Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today. TRIO is looking for a Clinical Research Physician to join our Medical Monitoring Unit team. Reporting to the Medical Monitoring Unit Manager, this will be a home-based, full-time position in the USA. Main Responsibilities: - Act as Medical Monitor, performing comprehensive medical monitoring activities. - Respond to medical inquiries from investigational sites and trial teams. - Review patient eligibility and protocol deviations. - Oversee patient safety by reviewing medical data at patient and trial levels. - Review Serious Adverse Events (SAEs), including coding, causality and expectedness assessments, and drafting company comments. - Prepares scientific slides, attends and/or presents protocol information at Investigator Meetings, Scientific Committee meetings, Safety Review Committee meetings, SIVs, etc. - Serve as the primary clinical point of contact for scientific questions from internal and external stakeholders (e.g., IRBs, sites, sponsor medical teams, trial teams). - Collaborates with the Medical Writing and Training Unit to write and/or review trial-specific medical documents (e.g., protocols, DSURs, CSRs). - Conducting medical training on selected trial-specific or non-trial-specific topics. Qualifications: - Medical Doctor degree required - Excellent knowledge and understanding of oncology and oncology clinical trials - At least 1 year of experience in medical monitoring in oncology trials - Current knowledge of ICH GCP guidelines - Advanced proficiency in MS Office in Word, Excel, and PowerPoint - Strong teamwork abilities and communication skills - Excellent level of English is required - Spanish language knowledge will be valued - Must be legally authorized to work in the country What TRIO Can Offer You: - Competitive Salary - 3 weeks of vacation plus paid Christmas Closure - 2 weeks paid personal/sick time - 100% health benefits for you and your family paid by TRIO - Flexible working hours - Monthly internet allowance - 401K Program 5% Salary Contribution - Home office allowance Pay Range: $110,000 - $150,000. Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data. Prior to applying please review TRIO's Applicant Information Notice To support efficiency, TRIO may use limited AI tools during the candidate review process. All hiring decisions are made by people, not AI. To ensure fairness and an accurate understanding of your skills, we ask that candidates refrain from using AI tools or AI‑generated responses during interviews or assessments. We want the opportunity to get to know you and your experience. Teamwork · Passion · Integrity · Innovation

Communicate with healthcare teams to clarify and obtain essential medical record documentation. Conduct in-depth chart reviews to ensure accurate coding and compliance with quality metrics, enhancing overall clinical documentation improvement efforts.

Monitor and manage clinical trials, ensuring compliance with protocols and regulatory requirements. Conduct site visits, verify data accuracy, and train site staff on procedures while maintaining effective communication with stakeholders.

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