IMMEDIATE NEED for Clinical Study Associate II to join oncology focused pharmaceutical company! Client is actively interviewing and making quick decisions!

Description:

Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU

Responsibilities

• Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the supervisor. Distribute key study documents to the CRO and vendors as appropriate.
• Request internal documents for TMF upload.
• 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.
• Complete portal access requests.
• Maintain study team lists.
• Collect information and coordinate with Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov).
• 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).

Education:

• A Bachelor's degree (preferred in Life Sciences) with relevant clinical development experience is acceptable.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.