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Clinical Study Startup Jobs in Virginia (NOW HIRING)

IQVIA

CRA 1, IQVIA Biotech

Fairfax, VA

$71K - $145K/yr

... clinical research studies by performing site monitoring and site management activities. In this ... startup activities based on study needs. Accurate and timely documentation is critical. The CRA I ...

IQVIA

CRA 1, IQVIA Biotech

Fairfax, VA

$71K - $145K/yr

... clinical research studies by performing site monitoring and site management activities. In this ... startup activities based on study needs. Accurate and timely documentation is critical. The CRA I ...

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Clinical Study Startup information

What is a Clinical Study Startup job?

A Clinical Study Startup job involves managing the initial phases of a clinical trial, ensuring all regulatory, ethical, and logistical requirements are met before patient enrollment begins. Responsibilities typically include submitting regulatory documents, coordinating with ethics committees, negotiating contracts, and ensuring trial sites are fully prepared. This role requires strong knowledge of clinical research regulations, timelines, and collaboration with internal and external stakeholders. Effective study startup is crucial for minimizing delays and ensuring compliance with industry standards.

What are the key skills and qualifications needed to thrive in the Clinical Study Startup position, and why are they important?

Success in a Clinical Study Startup role requires a strong understanding of clinical research processes, regulatory requirements, project management, and often a life sciences degree or related field. Familiarity with clinical trial management systems (CTMS), electronic trial master files (eTMF), and regulatory submission platforms is essential, along with certifications like GCP (Good Clinical Practice) being advantageous. Attention to detail, proactive problem-solving, and excellent organizational and communication skills help candidates excel. These qualifications ensure smooth study initiation, regulatory compliance, and effective cross-functional collaboration within demanding timelines.

What are the typical responsibilities of someone working in Clinical Study Startup?

Professionals in Clinical Study Startup are primarily responsible for coordinating and executing study initiation activities, including regulatory document collection, ethics submissions, site contracting, and start-up logistics. They work closely with investigators, sponsors, and cross-functional teams to ensure all regulatory and site requirements are met before the clinical trial begins. This role often involves tight deadlines and frequent communication with stakeholders both internally and externally. It's a fast-paced position that is ideal for individuals who enjoy detail-oriented work and project coordination in a collaborative environment.

What are the most commonly searched types of Clinical Study Startup jobs in Virginia? The most popular types of Clinical Study Startup jobs in Virginia are:
What are popular job titles related to Clinical Study Startup jobs in Virginia? For Clinical Study Startup jobs in Virginia, the most frequently searched job titles are:
What job categories do people searching Clinical Study Startup jobs in Virginia look for? The top searched job categories for Clinical Study Startup jobs in Virginia are:
Clinical Study Startup jobs near you
Clinical Research Regulatory & Source Document Specialist

Clinical Research Regulatory & Source Document Specialist

Clinical Research Partners

Richmond, VA • On-site

Full-time

Medical, Dental, PTO

Re-posted 6 days ago

Job description

We are seeking a detail-oriented Clinical Research Regulatory & Source Document Specialist to support our growing clinical research team. This position is responsible for creating and maintaining source documents, reviewing protocol amendments, updating study materials, and ensuring research documentation remains accurate, organized, and compliant with sponsor and regulatory requirements.

The ideal candidate is highly organized, proactive, and experienced in clinical research documentation and protocol management.

Responsibilities

  • Create, update, and maintain study source documents for clinical trials
  • Review protocol amendments and identify required study changes
  • Update source packets, visit worksheets, logs, and study tools following protocol revisions
  • Ensure all study documents remain compliant with sponsor, GCP, and site requirements
  • Communicate protocol and amendment changes to research staff as needed
  • Assist with study startup and ongoing document preparation
  • Support quality control efforts and audit readiness
  • Maintain accurate filing and version control of study documentation

Qualifications

  • Clinical research experience preferred
  • Experience reviewing protocols and amendments strongly preferred
  • Knowledge of GCP, FDA regulations, and research documentation standards
  • Strong attention to detail and organizational skills
  • Ability to manage multiple studies and deadlines simultaneously
  • Proficient in Microsoft Office and electronic documentation systems
  • Medical terminology knowledge preferred
  • CRC, regulatory, or research coordinator experience is a plus

Preferred Experience

  • Source document creation
  • Regulatory coordination
  • Protocol review and implementation
  • Research quality assurance or quality control
  • Sponsor and CRO communication