Clinical Research Coordinator jobs at Novant Health

USRC's greatest strength in being a leader in the dialysis industry is our ability to recognize and celebrate the differences in our diverse workforce. We strongly believe in recruiting top talent and creating a diverse and inclusive work climate and culture at all levels of our organization. The Clinical Coordinator is responsible for assisting with management and operation of clinic. This position assumes full responsibility for the dialysis clinic in the absence of the Administrator. Growth: Assist with clinical and operational processes to improve patient health and minimize hospitalizations and missed treatments. Assist with planning/coordinating patient scheduling to assure timely acceptance of patients and effective staffing levels. Demonstrate effective use of supplies and staff labor hours. Responsible for updating all logs and ensuring that dialysis run sheets and logs are sent to billing. Perform duties as assigned to meet the patient care or operational needs of the clinic. Outcomes: Coordinate the functions of all departments and develop standards and methods of measuring patient care services, including a chronological record of services provided to patients as required by the ESRD Network Coordinating Council and Medicare. Work with Administrator to maintain chronological, thorough, and appropriate documentation in the patient record of all treatments, activities, and communication with the patient, physician, and other healthcare professionals. Promote quality management program through education and involvement of staff and patients in outcomes as well as overall responsibility to achieve corporate goals for quality. Assist with program's target goals for patient outcomes in accordance with quality patient care and Company goals. Review all incident reports; make recommendations and take action relative to incidents as appropriate; report at monthly QAPI meeting as delegated by Administrator or Management. Operational Readiness: Knowledge of and remain current with federal, state, local laws and regulations, including health care professionals practice act requirements. Work with Administrator to assure clinic is in compliance with all applicable federal, state, and local laws and regulations. Assist Administrator with development, implementation and follow up of Corrective Action Plans required for internal and external surveys. May assume Charge Nurse's responsibilities as needed. May fulfill responsibility of facility Alternate CEO as delegated by Governing Body. Conduct and/or participate in both formal and informal meetings with the governing body, Regional Director, Medical Director and the staff as delegated. Assure that appropriate staff meetings, in-service education meetings, and team patient care planning meetings are held monthly as delegated. Assure that Quality Assessment & Performance Improvement Program is current at all times as delegated. Establish, maintain, and submit all required records and reports concerning staff, patients, and the operational affairs of the center if delegated by Administrator. Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly. Oversee the maintenance of equipment and supplies to meet current laws and regulations. Responds to all emergencies in clinic. Familiar with emergency equipment and all emergency operational procedures. Supervise the maintenance of equipment, building areas occupied by the center and other property belonging to the center. Partnerships: Maintain collaborative working relationship with Medical Director and physicians. Establish and maintain a positive relationship with all Administrators, area hospitals, agencies, vendors and the community. Actively promote GUEST customer service standards; develop effective relationships at all levels of the organization. Respond effectively to inquiries or complaints. Staff Development: Ensure all staff meet required qualifications for position held and perform duties within limitations established by and in accordance with company policy/procedures, health care professionals practice acts, applicable state and federal laws and regulations. Serves as a resource/subject matter expert for patient needs and concerns, staff education and in-service sessions as necessary. Assists with recruitment, training, development, and supervision of all personnel. Assists with maintaining effective personnel management and employee relations, including evaluating the performance of all personnel and counseling employees. Uphold management goals of corporation by leading staff in team concepts and promoting a team effort. Effectively communicate expectations; accept accountability and hold others accountable for performance. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Requirements include: Current RN license in applicable state. License must be maintained as current and in good standing. 12 months experience in providing nursing care, including 3 months of experience in providing nursing care to patients on maintenance dialysis. CPR certification required within 90 days of hire. Confirmation of ability to distinguish all primary colors. Demonstrated ability to function in a leadership position and to perform in new and emergent situations with sound judgment. Demonstrated working knowledge of the English language and ability to communicate verbally and in writing. Must have basic computer skills, including Microsoft Office (Word, Excel, Outlook); proficiency in all USRC clinical applications required within 90 days of hire. All Full Time employees are eligible for the following benefits: * Medical / Pharmacy * Dental * Vision * Voluntary benefits * 401k with employer match * Virtual Care * Life Insurance * Voluntary Benefits * PTO All Part Time employees are eligible for the following benefits: * 401k with employer match * PTO

