Source Job

$95,000–$125,000/yr
US Unlimited PTO

  • Oversee study start-up, site activation, and close-out activities while managing study plans and essential documents.
  • Collaborate with cross-functional teams, sponsors, and vendors to ensure timely and compliant project execution.
  • Mentor CTA team members and contribute to TMF quality, inspection readiness, and regulatory compliance.

Clinical Research Project Management Regulatory Compliance MS Office

20 jobs similar to Clinical Project Specialist

Jobs ranked by similarity.

US

  • Serve as the primary point of contact for assigned protocols, linking Country Operations with the clinical trial team.
  • Manage project timelines, deliverables, and performance for clinical studies from feasibility to close out.
  • Ensure compliance with ICH/GCP, country regulations, and company policies while leading local study teams.

Merck is a global healthcare leader with a diverse range of prescription medicines, vaccines, and animal health products. With over 100 years of history, the company employs tens of thousands worldwide and fosters a culture of innovation and inclusivity.

Spain

  • Responsible for executing one or more elements of clinical studies in compliance with quality standards and regulations.
  • Supports the Study Project Manager in leading cross-functional study teams and developing study protocols.
  • Manages vendor selection, oversight, and study-related training, and proactively resolves issues.

AbbVie is a biopharmaceutical company focused on discovering and delivering innovative medicines and solutions for serious health issues. It is a large global organization with a diverse workforce and a commitment to integrity and innovation.

US

  • Independently manages significant aspects of clinical trials and research projects.
  • Trains and provides guidance to less experienced staff, and oversees data management.
  • Ensures compliance with regulations, monitors IRB submissions, and interfaces with study sponsors.

Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate and prepare leaders for the future. The university is committed to diversity and inclusion, providing a supportive environment for staff and faculty.

$135,000–$159,000/yr
US

  • Provide study oversight as the primary liaison between CRAs, site staff, clients, and vendors across all study stages.
  • Ensure clinical monitoring activities comply with SOPs, regulations, GCPs, and study-specific requirements.
  • Support team training, review site visit reports, and manage oversight of the Trial Master File and eTMF.

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) trusted since 1996, delivering ethical services to pharmaceutical, biotech, and medical device companies. They foster a collaborative community where team members feel valued and empowered to make a meaningful impact on global health.

US

  • Serves as regulatory document specialist for clinical trial start-up, maintenance, and close-out.
  • Collects, reviews, and maintains essential documents in the electronic Trial Master File (eTMF).
  • Communicates with study teams and sites to ensure regulatory files remain complete and inspection-ready.

St. Jude Children’s Research Hospital is a leading research and treatment center focused on pediatric catastrophic diseases. It is a large institution with a collaborative culture and a strong emphasis on finding cures and saving children.

US

  • Leads the planning, conduct, and oversight of clinical studies per scope of work, ensuring compliance with protocols, SOPs, and regulatory requirements.
  • Acts as primary clinical point of contact for clients, develops study documents, and drives site feasibility and recruitment strategies.
  • Manages clinical teams, training, vendor oversight, and ensures data quality and timely deliverables across study phases.

Precision Medicine Group is a clinical research organization that provides outsourced clinical trial management services to pharmaceutical and biotechnology companies. The company fosters a collaborative culture focused on quality and compliance, and employs a team of experienced clinical professionals.

North America

  • Coordinate day-to-day execution of clinical studies including site onboarding, documentation, and timeline tracking.
  • Support regulatory compliance through IRB submissions, amendments, and maintaining study documentation.
  • Collaborate cross-functionally with science, bioinformatics, and product teams to ensure study operations.

Tiny Health advances lifelong health through precision microbiome science using shotgun metagenomics and AI. Founded in 2020, it is a remote-first startup with a diverse international team focused on making the microbiome measurable and actionable.

$90,000–$110,000/yr
US

  • Oversee clinical study operations from startup through close-out, ensuring quality and compliance.
  • Act as primary operational partner to sponsors, project teams, and clinical sites.
  • Foster a culture of quality by coaching peers on GCP compliance and documentation discipline.

Beacon Biosignals is transforming precision medicine for the brain, offering EEG and cardiopulmonary platforms for clinical development and diagnostics. The company has office hubs in Boston, New York, and Paris, and fosters a first-class remote work culture with a focus on diversity and impact.

$127,000–$142,000/yr
US

  • Develop and maintain successful working relationships with study sites, serving as the primary point of contact for clinical trial operations.
  • Conduct monitoring visits to ensure compliance with protocols, GCP, and regulatory requirements, preparing high-quality reports.
  • Collaborate with cross-functional teams including Clinical Project Managers, Data Management, and Regulatory Affairs to ensure end-to-end study execution.

CVRx pioneers unique therapies that harness and harmonize the body's natural systems, benefiting society and making CVRx a universal role model in healthcare. The company values commitments to others and fosters a culture of teamwork, collaboration, and positivity in a purpose-driven startup environment.

