• Manage all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. • In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities, e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities. • Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. • Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. • Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). • May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. • Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings. • Collaborate with the clinical team and other departments as needed to meet deliverables of the project. • Regularly communicate with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. • Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. • Responsible for the timely archiving of documents and study materials for the department. • Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. • Continuously monitor clinical trials to assess performance and ensure contractual obligations are met. • May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials. • Communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues. • May coordinate all start-up activities, and ensure that essential document quality meets the expectation of Regulatory Compliance Review. • Ensure timely regulatory submissions (if appropriate) are addressed. • Reviews and follows up on all questions raised by ethics committees. • Provide input into preparation of forecast estimates for clinical activities. • Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

Role Description Black Canyon Consulting (BCC) is searching for a Clinical Trials Coordinator to support our work for the National Center for Biotechnology Information (NCBI) at the National Library of Medicine (NLM), an institute of the National Institutes of Health. This opportunity is full time and onsite at the NIH-NCBI in Bethesda, MD and/or remote work. The National Center for Biotechnology Information (NCBI) is part of the National Library of Medicine (NLM) at the National Institutes of Health (NIH). NCBI is the world’s premier biomedical center hosting over six million daily users that seek research, clinical, genetic, and other information that directly impacts biomedical research and public health. You will join NCBI’s team of web developers and software engineers to build robust, flexible web applications, APIs, and services. This role calls for an expert web developer with knowledge and experience in modern web development, testing, UI design and usability principles, and the ability to work effectively with user researchers, designers, product managers, scientists, security, and DevOps engineers. Duties & Responsibilities - Assist with the development of protocol, policies, and procedures - Assist with documentation and training of new staff on protocol procedures and required competencies - Participate in protocol development, audits, and required reporting to regulatory bodies and intramural research programs - Ensure compliance with FDA and IRB requirements for IND protocol - Provide agendas for weekly team meetings and record minutes as needed - Contribute to scientific and technical writing including documentation, checklists, and contribution to protocol and manuscripts - Collaborate on related projects, particularly with shared equipment, purchases, and clinical needs - Monitor study progress and develop benchmarks to ensure performance goals are met - Develop and maintain spreadsheets to track study progress - Maintain data and records in compliance with NIH policies and ensure integration with other data systems - Create training materials and track training, including equipment and techniques - Perform lab research, record, and analyze data, including documentation of test results - Ensure adherence to timelines - Document progress using electronic lab notebooks - Prepare summaries and reports - Submit orders for supplies, equipment, and training using NIH systems (e.g., POTS) - Meet weekly with PI, lab members, and clinical staff - Communicate with prospective research participants, perform telephone screens, and work with NIH staff to determine eligibility - Coordinate subject payments, eligibility, calendars, etc. - Complete required clinical trainings and training for study-specific procedures Benefits - Competitive benefits package, including medical, dental, and vision coverage - 401(k) plan with employer contribution - Paid holidays, vacation, and tuition reimbursement - Competitive salary commensurate with experience and location

• Manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes. • Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards. • Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures. • Build and manage strong relationships with trial investigators and stakeholders. • Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines. • Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.

Role Description The Clinical Nurse Liaison, RN is responsible for patient education and strategic oversight in support of our sales strategy. This RN will work directly with sales to process Optum infusion referrals within the hospital system, serve as a key resource, and effectively anticipate the needs of the customers and patients to develop solutions for their needs. This position requires sales training as directed by the Regional Sales Director. If you are located in Western US, you will have the flexibility to work remotely* as you take on some tough challenges. Primary Responsibilities: - Conduct welcome calls and provide patient education on therapy, monitoring, and side effects; ensure patient is provided with the updates and tools they need for successful infusions both during our intake process and once on service. - Maintain and grow provider relationships and provide responsive customer service with assigned accounts. - Conduct initial clinical assessment based on clinical information provided. - Assist in creating letters of medical necessity as well as provide assistance to the office/patient with the necessary clinical evidence to overturn a denial. - Assist sales representatives in ensuring assigned referrals result in a start of care. - Manage clinical and account liaison team providing leadership/mentorship through regular 1:1 check-ins and development calls. - Lead regular cadence of meetings to foster a positive team culture and learn from best practices. - Facilitate, along with Sales RRVP, all hiring, training, and onboarding of Clinical Liaisons and maintain ongoing competency check-offs as required. - Field training and coaching by working alongside liaisons as determined by sales leadership team. - Collaborate with regional leadership on development of growth strategies and initiatives. - Manage metrics associated with defined roles and responsibility. Qualifications - Current, unrestricted RN license in the state of practice. - 2+ years of experience working with laptops and/or tablets – including the ability to type and talk at the same time and toggle between multiple applications. - 1+ years of experience in a Clinical Liaison role. - 1+ years of leadership and/or management experience. - 1+ years of clinical educator experience. - Ability to travel within local assigned territory up to 50%; minimal overnight travel to occur. Requirements - 2+ years of home healthcare experience. - 1+ years of sales and customer service experience. - Knowledge of the Infusion Nursing standards (INS) and nursing process. - Meets expectations on most recent Common Review. - Demonstrated effective communication and teaching skills with patients, family members, and other staff members. - Proven understanding of business goals and sales strategy to build upon. - Demonstrated ability to solve complex problems and develop innovative solutions. - Demonstrated ability to work autonomously, managing own workload and seeking out opportunities to expand service opportunities. Benefits - Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. - Comprehensive benefits package. - Incentive and recognition programs. - Equity stock purchase. - 401k contribution (all benefits are subject to eligibility requirements). - The salary for this role will range from $60,200 to $107,400 annually based on full-time employment. Application Deadline This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.