Research Study Activation Specialist

Tennessee Oncology•Nashville, TN

About The Position

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.

Requirements

Bachelor’s degree in a health, science, or related field; in lieu of a degree, a minimum of 6 years of directly related clinical research experience may be considered.
1 year of relevant previous research experience.
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.

Nice To Haves

Experience in oncology research or CRO/Sponsor is preferred.

Responsibilities

Lead and manage the end-to-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.
Track status of regulatory submissions and communicate updates to relevant parties.
Maintain detailed records of study activation progress, including timelines, milestones and any challenges encountered.
Prepare 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.