Clinical Study Associate

Support groundbreaking clinical trials-join us as a Clinical Study Associate and help ensure quality, compliance, and innovation in every step.

R&D Partners is seeking a Clinical Study Associate I to assist in the planning and execution of clinical studies under the close supervision of a Senior Manager or above within Clinical Operations. This role emphasizes adherence to protocols, Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations, EU Directives, and ICH guidelines. The position focuses on providing clinical administrative support to study teams and interacting with Contract Research Organizations (CROs) and other vendors to ensure compliance with quality oversight measures.

Applicants must have legal authorization to work in the United States.

Clinical Study Associate I / Band B

• 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.clinical trials.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)

Requirements:

• Bachelor's degree is a must
• Minimum of 2 years CTA experience is required from a pharmaceutical, biotech, or CRO company (no academia, cancer center, imaging company, etc.)
• Veeva experience is a must
• Oncology experience is a plus

Compensation:

• $35 - $41 Per Hour

For more information, please contact Elliott Croft.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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