Research Study Activation Specialist

The Research Study Activation Specialist plays a crucial role in initiating and managing the startup process for clinical research studies.

The specialist will conduct and facilitate specific study activation activities for new trials that may include site feasibility, vendor activities, essential document collection/review, and regulatory support. The specialist will work closely with the CRO/sponsor and appropriate internal staff to ensure study activation performance metrics are achieved. Ensure activation activities comply with GCP, institutional policies, SOPs, and applicable regulatory requirements

Ensure and maintain consistency between the site standard operating procedures (SOPs) and the study requirements

Coordinate with regulatory, budget/contracting, pharmacy, lab, tissue, data, and clinical operations teams to ensure activation requirements are met Facilitate activation meetings and ensure clear communication of expectations, responsibilities, and timelines Comply with IRB/IEC requirements Creates, maintains, and reviews essential study documents ensuring accuracy, completeness an adherence to regulatory requirements

Ability to work independently and to effectively prioritize tasks  Performs other duties as assigned
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Skills and Qualifications
** Bachelor’s degree in a health, science, or related field required; in lieu of a degree, a minimum of 6 years of directly related clinical research experience may be considered

Experience in oncology research or CRO/Sponsor is preferred 2 years of relevant previous research experience is required

Knowledge of GCP, ICH guidelines, FDA regulations, and institutional policies governing human subjects research

Excellent organization, communication, and time-management skills Proven ability to multi-task in a fast-paced environment. Knowledge of organization policies, procedures systems.

Strong written and verbal communication skills for interacting with various stakeholders. Ability to identify and resolve issues that may arise during the study activation process. Ability to build rapport and collaborate effectively with diverse teams.  
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* PHYSICAL REQUIREMENTS:

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