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 ...
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 ...
Leadsand managesthe end-to-end study activation process, including feasibility assessment, site selection,and site initiation readiness * Develops, tracks, andmaintainsactivation timelines ...
Leadsand managesthe end-to-end study activation process, including feasibility assessment, site selection,and site initiation readiness * Develops, tracks, andmaintainsactivation timelines ...
Regulatory Coordinator I - Study Activation
Saint Petersburg, FL · On-site
$23 - $30.50/hr
The Clinical Research Regulatory Coordinator I for Study Activation will be responsible for ensuring that accurate and up-to-date regulatory files are maintained for all pediatric clinical research ...
Regulatory Coordinator I - Study Activation
Saint Petersburg, FL · On-site
$23 - $30.50/hr
The Clinical Research Regulatory Coordinator I for Study Activation will be responsible for ensuring that accurate and up-to-date regulatory files are maintained for all pediatric clinical research ...
Regulatory Coordinator I - Study Activation
Saint Petersburg, FL · On-site
$23.25 - $31/hr
The Clinical Research Regulatory Coordinator I for Study Activation will be responsible for ensuring that accurate and up-to-date regulatory files are maintained for all pediatric clinical research ...
Regulatory Coordinator I - Study Activation
Saint Petersburg, FL · On-site
$23.25 - $31/hr
The Clinical Research Regulatory Coordinator I for Study Activation will be responsible for ensuring that accurate and up-to-date regulatory files are maintained for all pediatric clinical research ...
Study Start Up Operations Manager - Full Time - Wolf River - Registered Nurse (RN)/ Licensed Prac...
Manager, Study Start Up Operations About Us At West Cancer Center, we are committed to advancing ... The Manager ensures efficient activation of clinical trials while maintaining compliance with FDA ...
Study Start Up Operations Manager - Full Time - Wolf River - Registered Nurse (RN)/ Licensed Prac...
Manager, Study Start Up Operations About Us At West Cancer Center, we are committed to advancing ... The Manager ensures efficient activation of clinical trials while maintaining compliance with FDA ...
Study Start Up Operations Manager - Full Time - Wolf River - Registered Nurse (RN)/ Licensed Practic
Germantown, TN · On-site
Manager, Study Start Up Operations About Us At West Cancer Center, we are committed to advancing ... The Manager ensures efficient activation of clinical trials while maintaining compliance with FDA ...
Study Start Up Operations Manager - Full Time - Wolf River - Registered Nurse (RN)/ Licensed Practic
Germantown, TN · On-site
Manager, Study Start Up Operations About Us At West Cancer Center, we are committed to advancing ... The Manager ensures efficient activation of clinical trials while maintaining compliance with FDA ...
Clinical Research Regulatory Coordinator
Horseheads, NY · On-site
$22 - $30/hr
Track study activation milestones and regulatory deliverables. * Maintain study start-up trackers and timelines. Institutional Review Board (IRB) Management * Prepare and submit initial IRB ...
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Clinical Research Regulatory Coordinator
Horseheads, NY · On-site
$22 - $30/hr
Track study activation milestones and regulatory deliverables. * Maintain study start-up trackers and timelines. Institutional Review Board (IRB) Management * Prepare and submit initial IRB ...
Clinical Research Regulatory Coordinator (Brandon, Florida)
Brandon, FL · On-site
$22 - $29.25/hr
Essential Responsibilities Study Start-Up and Site Activation · Prepare and assemble study start-up regulatory packages. · Coordinate collection of essential documents required for study activation ...
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Clinical Research Regulatory Coordinator (Brandon, Florida)
Brandon, FL · On-site
$22 - $29.25/hr
Essential Responsibilities Study Start-Up and Site Activation · Prepare and assemble study start-up regulatory packages. · Coordinate collection of essential documents required for study activation ...
Study Activation & Operational Support * Partner with affiliated healthcare system teams to support research study activation and implementation within electronic medical record (EMR) systems.
Study Activation & Operational Support * Partner with affiliated healthcare system teams to support research study activation and implementation within electronic medical record (EMR) systems.
Clinical Research Regulatory Coordinator (Brandon, Florida)
Brandon, FL · On-site
$22 - $29.25/hr
Essential Responsibilities Study Start-Up and Site Activation • Prepare and assemble study start-up regulatory packages. • Coordinate collection of essential documents required for study ...
Clinical Research Regulatory Coordinator (Brandon, Florida)
Brandon, FL · On-site
$22 - $29.25/hr
Essential Responsibilities Study Start-Up and Site Activation • Prepare and assemble study start-up regulatory packages. • Coordinate collection of essential documents required for study ...
