Research Study Activation Specialist

Tennessee Oncology, one of the nation’s largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology’s mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home.

Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege. Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.

Job Description: 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 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.

ESSENTIAL FUNCTIONS

Lead s and manage s the end- to -end study activation process, including feasibility assessment, site selection, and site initiation readiness Develop s , track s , and maintai n s activation timelines, milestones, and deliverables to ensure on-time study activation Schedule s , coordinate s , and/or participate s in pre-study and site initiation visits Facilitate s communications between the CRO/sponsor during study activation Ensure s activation activities comply with GCP, institutional policies, SOPs, and applicable regulatory requirements Ensure s and maintain s consistency between the site standard operating procedures (SOPs) and the study requirements Ensure s required study documents are collected, reviewed, and approved prior to site initiation Identif ies risks and barriers to activation and proactively implement mitigation strategies Coordinate s with regulatory, budget/contracting, pharmacy, lab, tissue, data, and clinical operations teams to ensure activation requirements are met Facilitate s activation meetings and ensure s clear communication of expectations, responsibilities, and timelines Serve s as the primary point of contact for sponsors and CROs for study start-up related activities Track s and report s activation metrics (e.

g., time to activation, bottlenecks, workload distribution ) Identif ies opportunities to improve activation workflows , standardize processes, and reduce start-up timelines Support s implementation of new activation procedures, tools, and training initiatives Compl ies with IRB/IEC requirements Confirm s appropriate staff , facility, and equipment availability during study activation 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 s , establish es , and agree s on project planning and project timelines Ensure s monitoring measures are in place and implement s 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 h ealth, 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 rele vant 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: Physical Activity Required Amount of time None Less than 1/3 (Occasionally) 1/3 to 2/3 (Frequently) More than 2/3 (Regularly) Standing X Walking X Sitting X Fingering or manual dexterity X Repetitive finger motion X Lifting or exerting force Up to 50 pounds X Reaching or stretching X Climbing or balancing X Crouching or stooping X Speaking X Hearing X Seeing (with correction) X