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Study Startup Specialist Jobs (NOW HIRING)

Systimmune

Study Startup Specialist

Princeton, NJ · On-site

$70K - $95K/yr

The Startup Study Specialist is responsible for the successful initiation of clinical trials by coordinating and executing all study start-up activities across assigned projects within a fast-paced ...

Systimmune

Sr. Study Startup Specialist

Princeton, NJ · On-site

$90K - $115K/yr

The Senior Study Startup Specialist is responsible for leading complex and/or global study start-up activities across the clinical portfolio in a fast-paced biotech environment. This role serves as a ...

SystImmune, Inc

Study Startup Specialist

Princeton, NJ · On-site

$70K - $95K/yr

The Startup Study Specialist is responsible for the successful initiation of clinical trials by coordinating and executing all study start-up activities across assigned projects within a fast-paced ...

SystImmune, Inc

Sr. Study Startup Specialist

Princeton, NJ · On-site

$90K - $115K/yr

The Senior Study Startup Specialist is responsible for leading complex and/or global study start-up activities across the clinical portfolio in a fast-paced biotech environment. This role serves as a ...

CenExel

Study Startup Specialist I

Savannah, GA · On-site

Job Summary: Under moderate supervision, the Study Start Up Specialist I is responsible for initiating and implementing study start up activities for the daily operational and administrative ...

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Study Startup Specialist information

What is the difference between Study Startup Specialist vs Clinical Trial Coordinator?

AspectStudy Startup SpecialistClinical Trial Coordinator
CredentialsBachelor's degree, often in life sciences or related fieldBachelor's degree, often in health sciences or related field
Work EnvironmentPharmaceutical companies, CROs, or research institutions during study initiationClinical sites, hospitals, or research centers managing trial activities
Primary ResponsibilitiesPreparing startup documents, regulatory submissions, site qualificationManaging daily trial activities, patient recruitment, data collection

The Study Startup Specialist focuses on preparing and initiating clinical trials, ensuring regulatory compliance and site readiness. In contrast, the Clinical Trial Coordinator manages ongoing trial activities at the site level. Both roles require similar educational backgrounds but differ in scope and daily responsibilities, with the Specialist more involved in pre-trial setup and the Coordinator in trial execution.

Is CRA better than CRC?

A Study Startup Specialist typically works with Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs), who have different roles in clinical trials. CRAs monitor study sites and ensure compliance, while CRCs manage daily trial activities at the site level. Both roles are essential, and the preference depends on the specific responsibilities and career goals within clinical research.

Is CRC an entry level position?

A Study Startup Specialist is typically an entry-level role in clinical research, often suitable for individuals with a bachelor's degree and some familiarity with clinical trial processes. The position may require training on specific tools and protocols but generally does not require extensive prior experience.

What does a study startup specialist do?

A study startup specialist manages the initial phase of clinical trials by coordinating activities such as site selection, regulatory submissions, and staff training to ensure the trial begins smoothly. They work closely with cross-functional teams and often use project management tools to meet deadlines and compliance standards.

What are the key skills and qualifications needed to thrive as a Study Startup Specialist, and why are they important?

To thrive as a Study Startup Specialist, you need a solid understanding of clinical research processes, regulatory requirements, and project management, often supported by a degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), IRB/EC submission platforms, and tools like Microsoft Office is typically required. Strong organizational skills, attention to detail, and effective communication are vital soft skills for coordinating multiple stakeholders and meeting tight deadlines. These competencies ensure efficient study initiation, regulatory compliance, and smooth collaboration across research teams.

What are some common challenges a Study Startup Specialist faces during the site activation process?

A Study Startup Specialist often encounters challenges related to coordinating multiple stakeholders, such as clinical sites, regulatory bodies, and sponsors, to ensure timely completion of study documents and approvals. Delays may occur due to varying site readiness, complex regulatory requirements, or slow contract negotiations. Proactive communication, diligent tracking of tasks, and a collaborative approach with cross-functional teams are key to overcoming these challenges and keeping the study startup timeline on track.

What are Study Startup Specialists?

Study Startup Specialists are professionals responsible for managing and coordinating the initial phases of clinical trials. Their primary duties include preparing and submitting regulatory documents, obtaining ethics committee approvals, and ensuring all site activation requirements are met. They play a critical role in ensuring that clinical studies begin on time and comply with all regulatory and institutional guidelines. Study Startup Specialists work closely with cross-functional teams, clinical research sites, and sponsors to streamline the startup process and mitigate delays.

Do clinical trials pay well?

Study startup specialists typically do not directly participate in clinical trial payments, which are usually made to research sites or sponsors. Compensation for study startup roles varies based on experience, location, and the complexity of the trial, but these positions often offer competitive salaries within the clinical research industry. Skills in project management and regulatory knowledge can influence earning potential.
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Infographic showing various Study Startup Specialist job openings in the United States as of July 2026, with employment types broken down into 87% Full Time, 10% Part Time, 1% Temporary, and 2% Contract. Highlights an 81% Physical, 2% Hybrid, and 17% Remote job distribution.
Study Startup Specialist

Study Startup Specialist

Systimmune

Princeton, NJ • On-site

$70K - $95K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 19 days ago

Job description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
The Startup Study Specialist is responsible for the successful initiation of clinical trials by coordinating and executing all study start-up activities across assigned projects within a fast-paced startup environment. This includes managing essential document collection, site activation, regulatory submissions, and ensuring compliance with ICH-GCP, SOPs, and local regulatory requirements.
The SSUA ensures that clinical sites are ready to initiate and enroll patients on time, contributing to the overall success of the clinical development program.
This requires hybrid work (3 days onsite) at our Princeton, NJ location.
Responsibilities
  • Coordinate and oversee all aspects of study start-up activities for assigned clinical trials. Prepare and submit regulatory documents (e.g., IRB/EC applications, FDA forms) to ensure timely approvals.
  • Track and report startup milestones (e.g., site activation timelines, enrollment targets).
  • Support the development of SOPs and templates for scalable study execution.
  • Propose solutions to reduce site activation timelines in resource-constrained environments.
  • Prepare, review, and submit essential regulatory documents to ethics committees (ECs), institutional review boards (IRBs), and regulatory authorities.
  • Track submissions and approvals to ensure study timelines are met.
  •  Support contract and budget negotiations by liaising with key stakeholders.
  • Maintain accurate tracking systems and study documentation and document management systems (eTMF) and ensure audit readiness.
  • Communicate regularly with project teams, clinical research associates (CRAs), regulatory affairs, and clinical sites to ensure smooth site activation.
  • Contribute to continuous improvement initiatives related to start-up processes and tools.
  • Ensure compliance with ICH-GCP guidelines, company SOPs, and local regulations at all times.
  • Stay updated on evolving regulations (GCP, GDPR, etc.) and adapt processes accordingly.

Qualifications
  • Bachelor’s degree in Life Sciences, Business, or related field (advanced degree a plus).
  • 2+ years in clinical study startup, site activation, or regulatory submissions (startup experience preferred).
  • Familiarity with clinical trial platforms.
  • Exceptional organizational and project management skills.
  • Ability to thrive in ambiguity and pivot quickly.
  • Strong negotiation and communication skills (written and verbal).
  • Experience in oncology study. 

Compensation and Benefits:
The expected base salary range for this position is $70,000 - $95,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
 

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