Source Job

US

  • Partner with cross-functional teams and study sites to support clinical operations across all trial phases.
  • Perform remote monitoring of clinical trials and serve as secondary contact for sites supporting CRAs.
  • Ensure proper reporting and follow-up of SAEs, address non-compliance issues, and assist with audit/inspection readiness.

Clinical Trials Regulatory Compliance Communication

20 jobs similar to In-House Clinical Research Associate II, Sponsor-Dedicated (Contract)

Jobs ranked by similarity.

  • Perform on-site or remote pre-study, initiation, interim, and close-out monitoring visits to ensure adequate facilities and staff.
  • Identify investigators and verify qualifications, resources, and staff for conducting clinical studies.
  • Train investigational site staff and support regulatory submissions as applicable.

Ergomed is a specialist clinical research organization focused on rare disease and oncology trials. With a collaborative international team across North America, South America, Europe, Asia, and Australia, the company values teamwork, flexibility, and work-life balance.

Spain

  • Monitor clinical investigative sites to ensure protocol execution and regulatory compliance.
  • Conduct site qualification, initiation, interim monitoring, and closeout visits for Phase 1-4 studies.
  • Train site personnel, manage investigator payments, and identify new investigators and sites.

AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, and neuroscience. It is a global biopharmaceutical company committed to integrity, innovation, and transforming lives.

France

  • Monitor and own the progress of clinical studies at investigative sites, ensuring compliance with protocols and regulations.
  • Coordinate study setup activities, including investigator identification and regulatory submissions, while mentoring junior staff.
  • Interact directly with clients, manage payments, and participate in proposal activities, with travel up to 50-60%.

Precision for Medicine is a specialized CRO that combines agility with scientific expertise to support innovative clinical development programs. They foster a collaborative environment that values quality, accountability, and professional development, with a global team of experienced professionals.

France

  • Monitor clinical studies at investigative sites to ensure compliance with protocols, SOPs, and ICH-GCP.
  • Coordinate study setup and initiation activities, including investigator identification and regulatory submissions.
  • Identify study risks and propose mitigation strategies while maintaining high quality and detail.

Precision for Medicine is a CRO integrating clinical trial execution with scientific expertise and data sciences, focusing on Oncology and Rare Disease. It offers a supportive, small-CRO culture with high CRA retention and emphasis on work-life balance.

Ukraine

  • Conduct and report all types of onsite monitoring visits and be involved in study startup.
  • Perform CRF review, source document verification, and query resolution while managing site communication.
  • Support regulatory team in preparing documents and participate in feasibility research.

PSI is a leading Contract Research Organization with 30 years in the industry, offering a balance between stability and innovation to clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

US Unlimited PTO

  • Collaborate with the Clinical Operations team to support timely conduct of clinical studies according to protocols, GCP, SOPs, and regulations.
  • Lead operational management for assigned regions and sites, including vendor management and oversight of CRO monitors.
  • Contribute to the development and maintenance of study documents and ensure the Trial Master File is complete and inspection-ready.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has built a portfolio of 20+ drug development programs spanning preclinical to late-stage development across multiple therapeutic areas.

$85,000–$115,000/yr
US

  • Support Clinical Trial Managers with study start-up, protocol development, and Trial Master File preparation.
  • Coordinate with clinical sites on documentation, training, and compliance with FDA and GCP requirements.
  • Assist with tracking study payments and providing operational support across the full study lifecycle.

The company is a partner organization specializing in clinical research and development, operating through Jobgether. It offers a structured clinical operations environment with cross-functional teams and professional growth opportunities.

US

  • Conduct on-site or remote monitoring visits to ensure site adequacy for clinical trials.
  • Train investigational site staff and support regulatory submissions as needed.
  • Mentor junior staff and perform co-monitoring visits to assess performance.

Ergomed Group provides clinical research, pharmacovigilance, and consulting services to biopharmaceutical companies, focusing on oncology and rare diseases. With a global team, they emphasize collaboration, kindness, and professional growth in a values-driven culture.

US

  • Collaborate with project teams to support study startup and serve as primary point of contact for clinical sites.
  • Provide training on Beacon's devices and protocols, monitor progress, and maintain GCP/ICH compliance.
  • Address operational issues via Zendesk and Asana and deliver actionable site feedback for workflow improvements.

Beacon Biosignals is transforming precision medicine for the brain with at-home EEG and cardiopulmonary monitoring platforms for clinical development and diagnostics. They foster a remote-first culture with hubs in Boston, New York, and Paris, emphasizing curiosity, simplicity, and empathy.

$120,000–$250,000/yr
US

  • Provide medical oversight for clinical trials, safeguarding participant safety and ensuring protocol compliance.
  • Review adverse events and safety data, contributing to regulatory reporting and clinical documentation.
  • Collaborate with investigators and clinical teams to support study design, execution, and risk management.

