Clinical Study Associate I

Employment as a Contingent Worker aligns well with individuals seeking career flexibility and non-traditional work arrangements, while also being motivated to produce exceptional results in prominent roles. Magnit Direct Source is a service provided by Magnit Global that connects top-tier talent directly to an industry-leading company. Daiichi Sankyo, Inc. and Magnit Global, in collaboration, offer flexible contingent assignments across diverse projects creating opportunities for engaging work.  As a Contingent Worker, you will not be employed Daiichi Sankyo, Inc. You will be employed by our Managed Service Provider, Magnit Global, which oversees the majority of our temporary contract recruitment.

Job Schedule: Candidate must be able to come onsite to Basking Ridge, NJ office 1-4 times a week.

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).

Requirements :

Minimum of 1-year relevant experience is required. Veeva experience is a plus.

Oncology experience is a plus. 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.

Education :

Bachelor's degree required.

Hourly Pay Rate Range (dependent on location, experience, expectation)

The pay range that Magnit reasonably expects to pay for this position is: $ 29.46-$39.29/hr

Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met)

#Hybrid