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Global

  • Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
  • Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
  • Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.

Regulatory Compliance Project Management Microsoft Office Data Analysis

20 jobs similar to Lead Clinical Research Associate - Contract

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  • Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
  • Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
  • Collaborating with investigators and site staff to facilitate smooth study conduct.

ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of new medicines and treatments. As a values-driven company, ICON fosters a culture of integrity, collaboration, agility, and inclusion, employing a diverse workforce.

$109,000–$174,800/yr
United States

  • Serve as a subject matter expert for site management and monitoring strategies across complex clinical studies.
  • Collaborate with clinical teams, investigators, and stakeholders to ensure compliance, data quality, and trial success.
  • Mentor CRA staff, resolve escalated issues, and support site qualification, initiation, monitoring, and close-out visits.

Jobgether is a platform that uses AI-powered matching to connect candidates with job opportunities. They operate as a global healthcare and technology environment, offering professional growth and innovative solutions.

US

  • Serve as the primary point of contact and partner with investigative sites to ensure high-quality clinical trial conduct.
  • Conduct site evaluation, training, monitoring, and closure activities in compliance with regulations, GCPs, and SOPs.
  • Utilize risk-based monitoring and site engagement strategies to improve data integrity, compliance, and study performance.

AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. A large global biopharmaceutical company, AbbVie fosters a culture of innovation and integrity to transform patients' lives.

Brazil

  • Perform in-house and remote monitoring activities for clinical trials, ensuring compliance with regulatory requirements and study protocols.
  • Support study start-up, site selection, and document tracking while assisting CRAs with on-site and remote monitoring.
  • Communicate with investigative sites to resolve queries and maintain study tracking tools for deviations, SAEs, and data discrepancies.

Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. The environment is collaborative, international, and focused on improving patient outcomes through high-quality research.

Spain

  • You will monitor and own the progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
  • You will coordinate all activities to set up and monitor a study, including identifying investigators and preparing regulatory submissions.
  • You will travel domestically up to 50-60% for site visits and maintain fluency in English and local language.

Precision for Medicine is a clinical research organization focused on precision medicine for oncology and rare diseases. They are a smaller CRO with a strong culture and high employee retention.

Global

  • Provides study-level oversight and leadership for global clinical trials from inception through closure, managing vendors, recruitment, and cross-functional teams.
  • Develops and manages study materials including protocols, regulatory submissions, and budgets while ensuring compliance with quality standards and inspection readiness.
  • Contributes to system management like EDC, IRT, and eTMF, and supports process improvement initiatives or serves as a mentor.

AbbVie discovers and delivers innovative medicines and solutions to address serious health issues in immunology, oncology, neuroscience, and aesthetics. As a global biopharmaceutical company with a robust pipeline, they emphasize integrity and innovation, serving patients worldwide with a dedicated team.

US

  • Lead and mentor a high-performing team of Clinical Research Associates, ensuring operational excellence and efficient resource utilization.
  • Manage hiring, onboarding, performance management, and professional development activities for CRA staff.
  • Collaborate with Project Managers and cross-functional teams to support successful delivery of clinical trials.

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a balance between stability and innovation. They focus on delivering quality and on-time services across various therapeutic indications.

$138,600–$173,300/yr
US

  • Manage all aspects of clinical trials from start-up through close-out, ensuring timelines, costs, and quality metrics are met.
  • Oversee vendor/CRO selection and management, study contracting, budgeting, and forecasting.
  • Lead study-related activities including protocol preparation, investigator selection, and training, and collaborate with cross-functional teams.

Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.

Poland

  • Manage and deliver full clinical site monitoring services for complex multinational projects, ensuring compliance with SOPs, study guidelines, and GCP best practices.
  • Act as Lead CRA, serving as primary liaison between CRAs and project teams, and participate in development of monitoring plans, protocols, and tools.
  • Identify and recruit site investigators, oversee investigational site monitoring, and ensure site staff are compliant with training requirements.

Alimentiv is a clinical research organization providing monitoring and site management services for clinical trials. They are a full-time, permanent employer with a focus on building collaborative relationships and maintaining high standards in clinical study delivery.

US

  • Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for clinical trials.
  • Serve as the internal project manager for assigned oncology disease groups, providing timely updates and regulatory guidance.
  • Manage study activation processes and act as liaison between sponsors, investigators, and internal departments.

Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. Winship Cancer Institute is Georgia's only NCI-designated Comprehensive Cancer Center, dedicated to discovering cures for cancer and providing innovative therapies.