This position is listed on behalf of a partner company that manages all applications and next steps. The role supports global clinical research in a remote working environment with cross-functional collaboration.

Americas

  • Independently manage site monitoring activities for wound care clinical trials, ensuring data integrity and GCP compliance.
  • Collaborate with sponsors, investigators, and cross-functional teams to resolve issues and support effective trial delivery.
  • Contribute to study planning, regulatory documentation, audit readiness, and patient recruitment oversight.

The company is a clinical research organization focused on wound care trials. It offers a collaborative, international, and innovation-driven culture with opportunities for professional development and flexible remote work.

  • Conduct and report all types of onsite monitoring visits.
  • Perform CRF review, source document verification, and query resolution.
  • Support study startup, site communication, and audits.

PSI is a leading CRO with 30+ years in the industry, offering stability and innovation. We focus on quality and on-time services across therapeutic indications, with friendly and supportive colleagues.

Latin America

  • Lead planning, execution, and oversight of clinical studies across Latin America.
  • Act as primary client contact and ensure compliance with ICH-GCP, SOPs, and regulatory requirements.
  • Mentor CRAs and partners while shaping country-level recruitment and monitoring strategies.

Precision Medicine Group provides clinical development, regulatory, and commercial solutions for life sciences companies. It fosters a collaborative, high-integrity culture with opportunities for growth and leadership in a global remote environment.

US Brazil

  • Lead Risk-Based Quality Management (RBQM) activities to ensure clinical trial quality and alignment with study objectives.
  • Oversee centralized monitoring, including developing Central Monitoring Plans, reviewing KRIs/QTLs, and maintaining dashboards.
  • Collaborate with global teams and sponsors to identify risks, recommend mitigations, and support inspection readiness.

A global clinical research organization focused on advancing medical innovation and improving patient outcomes through high-quality clinical trials. The company fosters a collaborative, multidisciplinary remote environment with international teams and a strong emphasis on regulatory compliance and data-driven decision-making.

US

  • Manage an assigned portfolio of clinical research technology customers, building trust and driving strategic account plans.
  • Lead onboarding, adoption, and training to help research sites maximize value from the clinical trial management platform.
  • Drive retention and revenue growth through renewals, expansion opportunities, and cross-functional collaboration.

This partner company provides innovative clinical trial management technology for healthcare and clinical research organizations. They foster a collaborative, inclusive, and technology-driven culture with multidisciplinary teams.

$158,000–$188,000/yr
US

  • Serve as scientific lead for clinical programs, supporting trial design, execution, data interpretation, and regulatory activities.
  • Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Regulatory Affairs, and external partners.
  • Contribute to scientific publications, regulatory submissions, and relationships with investigators and key opinion leaders.

The company is a clinical-stage organization advancing innovative regenerative therapies for significant unmet needs in ophthalmology. It fosters a collaborative, high-performance culture with mentorship and professional growth opportunities.

  • Ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements across assigned sites.
  • Conduct remote and on-site monitoring activities, including source document review and data verification.
  • Collaborate with site personnel and project teams to support oncology study delivery and inspection readiness.

Parexel is a leading global clinical research organization delivering insight-driven clinical and consulting solutions to the life sciences industry. With over 22,000 employees worldwide, they foster a collaborative, patient-focused culture dedicated to accelerating the delivery of new therapies.

$120,000–$140,000/yr
US

  • Lead complex client implementations, from customer use cases to success metrics and clinical workflows.
  • Train and educate customers on BioIntelliSense product offerings and value proposition.
  • Provide ongoing clinical support and post-implementation optimization while coordinating across teams.

BioIntelliSense is a healthcare technology company providing FDA-cleared wearable monitors, like the BioButton, and AI-driven analytics for early detection of patient decline. The company has a remote-first culture with a global team and offices in Colorado and California.

$120,300–$222,600/yr
US

  • Oversee EMEA clinical trial operations, partnering with CROs and sites to ensure compliance and timely execution.
  • Lead regional regulatory submission strategies and proactively resolve operational challenges to maintain study timelines.
  • Mentor junior team members, review data and TMF documentation, and provide regular study updates to stakeholders.

Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on developing transformative treatments for metabolic diseases. The company fosters a collaborative culture of problem solvers dedicated to bringing bold scientific approaches to patients.

India

  • Lead medium- to high-complexity clinical trials with full accountability for timelines, budgets, resources, and quality.
  • Oversee financial performance, risk mitigation, and quality standards while ensuring regulatory compliance.
  • Mentor Project Leaders and represent project leadership in client meetings, bid activities, and conferences.

A clinical research organization managing complex clinical trials and therapies. It fosters a fast-paced, collaborative environment focused on innovation, accountability, and professional development.