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location: North Chicago, Illinois
job type: Contract
salary: $35.00 - 38.52 per hour
work hours: 9 to 5
- Assist the Trial Disclosure (TD) area with the execution of Company clinical drug trial registration per the applicable regulatory and SOP requirements.
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Work closely with/support the Project Manager(s) and Sr. Clinical Trial Disclosure Associate(s) of TD: to determine the Company drug trials required to be registered, to effectively communicate this information and related timelines to the applicable individuals involved in these activities, to provide guidance to and build cross-functional collaborative relationships, to coordinate the completion of these activities to achieve/ensure timely disclosure of accurate and complete information (including populating each Protocol Record with disclosure information on ClinicalTrials.gov (CT.gov).
- Work closely with/support the Project Manager(s) and Sr. Clinical Trial Disclosure Associate(s) of TD in operationalizing changes in both the US and International regulatory environment via participation in the implementation of SOPs/processes as well as creating efficiency improvements/further system automation and related communication and training activities.
- Participate in TD compliance prevention by providing QC checks and metrics as requested.
- Maintain/track TD for Company clinical drug trials, including the documentation and storage of the information.
- Cross-train with other TD staff.
- Accountable for meeting the main objectives of assigned projects/roles and responsibilities within established timelines and with an appropriate quality level.
- Accountable to Associate Director of TD. Act as a key contributor, who exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.
- Daily interaction with TD Project Manager(s) and/or Sr. Clinical Trial Disclosure Associate(s) of TD as well as significant interface/communication with cross-functional areas.
- Expedient escalation of issues to management is essential and may have a direct impact on TD compliance.
- Bachelor's degree (BA/BS), from an accredited college or university is required, preferably in a health or biological science field.
- Must have 2+ years of clinical research experience or experience in a related area such as quality or regulatory and working knowledge of drug development.
- Must be familiar with ICH and GCP Guidelines and have good organizational and communication skills and competent in application of standard business procedures (SOPs/Work Instructions, OEC).
- Must have the ability to prioritize roles and responsibilities daily and work well under deadline pressure in a team environment in order to execute goals to ensure they are achieved (i.e. maximize individual skills utlizing the collective skills of the CTD area).
skills: SOP, GCP (Good Clinical Practice), Trial Disclosure, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.