About this role
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 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.
ESSENTIAL FUNCTIONS:
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 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
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
Required Skills and Qualifications
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
Experience in oncology research or CRO/Sponsor is preferred
2 years of relevant previous research experience is required
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.
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
Other facts
About OneOncology
Tennessee Oncology is one of the nation’s largest community-based cancer care specialists and 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. To this day, our growing network of physicians and number of locations is based on this mission. In 2018, Tennessee Oncology joined OneOncology, a partnership of oncologists and industry leading experts driving the future of community-based cancer care in the United States, as a founding practice partner.
Physicians specializing in gynecologic oncology, palliative care, radiation oncology, and health psychology comprise our group.
Tennessee Oncology provides a full range of diagnostic services, including oncology specific expertise in PET/CT and laboratory services. Clinic locations provide on-site chemotherapy treatments so that patients receive care in their community and close to their home.
Our physicians utilize the latest in molecular diagnostics and profiling to choose treatments specific to the genetics of your cancer.
Oncology research is the largest area of new drug development. Self -administered medications, those taken by mouth or injected by the patient, comprise approximately 40% of these investigative medications. Tennessee Oncology’s in house pharmacy, Park Pharmacy, stocks oncology and hematology medications not readily available at community retail pharmacies. A URAC accredited Specialty Pharmacy, Park provides insurance and benefits investigation, prior authorization services for insurance coverage, co-pay assistance through manufacturer or foundation programs, extensive medication education, and access to a pharmacist 24 hours a day, 7 days a week.
What you'll do
- The Research Study Activation Specialist is responsible for initiating and managing the startup process for clinical research studies, including feasibility assessments and site initiation readiness. They will coordinate with various teams to ensure compliance with regulatory requirements and track activation metrics.
Ready to join OneOncology?
Take the next step in your career journey