TheClinicalResearchStudy ActivationSpecialistplays a crucial role in initiating and managing the startup process for clinical research studies. The specialist will conduct andfacilitatespecific study activation activitiesfor new trials that may include site feasibility, vendor activities, essential document collection/review, and regulatory support.The specialist will work closelywith the CRO/sponsor andappropriate internalstaff to ensure study activation performance metrics are achieved.

ESSENTIAL FUNCTIONS:

• Leadsand managesthe end-to-end study activation process, including feasibility assessment, site selection,and site initiation readiness

• Develops, tracks, andmaintainsactivation timelines, milestones, and deliverables to ensure on-timestudy activation

• Schedules, coordinates, and/orparticipatesin pre-study and site initiation visits

• Facilitatescommunications between the CRO/sponsor during study activation

• Ensuresactivation activitiescomply withGCP, institutional policies, SOPs, and applicable regulatory requirements

• Ensuresandmaintainsconsistency between the site standard operating procedures (SOPs) and the study requirements

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

• Identifiesrisks and barriers to activation and proactively implement mitigation strategies

• Coordinateswith regulatory, budget/contracting, pharmacy, lab, tissue, data, and clinical operationsteams to ensure activation requirements are met

• Facilitatesactivation meetings and ensuresclear communication of expectations, responsibilities, and timelines

• Servesas the primary point of contact for sponsors and CROs for study start-uprelated activities

• Tracksand reportsactivation metrics (e.g., time to activation, bottlenecks, workload distribution)

• Identifiesopportunities to improve activationworkflows, standardizeprocesses, and reduce start-up timelines

• Supportsimplementation of new activation procedures, tools, and training initiatives

• ComplieswithIRB/IEC requirements

• Confirmsappropriate staff, facility, and equipment availability during study activation

• Tracks status ofregulatory 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 agreeson project planning and project timelines

• Ensuresmonitoring measures are in place and implementscontingency 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, orrelated fieldrequired; in lieu of a degree, a minimum of 6 years ofdirectly relatedclinical research experience may be considered

• Experience in oncology research or CRO/Sponsor is preferred

• 1year of relevantpreviousresearch experience isrequired

• Knowledge of GCP, ICH guidelines, FDA regulations, and institutional policies governing humansubjectresearch

• Must have ACRP/SOCRA certification; obtain research certification after 1 year but not more than18 monthsafter employment

• Excellent organization, communication, and time-management skills

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

• Knowledge of organizationpolicies,procedures systems

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

• Strong written and verbal communication skills for interacting with various stakeholders

• Ability toidentifyand 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: