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Unicon Pharma Inc · 1 day ago

Clinical Research Coordinator

New Jersey, United States

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 executing clinical studies. The role involves providing administrative support to study teams, interacting with vendors, and ensuring compliance with regulatory standards.

BiotechnologyMedicalPharmaceutical

Growth Opportunities

Hiring Manager

Navya Matha

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 Daiichi Sankyo (DS) 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

Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov). Works with Insurance Brokers to obtain study site Insurance Under the guidance of the supervisor, analyze site metrics reports to identify potential areas of concern and bring to supervisor's attention. 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 the supervisor

Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices)

Qualification

Clinical research experienceOncology experienceVeeva experienceGCP knowledgeSOP knowledgeFDA regulations knowledgeMicrosoft Office proficiencySoft skills

Required

Minimum of 1-year relevant experience is 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)

Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant

Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook

Bachelor's degree required