• Support multiple projects in clinical research and clinical trials. • Manage tasks related to clinical trials: recruitment, data management, and regulatory management. • Assist with audits and quality assurance reviews; prepare and attend site visits. • Assist with the preparation of IRB applications and document maintenance. • Collect and process biological specimens for studies when needed (Ex: blood, saliva, urine, placenta, breastmilk). • Evaluate and track the eligibility of all patients seen in the clinic. • Recruit subjects to participate in the assigned study using approved methodologies. • Conduct the enrollment of study participants, explain research procedures, and obtain informed consent. • Schedule appointments of study participants; conduct reminder phone calls and/or send mail-outs. • Perform biospecimen collection for study purposes, including but not limited to: blood (phlebotomy), saliva (cheek swabs), urine collection, breastmilk collection, and placental tissue. • Perform office-related duties such as managing communications, updating policy manuals, maintaining records, etc. • Review and abstract medical records for inclusion/exclusion criteria. • Access patient demographic and clinical information from clinical systems. • Supervise and train student research assistants in EMR data abstraction and data entry. • Review data for quality and completeness.

• Support the execution of cardiovascular trials by translating scientific and clinical strategy into high-quality study delivery across global, complex, late-stage clinical trials. • Provide hands-on oversight of protocol execution, medical data review, endpoint quality, and cross-functional issue resolution to enable timely, decision-ready data. • Serve as a clinical and scientific subject-matter expert for cardiovascular trials, with deep understanding of cardiovascular disease, endpoint strategy, protocol execution, and data integrity. • Contribute to medical monitoring activities and support ongoing review of subject-level and aggregate clinical data to identify safety signals, endpoint trends, protocol deviations, and emerging operational or scientific risks. • Present information internally and externally, anticipating and actively managing issues across a broad spectrum of cross-functional stakeholders, governance bodies, and external partners. • Provide guidance and oversight in the identification and management of collaborators, consultants, adjudication vendors, and/or Clinical Research Organizations (CROs) to support successful trial delivery. • Work cross-functionally to translate clinical strategy into study concept documents, protocols, endpoint definitions, charters, data review plans, and other key trial documents required for CV trial execution. • Ensure the scientific and operational integrity of protocols and clinical plans, including delivery of final protocol content and governance approvals for large, global, event-driven studies. • Provide clinical input into study startup, trial conduct, enrollment oversight, endpoint ascertainment, adjudication readiness, data review, and interpretation of results. • Review and analyze clinical trial data to ensure accuracy, completeness, consistency, and adherence to protocol, endpoint definitions, and regulatory requirements, with strong focus on MACE and other cardiovascular outcome measures where applicable. • Lead thorough data quality assessments in the context of a data monitoring and review plan to maintain high standards of endpoint reliability, safety oversight, and inspection readiness throughout the trial lifecycle.

