breast Cancer and Sarcoma. This included interaction and

coordination with the Attending physician, patient and industrial or organizational study trials. Interaction with the patient

includes guiding them correctly through the protocol by scheduling tests (CT Scans, Office visits, Lab specimen collection,

Pathology specimen collection, ensuring adequate supplies of study medications and helping set up infusion

appointments, etc.) Responsibilities also included obtaining proper informed consent, data collection, management of

case report forms, assist in study site visits and ensuring that Adverse Events and Serious Adverse Events paperwork

were sent to the appropriate IRB, company, or group.

9/2001 10/2004 Assistant in Research Faculty

Department of Anesthesiology

University of South Florida

Tampa, FL

I worked with the Critical Care Clerkship during the medical students 4th year. I provided a once a week didactic simulator

session for the entire class and worked with the students on a one to one basis covering various medical and traumatic

patient emergencies in preparation for the course practical final examination. I created and helped administer the

scenarios for this final practical. I have developed a competence in running the existing scenarios and building new ones

as needed to enhance the experience and challenge the students. I assisted in the operation, maintenance and repair of

the METI Human Patient Simulator at The Tampa General Hospital (TGH) and the University of South Florida (USF).

Additionally, I was a certified ACLS Instructor and oversaw the administrative functions and operation of a "Teaching

Center" for the American Heart Association. In conjunction with a colleague, we taught courses to 4th year medical

students, as well as, labor and delivery nurses. I have enjoyed the collaborative experience with the USF College of

Nursing to provide patient simulator experiences for graduate nursing students. Also, I taught a basic airway management

course for 2nd year medical students at the request the Department of Infectious Disease. Other duties included

conducting funded research protocols and

working in the ICU's, OR's and Labor and Delivery. I enjoyed the interaction with patients, their families, and staff.

03/1999 08/2001 Scientific Research Manager

Department of Anesthesiology

University of South Florida

Tampa, FL

Primary responsibilities were management of gas chromatography laboratories at TGH and USF College of Medicine. This

lab of was one of six in the US and Canada validated for performing the Multiple Inert Gas Elimination Technique

(MIGET). This included building of lab, operation, ordering, repair and purchasing of all equipment and supplies for these

laboratories; adaptation of research protocols involving the Multiple Inert Gas Elimination Technique to be performed in

any clinical or experimental setting. I assisted the Technical Director of Research in the operation and maintenance of the

METI™ Human Patient Simulator and teaching laboratories at TGH and USF. In addition, I provided assistance in the non

clinical laboratory with protocols involving various animal models. Duties included administration of anesthesia, surgical

procedures, data collection, animal euthanasia, bloodgas, co oximetry and tonometry analysis of animal blood, as well as,

collaboration on intra disciplinary research protocols.

08/1988 02/1999 Senior Biological Scientist

Department of Anesthesiology

University of South Florida

Tampa, FL

Operation and maintenance of Malignant Hyperthermia Laboratory at The Tampa General Hospital, one of thirteen MH

laboratories across the US and Canada. I was responsible for building the lab, maintaining supplies and equipment and

validation of the procedure. We severed as the only referral center for the Southeastern United States. I also facilitated

the clinical research of faculty, residents and fellows in any area of the hospital. Responsibilities included, but were not

limited to: data collection, chart review, obtaining patient's health histories and current health status, collection such as

urine and blood (performed venipuncture when needed); collaborated with pharmaceutical companies when conducting

multi center drug or equipment protocols; assisted the Technical Director of Research with creating, locating, or modifying

equipment to meet the requirements of the protocols.

04/1987 05/1988 Electro Cardiograph Technician

Cardiology Department

LDS Hospital

Salt Lake City, UT

Responsible for performing ECGs throughout 540 bed hospital, as well as, responding with the cardiac and trauma code

teams. Additional duties included preliminary basic 12 Lead ECG and Holter monitor scan interpretation.

Abstracts, Presentations, and Acknowledgments

Abstracts and Presentations:

Hodges MR, Preece LP, Downs JB: Clinical Experience with Pulse Oximetry in the Presence of Elevated

Carboxyhemoglobin, abstracted.

Anesthesiology 71:A368, 1989.

Thrush D, Hodges MR, Preece LP, Downs JB: Preoperative Medication: It May Do More Harm Than Good! 12th

Annual Meeting of the Society of Cardiac Anesthesiologists, Orlando, Florida, May 1990.

Thrush DN, Marath A, McKeown P, Hodges MR, Jackson C, Preece P. VA/Q Relationships and Dead Space after

Reduction Pneumoplasty. Anesthesiology 85:A1112, 1996.

Schweiger JW, Jackson C, Preece P: Authenticity of the METI™ Anesthesia Patient Simulator: Medical Students

Perception. Anesthesiology 93:A1221, 2000

Acknowledgements:

Naidu KA, Fu E, Prokop L: Epinephrine Increases the Selective Permeability of Epidurally Administered [3H] D

Mannitol and [14C] Carboxyl Inulin across the Blood Spinal Cord Barrier., The Journal of Spinal Cord Medicine,

Vol. 19:Number 3, 1996.

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