Employment Type: Full timeShift: Day Shift Description: POSITION PURPOSE Work Remote Position Pay Range: $36.3426-$54.5140) Utilizes advanced clinical and coding expertise to direct efforts toward the integrity of clinical documentation through the roles of reviewer, educator and consultant. Facilitates the overall quality, completeness, accuracy and integrity of medical record documentation through extensive record review. Through extensive interaction with physicians and other members of the healthcare team, achieves appropriate clinical documentation to support code assignment, medical necessity, severity of illness, risk of mortality and level of services rendered to all patients. Participates in the development and delivery of education for providers and members of the healthcare team. ESSENTIAL FUNCTIONS Knows, understands, incorporates, and demonstrates the Trinity Health Mission, Vision, and Values in behaviors, practices, standards, policies, procedures and decisions. Demonstrates understanding of appropriate clinical documentation to ensure that the severity of illness, risk of mortality, quality indicators and level of services provided are accurately reflected in the health record. Assists in overall quality, timeliness and completeness of the health record to ensure appropriate data, provider communication and quality outcomes. Serves as a resource for appropriate clinical documentation. Communicates with and educates physicians and all other members of the healthcare team regarding clinical documentation and monitors provider engagement. Identifies learning opportunities for healthcare providers. Conducts concurrent reviews of selected patient health records to address legibility, clarity, completeness, consistency and precision of clinical documentation. Formulates compliant clarifications/queries following Trinity Health’s documentation integrity procedures. Interacts with physicians, nurses and ancillary staff regarding compliant documentation requirements, clarification/query requests and educational opportunities. Codes all relevant, appropriate and compliant working diagnoses codes, establishing a working principle diagnosis and working DRG (MS or APR). Collaborates with coding staff to ensure documentation of discharge diagnoses and co-morbidities are a complete reflection of the patient’s clinical status and care. Resolves all discrepancies in a courteous manner. Demonstrates expertise in problem-solving skills based on theoretical knowledge, clinical experience and sound judgement and serves as a professional role model by demonstrating desirable practice behaviors. Leverages the functions of 3M/360 for entering data related to CDI efficiencies and effectiveness. Performs other duties as assigned by leadership. Maintains a working knowledge of applicable Federal, State and local laws and regulations, accrediting agencies, Trinity Health’s Organizational Integrity Program, Standards of Conduct, Code of Ethics, as well as other policies and procedures in order to ensure adherence in a manner that reflects honest, ethical and professional behavior. MINIMUM QUALIFICATIONS Must possess an Associate/Diploma Degree in Nursing, or Health Information Technology (HIT) or an Advanced degree in nursing or medical field such as MD, DO, NP/APN or PA. In the absence of a college degree, must have 3 or more years’ experience as an inpatient coder or clinical documentation specialist. Preferred certification or licensure includes: Current Registered Nurse License, Registered Health Information Administrator (RHIA), Registered Health Information Technician (RHIT), Certified Coding Specialist (CCS), Certified Clinical Documentation Specialist (CCDS) Certified Documentation Improvement Professional (CDIP). Experience in Critical Care, Medical or Surgical Inpatient Care Nursing, as an RN, physician assistant (PA), nurse practitioner/advanced practice nurse (NP/APN), medical school graduate or as an inpatient coder preferred. Excellent communication (verbal and written), interpersonal, collaboration and relationship-building skills. Strong critical thinking skills and ability to integrate knowledge. Prioritization and organizational skills required. Effective presentation/facilitation skills to accomplish educational goals for all members of the healthcare team. Demonstrated ability to use a standard desktop and Windows based computer system, including a basic understanding of email, internet and computer navigation. Ability to use other software as required to perform the essential functions on the job. Experience with databases, spreadsheet software and presentation software preferred. Data entry skills and typing skills at minimum 30 wpm. Must be comfortable operating independently and in a collaborative environment. Must possess a personal presence that is characterized by a sense of honesty, integrity and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals and values of Trinity Health. PHYSICAL AND MENTAL REQUIREMENTS AND WORKING CONDITIONS Must be able to set and organize own work priorities and adapt to them as they change frequently. Must be able to work concurrently on a variety of tasks/projects in an environment that may be stressful with individuals having diverse personalities and work styles. Must possess the ability to comply with Trinity Health policies and procedures. Must be able to spend majority of work time utilizing a computer, monitor and keyboard. Must be able to work with interruptions and perform detailed tasks. Ability to concentrate and read for long periods