Coord, Clinical Trials- Lewisville, TX in Lewisville, TX at Quest Diagnostics

Date Posted: 12/27/2019

Job Snapshot

Job Description

Coord, Clinical Trials- Lewisville, Texas - Monday through Friday
Look for more than answers.  Patients and Physicians rely on our diagnostic testing, information and services to help them make better healthcare decisions. These are often serious decisions with far reaching consequences, and require sensitivity, tact and a clear dedication to service. It’s about providing clarity and hope. 
You will work for the world leader in the industry, with a career where you can expand your skills and knowledge. You’ll have a role where you can act with professionalism, you can inspire colleagues, and you can care about the work we do and the people we serve. 
At Quest, we are on a continuous journey of discovery and development. It’s this attitude that has made us an industry leader and the #1 Diagnostic Lab in the US. For those joining us, we offer exciting and fast moving career opportunities where you can affect change at a rate unheard of in many organizations of our size and scope. While we invest in and develop technology to drive our innovations, our ongoing success relies on our people.
Assist Contract Research management in all responsibilities related to clinical trials.  This requires an awareness of various ongoing clinical trials at PhenoPath and their different requirements.  This position will handle the majority of the day-to-day duties related to the clinical trial projects.
DISTINGUISHING CHARACTERISTICS
Work with Contract Research management staff on the drafting, reviewing, or revising of study project SOWs, SOPs, forms and templates, assist in accessioning and tracking study specimens; assembly and send outs of shipping kits, correspondence with client(s) and send back of materials. Participate in QA audits and responses.  High attention to detail and ability to multitask is a must.
1) Position Responsibilities
Contract Research Clinical Trials and R&D Projects Duties:
• Assist Project Managers in study management duties
o Assist in preparing study related documents and SOPs.
o Provide specimen management support including accessioning clinical trial
specimens, correspondence with sponsor(s) and/or site managers to resolve questions
and discrepancies.
o Route samples for testing, communicating with the clinical and research bench technologists to assure timely completion of studies.
o Sign out cases with pathologists, transcribe data, and report per study specifications.
o Manage return shipments.
o Archive study slides and raw data according to testing protocol or SOW.
o Assist with data entry and/or auditing of data in a manner compliant with DTA of
study.
o Document all projects at an appropriate level.
o Participate in QA audits and respond to findings when necessary.
• Participate in meetings, trainings, committees and teleconferences as needed.
Safety, Security, and Waste Handling
• Follow all company laboratory hazardous waste practices and safety protocols.
Participate in GLP Projects in compliance with Testing Protocol and GLP requirements
• Remain current on GLP regulations. Attend all required training.
• Support the preparation for site QA audits and assist in the follow up on audit recommendations.
Other Duties
• Able to manage several projects under supervision.
• Able to understand and address customer issues and work with management to ensure effective and long-term solutions.
2) Physical Demands Requirements
PhenoPath Laboratories                                                                                                                 Clinical Trial Coordinator Job Description
Section: Contract Research Laboratory                                                                                                                                            Page 2 of 2
Reports to: FLOW Supervisor                                                                                                                                 FLSA Status:  Non-Exempt
Created on: 01-13-2012                                                                                                                                         last updated: 05.15.2018  kc
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Physical Demands: While performing the duties of this job, the employee is occasionally required to walk; sit; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; balance; stoop; talk and hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by the job include close vision, distance vision, peripheral vision, depth perception, and the ability to adjust focus.
• Work Environment: While performing the duties of this job, the employee is working in a laboratory setting. The noise level in the work environment is usually minimal. May be required to handle hazardous material, chemicals and waste in accordance with approved procedures and laboratory safety standards.
3) Required and Preferred Skills and Experience
• Required Skills and Experience
o Bachelor’s degree in Biology, Chemistry, or a related science
o Minimum two years of experience in a clinical laboratory or CRO
• Preferred Skills and Experience
o Degree in Biology, Chemistry, or a related science
o MT or HTL
o Prior pathology accessioning experience
4) General
• Maintain and foster an open and communicative work environment.
• Follow good laboratory practices and safety protocols, and coordinate efforts with the safety officer.
• Follow the security procedures for PhenoPath Laboratories.
• Adhere to all company policies
This job description is not an employment contract. Employment is at-will, and PhenoPath reserves the right to alter the job description at any time without advance notice.

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