Offer summary

Qualifications:

Bachelor’s Degree or equivalent in clinical research or a related field., Minimum of 3 years experience in clinical or lab data review, especially lab/analyte data., Experience with Electronic Data Capture (EDC) systems is preferred., Oncology or Inflammatory therapeutic area experience is a plus..

Key responsibilities:

Define and improve responsibilities and processes for Local Lab Handling Coordinators.

Collaborate with partners to obtain and update local laboratory information in the EDC system.

Ensure accurate and complete lab data, including analyte and reference ranges, for clinical trials.

Support and mentor team members, and participate in departmental meetings.

Job description

The Senior Local Lab Handling Coordinator is responsible for defining and continually improving the responsibilities of the Local Lab Handling Coordinators and the process for managing local laboratory information. In addition, this senior role will act as the team leader and subject matter expert for the Local Lab Handling Coordinators.

The Senior Local Lab Handling Coordinator is also responsible for collaborating with internal and external partners to obtain the information required, per the protocol, to enter local laboratory information into the Electronic Data Capture (EDC) system. This role will also be responsible for updating local laboratory information, as needed, throughout the progression of clinical trials in the EDC system. In addition, this role work with the relevant parties to ensure that complete and accurate analyte and reference range information is available in the EDC system for clinical trials in a timely manner.

Summary of the Essential Functions of the Job

Defines the responsibilities of the Local Land Handling Coordinators as well as the process for managing local laboratory information
Receives relevant local laboratory information from investigative sites and transcribes this information into the EDC system or into a template to be imported into the EDC system
Crosschecks the information provided with the protocol to certify that all required analytes are accounted for
Works with the Clinical Data Managers (CDMs), Clinical Research Associates (CRAs) and investigative sites to clarify any source documentation issues and obtain any further updates which might be needed
Regular attendance at Clinical Data Management group meetings and any departmental trainings
Serve as a mentor to team members by guiding work, resolving challenges, and offering support