Title: Digital Decision Aid Clinical Research Coordinator (Hybrid Opportunity) (2-Year Fixed-Term) Location: Stanford United States Job Description: The Stanford Prevention Research Center (SPRC) is a consortium of renowned experts who are world leaders in investigating chronic disease prevention and management. Their work focuses on identifying practical, science-based solutions for addressing some of society's most pervasive and burdensome health issues, such as obesity, diabetes, hypertension, and heart disease. As an internist and epidemiologist in the Center, Randall Stafford, MD, PhD, is the Director of the Center's Program on Prevention Outcomes and Practices. He and his research team focus on creating healthcare models that emphasize effective health communication and patient empowerment. His mission is to improve population health outcomes in the U.S. and globally through research that facilitates the development and broad dissemination of effective, efficient, patient-centered, and evidence-based healthcare strategies. Examples of these innovations include team-based care, patient self-management, health policy strategies, use of AI, and leveraging digital health technology. Dr. Stafford and his co-investigators seek an experienced and enthusiastic Clinical Research Coordinator 2 to join a multidisciplinary team conducting an NIH-funded clinical trial testing the effectiveness of a digital decision-making app in older people with advanced heart failure considering placement of an implantable cardioverter-defibrillator (ICD). The Clinical Research Coordinator 2 will manage multiple aspects of the clinical trial at Stanford, while also contributing to management of two additional clinical sites. Major tasks will include: - Clinical trial preparation, including human subjects and REDCap database construction - Training of participating clinicians - Participant recruitment and randomization - Participant data collection and follow-up scheduling - Protocol integrity, outcomes, and data monitoring - Coordinating the three clinical sites - Helping to disseminate the ICD app - Contributing to the team's broad research mission This is a hybrid eligible position. This is a two-year fixed-term position. Duties include: - Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. - Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data. - Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes. - Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work. - Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions. - Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries. - Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices. - Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones and invoice sponsors according to study contract. - Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance. - Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. DESIRED QUALIFICATIONS: - 4+ years of experience coordinating investigator-initiated clinical trials within an academic medical center. - Cardiology, medical device, and/or decision-making clinical trials coordination experience. - Enjoy working independently with older adults and their families. - Experience working with clinical research databases, particularly REDCap or similar platforms. - Experience with local and single-IRB requirements and submissions. - Proficiency in Spanish or Mandarin would be a bonus. EDUCATION & EXPERIENCE (REQUIRED): - Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): - Strong interpersonal skills. - Proficiency in Microsoft Office and database applications. - Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. - Knowledge of medical terminology. CERTIFICATIONS & LICENSES: - Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. - May require a valid California Driver's License. PHYSICAL REQUIREMENTS*: - Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. - Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. - Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. WORKING CONDITIONS: - Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. - May require extended or unusual work hours based on research requirements and business needs. WORKING STANDARDS: - Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. - Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. - Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu/. The expected pay range for this position is $86,248 to $100,158 per annum. Stanford University provides pay ranges representing its good faith estimate of the salary or hourly wage the university reasonably expects to pay for a position upon hire. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process. Why Stanford is for You Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with: - Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak. - A caring culture. We provide superb retirement plans, generous time-off, and family care resources. - A healthier you. Climb our rock wall or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits. - Discovery and fun. Stroll through historic sculptures, trails, and museums. - Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more. Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. Additional Information - Schedule: Full-time - Job Code: 4923 - Employee Status: Fixed-Term - Grade: H - Requisition ID: 108449 - Work Arrangement : Hybrid Eligible

Coordinate pediatric clinical study activities, manage data entry and electronic systems, assist in protocol development, and ensure compliance with research regulations while collaborating with multiple departments and stakeholders.

Coordinate data collection and participant recruitment for pediatric research, ensuring accurate documentation and safety. Assist with lab procedures and maintain regulatory records while traveling to participants' homes for data collection.

