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Unicon Pharma Inc · 1 day ago

Clinical Research Coordinator

Basking Ridge, NJ

Contract

Onsite

Entry Level

1+ years exp

Unicon Pharma Inc is a company focused on clinical operations, and they are seeking a Clinical Research Coordinator to assist in planning and execution of clinical studies. The role involves providing clinical administrative support to study teams and ensuring compliance with regulatory guidelines.

BiotechnologyMedicalPharmaceutical

Growth Opportunities

Hiring Manager

Vineeth Pasupuleti

Responsibilities

Assist in planning and execution of clinical studies, under the close supervision of a Senior Manager (or above) 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 administrative support to study teams and on interacting with the Contract Research Organizations (CROs) and other vendors conducting the study to help monitor compliance with Quality Oversight measures

Support and assist the transmittal of trial and site level document to the DS Document Control Center (DCC) in support of the Trial master File (TMF)

Reconcile the TMF document trackers generated by the CRO with the document archive

Bring issues with the reconciliation to the attention of the supervisor

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

Qualification

Clinical research experienceVeevaOncology experiencePharmaceutical experienceBachelor's degree

Required

Minimum of 1-year relevant experience is required

Education: Bachelor's degree required

Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO), and Contract Research Organization (CRO)