Loma Linda, CA · On-site
The Study Start Up Specialist is responsible for reviewing clinical research studies to determine whether the study is a qualifying study pursuant to Medicare's National Coverage Determination (310 ...
Loma Linda, CA · On-site
The Study Start Up Specialist is responsible for reviewing clinical research studies to determine whether the study is a qualifying study pursuant to Medicare's National Coverage Determination (310 ...
Chicago, IL · On-site
$55K - $70K/yr
Act as the single point of contact from Tempus for JIT and expedited site activations, including maintaining site activation timelines and answering study start-up related questions. * Coordinate ...
Chicago, IL · On-site
$55K - $70K/yr
Act as the single point of contact from Tempus for JIT and expedited site activations, including maintaining site activation timelines and answering study start-up related questions. * Coordinate ...
$55K - $70K/yr
Act as the single point of contact from Tempus for JIT and expedited site activations, including maintaining site activation timelines and answering study start-up related questions. * Coordinate ...
$55K - $70K/yr
Act as the single point of contact from Tempus for JIT and expedited site activations, including maintaining site activation timelines and answering study start-up related questions. * Coordinate ...
Loma Linda, CA · On-site
The Study Start Up Specialist is responsible for reviewing clinical research studies to determine whether the study is a qualifying study pursuant to Medicare's National Coverage Determination (310 ...
Loma Linda, CA · On-site
The Study Start Up Specialist is responsible for reviewing clinical research studies to determine whether the study is a qualifying study pursuant to Medicare's National Coverage Determination (310 ...
Regulatory Start-Up Specialist The Regulatory Start-Up Specialist serves as the main point of contact for project-specific study start-up activities within the regulatory department and provides ...
Regulatory Start-Up Specialist The Regulatory Start-Up Specialist serves as the main point of contact for project-specific study start-up activities within the regulatory department and provides ...
Durham, NC · Remote
$85/hr
Our FSP team is currently seeking a Lead Study Start Up Specialist to join our growing team! Candidates must be within the United States or Canada. Summary: * Drive rapid, accurate, and data-driven ...
Durham, NC · Remote
$85/hr
Our FSP team is currently seeking a Lead Study Start Up Specialist to join our growing team! Candidates must be within the United States or Canada. Summary: * Drive rapid, accurate, and data-driven ...
$85/hr
Our FSP team is currently seeking a Lead Study Start Up Specialist to join our growing team! Candidates must be within the United States or Canada. Summary: * Drive rapid, accurate, and data-driven ...
$85/hr
Our FSP team is currently seeking a Lead Study Start Up Specialist to join our growing team! Candidates must be within the United States or Canada. Summary: * Drive rapid, accurate, and data-driven ...
This role supervises the Study Start-Up Specialist and Research Specialist positions and serves as the primary operational lead for feasibility, site activation, sponsor communication, start-up ...
This role supervises the Study Start-Up Specialist and Research Specialist positions and serves as the primary operational lead for feasibility, site activation, sponsor communication, start-up ...
Germantown, TN · On-site
This role supervises the Study Start-Up Specialist and Research Specialist positions and serves as the primary operational lead for feasibility, site activation, sponsor communication, start-up ...
Germantown, TN · On-site
This role supervises the Study Start-Up Specialist and Research Specialist positions and serves as the primary operational lead for feasibility, site activation, sponsor communication, start-up ...
Summary We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site ...
Summary We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site ...
Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate / Study Start up specialist experience. * Experience working with clinical trial management systems (e.g ...
Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate / Study Start up specialist experience. * Experience working with clinical trial management systems (e.g ...
Arden Hills, MN · On-site +1
$35.25 - $48/hr
Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate / Study Start up specialist experience. * Experience working with clinical trial management systems (e.g ...
Arden Hills, MN · On-site +1
$35.25 - $48/hr
Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate / Study Start up specialist experience. * Experience working with clinical trial management systems (e.g ...
Watertown, MA · On-site
$195K - $275K/yr
Provide strategic and operational leadership for end-to-end study start-up activities across assigned clinical programs, ensuring timely, compliant, and high-quality site activation. * Accountable ...
Watertown, MA · On-site
$195K - $275K/yr
Provide strategic and operational leadership for end-to-end study start-up activities across assigned clinical programs, ensuring timely, compliant, and high-quality site activation. * Accountable ...
This position may manage Study Start Up Leads (SSUL), Clinical Operations Specialists (COS) and other functions involved in study start up activities, depending oncountries. Responsibilities This ...
This position may manage Study Start Up Leads (SSUL), Clinical Operations Specialists (COS) and other functions involved in study start up activities, depending oncountries. Responsibilities This ...
Blue Bell, PA · On-site
Manager of Study Start Up ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...
Blue Bell, PA · On-site
Manager of Study Start Up ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...
Position Summary The Senior Manager, Study Start Up & Records Management is responsible for assisting the study team by performing tasks related to study start-up, study/site management, clinical ...
Quick apply
Position Summary The Senior Manager, Study Start Up & Records Management is responsible for assisting the study team by performing tasks related to study start-up, study/site management, clinical ...
Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate / Study Start up specialist experience. * Experience working with clinical trial management systems (e.g ...
Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate / Study Start up specialist experience. * Experience working with clinical trial management systems (e.g ...
Manager of Study Start Up ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...
Quick apply
Manager of Study Start Up ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...
Blue Bell, PA · On-site +1
Manager of Study Start Up ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...
Blue Bell, PA · On-site +1
Manager of Study Start Up ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...
Blue Bell, PA · On-site +1
Manager of Study Start Up ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...
Blue Bell, PA · On-site +1
Manager of Study Start Up ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...
$11.30 - $17.07
13% of jobs
$22.28 is the 25th percentile. Wages below this are outliers.
$17.07 - $22.84
14% of jobs
$22.84 - $28.61
12% of jobs
The median wage is $32.29 / hr.
$28.61 - $34.38
19% of jobs
$38.90 is the 75th percentile. Wages above this are outliers.
$34.38 - $40.14
23% of jobs
$40.14 - $45.91
3% of jobs
$45.91 - $51.68
2% of jobs
$51.68 - $57.45
2% of jobs
$57.45 - $63.22
1% of jobs
$63.22 - $68.99
4% of jobs
$68.99 - $74.76
7% of jobs
$11
$36
$74
A Study Start Up (SSU) Specialist is responsible for managing the initial stages of clinical trials, including regulatory submissions, ethics committee approvals, site contract negotiations, and essential document collection. They work closely with sponsors, clinical research organizations (CROs), and investigative sites to ensure compliance with regulatory requirements and timelines. Their role is critical in minimizing delays and ensuring that clinical trials start efficiently and successfully. Strong attention to detail, knowledge of regulatory guidelines, and effective communication skills are essential for success in this position.
To thrive as a Study Start Up Specialist, you need a background in clinical research, project management, and regulatory compliance, often supported by a bachelor's degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), electronic trial master files (eTMF), and knowledge of ICH-GCP guidelines and regulatory requirements are essential. Outstanding organizational skills, attention to detail, and proactive communication help candidates excel in this collaborative, deadline-driven environment. These skills ensure smooth study initiation, regulatory accuracy, and effective coordination across stakeholders to keep drug development projects on track.
A Study Start Up Specialist is primarily responsible for coordinating and facilitating all activities required to initiate clinical trials, including preparing regulatory submissions, managing essential documents, and ensuring timelines are met for site activation. You'll routinely interact with clinical research sites, regulatory authorities, and cross-functional teams to address submission queries, resolve compliance issues, and track progress. This role often involves reviewing site contracts, budgets, and regulatory binders, as well as updating systems to reflect study milestones. Candidates who excel in this position are highly organized, thrive in a fast-paced setting, and enjoy troubleshooting regulatory or operational challenges to keep studies moving forward.
Other
This job post has expired today. Applications are no longer accepted.
8.2
Based on 88 frontline employees who took The Breakroom Quiz
96th of 1,054 rated hospitals
Shared Services: Clinical Trial Center- (Full-Time, Day Shift) -
Job Summary: The Study Start Up Specialist is responsible for reviewing clinical research studies to determine whether the study is a qualifying study pursuant to Medicare's National Coverage Determination (310.10). Coordinates the startup process of clinical research studies submitted to the Clinical Trial Center by reviewing study protocols and related regulatory documents in order to assist with feasibility determination, billing plan creation, complete coverage analyses and study startup kit completion. Is responsible for establishing research records in electronic medical record system. Performs other duties as needed.
Education and Experience: Bachelor's Degree in a health-related discipline required. Minimum two years of experience in clinical research required. One year of experience with HCPCS/CPT coding preferred. Experience may be accepted in lieu of degree.
Knowledge and Skills: Understanding of FDA and Medicare regulations related to clinical trials. Ability to interpret research contracts, study budgets and clinical protocols and consent forms to extrapolate billing/coverage data. Able to use a computer, printer, and software programs necessary to the position (e.g., Word, Excel, Outlook, PowerPoint). Operate/troubleshoot basic office equipment required for the position. Able to work calmly and respond courteously when under pressure; collaborate and accept direction. Able to think critically; manage multiple assignments effectively; organize and prioritize workload; work well under pressure; problem solve; recall information with accuracy; pay close attention to detail; work independently with minimal supervision. Able to distinguish colors as necessary; hear sufficiently for general conversation in person and on the telephone, and identify and distinguish various sounds associated with the workplace; see adequately to read computer screens, and written documents necessary to the position.
Licensures and Certifications: None.
Our mission is to continue the teaching and healing ministry of Jesus Christ. Our core values are compassion, excellence, humility, integrity, justice, teamwork and wholeness.Get the full story on Breakroom
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Loma Linda University Health (LLUH) is an esteemed healthcare organization situated in Loma Linda, California, US. Established in 1905, it was initially known as the College of Medical Evangelists, and it operated as the official medical institution of the Seventh-day Adventist Church until the name was changed to LLUH in 1961. LLUH is very much active in the healthcare and education sectors, providing a vast range of services such as medical treatment, research, and health education. The organization’s core mission is "to continue the teaching and healing ministry of Jesus Christ", which underlines its binding values of compassion, integrity, excellence, freedom, and justice.
Health care and social assistance and hospitality services
10,000+ Employees
Loma Linda, CA, US
