• Responsible for the management of Clinical Trials from vendor selection through Clinical Study Report (CSR) completion. • Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements. • Create and implement study-specific clinical monitoring tools and documents, including informed consent development and EU CTR. • Lead the identification, evaluation, selection, and oversight of clinical trial sites. • Author and implement operational plans to ensure efficient study enrollment and high-quality monitoring activities at clinical sites. • Review/approve vendor and site invoices and track study budget to forecast, working closely with finance and clinical business operations. • Responsible for implementation and oversight of Trial Master File for inspection readiness. • Drive overall process and provide support to cross-functional teams in the development of study documents including study protocols, consent forms and budget templates. • Serve as lead in the creation of project plans, logs, templates, newsletters, and other documents. • Review and approve site specific documents (such as informed consent forms, site budgets, monitoring reports) along with other relevant project team members. • Provide study updates and reports, inclusive of study risks and issues. • Lead internal and external meetings for assigned clinical trial(s), including Investigator Meetings, conferences, events and study management meetings. • Responsible for ongoing study data reviews and data cleaning activities. • Provide oversight of CTA and CRA activities such as site identification, qualification, selection, initiation, data quality, sample tracking, interim monitoring and close out activities. • Manage trial-level quality risk management. • Oversee study supplies management. • Support the development and complete the delivery of study training to investigators, site staff and internal staff on study processes. • Participate in the preparation and follow up of internal process audits, vendor, and study site quality audits as well as regulatory inspections. • Other duties as assigned.

• Design and analyse clinical trials • Drive clinical operations performance, ensuring quality • Oversee the planning, execution, and management of clinical trials • Provide strategic direction and guidance to cross-functional teams • Collaborate with key stakeholders to develop and implement innovative clinical trial strategies • Ensure compliance with regulatory requirements and industry standards

• Provide operational oversight and support for multiple clinical research sites within the network. • Monitor site performance metrics including enrollment, retention, protocol compliance, data quality, query resolution, and study timelines. • Ensure consistent implementation of SOPs, operational workflows, and best practices across all assigned sites. • Identify operational gaps and implement process improvement initiatives to enhance efficiency and site performance. • Support study startup activities including feasibility, site activation, staffing readiness, staff training, and sponsor/CRO coordination. • Partner with site leadership to optimize resource allocation, staffing coverage, and workflow management. • Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols. • Support audit readiness and assist with sponsor, CRO, and regulatory inspections/audits. • Monitor protocol deviations, CAPAs, and quality-related issues and collaborate with site teams on corrective actions. • Promote a culture of compliance, quality, and patient safety throughout the site network. • Serve as a primary operational partner to PIs, Sub-Is, CRCs, and site staff. • Provide mentorship, coaching, and operational guidance to clinical research personnel. • Assist with onboarding, training, and ongoing development of site staff. • Foster strong collaboration and communication across cross-functional teams and site locations. • Track and report on key operational and financial metrics across assigned sites. • Support achievement of enrollment targets, study milestones, and organizational growth initiatives. • Collaborate with leadership on strategic initiatives, expansion opportunities, and operational scaling efforts.

Role Description The Medical Records Technician (Clinical Documentation Improvement Specialist (CDIS - Inpatient)) is located in the Health Information Management (HIM) section of the Health Administration Service at the VA Maryland Health Care System. Medical Records Technicians are skilled in classifying medical data from patient health records in the hospital setting, and/or physician-based settings. - Responsible for reviewing the overall quality and completeness of clinical documentation. - Applies comprehensive knowledge of: - Medical terminology - Anatomy & physiology - Disease processes - Treatment modalities - Diagnostic tests - Medications - Procedures - Principles and practices of health services - Organizational structure - Collaborates with clinical staff through written, verbal, or electronic clarification requests or queries. - Reviews clinical documentation and provides education to clinical staff on both inpatient and outpatient episodes of care including: - Admissions and discharges - Observation - Emergency department/urgent care - Clinic visits - Prepares and conducts provider education on documentation processes in the health record. - Provides education to providers on: - Accurate and complete documentation - Appropriate code selection of Evaluation and Management (E/M), CPT, and ICD-10 diagnosis codes - Ensuring documentation supports the codes selected to the highest degree of specificity - Assists facility staff with documentation requirements to accurately reflect patient care provided. - Directly consults with professional staff for clarification of conflicting or ambiguous clinical data. - Reports incorrect documentation in the electronic patient health record. - Adheres to accepted coding practices, guidelines, and conventions. - Expertly searches the patient health record to find documentation justifying code assignment. - Queries medical staff and other clinical caregivers as necessary to obtain accurate and complete documentation. - Uses a variety of computer applications in day-to-day activities, such as Outlook, Excel, Word, and Access. - Develops and conducts seminars, workshops, short courses, informational briefings, and conferences on health record documentation. - Ensures active intra-departmental training program is in place for HIM staff. - Determines and meets training needs of extra-departmental personnel. - Facilitates improved overall quality, completeness, and accuracy of health record documentation. Qualifications - United States Citizenship. - Experience: One year of creditable experience indicating knowledge of medical terminology, anatomy, physiology, pathophysiology, medical coding, and health records. - Education: An associate's degree from an accredited college or university with a major in health information technology/management, or related degree. - Completion of an AHIMA approved coding program or other intense coding training program. - Certification: Must have either: - Apprentice/Associate Level Certification through AHIMA or AAPC. - Mastery Level Certification through AHIMA or AAPC. - Clinical Documentation Improvement Certification through AHIMA or ACDIS. - English Language Proficiency. Requirements - Knowledge of coding and documentation concepts, guidelines, and clinical terminology. - Knowledge of anatomy and physiology, pathophysiology, and pharmacology. - Ability to collect and analyze data and present results. - Ability to establish and maintain strong communication with providers. - Knowledge of regulations defining healthcare documentation requirements. - Extensive knowledge of coding rules and regulations. - Knowledge of severity of illness, risk of mortality, and complexity of care for inpatients. - Knowledge of training methods and teaching skills. Benefits - Competitive salary and regular salary increases. - 37-50 days of annual paid time off per year. - Up to 12 weeks of paid parental leave after 12 months of employment. - Childcare subsidy for eligible employees. - Traditional federal pension and federal 401K with contributions by VA. - Federal health/vision/dental/term life/long-term care insurance. - Telework options available. - This is a virtual position.