Position: Clinical Research Coordinator II, Pediatrics Location: Boston, MA Schedule: 40 hours per week, Remote ABOUT BMC: At Boston Medical Center (BMC), our diverse staff works together for one goal — to provide exceptional and equitable care to improve the health of the people of Boston. Our bold vision to transform health care is powered by our respect for our patients and our commitment to ensure everyone who comes through our doors has a positive experience. You’ll find a supportive work environment at BMC, with rich opportunities throughout your career for training, development, and growth. POSTION SUMMARY : The Clinical Research Coordinator (CRC) II will support multiple projects in clinical research and clinical trials. The CRC will manage tasks related to clinical trials: recruitment, data management, and regulatory management. Will also assist with audits and quality assurance reviews; and prepares and attends site visits. Assists with the preparation of IRB applications and document maintenance and collects and processes biological specimens for appropriate studies when needed (Ex: blood, saliva, urine, placenta, breastmilk). JOB RESPONSIBILITIES: - Evaluating and tracking the eligibility of all patients seen in the clinic. Recruits subjects to participate in the assigned study by using approved methodologies, such as, reaching to healthcare providers for referrals, visiting clinics, using approved advertisements. - Conducts the enrollment of study participants, including explaining research procedures, and obtaining informed consent of subject and registering patients to cohort studies and other protocols. - Schedules appointments of study participants; conducts reminder phone calls and/or sends mail-outs. - Performs biospecimen collection for study purposes, including but not limited to: blood (phlebotomy), saliva (cheek swabs), urine collection, breastmilk collection, and placental tissue. - Performs office-related duties such as answering phones, picking up and delivering mail, storing and distributing office supplies, handling faxes, scanning, filing, photocopying, collating materials, maintaining the update of policy manuals, etc. - Reviews and abstracts the medical records for patients, including review of all records for inclusion/exclusion criteria. Accessing patient demographic and clinical information from the clinical systems. - Supervises and trains student research assistants in EMR data abstraction and data entry. - Reviewing data for quality and completeness for each enrollee for completion and quality (QA). Answers queries; performs data collection entry into database; maintains clear, concise, accurate and legible records. - Assists with the coordination of the collection, processing, organization, and storage of biological specimens in the systems. Maintaining on-going communications with research managers and PIs for data collection needs. - May assist in the preparation for IRB and regulatory submissions and maintenance of regulatory files (The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job. The above is not intended to represent an exhaustive list of accountable duties and responsibilities required). JOB REQUIREMENTS EDUCATION: CRC II: Experienced Level Position - Bachelor’s Degree by time of hire and 2-5 years of experience OR - Master's Degree - Special Intermittent Project Responsibilities (2-5 per year) EXPERIENCE: - Experience in a clinical research setting highly desirable. KNOWLEDGE, SKILLS & ABILITIES: - Excellent organization and communications skills required - REDCap knowledge strongly preferred - Strong interpersonal skills; ability to effectively interact with all levels of staff and externals contacts - Cultural sensitivity and comfort with a wide range of social, racial and ethnic populations - Must be detail oriented and have the ability to follow-through - Ability to effectively manage time and prioritize workload. Must practice discretion and adhere to hospital confidentiality guidelines at all times - Must have computer skills including the use of Microsoft Office Suite JOB BENEFITS: - Competitive pay - Tuition reimbursement and tuition remission programs - Highly subsidized medical, dental, and vision insurance options - Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base especially for individuals pursuing careers in medicine or biomedical research. - Pioneering Research: Engage in groundbreaking research projects that are driving the forefront of biomedical science. ABOUT THE DEPARTMENT: As the primary teaching hospital for Boston University Chobanian & Avedisian School of Medicine and BU schools of public health and dentistry, intellectual rigor shapes our inquiries. Our research is led by a belief that skin color, zip code, and financial circumstances shouldn’t dictate health. Boston Medical Center is an Equal Opportunity/Affirmative Action Employer. If you need accommodation for any part of the application process because of a medical condition or disability, please send an e-mail to Talentacquisition@bmc.org or call 617-638-8582 to let us know the nature of your request. Compensation Range: $42,500.00- $59,500.00This range offers an estimate based on the minimum job qualifications. However, our approach to determining base pay is comprehensive, and a broad range of factors is considered when making an offer. This includes education, experience, skills, and certifications/licensures as they directly relate to position requirements; as well as business/organizational needs, internal equity, and market-competitiveness. In addition, BMCHS offers generous total compensation that includes, but is not limited to, benefits (medical, dental, vision, pharmacy), discretionary annual bonuses and merit increases, Flexible Spending Accounts, 403(b) savings matches, paid time off, career advancement opportunities, and resources to support employee and family well-being. NOTE: This range is based on Boston-area data, and is subject to modification based on geographic location. Equal Opportunity Employer/Disabled/Veterans According to the FTC, there has been a rise in employment offer scams. Our current job openings are listed on our website and applications are received only through our website. We do not ask or require downloads of any applications, or “apps” job offers are not extended over text messages or social media platforms. We do not ask individuals to purchase equipment for or prior to employment.

Conduct clinical assessments of individuals with serious mental illness or intellectual disabilities, recommend appropriate levels of care, and ensure timely completion of evaluations while adhering to program compliance and standards of practice.