Research Study Activation Specialist

Tennessee Oncology•Nashville, TN

About The Position

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 st udy 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 st udy activation performance metrics are achieved.

Requirements

Bachelor’s degree in a h ealth, science, or related field ; in lieu of a degree, a minimum of 6 years of directly related clinical research experience may be considered
2 years of rele vant previous research experience is
Knowledge of GCP, ICH guidelines, FDA regulations, and institutional policies governing human subjects 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.

Nice To Haves

Experience in oncology research or CRO/Sponsor is preferred

Responsibilities

Lead and manage the end-end-end study activation process, including feasibility assessment, site selection, and site initiation readiness
Develop, track, and maintain activation timelines, milestones, and deliverables to ensure on-time study activation
Schedule, coordinate, and/or participate in pre-study and site initiation visits
Facilitate communications between the CRO/sponsor during study activation
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
Ensure required study documents are collected, reviewed, and approved prior to site initiation
Identify risks and barriers to activation and proactively implement mitigation strategies
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
Serve as the primary point of contact for sponsors and CROs for study start-up related activities
Track and report activation metrics (e.g., time to activation, bottlenecks, workload distribution )
Identify opportunities to improve activation workflows , standardize processes, and reduce start-up timelines
Support implementation of new activation procedures, tools, and training initiatives
Comply with IRB/IEC requirements
Confirm appropriate staff , facility, and equipment availability during study activation
Creates, maintains , and reviews essential study documents ensuring accuracy, completeness an adherence to regulatory requirements
Tracks status o f 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
Review, establish and agree on project planning and project timelines
Ensure monitoring measures are in place and implement 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