Role Description The Director of Clinical Research reports to the VP of Clinical Research and is responsible for oversight of the day-to-day operations of research physician/clinical site partners who conduct multiple FDA regulated clinical trials. Responsibility also includes management of Clinical Research Coordinators (CRC) and upholding U.S. Renal Care's research practices and policies. - Manages the operational and logistical tasks of clinical research to ensure efficient execution of trials within established budgets and timelines. - Ensures all activities are in compliance with the appropriate regulations (Good Clinical Practice (GCP), Food and Drug Administration (FDA) Federal Code of Regulations, all applicable state and local agencies). - Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, patient recruitment, and trial plan. - Assists with the recruitment of new industry partners, research opportunities, and access to novel therapies. - Promotes growth of USRC's research footprint by identifying and pursuing future nephrology research investigator physicians and practices in both the CKD and dialysis space. - Maintains productive and effective current physician research collaborations. - Collaborates with applicable internal teams to deliver efficient clinical research integration into USRC facilities and a seamless transition for new nephrology practices interested in clinical trials. - Assists with the maintenance of the Clinical Trials Management System, including oversight of patient stipend payments. - Assists field coordinators with all aspects of sponsor relations (on-site visits such as site initiations and written requests for information). - Develops and maintains professional relationships with industry partners, contract research organizations (CROs), research investigator physicians, and USRC clinical and business operations divisions. - Fosters a patient-care culture that emphasizes patient safety and quality in all activities. - Positively represents USRC at sponsor investigator meetings, national conferences, and in the field environment (clinical research sites). - Collaborates with VP of Clinical Research to develop a quality assurance program and ensure metrics are upheld by USRC research investigator physicians and practices. - Conducts site GCP audits to ensure program requirements are met. - Maintains a working knowledge of current clinical research practice standards and regulatory requirements. - Recruits, trains, develops, and supervises clinical research department personnel as well as assists with training and onboarding of new research investigator physicians. - Ensures appropriate licensures and certifications are in place. - Maintains effective personnel management and employee relations, including evaluating the performance of CRC personnel. - Approves and submits all hours worked and counsels and disciplines staff as needed. - Upholds management goals of the corporation by leading staff in team concepts and promoting teamwork. - Effectively communicates expectations; accepts accountability and holds others accountable for performance. - Regular and reliable attendance is required. Qualifications - Eight (8) plus years of experience in clinical research. - A four-year college degree preferred. An equivalent combination of work experience and education will be considered in lieu of a degree. - Clinical Research Coordinator Program (CCRP) Certification or similar required. - Nephrology experience preferred. - Knowledge of kidney care and/or End-Stage Renal Disease (ESRD) or similar field is a plus. - Work experience within a dialysis organization or in direct patient care is a plus. - Extensive knowledge of FDA regulations, IRB requirements, and Good Clinical Practice. - Excellent interpersonal and communication skills, both verbally and in writing. - Intermediate computer skills, including Microsoft Office (Word, Excel, PowerPoint, Outlook, and web-based tools) required; proficiency in USRC applications required within 90 days of hire.

Title: Sr. Clinical Trial Manager (CTM) - Non-Interventional Studies (NIS) Location: Remote North Carolina United States of America Full time Remote The Senior Clinical Team (Trial) Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. The role involves working to ensure that all clinical deliverables meet the customer's time/quality/cost expectations, and maintaining profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically, the Senior Clinical Team (Trial) Manager works independently on projects of moderate to high complexity and may assume regional lead or Clinical Study Manager responsibilities. What You'll Do: • 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. Responsibility may vary based on project timelines. • 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. Education & Experience Requirements: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). • In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. • Preferred experience: experience in STM role and/or previous experience in non-interventional / Phase IV studies / RWE studies. Knowledge, Skills, Abilities: • Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams. • Strong planning and organizational skills to enable effective prioritization of workload and workload of team members • Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization • Solid understanding of change management principles • Comprehensive understanding of the practices, processes, and requirements of clinical monitoring • Strong judgment, decision making, escalation, and risk management skills • Effective oral and written communication skills, including English language proficiency • Capable of evaluating own and team members workload against project budget and adjust resources accordingly • Strong financial acumen and knowledge of budgeting, forecasting and fiscal management • Strong attention to detail • In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. • Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. • Capable of independently managing clinical only studies.

Title: CRA (Level II) - FSP Vaccine - Central US Location: Chicago Illinois United States of America Full time Remote   Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. What You’ll Do: • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. • Participates in investigator meetings as necessary. Identifies potential • investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. • Responds to company, client and applicable regulatory requirements/audits/inspections. • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. • Contributes to other project work and initiatives for process improvement, as required. Education and Experience Requirements: • Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. • Valid driver's license where applicable. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Proven clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Good oral and written communication skills, with the ability to communicate effectively with medical personnel • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues • Good organizational and time management skills • Effective interpersonal skills • Attention to detail • Ability to remain flexibile and adaptable in a wide range of scenarios • Ability to work in a team or independently as required • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software • Good English language and grammar skills • Good presentation skills Working Conditions and Environment: • Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. • Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays. • Exposure to biological fluids with potential exposure to infectious organisms. • Personal protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions   Compensation and Benefits This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: - A choice of national medical and dental plans, and a national vision plan, including health incentive programs - Employee assistance and family support programs, including commuter benefits and tuition reimbursement - At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy - Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan - Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Title: Clinical Research Associate (Level II) - Functional Service Provider - West Region - Remote, California, United States of America - Remote, Idaho, United States of America - Remote, Colorado, United States of America - Remote, Washington, United States of America - Remote, Nevada, United States of America - Remote, Utah, United States of America - Remote, New Mexico, United States of America - Remote, Montana, United States of America - Remote, Arizona, United States of America - Remote, Oregon, United States of America - Remote, Wyoming, United States of America Full time Remote   Must be legally authorized to work in the United States without sponsorship.  Must be able to pass a comprehensive background check, which includes a drug screening.    Discover Impactful Work Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments. Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.   A Day in the Life - Monitors investigator sites with a risk-based monitoring approach: applies root Functions cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.  Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.  Assess investigational product through physical inventory and records review.  Documents observations in reports and letters in a timely manner using approved business writing standards.  Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.  May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.  Conducts monitoring tasks in accordance with the approved monitoring plan.  Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. - Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. - Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. - Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). - Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. - Responds to company, client and applicable regulatory requirements/audits/inspections. - Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. - Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. - Contributes to other project work and initiatives for process improvement, as required.   Keys to Success Education and Experience Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Valid driver's license where applicable.     Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor).   In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role   Knowledge, Skills, Abilities - Proven clinical monitoring skills - Demonstrated understanding of medical/therapeutic area knowledge and medical terminology - Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents - Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving - Ability to manage Risk Based Monitoring concepts and processes - Good oral and written communication skills, with the ability to communicate effectively with medical personnel - Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues - Good organizational and time management skills - Effective interpersonal skills - Attention to detail - Ability to remain flexible and adaptable in a wide range of scenarios - Ability to work in a team or independently as required - Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software - Good English language and grammar skills - Good presentation skills Compensation and Benefits The salary range estimated for this position based in California is $100,000.00–$112,000.00.   This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: - A choice of national medical and dental plans, and a national vision plan, including health incentive programs - Employee assistance and family support programs, including commuter benefits and tuition reimbursement - At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy - Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan - Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discoun