Tiereney K. Mack-Colwell

**** ******* *****. 484-***-****

Bethlehem, PA 18018 adxn4k@r.postjobfree.com

Clinical Data Coordinator

Objective

Seeking a rewarding and challenging position supporting health care, clinical research, and/or pharmaceutical development.

Interest

Clinical Research, Pharmaceutical Development, Health Care

Summary

Data Management Professional with 6+ years of experience in the CRO (Data Management) industry and 3+ years in Pharmaceuticals (Global Safety). Detail oriented with a talent and passion to provide thorough quality control checks on data. Proven ability to work well with others and perform well under tight timelines while handling multiple tasks. Able to perform with cross functional teams and provide exceptional customer service. Excellent organization skills, excellent written and verbal communication skills also. Areas of expertise include:

* Date Entry Input

* Manual Review

* Data Review (QC)

* Edit Check Review

* Query Resolution/Generation

* Creating Data Validation Guidelines

* Creating Mock Data for CRFs

* Security Administration

* UAT validation

* Database Validation

* Overall Data Project Management

Therapeutic Areas

Oncology

Cardiovascular

Dermatology

Central Nervous System

Respiratory

Allergy/Immunology

Professional Experience

St. Luke's University Health Network. Bethlehem,PA

Certified Medical Assistant 2012 - present

Core Qualifications

Clinical and administrative expertise

Blood draws, injections and dressings

Exceptional verbal and written communication skills

BLS certified

Proficient with EMRs, CPOE and relevant computer applications

Maintain patient files

Equipment and supply maintenance

Time management

Greeted more than 35 patients daily, prepared them for exam and assessed and recorded vital signs.

Assisted physicians on more than 4,000 tests, procedures, dressings and lab tests.

Administred injections and medications as directed by physicians.

Prepared and maintained supplies for exam rooms.

Prepared patients for exams, took medical histories and vital signs and assisted during exams for approximately 20 patients a day.

Collected lab specimens and performed basic tests.

Input information and updated patient electronic medical records.

Entered more than 2,000 lab, radiology and medication orders in CPOE for Medical and Medicare patients.

Answered telephones, greeted patients and assisted front office staff as needed.

Maintained exam rooms and supplies.

Joule Technical Staffing Edison, NJ

Contract Employee for MERCK (formerly Schering Plough Corporation) 2007 - 2010

Project Coordinator

In a 4 - 6 person group coordinating project guidelines for Adverse Event and Serious Adverse events as directed by the Project Manager.

* Reporting status of tasks to the Project Manager

* Preparation and submission of project-specific requests

* Coordination and execution of verification and other processing activities associated with

project-specific requests

* Distribution of communications to team members and users

* Participation in the analysis and resolution of issues/requests.

* Liaised with IT, Validation Unit and related application owners when processing system

configuration changes and security responsibilities for GPV

* Prepared system configuration change requests as per departmental procedures,

performed abbreviated and full business verification (UAT) for system configuration

changes, and then communicated system configuration changes to the global GPV user

community

* Performed requested updates as Administrator to cases in AE database as per departmental

Procedures

* Provided user security administration for GPV users

* Tracking of project tasks and facilitation of task completion.

Clinsys Clinical Research, Inc. (formerly Target Research Assoc.) Berkeley Heights, NJ

Clinical Data Technician / Coordinator 2001 - 2007

In an 8 -10 person group created completion guidelines to be used in conjunction with CRFs. Provided advance double data entry input when needed. Issued and resolved queries to sites and monitors. Executed SAS programs to check for data errors within database. Performed extensive review of data listings for consistency and logic. Provided Data Management updates during department meetings. Interacted with sites for resolutions throughout the life of the project. Entered and verified confidential statistics in clinical database. Maintained an accurate and precise count of all CRFs in-house. Performed extensive reviews of data entered into the database as compared to the CRFs

* Provided quality control of the database

* Tested database for new projects

* Edit Check Review / Manual Review / Listing Review

* Screen Validation

* Database/CRF Design (mock data)

* Query generation/resolution

* Trained all new employees

Education

Northampton Community College Bethlehem, PA. 2012 - Present

Nursing, RN

References are available upon request.

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