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Study Startup Associate Jobs (NOW HIRING)

Emmes Group

Study Start-Up Associate II

Rockville, MD · On-site

$34.25 - $46.75/hr

Primary Purpose As part of Emmes' centralized Site and Patient Access group, the Study Startup Associate II provides administrative support to other team members on preparation of regulatory ...

Emmes

Study Start-Up Associate II

Rockville, MD · On-site +1

$34.25 - $46.75/hr

Primary Purpose As part of Emmes' centralized Site and Patient Access group, the Study Startup Associate II provides administrative support to other team members on preparation of regulatory ...

BeiGene USA

Senior Director, Global Site Contracts

Provide strategic oversight and guidance on study startup activities and contracting dependencies ... Partner with Contract Managers, Legal Counsel, Contract Associates, and Site Contract leaders ...

OCUGEN OPCO INC

TMF Lead

Malvern, PA · On-site

$32.75 - $45/hr

Lead and own TMF activities across assigned clinical studies from study startup through closeout and archival, ensuring TMF completeness, quality, and continuous inspection readiness at every phase ...

Ocugen Inc

TMF Lead

Malvern, PA · On-site

$32.75 - $45/hr

Lead and own TMF activities across assigned clinical studies from study startup through closeout and archival, ensuring TMF completeness, quality, and continuous inspection readiness at every phase ...

Ocugen Opco Inc

TMF Lead

Malvern, AR · On-site

$29.25 - $40/hr

ResponsibilitiesLead and own TMF activities across assigned clinical studies from study startup through closeout and archival, ensuring TMF completeness, quality, and continuous inspection readiness ...

PSI CRO

Clinical Research Associate I

As a Clinical Research Associate you will work on the frontline of communication with project ... Be involved in study startup (if applicable) * Perform CRF review, source document verification and ...

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As of Sep 10, 2026, the average hourly pay for study startup associate in the United States is $19.87, according to ZipRecruiter salary data. Most workers in this role earn between $14.90 and $20.67 per hour, depending on experience, location, and employer.

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Infographic showing various Study Startup Associate job openings in the United States as of September 2026, with employment types broken down into 92% Full Time, and 8% Part Time. Highlights an 77% In-person, 8% Hybrid, and 15% Remote job distribution, with an average salary of $41,327 per year, or $19.9 per hour.

Study Start-Up Associate II

Rockville, MD • On-site

Emmes Group
See more jobs at Emmes Groupexternal

$34.25 - $46.75/hr

Full-time

Medical, Retirement

Re-posted 26 days ago

Job description

Overview
Study Start-Up Associate II
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
As part of Emmes' centralized Site and Patient Access group, the Study Startup Associate II provides administrative support to other team members on preparation of regulatory submission packages on international clinical trials. Gets involved in creation, filing, and updating of trackers and templates
and assists in expedited startups and coordinates with other study team members on project specific communication. Liaise with cross functional teams as required.
Responsibilities
  • Creates MS project files to establish study start up timelines and processes for each country.
  • Works with team members on preparation of regulatory submission packages.
  • Tracks and follow up on missing documents.
  • Prepares and submits applications to Regulatory Authorities, Central and Local IEC/IRB and other country specific application such as for Data Protection, Import License etc. as required.
  • Helps prepare and coordinate activities related to ongoing submissions, amendments, and regular safety reporting and notification to IEC and regulatory authorities as required.
  • Tracks the regulatory documents and assist in regulatory coordination, as instructed by other team members.
  • Assists in review of the regulatory documents for completeness.
  • Assists with translations coordination, e.g., for contracts across EU etc.
  • Assists Senior Study Startup Associate and Study Startup Leads in coordinating with the sponsor to secure authorization of regulatory documents.
  • Maintains up to date and accurate tracking on the status for each site in study trackers.
  • Coordinates with study team members to collect and track essential documents for site activation.
  • Interacts with other team members of Study Startup function on project specific status, communication, and deliverables.
  • Works to the study timelines, documents/escalates study challenges, and communicates updates to the Lead as required.
  • Maintains quality and regulatory compliance among investigational sites during Site Startup Provides updates to Lead/Manager on a regular basis and communicates any out of scope activities.

Qualifications
  • Bachelor degree Life Sciences, Health Sciences, Nursing, or a related field required.
  • Master's Degree MS, MPH, PharmD (Preferred)
  • 1 to 3 years working within pharma and/or CRO, preferably 1-2 years of
    experience in working on study start up activities. Equivalent
    combination of education, training and experience.
  • Knowledge of clinical research process related to study startup and medical terminology.
  • Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members.
  • Excellent organizational and interpersonal skills
  • Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
  • Ability to manage multiple competing priorities within various clinical trials.
  • Ability to work independently, prioritize and work with a matrix team environment is essential.
  • Working knowledge of MS Project, Word and Excel is required.

Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
  • Flexible Approved Time Off

  • Tuition Reimbursement

  • 401k Retirement Plan
  • Work From Home Anywhere in the US

  • Maternal/Paternal Leave

  • Casual Dress Code & Work Environment

CONNECT WITH US!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - Emmes
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.
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