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: • Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. • Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. • May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. • Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. • Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. • Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. • Performs study-related training. • Manages the development and maintenance of study documents, processes and systems as assigned. • Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. • Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. • Attends internal and external meetings as required. • Provides all job-related progress reports and visit documentation as required. • May support safety activities such as narrative writing, managing the CEC/DSMB, etc. • OUS: Prepares and coordinates submissions to regulatory authorities. • May perform other activities as assigned. Qualifications & Technical Competencies: • Fluency in English and local language, if different, required. • Higher education degree or equivalent education, training, and experience. • Preferred 2 years clinical trial experience. • Preferred monitoring experience. • Able to work independently once trained. • Good verbal and written communication skills. • Strong organizational skills. • Basic computer proficiency. • Understanding of clinical research processes and regulations. • Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: • Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. • Extensive use of a computer keyboard. Pay Range Minimum: $54,400.00 Pay Range Target: $80,100.00 Pay Frequency: Annual Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: • May operate equipment • Records data timely and accurately • May analyze and interpret data • Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.

Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. Responsibilities: Review patient clinical records and use relevant data to determine clinical trial matches. Independently manage clinical trial workflows, adapting to changing priorities and business needs to ensure efficiency and consistency. Work collaboratively with cross-functional teams at Tempus (including scientists, pathologists, and product development) to create customized clinical reports. Navigate and synthesize information from multiple data sources and systems. Ensure clinical reports are accurate, clear, and aligned with requirements. Support ongoing and future projects within the team. Contribute to a dynamic work environment by maintaining flexibility and responsiveness to shifting workflows. Other duties as assigned. Qualifications: Bachelor's or Master's degree in Genetics, Molecular Genetics, Cancer Biology, or Biological Sciences. Willingness to work flexible hours and adapt to business needs. Strong written and verbal communication skills. Proficient in critical thinking, interpersonal, and problem-solving abilities. Ability to manage complex tasks efficiently under time constraints. Highly detail-oriented with a commitment to accuracy and consistency. Self-motivated and able to thrive independently as well as within a collaborative, high-performing team. Demonstrated passion for making an impact in a fast-paced, mission-driven environment. Preferred Qualifications: Experience reviewing hematology/oncology clinical records. Experience critically evaluating clinical trials. Basic knowledge of generative AI. CHI: $46,000-$50,000 The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position. We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

This position may be filled at the coordinator level 1 or level 2, based on experience/qualifications and requires the incumbent to reside in Central Oregon: Level 1 Pay range: $25.18 - $37.77 per hour. Level 2 Pay range: $27.20 - $40.79 per hour. St. Charles Health System is a leading healthcare provider in Central Oregon, offering a comprehensive range of services to meet the needs of our community. We are committed to providing high-quality, compassionate care to all patients, regardless of their ability to pay. Our values of compassion, excellence, integrity, teamwork, and stewardship guide our work and shape our culture. What We Offer: Competitive Salary Comprehensive benefits including Medical, Dental, Vision for you and your immediate family 403b with up to 6% match on Retirement Contributions Generous Earned Time Off Growth Opportunities within Healthcare ST. CHARLES HEALTH SYSTEM JOB