Research Study Activation Specialist

OneOncology•Nashville, TN

3d•Onsite

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 required; 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 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

Nice To Haves

Experience in oncology research or CRO/Sponsor is preferred

Responsibilities

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