Role Description The Clinical Documentation Specialist is responsible for the evaluation of physician documentation utilizing their clinical expertise to ensure the patients’ severity of illness is accurately portrayed in the medical record for specificity of coding and increased coding accuracy. They provide guidance to the physicians, nursing, and ancillary staff on clinical documentation best practices. They must be self-motivated and be adaptive to change. - Responsible for the day-to-day evaluation of inpatient documentation in accordance with the Clinical Documentation Program requirements. - Ensures the accuracy and completeness of clinical information which is used for measuring and reporting physician and hospital outcomes. - Communicate with members of the medical staff on an ongoing basis to assure the documentation in the medical record adequately reflects the diagnoses being treated and the procedure performed. - In addition to the above job responsibilities, other duties may be assigned. Qualifications - RN, graduate of accredited nursing program and Bachelor of Science in Nursing required within 5 years of hire. - A minimum of three years of experience as a Clinical Documentation Specialist is required. - Clinical experience in multiple areas, particularly in the ICU, is preferred. - Licensed to Practice as a Registered Nurse in the Commonwealth of Virginia. Requirements - Starting Rate: $35.31/hour - Reference Check Process: Reference Checks will be completed by UVA’s third-party partner, SkillSurvey, during the final phase of the interview process. Five references will be requested, with at least three responses required. - Physical Demands: This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings and programs. - The starting base rate for this role is $35.31 hourly. Individual compensation will be determined by the selected candidate's qualifications, previous work experience, and/or education. Benefits - Comprehensive Benefits Package: Medical, Dental, and Vision Insurance - Paid Time Off, Long-term and Short-term Disability, Retirement Savings - Health Saving Plans, and Flexible Spending Accounts - Certification and education support - Generous Paid Time Off Company Description UVA Health is a world-class Magnet Recognized academic medical center and health system with a level 1 trauma center. 2023-2024 U.S. News & World Report “Best Hospitals” guide rates UVA Health University Medical Center as “High Performing” in 5 adult specialties and 14 conditions/procedures. - We are one of 70 National Cancer Institute designated cancer centers. - UVA Health Children’s is named by 2023-2024 U.S. News & World Report as the best children's hospital in Virginia with 9 specialties ranked among the best in the nation. - Our footprint also encompasses 3 community hospitals and an integrated network of primary and specialty care clinics throughout Charlottesville, Culpeper, Northern Virginia, and beyond. The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Learn more about UVA’s commitment to non-discrimination and equal opportunity employment.

Role Description The Senior Clinical Research Monitor is responsible for monitoring and supporting clinical trials to ensure they are conducted in accordance with study protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements. This role works closely with investigators, clinical research organizations (CROs), hospitals, and internal stakeholders to initiate, monitor, and manage clinical studies while ensuring high-quality execution and compliance. This position can be remote within the US. - Monitor clinical trials at the site level and/or headquarters to ensure compliance with protocols, SOPs, GCP, and regulatory requirements. - Serve as a liaison with clinical investigators, CROs, hospitals, and research institutions to support the initiation and execution of clinical studies. - Review adverse events with investigators and ensure appropriate reporting and documentation. - Manage study timelines, budgets, and schedules; prepare study documents and status reports. - Train investigators and site personnel on study protocols and requirements. - Support implementation of clinical development strategies and assist with clinical evaluation projects. - Identify and recommend qualified investigators and assist with site initiation activities. - Support patient recruitment and retention efforts. - Provide guidance to junior clinical research professionals and may lead or manage assigned projects. Qualifications - Bachelor’s Degree and 4 years of relevant clinical research experience OR Advanced Degree with 2 years of relevant clinical research experience. Requirements - Prior experience monitoring medical device clinical trials. - Experience working with CROs and managing external research partners. - Knowledge of global regulatory requirements (e.g., FDA, EU MDR, ISO 14155). - Experience with electronic data capture (EDC), CTMS, and clinical trial management systems. - Demonstrated ability to manage multiple clinical sites and prioritize competing timelines. - Previous experience mentoring junior CRAs or supporting cross-functional clinical study teams. Benefits - Competitive salary and flexible benefits package. - Health, dental, and vision insurance. - Access to a Health Savings Account and Healthcare Flexible Spending Account. - Life insurance and long-term disability leave. - Dependent daycare spending account. - Incentive plans and a 401(k) plan with company match. - Short-term disability coverage. - Paid time off and holidays. - Participation in the Employee Stock Purchase Plan. - Access to the Employee Assistance Program. - Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.

Role Description The Clinical Trial Manager is responsible for managing the execution of clinical studies and data collection. The incumbent oversees the review, monitoring, and adherence to clinical protocols, as well as fulfilling activities related to study completion. The Clinical Trial Manager will interact internally and externally with members of the cross-functional study team. - Provide oversight of clinical research studies across all functional areas of the drug development process. - Provide operational and strategic input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc. - Develop the subject recruitment/retention strategy and related initiatives. - Oversight of TMF set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate site insurance, and/or supervision of team members performing these activities. - Develop training materials for study team, investigational sites, and vendors. - Proactively manage information sharing with key stakeholders using standardized reports and other mechanisms. - Assure clinical studies are compliant with ICH/GCP and other regulations as appropriate. - Oversee preparation of RFPs and prepare bid templates to facilitate selection of the CROs/vendors, and/or collaboration/supervision with team members performing these activities. - Collaborate with counsel to negotiate and draft research contracts and agreements with CROs/vendors and clinical study sites, as needed. - Act as liaison with Regulatory Affairs to assure adherence to GCPs; maintenance of SOPs; and assure site and CRO/vendor audits are completed. - Perform study risk management and implement mitigations. - Identify potential study issues and recommend and implement solutions or corrective actions as needed. - Create realistic plans that clearly define goals, milestones, responsibilities, and results. - Maintain focus on strategic objectives while accomplishing operational goals. - Make timely, data-driven decisions. - Manage daily activities, assign tasks, goals, and development of direct reports. - Other duties as assigned. Qualifications - Bachelor’s degree required, preferably in scientific discipline. An equivalent combination of relevant education and applicable job experience may be considered. - Minimum of 7 years of prior clinical operations experience preferably with CRO/small biotech experience and 2 years of experience in a supervisory role. Experience in early phase studies is preferred. - Must be able to travel up to 5% of time, may be higher in accordance with project requirements. - Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, document repository, CTMS, IRT, and EDC systems. - Excellent understanding of drug development process. - Able to make appropriate decisions to move the project(s) forward. - Effective verbal and written communication skills. - Data flow from sites to data processing, review, and resolution. - Analysis, report generation, and presentation to broader teams as needed. - FDA regulatory requirements (i.e. GCPs, CFRs, etc.). - Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. - Study initiation procedures. - Ability to exercise judgment and determine appropriate action. Physical Demands and Work Environment - On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. - Some walking and lifting up to 25 lbs. may be required. - The noise level in the work environment is typically low to moderate. - The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Travel - You may be required to travel for up to 5% of your time. Equal Opportunity Employer Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Salary Range The salary range for this position is: $122,000 - $152,000. - In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. - We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance. - 20 days of PTO, 10 paid holidays, and a winter company shutdown.

Role Description The Manager Clinical Research Billing provides supervision, operational oversight, and resource management for BSMH’s centralized clinical research finance infrastructure. This role focuses on system-wide workflow standardization, regulatory risk mitigation, and financial performance for all clinical research across BSMH. The Manager drives team throughput by tracking pipeline metrics, removing barriers, optimizing workflows for study activation, revenue cycle, and financial accounting and reporting. The Manager leverages practical experience in clinical research coordination, trial management, and site operations to lead a system, centralized team. The role provides strategic oversight and operational efficiencies for a team with specialized capabilities who are responsible for: - Technical execution of clinical trial billing - Development of Medicare Coverage Analyses - Budget development and negotiation - Financial accounting, invoicing, reconciliation, and reporting Responsible for communicating financial predictions for research enrollment to research teams. The Manager is responsible for ensuring that BSMH’s Clinical Trial Management System (CTMS) is used consistently, efficiently, and comprehensively across all BSMH research sites. Partners with BSMH Compliance and Internal Audit on clinical trial billing matters. This position requires active knowledge or pursuit and acquisition of foundational technical competencies through internal training, enabling the Manager to also provide direct, hands-on back-up and load-sharing support during peak-volume periods. Qualifications - Bachelors Degree (required) - Masters Degree (preferred) - AHIMA, Certified Clinical Research Professional (CCRP) or similar (preferred) Requirements - 7+ years of progressive experience in clinical research operations, trial coordination, site management, or research compliance administration (required) - 3+ years supervisory experience (required) - 1 year experience in basic accounting functions; experience (or equivalent education) in clinical research or related fields, preferably in billing, coverage determinations and budgeting and/or understanding of research billing regulations; hospital and professional coding experience, and reimbursement (preferred) Benefits - Competitive pay, incentives, referral bonuses and 403(b) with employer contributions (when eligible) - Medical, dental, vision, prescription coverage, HSA/FSA options, life insurances, mental health resources and discounts - Paid time off, parental and FMLA leave, short- and long-term disability, backup care for children and elders - Tuition assistance, professional development and continuing education support - Benefits may vary based on the market and employment status.