Clinical Study Associate - The Fountain Group

Basking Ridge, NJ

About the Job

Immediate opening for a Clinical Study Associate located in Basking Ridge, NJ (Hybrid).
Details for the position are as follows:
Job Description:

Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.
Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with CLIENT Clinical Study Oversight Plan (CSOP).
Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.
Distribute key study documents to the CRO and vendors as appropriate.
Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.
Collect information and coordinate with CLIENT Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov).
Support Fair Market Value process in evaluating study budgets
Under supervision, review and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor.
Compile and maintain a monitoring review spreadsheet.
Ensure the Trial Master Files are inspection ready.
Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to your supervisor.
Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices).
Analyze study site metrics reports to identify potential areas of concern and bring to supervisor's attention.
Shift Schedule: Monday – Friday, 40hrs./week (Candidate must be able to come onsite to Basking Ridge, NJ office 1-4 times a week)
Pay Rate: $40 – 46/Hour

Qualifications:

Bachelor Degree, Minimum Required
3+ Years of Clinical Research Experience
Experience providing clinical trial management support to study teams (i.e., tracking CRO/Vendor performance, project milestones, compliance with clinical study plan)
Experience with Trial Master Files (TMF/eTMF)
Certification/License: Clinical Study Oversight Plants (CSOP), Preferred
Contract to Start, conversion/extension on performance

Who We Are:
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.
Browse our website below for additional information on our company.
The Fountain Group
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”

Source : The Fountain Group