The Office of Human Subjects Research is seeking a Biospecimen Program Administrator. The purpose of this position is to ensure that best practices are applied to the ethical acquisition, use, and distribution of human biospecimens by JHU researchers and their collaborators. Best practices include educational, operational, technical, ethical, legal, and policy approaches to facilitate the responsible stewardship of human biospecimens used for research purposes. This position includes the role of JHU Institutional Stem Cell Research Oversight (ISCRO) Administrator and provides support to the activities of the ISCRO and related activities of the JHU Institutional Review Boards (IRBs). This position works closely with leadership across the Institution, including leaders from the Office of Research Administration (ORA), Johns Hopkins Technology Ventures (JHTV), Conflict of Interest Committee (COIC), HIPAA Privacy Office, the IRBs of the Johns Hopkins School of Public Health and Homewood Schools and other stakeholders (such as the ancillary committees engaged in the review of research with biospecimens, and the Animal Care and Use Committee). The Biospecimen Program Administrator also serves as a liaison for external entities for matters related to biospecimens in research. Specific Duties & Responsibilities - Provide leadership and vision for a centralized human biospecimen program at JHU. - Oversee development and implementation of related policies, procedures and programs for a human biospecimen program in compliance with federal regulations, state laws and Institutional requirements. - Provide direct support to the Biospecimen Transfer Committee (BTC) (to review and approve requests for use of human biospecimens obtained at JHU. The BTC will provide guidance for the acquisition, use, and transfer of human biospecimens for research, internal and external to JHU. - Serve as a member of the BTC and perform expedited reviews. - Work with the appropriate sponsored projects and contracting offices to facilitate the processes for Biospecimen Transfer Agreements. - Oversee development and implementation of education and training programs for the research community related to responsible derivation, use and distribution of biospecimens, including human stem cell-related research. - Develop and maintain registry of JHU ISCRO approved human embryonic stem cell lines to ensure timely and thorough review and approval of research protocols. - Serve as a representative for JHU's Biospecimen Program to both internal and external stakeholders. - Assist with the design, development and maintenance of electronic systems to support research with biospecimens, including but not limited to, eISCRO, eIRB, and any new tools needed to support the programs goals. - Provide reports to Institutional Officials related to research activities involving human biospecimens, as needed. - Maintain knowledge of current policy, guidance, and regulatory requirements related to human stem cell research and research with biospecimens (e.g., NAS, ISSCR, NIH, IRB, etc.) through continuing education, including attendance at related conferences. - Facilitate the development and implementation of new policies and educational programs as they arise. - Serve as the ISCRO Administrator, which includes the following responsibilities. - In collaboration with the ISCRO Co-chairs, provide guidance to researchers at JHU working with human pluripotent stem cells. - Serve as a liaison to the JHU IRBs for issues related to human pluripotent stem cells. Activities include select grant reviews, providing annual reports on ISCRO activities, assisting with review of applicable consent form language, and determinations regarding the need for ISCRO review. - Investigate provenance information for human embryonic stem cell lines requested for use by researchers. - Function as an alternate ISCRO member and conduct expedited reviews as designated. - Identify compliance issues and report to ISCRO Co-chairs. - Manage committee membership (orientation for new members, maintain roster, Bio sketches, membership renewals, attendance, and ensure payments to community members). - Oversee the day-to-day activities of the Biospecimen Program Analyst in provision of administrative support to the Biospecimen Transfer Committee and the ISCRO Committee including scheduling of convened and expedited actions for Committee review, pre-screening applications to ensure they have sufficient information for review, preparing agendas, timely preparation of meeting minutes and issuance of determination letters. - Maintains and updates the website for Human Stem Cell and Other Related Research and website content on the Office of Human Subjects Research website related to research with biospecimens. - Other duties as assigned. Minimum Qualifications - Master's Degree in a related scientific, legal, or business field. - Three years of related research and/or research ethics experience. - Additional education may substitute for required experience and additional related experience may substitute for required education beyond high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula. Preferred Qualifications - Knowledge of and familiarity with the regulatory agencies involved in human subjects research and pertinent laws and regulations and must have knowledge of related ethical considerations. - Ability to apply regulatory requirements to proposed research protocols and have excellent oral and written skills. Classified Title: Biospecimen Program Administrator Role/Level/Range: ATP/04/PE Starting Salary Range: $73,300 - $128,300 Annually ($95,000 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: Monday - Friday 8:30am - 5:00pm FLSA Status: Exempt Location: Remote Department name: SOM Admin Clinical Invest Human Subjects Personnel area: School of Medicine