DESCRIPTION TITLE: Clinical Research Coordinator I REPORTS TO POSITION: Research Manager DEPARTMENT: Research DATE LAST REVIEWED: November 15, 2024 OUR VISION: Creating America's healthiest community, together OUR MISSION: In the spirit of love and compassion, better health, better care, better value OUR VALUES: Accountability, Caring and Teamwork DEPARTMENTAL SUMMARY: St. Charles Research Department conducts clinical trials for promising new treatments and therapies in a wide variety of medical fields, including cancer treatment and prevention, cardiovascular disease and supportive care. POSITION OVERVIEW: The Clinical Research Coordinator I is responsible for conducting clinical trials in compliance with FDA regulation, ICH Guidelines and applicable industry standards. The Clinical Research Coordinator 1 will oversee up to ten clinical trials as the main research coordinator. This position does not directly manage other caregivers, however may be asked to review and provide feedback on the work of other caregivers. ESSENTIAL FUNCTIONS AND DUTIES: Maintains surveillance system to identify potential subjects for study eligibility, prescreen patients, and assists physicians in determining eligibility. Obtains informed consent according to GCP and ICH guidelines. Performs study procedures and assessments following protocol specific guidelines. Assures research is conducted in an ethical and safe manner according to FDA, ICH and St. Charles Health System guidelines. Adheres to St. Charles Health System's compliance plan. Attends IRB meetings as requested by the IRB. Supports the processing of study alerts, protocol revisions, amendments, accrual suspension notices, informed consent modifications, product information and advertisement, and related memoranda. Supports the modification of template informed consent forms for local application in compliance with federal guidelines for patients in lay language at appropriate reading level Prepares for and participates in required sponsor and regulatory audits. Attend Investigator meetings as required to assure seamless study start-up. Assists with subject education and informed consent process, including tissue and genetics consent when indicated. Surveys for re-consent and obtains from eligible subjects. Educates patients regarding protocol diagnostic tests and assists with appointments. Process tissue/blood specimens and prepare it for shipment. Manages treatment and follow-up schedules to assure protocol compliance. Attends subject clinic visits and interacts with subjects and staff as appropriate to assist in protocol adherence. Track study drug usage per protocol and oversee study drug supply. Maintains subject research records including long-term follow up and reporting. Participates in institutional research activities (committee meetings, Tumor Boards, Grand Rounds, other conferences, etc.) that are relevant to the Position. Keeps current with new developments in research methodologies. Participates in quality assurance program for St. Charles Health System and affiliated research partners. Supports the vision, mission and values of the organization in all respects. Supports Value Improvement Practice (VIP- Lean) principles of continuous improvement with energy and enthusiasm, functioning as a champion of change. Provides and maintains a safe environment for caregivers, patients and guests. Conducts all activities with the highest standards of professionalism and confidentiality. Complies with all applicable laws, regulations, policies and procedures, supporting the organization's corporate integrity efforts by acting in an ethical and appropriate manner, reporting known or suspected violation of applicable rules, and cooperating fully with all organizational investigations and proceedings. Delivers customer service and/or patient care in a manner that promotes goodwill, is timely, efficient and accurate May perform additional duties of similar complexity within the organization, as required or assigned. EDUCATION: Required: Bachelor of Science degree, or combination of college level education and Research experience to perform the full scope of position duties. Preferred: Bachelor of Science degree in related field. LICENSURE/CERTIFICATION/REGISTRATION Required: Association of Clinical Research Professional (ACRP) or Society of Clinical research Associates (SOCRA) certification or must obtain within 2 years of full time employment. Current American Heart Association (AHA) Basic Life Support for Healthcare Provider certification. Preferred: N/A EXPERIENCE: Required: None Required. Preferred: Experience as a Clinical Research Coordinator. Experience dealing with multidisciplinary teams. Basic Clinical task knowledge. ADDITIONAL POSITION INFORMATION: N/A Schedule Weekly Hours: 40 Caregiver Type: Regular Shift: First Shift (United States of America) Is Exempt Position? No Job Family: COORDINATOR CLERICAL Scheduled Days of the Week: Monday-Friday Shift Start & End Time: Variable

