One of the nation's largest contract research organization, our client helps pharmaceutical and biotech companies worldwide develop new drugs by providing a full range of testing services, from pre-clinical investigations all the way through designing and carrying out human clinical trials and conducting post-marketing studies to determine if drugs are safe and/or effective. The company's customers include pharmaceutical, biotech, and medical device firms within chemical, agrochemical, and food industries.
Essential Job Duties:
Those duties shown below with an '*' are client or external contact.
Ensure Referral Lab Data Quality
o Manage the flow of order and result files.
o Monitor and respond to email communication including the team distribution list.*
o Define, modify and close projects in the RLI database application.
o Maintain and distribute Referral Lab-specific documents.
o Perform manual resulting as needed.
Represent Referral Lab Interface (RLI)
o Liaise between External Data Resulting Services (EDRS) and Referral Laboratory contacts.*
o Interact with Investigator Support to resolve queries.
o Consult Medical Affairs as needed.
o Collaborate with Project Managers and Technical Administrators, proactively and reactively regarding study questions.
o Manage and resolve issues within Specimen Management.
o Initiate data changes to Data Revision Center and revise all non-compliant requests.
o Partner with other departments and provide support and process improvements as needed.
Ensure client service globally.*
o Support peers by sharing technical knowledge and customer service skills.
o Provide coverage for peers as needed globally.
Maintain continuous learning objectives.
o Complete on-boarding training.
o Participate in Corporate training.
o Complete mandatory QA training sessions.
o Attend mandatory meetings.
o Participate in job-shadowing or inter-departmental development opportunities.
o Participate in on-going training initiatives regarding process and systems changes and/or updates.
o Complete advanced training for continuing development.
o Support other department training as needed.
Ensure compliance with departmental guidelines and company standards.
o Manage training folders and update documentation as needed.
o Review standard operating procedures and other documents in a timely manner.
o Update departmental metrics tools.
o Provide monthly reports to management.
Assist in audits.*
o Research questions and provide Referral Lab-specific documentation.*
o Request and deliver result data from the data repository (Saturn) and archive tapes as needed.*
Perform other duties as assigned.
Eight Eleven Group provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.