of time. Ability to work in an onsite and virtual environment. Must possess a valid driver’s license and be able to travel to the various Trinity Health sites (10%) as needed. The above statements are intended to describe the general nature and level of work being performed by persons assigned to this classification. They are not to be construed as an exhaustive list of duties so assigned. Our Commitment Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Research Associate III - Patient Preference and Experience This position can be home based across the EMEA region Thermo Fisher Scientific’s Patient-Centered Research (PCR) group supports sponsors in incorporating the patient voice in all relevant healthcare decisions, from development over regulatory to reimbursement and product launch. The PCR group blends a unique combination of scientific fields, including health sciences, psychometrics, epidemiology, psychology, health economics and others. Our work has helped identify and clarify unmet clinical needs, assess burden of illness and evaluate patient outcomes, preference and/or adherence, while supporting promotional and labeling claims on a global scale. The advertised role will contribute to this research agenda and help ensure the patient voice is heard. The Research Associate III will support the delivery of both patient preference and patient experience research by leading scientific input from junior Research Associates and aligning with other functions (e.g., Project Management Office, Editorial Service, Data Collection Management & Analysis), in close collaboration with study Principal Investigators (PIs). The Research Associate III will adopt an essential role in planning, conducting, reporting and disseminating best-practice research. This is a client-facing role, and the successful candidate will have the opportunity to collaborate closely with a wide range of study sponsors across multiple applications. This fast-pathed and diverse role offers a wide range of opportunities to grow scientific knowledge and consulting skills. Essential Functions Projects Support in the development and fielding of both patient preference and experience studies using relevant methodologies (qualitative and quantitative methods including but not limited to online surveys, DCE, BWS, thresholding etc.), including the following specific tasks: - Support study PIs in the development of study design (including preference instrument experimental design), budget and proposals - Develop deliverables ready for PI and client review (e.g., protocol, statistical analysis plan, technical report) - Coordinate and support junior staff throughout projects - Communicate and manage internal and external recruitment partners (e.g., vendors, patient advocacy groups, other departments) - Manage data analysis and data quality control - Contribute to scientific dissemination, where applicable (incl., manuscripts, posters, oral presentations at conferences) - Report project time accurately at the end of each week - Contribute to research projects of the wider Patient-Centered Research (PCR) team, depending on capacity and availability Teamwork and Quality - Complete relevant training courses on time (e.g., adverse event training, SOPs, ethics) - Efficiently delegate and communicate with project teams - Take active responsibility for on-the-job learning of junior project team members - Work with the Project Management Office to track and drive the project timelines and budget use - Be familiar with electronic and paper filing requirements, relevant SOPs and IRB needs - Communicate effectively with clients Organizational Contributions - Stay up to date with relevant research - Contribute to initiatives in the Patient-Centered Research (PCR) team (e.g., budget-review committee, practical process improvements, contribution to training in the PCR University, serve as mentor or buddy to junior staff) - Take part in team meetings and organizational discussions - May supervise junior staff Qualifications: Education and Experience: - PhD in relevant scientific discipline or - Master’s degree in a relevant scientific discipline and at least three years of experience in relevant field or - Bachelor’s degree in a relevant scientific discipline and at least five years of experience in relevant field Knowledge, Skills, and Abilities: - Outstanding analytical and problem-solving skills - Excellent communication and scientific writing skills - Demonstrated ability to proactively and independently drive research projects - Experience and skill in design, implementation, and interpretation of surveys to assess patient experience and preference studies or preference elicitation techniques, including DCEs, BWS and thresholding techniques - Experience and skill in design, implementation, analysis and interpretation of qualitative research to support development of quantitative surveys and/or preference instruments - Experience in the analysis of quantitative survey data desirable - Proficient in the use of MS Word, PowerPoint, and Excel - Experience with PubMed, or similar literature databases, advantageous. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.