US Unlimited PTO

  • Lead interdisciplinary oncology clinical research projects from study launch through closeout, ensuring quality, timelines, budgets, and compliance.
  • Serve as the primary liaison between the organization and the sponsor, overseeing project deliverables, risk management, and financial performance.
  • Maintain accountability for study documentation, inspection readiness, and accurate information across relevant databases and systems.

Jobgether uses AI to match job seekers with roles. They are a platform that partners with hiring companies to manage applications and next steps.

US

  • Collaborate with project teams and clinical sites to support study startup, training, and device deployment.
  • Ensure compliance with GCP, ICH guidelines, and regulatory standards while monitoring project progress.
  • Address operational issues and provide feedback to improve devices and workflows.

Beacon Biosignals is transforming precision medicine for the brain by offering at-home EEG platforms for clinical development and diagnostics. The company fosters a remote-first culture with office hubs in Boston, New York, and Paris, emphasizing asynchronous work and collaboration.

$160,000–$175,000/yr
US

  • Manage operational activities for all phases of clinical studies, from start-up to close-out.
  • Provide sponsor oversight of CROs and vendors to ensure compliance and quality.
  • Support data review, TMF maintenance, and cross-functional collaboration for trial success.

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company developing off-the-shelf cell therapies for devastating diseases. The company fosters an open, collaborative culture where diverse perspectives are welcomed, with teams working from Berkeley or remotely.

Europe

  • Provides leadership and strategic direction to the Site Start-up department, contributing to the expansion of people, processes, and systems.
  • Collaborates with cross-functional teams to secure SSU delivery and client satisfaction on activities such as regulatory submissions and site contracts.
  • Ensures compliance with regulatory requirements, ICH Guidelines, and Good Clinical Practices for clinical trials.

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. We apply our expertise to trials at all stages from early development through approval, with embedded experience in oncology and rare disease.

Brazil

  • Support clinical trial activities across patient engagement, study coordination, recruitment, regulatory support, data management, and operations.
  • Coordinate participant visits, recruitment, and regulatory documentation while maintaining accurate information in clinical research systems.
  • Foster communication between sponsors, CROs, investigators, and sites to ensure study compliance and milestone achievement.

This partner company supports fast-growing remote clinical research environments, helping keep clinical trials organized, compliant, and moving forward. They collaborate with research sites, sponsors, CROs, and healthcare organizations globally, offering multidisciplinary roles in a remote setting.

US

  • Support study execution by managing meeting logistics, documenting decisions, and tracking action items.
  • Partner with Clinical Operations and site monitors to ensure protocol compliance and quality standards.
  • Responsible for filing site-level documents into Trial Master Files and assisting with regulatory submissions.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. As a small, mission-driven team, we foster a collaborative culture built on trust, ownership, curiosity, and results.

Global

  • Provide leadership and mentorship across regional clinical trials while ensuring high-quality study execution with minimal travel.
  • Oversee monitoring visit reports, manage study risks, and ensure compliance with corrective measures at country and regional levels.
  • Collaborate with cross-functional teams, lead project calls, and deliver training to support data integrity and site performance.

PSI CRO is a privately owned, global Contract Research Organization dedicated to advancing medical science and bringing new therapies to patients worldwide. Founded in 1995, the company has over 3,000 employees and prides itself on long-term stability, having never undergone a merger, acquisition, or company-wide layoffs.

US

  • Coordinate and oversee all activities for site activations in accordance with contract, protocol, ICH-GCP, and regulatory requirements.
  • Act as primary point of contact for Sponsor and internal stakeholders during study start-up, developing strategy and managing regulatory deliverables.
  • Prepare, collect, review regulatory information for submissions and track essential documents to facilitate efficient site initiation and activation.

Ergomed is a specialist clinical research organization focused on rare disease and oncology indications. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance.

US

  • Lead and manage a team of Project Directors and Project Managers for global clinical trials.
  • Oversee project delivery, sponsor interactions, and profitability across clinical programs.
  • Ensure compliance with GCP/ICH and drive continuous improvement and KPIs.

Precision Medicine Group is a precision medicine company providing clinical research and development services. They emphasize quality, people, clients, and performance, with a collaborative team environment.

$96,500–$183,500/yr
Global

  • Leads and oversees global clinical trials from inception through closure, ensuring quality and efficiency.
  • Manages external vendors, recruitment strategies, and cross-functional team coordination.
  • Maintains inspection readiness and contributes to risk management and process improvement.

AbbVie discovers and delivers innovative medicines and solutions for serious health issues across immunology, oncology, and neuroscience. The company is a global biopharmaceutical leader with a focus on making a remarkable impact.

$110,000–$140,000/yr
North America

  • Create and maintain SOPs and guidance documents in compliance with ICH-GCP and federal and local regulations.
  • Conduct internal study reviews to ensure compliance and prepare official reports with findings and corrective actions.
  • Collaborate with operations teams to remediate noncompliance and participate in quality investigations and audits.

Headlands Research is dedicated to enhancing clinical trial delivery within communities. Founded in 2018, the company operates 20+ clinical trial sites across the US and Canada and is rapidly expanding.