The American College of Radiology is a professional association serving over 40,000 members across the country. Consistent with the ACR’s mission to advance the practice of radiology and improve the health outcomes of the populations we serve, the ACR’s Center for Research and Innovation (CRI) has been a world leader in radiology clinical research for over 50 years. Over this period, the CRI has conducted clinical research trials and other research projects which have transformed the practice of radiology, informed the development of clinical practice standards, led to new device approvals, and changed healthcare policy.
The CRI serves as the core radiology resource for NCI multicenter clinical trials involving diagnostic or therapeutic radiology. And, through active research committees in neuroradiology, cardiology, oncology, and pediatrics, the CRI has developed and delivered a diverse range of research studies in partnerships with academia and with commercial sponsors. Research studies range from prospective clinical trials to retrospective reader studies, novel imaging methods and imaging software, validation of biomarkers, radiomic feature analysis, and AI algorithm development and validation.
To support these strategic objectives, ACR is seeking a Clinical Research Attorney. The Attorney will provide strategic, legal and ethics guidance to ACR leadership and staff in contractual, regulatory, procurement, and other ACR business matters.
As a member of the ACR team you will:
- Draft, negotiate, and review: Clinical Trial Agreements (CTAs), Business Associate Agreements (BAAs), and Data Use Agreements from both federally and privately funded research programs;
- Review contracts for legal and corporate issues and to ensure compliance with State/Federal statutes and regulations;
- Review procurement documents, including Request for Proposals, Invitation for Bids, other solicitations and associated documents;
- Conduct complex legal research and render opinions in contractual, fiscal, and other research matters, requiring thorough knowledge of specialized regulations and procedures;
- Provide legal advice and representation in matters involving the research program;
- Contribute to developing and implementing contracting policies and risk management strategies.
Qualified candidates will possess the following:
- 10+ years of related experience required. 5+ years of legal experience at a pharmaceutical, biotechnology, medical device, life sciences, or university research office preferred.
- Experience drafting and negotiating Clinical Trial Agreements with industry sponsors, government agencies, universities, and large healthcare companies.
- Experience drafting and negotiating documents including informed consent forms, confidentiality, regulatory, consulting, supply, and other related clinical trial agreements.
- Knowledge of laws, regulations, practices, and industry standards governing clinical trials, such as FDA regulations, HIPAA, GDPR, International Conference on Harmonization(ICH) Guidelines, and Good Clinical Practice (GCP).
- Ability to collaborate with various teams in a dynamic environment with multiple priorities and objectives.
- Admission to, and active membership in, the Pennsylvania bar required.
If you would like to put your experience to great use in a professional team-oriented environment, please apply online. To learn more about ACR’s rewarding employee experience, culture, and benefits, visit: https://www.acr.org/About-ACR/Work-With-Us
ACR offers a rewarding employee experience: innovative culture, professional growth potential, competitive compensation and an exceptional benefits package, including a defined contribution pension plan, 403(b); generous paid time off package; insurance plans with the leading providers; flexible spending; tuition reimbursement; training opportunities; and wellness reimbursement.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)