Job Description Clinical Research Associate Location: North West England Travel: Approximately 65–75% (about 2–3 days per week, domestic and international) About our company Our company is committed to advancing high-quality clinical research that upholds ICH/GCP standards and local regulatory requirements. We collaborate across global and regional teams to deliver studies with excellence, integrity, and patient safety at the core. Role overview We are seeking a highly skilled Clinical Research Associate (CRA) to lead performance and compliance for assigned protocols and sites within the South East. Under the oversight of the CRA Manager or Clinical Research Director (CRD), you will serve as the primary site contact throughout all phases of clinical studies, ensuring rigorous adherence to ICH/GCP, local regulations, our company policies and procedures, quality standards, and adverse event reporting requirements. You will take ownership of allocated sites, actively expand our clinical research territory by identifying and developing new sites and contribute as a subject matter expert on monitoring processes and systems across internal workstreams. Key responsibilities - Build and sustain strong relationships with investigative sites across all trial phases. - Perform site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws/regulations, protocol, site monitoring plans, and related documents. - Develop deep understanding of study protocols and procedures. - Coordinate cross-functional tasks to achieve Site Ready status. - Participate in site selection and validation; provide informed input to decisions. - Conduct remote and on-site monitoring to ensure: - Data integrity (complete, accurate, unbiased). - Protection of subjects’ rights, safety, and well-being. - Execute validation, initiation, monitoring, and close-out visits; document clear, comprehensive visit and non-visit reports in a timely manner. - Collect, review, and monitor regulatory documentation for start-up, maintenance, and close-out. - Communicate proactively with investigators and site staff on protocol conduct, recruitment/retention, deviations, regulatory findings, audits/inspections, and site performance. - Identify, assess, and resolve site performance, quality, or compliance issues; escalate appropriately per the CRA escalation pathway in collaboration with CRA Manager, CRM, TA Head, and CRD. - Partner with internal teams (country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ) and external stakeholders (vendors, IRB/IEC, regulatory authorities). - Maintain accurate, timely documentation in CTMS, eTMF, and other systems. - Act as a process SME: share best practices, drive continuous improvement, and deliver training. - Support and/or lead audit/inspection activities. - Contribute to country strategy by identifying and onboarding potential new sites; build site capabilities. - Mentor and buddy junior CRAs; conduct co-monitoring and quality control visits where appropriate. Travel requirements - Ability to travel domestically and internationally approximately 65–75% of working time (about 2–3 days per week). - Valid driver’s license preferred; required in certain countries. Qualifications, skills, and experience Core competencies - Fluent in English, with strong written and verbal communication skills and the ability to present technical information effectively. - Robust knowledge of clinical research, trial phases, ICH/GCP, and local clinical research regulations and guidelines; ability to work within global, country, and regional frameworks. - Demonstrated mentoring and leadership capability. - Hands-on knowledge of Good Documentation Practices. - Proven site management expertise, including independent oversight of site performance and patient recruitment. - High-level monitoring skills with sound, independent professional judgment. - Strong IT proficiency (MS Office and clinical applications across computer, tablet, and mobile); adaptable to new tools. - Ability to interpret data/metrics and take appropriate action, including in virtual settings. - Experience conducting site motivation visits to boost enrollment. - Solution-oriented approach to complex issues; capable of root cause analysis and implementing preventive/corrective actions. - Ability to mentor junior CRAs and perform co-monitoring visits. Behavioral competencies - Excellent time management, organization, interpersonal skills, conflict management, and problem solving. - High independence across multiple protocols, sites, and therapy areas. - Strong sense of accountability and urgency; able to prioritize and multitask in changing environments. - Effective in a matrixed, multicultural setting; fosters culturally sensitive relationships. - Customer-focused mindset with high standards of quality and compliance. - Positive, growth-oriented, self-driven, and professional demeanor aligned with company values. Education and experience - Bachelor’s degree (or higher) with extensive direct site management (monitoring) in bio/pharma/CRO. What we offer - Opportunity to shape clinical research at high-performing sites and contribute to global development programs. - A collaborative environment with growth, mentorship, and continuous improvement. - Competitive compensation and benefits. How to apply Please submit your resume/CV and a brief cover letter outlining your relevant monitoring experience and site leadership achievements Required Skills: Accountability, Adaptability, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP) Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Remote Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 05/5/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Description Clinical Research Associate Location: Scotland Travel: Approximately 65–75% (about 2–3 days per week, domestic and international) About our company Our company is committed to advancing high-quality clinical research that upholds