Canada

  • Conduct and report SIV, RMV, COV onsite monitoring visits and perform CRF review, source document verification, and query resolution.
  • Manage site communication and be the point of contact for in-house support services and vendors, while communicating with internal project teams on study progress.
  • Support regulatory teams in preparing documents for study submissions and prepare for and participate in audits and inspections.

The company is a dynamic, global mid-size clinical research organization founded in 1995, bringing together more than 3,000 dedicated individuals. They work on the frontline of medical science, changing lives and bringing new medicines to those who need them.

United States

  • Serves as clinical trial lead, overseeing study planning, conduct, and oversight per protocol and regulations.
  • Develops study documents, manages site feasibility, and drives recruitment strategies.
  • Leads internal clinical team meetings and ensures quality deliverables through metric reporting.

Precision Medicine Group is a life sciences company that supports clinical research and development. The company is large enough to offer a range of benefits and emphasizes a collaborative, ethical culture focused on quality and compliance.

Poland

  • Monitor and own the progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
  • Coordinate all necessary activities to set up and monitor a study, including investigator identification, regulatory submissions, and pre-study/initiation visits.
  • Identify potential study risks, propose solutions, and handle conflict using resolution strategies while maintaining quality and attention to detail.

Precision for Medicine, Oncology & Rare Disease is a precision medicine CRO that combines novel clinical trial designs, operational expertise, and biomarker analytics to advance oncology and rare disease treatments. The company fosters a culture with high CRA retention, small team influence, and a focus on work/life balance.

$75,000–$142,500/yr
US

  • Acts as primary point of contact for investigative sites, providing training and support to ensure compliance with protocols and regulations.
  • Conducts site evaluation, monitoring, and closure activities while managing recruitment and retention plans based on patient journey.
  • Collaborates with central monitoring to assess risks and ensure data quality, safety reporting, and audit readiness at assigned sites.

AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, and neuroscience. It is a large pharmaceutical company with a global presence and a culture focused on remarkable impact.

US

  • Accountable for leading assigned clinical research activities and partnering with stakeholders on study design.
  • Conducts on-site and remote site visits, including qualification, initiation, monitoring, and close-out.
  • Tracks study progress, manages budgets, and mentors junior clinical study managers.

Intuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to minimally invasive care. With over 25 years of experience, the company fosters an inclusive and diverse team culture where employees are empowered to do their best work.

Latin America

  • Acts as primary site contact and liaison for study management issues, ensuring compliance with ICH-GCP and regulatory requirements.
  • Manages essential document collection, maintenance, and TMF organization, and coordinates investigator recruitment activities.
  • Assists with data review, EDC entry, and supports offsite central monitoring and study supply management.

Precision Medicine Group is a clinical research organization providing services to pharmaceutical and biotech companies. The company has a global presence and fosters a collaborative culture focused on precision medicine.

Europe

  • Manage and oversee all clinical aspects of trials across multiple countries, ensuring timeline adherence, quality, and scope.
  • Lead CRAs and collaborate with cross-functional teams to achieve high client satisfaction and smooth trial operations.
  • Identify risks, develop creative action plans, and maintain focus on study priorities through effective communication.

Precision for Medicine is a precision medicine CRO that combines novel trial designs, advanced biomarker analytics, and deep oncology expertise to accelerate drug development. The company fosters a dynamic, high-energy culture and values dedicated professionals who thrive in challenging environments.

Global

  • Manage a team of 15-17 Study Management Associates (SMAs) to deliver best-in-class study execution.
  • Drive performance management, mentoring, and professional development for direct reports.
  • Support resource management, adherence to regulations, and continuous process improvements.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. The company operates across several therapeutic areas including immunology, oncology, and neuroscience, with a significant global presence and a culture focused on innovation and impact.

Mexico

  • Reviews patient data for Phase I-IV clinical research and non-interventional studies to ensure compliance with protocols and regulatory requirements.
  • Communicates and escalates serious issues to the project team and develops action plans as needed.
  • Maintains working knowledge of ICH/GCP guidelines and company SOPs, documenting activities per project requirements.

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We are a global company with over 29,000 employees, dedicated to developing our people and building an inclusive culture.

India

  • Provide administrative and operational support to project teams throughout the clinical research project lifecycle.
  • Coordinate meeting logistics, documentation, and stakeholder communications to ensure smooth execution.
  • Assist with data entry, report generation, and compliance with regulatory requirements.

This partner company provides clinical research project management services to clients globally. They offer a fully remote, collaborative work environment focused on quality and continuous improvement.