Research Study Activation Specialist

The Clinical 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.  

ESSENTIAL FUNCTIONS: 

• Leads and manages the end-to-end study activation process, including feasibility assessment, site selection, and site initiation readiness 

• Develops, tracks, and maintains activation timelines, milestones, and deliverables to ensure on-time study activation 

• Schedules, coordinates, and/or participates in pre-study and site initiation visits 

• Facilitates communications between the CRO/sponsor during study activation 

• Ensures activation activities comply with GCP, institutional policies, SOPs, and applicable regulatory requirements 

• Ensures and maintains consistency between the site standard operating procedures (SOPs) and the study requirements 

• Ensures required study documents are collected, reviewed, and approved prior to site initiation 

• Identifies risks and barriers to activation and proactively implement mitigation strategies 

• Coordinates with regulatory, budget/contracting, pharmacy, lab, tissue, data, and clinical operations teams to ensure activation requirements are met 

• Facilitates activation meetings and ensures clear communication of expectations, responsibilities, and timelines 

• Serves as the primary point of contact for sponsors and CROs for study start-up related activities 

• Tracks and reports activation metrics (e.g., time to activation, bottlenecks, workload distribution) 

• Identifies opportunities to improve activation workflows, standardize processes, and reduce start-up timelines 

• Supports implementation of new activation procedures, tools, and training initiatives 

• Complies with IRB/IEC requirements  

• Confirms appropriate staff, facility, and equipment availability during study activation  

• Tracks status of regulatory submissions and communicates updates to relevant parties 

• Maintains detailed records of study activation progress, including timelines, milestones and any challenges encountered 

• Prepares reports for internal and external stakeholders 

• Reviews, establishes, and agrees on project planning and project timelines 

• Ensures monitoring measures are in place and implements contingency plan as needed 

• May have direct contact with sponsors on specific initiatives 

• Ability to work independently and to effectively prioritize tasks  

• Performs other duties as assigned 

Required 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 

• 1 year of relevant previous research experience is required 

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

• Must have ACRP/SOCRA certification; obtain research certification after 1 year but not more than 18 months after employment 

• Excellent organization, communication, and time-management skills 

• Proven ability to multi-task in a fast-paced environment 

• Knowledge of organization policies, procedures systems 

• Understanding of clinical research principles, regulatory guidelines, FDA, GCP and study start-up process  

• 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  

• Meticulous attention to detail is crucial for ensuring accuracy in document preparation and data management 

• Ability to build rapport and collaborate effectively with diverse teams 

PHYSICAL REQUIREMENTS: