Randstad Clinical Research Associate in North Chicago, Illinois
Clinical Research Associate
North Chicago, IL
Wednesday, October 12, 2016
Randstad Life Sciences
Job Title: Clinical Research Associate - C
- Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary.
Conduct remote monitoring activities in house for one or more studies.
Safety review experience preferred.
Other potential responsibilities may be to assist Study Project Manager (SPM) for one or more clinical studies.
Assist with management of vendors such as Clinical Research Organizations (CRO), Central Lab and other suppliers.
Work with other functional areas.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Assist SPM in planning and management of one or more clinical studies.
Assist SPM in the coordination of activities of cross-functional areas for the initiation, conduct and completion of one or more clinical studies on time and within budget (track expenditures).
Coordinate study activities such as study design, protocol preparation, investigator selection, investigator meeting and contract preparation, vendor selection & CRF design and other activities to ensure on time completion of studies.
Assist SPM in assessment of study conduct, development of monitoring plan and progress of study for adherence to the plan.
Identify site issues that potentially impact evaluable study data, ethical study conduct and ICH compliance.
Identify and escalate issues impacting study hygiene and make recommendations for corrective action.
Liaison with functional areas contributing to the outcome of clinical studies.
Assist in the management of study completion activities through timely oversight of CRF collection, DCF resolution, site-close out activities and activities of other contributing/cross functional areas.
Coordinate activities of study vendors that are necessary for completion of study and availability of data for analysis.
Assist in planning and execution of meetings and may present at Investigator Meetings and may assist Medical Writing in data line listings, statistics table review, or QCl 3-5 yrs of exp.
5+ Years Experience required.
Experience with EDC is required.
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance