PharmaDx Technical Project Coordinator

Schedule:
Monday - Friday (40 hrs/wk)
8:00 AM - 5:00 PM

Department: PharmaDx - 511

Primary Purpose:

The PharmaDx Technical Project Coordinator is responsible for coordinating and managing project activities of both technical and non-technical nature for assigned projects. The PharmaDx Technical Project Coordinator functions as a liaison between PharmaDx project management and ARUP laboratory sections on PharmaDx projects to support the achievement of project deliverables. The PharmaDx Technical Project Coordinator works independently and in a team environment on assigned projects to demonstrate enhanced knowledge of technical material, high complexity project tasks and problem solving.

The PharmaDx Technical Project Coordinator works under the direction of project managers or program managers and reports to the PharmaDx Group Manager.

About ARUP:

ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.

ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient's life. We never forget that there is a patient behind every specimen we receive.

We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.

Essential Functions:

Manages technical and non-technical project activities for support of complex projects.

Coordinates communications between PharmaDx project managers, laboratory staff and other internal stakeholders as warranted by project scope.

Possesses strong working knowledge of Good Clinical Practices (GCP) and Medical Device Design Control Requirements.

Interacts with clients including written, telephone and face-to-face communication in coordination with project or program managers.

Demonstrates knowledge of method validation practices and regulatory requirements, with focus on bioanalytical validation regulatory guidances, including practical experience implementing these guidances.

Coordinates and collaborates with subject matter experts to conduct data analysis and risk assessments in relation to compliance with established procedures.

Reviews data, verifies accuracy, and enters data in the laboratory information system or data repository, along with appropriate explanatory or interpretive information in a timely manner.

Collects and monitors QC data for unexpected results or problematic trends and escalates as required.

Recognizes unexpected results, errors, and problems with clinical trial sample tests and escalates as required.

Understands the theory of laboratory procedures and evaluates potential causes of unexpected test results in coordination with the laboratory staff.

Evaluates technical errors, special circumstances and deviations to establish corrective and preventative actions and determine impact on data integrity.

Tracks technical and non-technical issues related to projects and ensures problem resolution.

Collaborates with laboratory management to prioritize testing of clinical trial samples for PharmaDx, when needed, and coordinates general work flow activities related to PharmaDx sample testing.

Provides technical information and/or instruction to clients, new team members, laboratory personnel, and peers as requested and where appropriate.

Reports on project progress to project and laboratory management and clients.

Writes and reviews technical documentation including end of study reports, sample analysis reports, and bioanalytical reports.

Maintains sample inventory and sample chain-of-custody information.

Other duties as assigned.

Physical and Other Requirements:

Stooping: Bending body downward and forward by bending spine at the waist.

Reaching: Extending hand(s) and arm(s) in any direction.

Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.

Communicate: Effectively communicates with others.

PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company/departmental policies.

ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.

Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.

Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.

Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as make general observations of depth and distance.

Color Vision: Perception of and ability to distinguish colors.

Continuing Education: Continual assessment of current literature and best practices.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)