Clinical Research Regulatory Coordinator
Cortland, NY · On-site
$22 - $30/hr
Track study activation milestones and regulatory deliverables. * Maintain study start-up trackers and timelines. Institutional Review Board (IRB) Management * Prepare and submit initial IRB ...
Quick apply
Clinical Research Regulatory Coordinator
Cortland, NY · On-site
$22 - $30/hr
Track study activation milestones and regulatory deliverables. * Maintain study start-up trackers and timelines. Institutional Review Board (IRB) Management * Prepare and submit initial IRB ...
Study Activation & Operational Support * Partner with affiliated healthcare system teams to support research study activation and implementation within electronic medical record (EMR) systems.
Study Activation & Operational Support * Partner with affiliated healthcare system teams to support research study activation and implementation within electronic medical record (EMR) systems.
Study Start-Up and Clinical Trial Budgeting * Provides strategic and operational leadership for end-to-end study start-up and activation activities across the CTSI Clinical Research Centers portfolio ...
Study Start-Up and Clinical Trial Budgeting * Provides strategic and operational leadership for end-to-end study start-up and activation activities across the CTSI Clinical Research Centers portfolio ...
Developing and implementing comprehensive strategies for study start-up, site activation, and regulatory delivery that align with organizational goals, client expectations, and evolving industry ...
Developing and implementing comprehensive strategies for study start-up, site activation, and regulatory delivery that align with organizational goals, client expectations, and evolving industry ...
Protocol Activation Coordinator II
Gainesville, FL · On-site
$61K - $70K/yr
Protocol Activation Coordinator II Job no: 539864 Work type: Staff Full-Time Location: Main Campus ... Building a coverage analysis by working closely with the study team, University of Florida Clinical ...
Protocol Activation Coordinator II
Gainesville, FL · On-site
$61K - $70K/yr
Protocol Activation Coordinator II Job no: 539864 Work type: Staff Full-Time Location: Main Campus ... Building a coverage analysis by working closely with the study team, University of Florida Clinical ...
This role is responsible for driving cross-functional process improvement across OneR, OneOncology's site management organization - spanning contracting & budgeting, study activation, regulatory ...
New
This role is responsible for driving cross-functional process improvement across OneR, OneOncology's site management organization - spanning contracting & budgeting, study activation, regulatory ...
New
Vice President, Site Activation Project Management and Global Regulatory Oversight
Blue Bell, PA · Remote
Developing and implementing comprehensive strategies for study start-up, site activation, and regulatory delivery that align with organizational goals, client expectations, and evolving industry ...
Vice President, Site Activation Project Management and Global Regulatory Oversight
Blue Bell, PA · Remote
Developing and implementing comprehensive strategies for study start-up, site activation, and regulatory delivery that align with organizational goals, client expectations, and evolving industry ...
Vice President, Site Activation Project Management and Global Regulatory Oversight
Reading, PA · Remote
Developing and implementing comprehensive strategies for study start-up, site activation, and regulatory delivery that align with organizational goals, client expectations, and evolving industry ...
Vice President, Site Activation Project Management and Global Regulatory Oversight
Reading, PA · Remote
Developing and implementing comprehensive strategies for study start-up, site activation, and regulatory delivery that align with organizational goals, client expectations, and evolving industry ...
Study Start-Up and Clinical Trial Budgeting * Provides strategic and operational leadership for end-to-end study start-up and activation activities across the CTSI Clinical Research Centers portfolio ...
Study Start-Up and Clinical Trial Budgeting * Provides strategic and operational leadership for end-to-end study start-up and activation activities across the CTSI Clinical Research Centers portfolio ...
Vice President, Site Activation Project Management and Global Regulatory Oversight
Blue Bell, PA · Remote
Developing and implementing comprehensive strategies for study start-up, site activation, and regulatory delivery that align with organizational goals, client expectations, and evolving industry ...
Quick apply
Vice President, Site Activation Project Management and Global Regulatory Oversight
Blue Bell, PA · Remote
Developing and implementing comprehensive strategies for study start-up, site activation, and regulatory delivery that align with organizational goals, client expectations, and evolving industry ...
Study Activation information

Full-time
Posted 21 days ago
Tennessee Oncology rating
6.4
Based on 26 frontline employees who took The Breakroom Quiz
Job description
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 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:
- 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
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
- 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
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
What Tennessee Oncology employees say
Pay
Benefits
Hours and flexibility
Workplace
Get the full story on Breakroom
About Tennessee Oncology
Sourced by ZipRecruiter
Industry
Health care and social assistance
Company size
501 - 1,000 Employees
Headquarters location
Nashville, TN, US
Year founded
1976