Description
Sr. CLINICAL RESEARCH MONITOR (Sr. CRA)
Every day, Kelly Scientific Resources (KSR) Clinical Research connects scientific professionals with opportunities to advance their careers.
We currently have an exciting long term contract opportunity for a Sr. Clinical Research Monitor/Associate (Sr. CRA) with a local major biotech company in the Minneapolis, MN. Please review the job description below and then click on 'Apply Now' to take your career to new heights!
RESPONSIBILITIES: ' Will be responsible for identifying regulatory and study specific compliance issues by conducting site visits for multiple product platforms. ' Will work closely with study teams, site personnel, company field personnel and monitoring supervisor to resolve site issues, develop written corrective action plans and assist in determining impact of non-compliance on study objectives. ' Will play a lead role in the managing monitoring activities for a clinical study or studies. ' May work with sites in preparation for regulatory inspections conducting training and remedial training for non-compliant sites. ' Will actively participate on Clinical and/or Corporate Clinical initiatives/projects. ' Will work with minimal supervision and follows established procedures Contributes to the successful conduct of studies consistent with Research, Development and Marketing plans. ' May include interfacing with representatives from key functional groups ' Will write and/or review monitoring plans, corrective action plans, trending reports and CAPAs. ' Will provide oversight to others completing these tasks. ' Will draft new guidance/guideline documents. ' Will conduct components of new monitor training. ' Will develop and conduct study specific training materials. ' Will function as resource for others. ' Will communicate items requiring follow-up and/or compliance issues to study team following site visits. ' Will develop a corrective action plan with input from supervisor and study team as needed. ' Will function as a resource to monitors and study team for site corrective actions. . ' Will schedule and conduct monitoring activities at non-compliant centersto resolve outstanding issues. ' Will work closely with supervisor, study team, field, and Quality to develop corrective and preventative action plans. ' Will communicate visit findings with site personnel and complete a written letter for distribution to the Principle Investigator and Site Coordinator for follow-up. ' Will complete 1st and/or 2nd review of peer reports and letters. ' Will prepare timely, accurate and complete written monitoring reports for distribution to the study team and project file. ' Will identify and track monitoring action items along with their recommendations for corrective action and resolution. ' Will review all monitoring action items and appropriately code in accordance with SOP CAPA codes. ' Will collaborate with study team to ensure timely resolution. ' Will function as resource for others in action item resolution/coding. . ' May function as a mentor to other monitors or other personnel. ' May develop training materials and conduct training sessions. ' Will compile and Evaluate action items quarterly to identify trends within a study and/or across studies. ' Will summarize graph data and present to study team and develop corrective and/or preventative action plans. May assist with site selection and/or conduct pre-study evaluation or site initiation visits.
REQUIREMENTS: ' Must have a BS/BA degree ' BSN/RN(Nursing) strong preferred ' Must have a minimum of 5 years experience as a Monitor/CRA ' Must have experience with Medical Devices ' Experience with Cardiac/Cardiology strongly preferred ' Must have excellent oral and written communication skills ' Must have excellent computer skills (MS Word, Excel, Outlook) ***Must be willing to travel approx 70% or as required
Kelly Scientific Resources® has grown into a $200 million global business as the scientific business unit of Kelly Services. Clinical Research is the clinical business unit of Kelly Services. Our staff of scientists provides scientific staffing to a broad spectrum of industries including: chemical, cosmetics, food science pharmaceutical, biomedical, consumer products, environmental, medical device, petrochemical, and clinical research.
With more than 2,600 company-owned and operated offices in 30 countries, Kelly provides an incredible opportunity to job seekers all over the globe. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:
www.kellyscientific.com Kelly Services is an Equal Opportunity Employer