Project Coordinator

Troy - Michigan - United States - Life Sciences & Health Care - Health Care - Project Management & Services - Academic Bachelor

Location: West Chester PA - 100% on site
Length of Contract: 1 year + Open ended

Feel free to contact

Arpita Sharma, Account manager

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About this role

Responsibilities:

  • Coordinate test samples for evaluation at internal and external contract laboratories, including calculation of sample numbers required for testing, ensuring proper labelling of samples, and clear communication with research teams providing samples;
  • Requesting quotes from CROs;
  • Receiving and distributing samples as per GLP and departmental SOPs, maintaining accurate and contemporary tracking records;
  • Track study progress to ensure timely delivery of data and reports;
  • Ensure appropriate documentation is established & maintained in study files to ensure study integrity and timely submission to document archives; verify information in protocols and reports;
  • Act independently as sponsor’s representative for compendia studies;
  • Ensure that testing meets all international & domestic test requirements according to ISO (International Organization for Standardization), FDA (Food & Drug Administration)-CDRH (Center for Devices and Radiological Health) and GLP (Good Laboratory Practice);
  • Maintain the Toxicology mailbox as a communication tool for project team requests for Toxicology and biocompatibility support and for record of department activity;
  • Maintain proper records of project request and testing to allow for preparation of metrics and reporting to management;
  • Report to management on department activities, non-conformances, and problems related to sample preparation, CRO delays, and overall project flow for planning purposes;
  • Apply knowledge of biocompatibility evaluation as related to the ISO 10993 standards and regulatory authority requirements for product safety to select testing in conjunction with the Toxicologist and Biocompatibility Scientist;
  • Support on-site and off-site Regulatory Authority audits to support product evaluation and testing as required (e.g. Test Article Control Room audits, GLP Archives audits);
  • Maintain a collaborative spirit of the work environment that is both professional and ensures the engagement of others as partners and team members.

Qualifications

  • A Bachelor’s degree in biology, chemistry, microbiology, biomedical engineering or a related scientific field is required;
  • A minimum of 2 years of experience in industrial research, academic research, or product development experience in a highly regulated healthcare environment is required;
  • Experience working with contract research organizations is preferred;
  • Ability to work collaboratively as a team member across various functions in a challenging and changing environment is required;
  • Experience working in a regulated environment of medical device safety and supporting product submission and audit to support worldwide market registration is preferred;
  • Proven experience with project management skills, managing priorities and time management is required;
  • Ability to be on-site to execute sample transfers in a timely manner is required;
  • Familiarity with medical device product development is preferred;
  • Excellent communication skills to serve as a Toxicology and Biocompatibility spokesperson on scheduling issues (as appropriate) is required;
  • Ability to handle multiple tasks and responsibilities and prioritize tasks according to broad project goals is required;
  • Basic algebra and geometry skills to perform test article needs calculations for testing requirements is required;
  • Self-directed performance in unsupervised environment is required;
  • Experience in word processing, project planning, presentation, e-mail business practices and spreadsheet software utilization is required.

Summary

  • Vacancy number: PUB203310
  • Location: Troy
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branche: Health Care
  • Education level: Academic Bachelor
  • Area of Expertise: Project Management & Services
  • Closing date: Thursday, May 2, 2019
Apply now

Feel free to contact

AS

Arpita Sharma

Account manager Brunel Canada Toronto

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