HireTalent - Staffing & Recruiting Firm · 13 hours ago
Clinical Research Coordinator
Basking Ridge, NJ
Contract
Hybrid
Entry Level
$32/hr - $35/hr
1+ years expHireTalent is a staffing and recruiting firm seeking a Clinical Study Associate I to assist in planning and executing clinical studies. The role involves providing administrative support to study teams, interacting with vendors, and ensuring compliance with clinical regulations and guidelines.
DeliveryHuman ResourcesStaffing Agency
Hiring Manager
Suvidha Gundekar
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 the Client Quality Oversight measures
Support and assist the transmittal of trial and site level document to the 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 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
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
Basic oral and written communication skills
Preferred
Veeva experience is a plus
Oncology experience is a plus
Company
HireTalent - Staffing & Recruiting Firm
HireTalent is a certified Minority Business Enterprise (MBE) workforce solutions firm, specializing in securing the best talent fits in Executive/Retained Search, Direct Hire Placements, MSP, SOW, and nationwide hiring program management and support.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Ashish Kaushal
CEO / Founder
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