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.
Provide leadership and high-level technical support for research compliance, including reviewing human subjects research submissions and non-research determinations.
Support project teams with data management plans and ensure compliant closeout of learning activities.
Collaborate with the IRBhelp team to ensure timely review and feedback on submissions.
Jhpiego is a nonprofit global health organization affiliated with Johns Hopkins University, focused on improving the health of women and families. With a global presence, it operates in challenging environments across Africa, Asia, and Latin America, emphasizing research compliance and program learning.
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.
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.
Responsible for site activation readiness, including preparation and submission of Clinical Trial Application Forms to Competent Authorities and Ethics Committees.
Manage collection of essential documents, customize informed consent forms, and coordinate translations for study-specific documents.
Maintain communication with key functions (Feasibility, Clinical Operations, Regulatory) and update project trackers and regulatory intelligence tools.
Precision for Medicine is a Clinical Research Organization focused on precision medicine, combining novel clinical trial designs and advanced biomarker solutions, particularly in rare diseases and oncology. The company is growing and seeks dedicated professionals to support its mission, fostering a culture where employees feel appreciated and their ideas valued.
Lead and supervise staff performing pre-award activities for sponsored projects research portfolio.
Develop budgets, compile proposal contents, and assist in submission of JIT forms and sub-award documents.
Apply federal and university rules to manage effort allocation and ensure customer service to faculty and 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. It provides a collaborative environment with a focus on academic and research achievements.
Serve as the primary liaison for investigator sites, conducting monitoring activities including initiation, routine visits, and close-out while ensuring ICH-GCP compliance.
Support site activation, recruitment, and enrollment, oversee adverse event reporting, and maintain accurate study documentation.
Manage investigational product handling, develop corrective actions for site issues, and participate in audit readiness activities.
Jobgether is a platform that uses AI-powered matching to connect candidates with clinical research roles. The company evaluates applications objectively and shares top candidates with hiring partners, focusing on improving patient access to innovative therapies.
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.
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.
Leads and supervises post-award staff for sponsored projects research portfolio.
Applies federal and university rules to effort allocation and costing for funded projects.
Ensures strong customer service to faculty and departments, monitoring performance and resolving issues.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. Emory is an equal opportunity employer committed to diversity and inclusion.
Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Manages post-award activities for a portfolio of grants and contracts using knowledge of grant management rules and regulations.
Interacts regularly with faculty, ensures adherence to policies, and solves problems related to post-award activities.
Coordinates budget adjustments, financial reporting, and compliance monitoring through the lifecycle of awards.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We are a large academic institution committed to equal opportunity and diversity.
Acts as a signatory for Harvard College on sponsored research documents and reviews awards for compliance with policies.
Negotiates terms and conditions for agreements like DUAs and awards, providing support for award management.
Communicates consistently with stakeholders and resolves issues with high-level judgment as an expert in research administration.
Harvard University is a vibrant community advancing world-changing missions through innovation and collaboration. The Harvard T.H. Chan School of Public Health is a world-renowned institution dedicated to public health research, education, and global collaboration, fostering a collaborative and inclusive work environment.
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.
Create, maintain, and control accurate versions of source documents for clinical trials following GCP and 21 CFR Part 11.
Design e-Source and paper source templates based on protocol reviews and coordinate review and update processes.
Manage version control, communication with site staff, and ensure source documents record all required trial data.
Care Access works to improve global health by bringing clinical research and health services directly to communities. They operate hundreds of research locations and mobile clinics worldwide, focusing on accessibility and community impact.
Design and execute IRB protocols, managing consent and patient enrollment for high-priority clinical studies.
Build cross-functional research infrastructure with Clinical Operations, Product, and Data teams.
Draft white papers, conference abstracts, and contribute to peer-reviewed publications.
Nourish is building the largest dietitian-led metabolic health clinic, offering AI-native digital health services across all 50 states. Founded four years ago, the company has completed millions of appointments, tripled year-over-year, and raised $215M in funding, partnering with health plans covering over 200M Americans.
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.
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.
Draft, review, and negotiate clinical site agreements and related documents to ensure compliance with regulatory standards.
Manage the full contract execution process, including tracking timelines, resolving issues, and coordinating signatures.
Act as a key liaison between internal teams and clinical sites, ensuring clear communication and adherence to budgets and regulations.
Our partner is a company in the life sciences industry focused on clinical trial execution and regulatory compliance, contributing to the development of life-changing therapies. The environment is collaborative, quality-driven, and fast-paced, with a strong emphasis on accuracy, communication, and professional growth.
Leads writing and preparing clinical and regulatory documents for drug and device development.
Coordinates review, approval, and quality control across functions to ensure compliance and timelines.
Develops knowledge of US and international regulations and participates in process improvements.
AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, neuroscience, and aesthetics. They are a large global biopharmaceutical company committed to having a remarkable impact on people's lives.