ICH/GCP standards and local regulatory requirements. We collaborate across global and regional teams to deliver studies with excellence, integrity, and patient safety at the core. Role overview We are seeking a highly skilled Clinical Research Associate (CRA) to lead performance and compliance for assigned protocols and sites within the South East. Under the oversight of the CRA Manager or Clinical Research Director (CRD), you will serve as the primary site contact throughout all phases of clinical studies, ensuring rigorous adherence to ICH/GCP, local regulations, our company policies and procedures, quality standards, and adverse event reporting requirements. You will take ownership of allocated sites, actively expand our clinical research territory by identifying and developing new sites and contribute as a subject matter expert on monitoring processes and systems across internal workstreams. Key responsibilities - Build and sustain strong relationships with investigative sites across all trial phases. - Perform site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws/regulations, protocol, site monitoring plans, and related documents. - Develop deep understanding of study protocols and procedures. - Coordinate cross-functional tasks to achieve Site Ready status. - Participate in site selection and validation; provide informed input to decisions. - Conduct remote and on-site monitoring to ensure: - Data integrity (complete, accurate, unbiased). - Protection of subjects’ rights, safety, and well-being. - Execute validation, initiation, monitoring, and close-out visits; document clear, comprehensive visit and non-visit reports in a timely manner. - Collect, review, and monitor regulatory documentation for start-up, maintenance, and close-out. - Communicate proactively with investigators and site staff on protocol conduct, recruitment/retention, deviations, regulatory findings, audits/inspections, and site performance. - Identify, assess, and resolve site performance, quality, or compliance issues; escalate appropriately per the CRA escalation pathway in collaboration with CRA Manager, CRM, TA Head, and CRD. - Partner with internal teams (country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ) and external stakeholders (vendors, IRB/IEC, regulatory authorities). - Maintain accurate, timely documentation in CTMS, eTMF, and other systems. - Act as a process SME: share best practices, drive continuous improvement, and deliver training. - Support and/or lead audit/inspection activities. - Contribute to country strategy by identifying and onboarding potential new sites; build site capabilities. - Mentor and buddy junior CRAs; conduct co-monitoring and quality control visits where appropriate. Travel requirements - Ability to travel domestically and internationally approximately 65–75% of working time (about 2–3 days per week). - Valid driver’s license preferred; required in certain countries. Qualifications, skills, and experience Core competencies - Fluent in English, with strong written and verbal communication skills and the ability to present technical information effectively. - Robust knowledge of clinical research, trial phases, ICH/GCP, and local clinical research regulations and guidelines; ability to work within global, country, and regional frameworks. - Demonstrated mentoring and leadership capability. - Hands-on knowledge of Good Documentation Practices. - Proven site management expertise, including independent oversight of site performance and patient recruitment. - High-level monitoring skills with sound, independent professional judgment. - Strong IT proficiency (MS Office and clinical applications across computer, tablet, and mobile); adaptable to new tools. - Ability to interpret data/metrics and take appropriate action, including in virtual settings. - Experience conducting site motivation visits to boost enrollment. - Solution-oriented approach to complex issues; capable of root cause analysis and implementing preventive/corrective actions. - Ability to mentor junior CRAs and perform co-monitoring visits. Behavioral competencies - Excellent time management, organization, interpersonal skills, conflict management, and problem solving. - High independence across multiple protocols, sites, and therapy areas. - Strong sense of accountability and urgency; able to prioritize and multitask in changing environments. - Effective in a matrixed, multicultural setting; fosters culturally sensitive relationships. - Customer-focused mindset with high standards of quality and compliance. - Positive, growth-oriented, self-driven, and professional demeanor aligned with company values. Education and experience - Bachelor’s degree (or higher) with extensive direct site management (monitoring) in bio/pharma/CRO. What we offer - Opportunity to shape clinical research at high-performing sites and contribute to global development programs. - A collaborative environment with growth, mentorship, and continuous improvement. - Competitive compensation and benefits. How to apply Please submit your resume/CV and a brief cover letter outlining your relevant monitoring experience and site leadership achievements Required Skills: Accountability, Adaptability, Adverse Event Reporting System, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trials Monitoring, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Protocol Adherence Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Remote Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 05/5/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.