**Discover Your Career at Emory University** Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. **Description** The Clinical Research Coordinator handles or assists with the administrative activities generally associated with the conduct of clinical trials. KEY RESPONSIBILITIES: + Maintains data pertaining to research projects, completes source documents/case report forms, and performs data entry. + Assists with patient recruitment. + Attends study meetings. + Orders and maintains equipment and supplies. + Reviews medical records and/or conducts screenings for recruitment of study participants, performs interviews and QOL questionnaires. + Collects study specimen according to protocol which may include phlebotomy, processing, and preparation for shipping. + Coordinates services, schedules procedures, creates and maintains case packages, and monitors charges. + Assists with quality assurance and tracks regulatory submissions. + Performs related approved responsibilities as required. MINIMUM QUALIFICATIONS: + High School Diploma or GED and three years of administrative support experience. + Or two years of college in a scientific, health related, or business administration program and one year of admin support or customer service experience. + Or be a licensed as a practical nurse (LPN) and one year admin support or one year of licensed practical nursing experience. + Or a Bachelor's degree, Master's degree, MD or PhD in a scientific, health related or business administration program. PREFERRED QUALIFICATIONS: + Ability to handle tasks, such as keeping and maintaining regulatory records may be required. + BA/BS degree in life sciences (neurosciences, psychology) preferred. This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher. NOTE: Position tasks are required to be performed in-person at an Emory University location; working remote is not an option. Emory reserves the right to change this status with notice to employee **Additional Details** Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: ************ (V) | ************ (TDD). Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call ************ (Voice) | ************ (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination. **Connect With Us!** Connect with us for general consideration! **Job Number** _158422_ **Job Type** _Regular Full-Time_ **Division** _School Of Medicine_ **Department** _SOM: Psych: Adult_ **Job Category** _Clinical Research_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Executive Park 12_ **Remote Work Classification** _No Remote_ **Health and Safety Information** _Position involves clinical patient contact, Working with human blood, body fluids, tissues, or other potentially infectious materials_

**Discover Your Career at Emory University** Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. **Description** The Clinical Research Coordinator II handles administrative activities generally associated with the conduct of clinical trials. KEY RESPONSIBILITIES: + Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms. + Provides guidance to less experienced staff. + Interfaces with research participants, determines eligibility and consents study participants according to protocol. + Approves orders for supplies and equipment maintenance. + Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires. + Supervises collection of study specimens and processing. + Establishes case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed. + Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors. + Prepares regulatory submissions. + With appropriate credentialing and training may perform phlebotomy or diagnostics. + Performs related approved responsibilities as required. ADDITIONAL JOB DETAILS: The clinical research coordinator will work in the Sleep Epidemiology Research Group, led by Dr. Dayna Johnson. This position involves working on several projects that are aimed at observational and interventional studies focused on determinants and health consequences of sleep problems. Working evenings and weekends (3-4 hours, once a month) may be a requirement for this position. The candidate will be responsible for recruiting/scheduling research participants, completing research visits (data collection) at the hospital, school of public health and/or homes of participants, and processing participant incentives. For the ARISE study, in partnership with another team member, they will conduct the field visits which entail administering questionnaires, initializing air, light and noise monitoring devices, instructing participants on the sleep monitor and ambulatory blood pressure monitoring, and processing and mailing saliva samples. Several times a week, they may visit the homes of participants in the evenings to conduct the research visits, thus reliable transportation is required (mileage will be reimbursed). They will also oversee mailing the sleep and cardiovascular feedback letters to the participants, and to their physicians upon request from participants. For the RECOVER-Sleep study, they will enroll participants in a clinical trial at Emory Midtown 3 times per week. Data collection involves questionnaires, wearables, medication, as well as other materials. The candidate will engage in other research-related tasks as needed. MINIMUM QUALIFICATIONS: + High School Diploma or GED and five years of clinical research experience. + Or two years of college in a scientific, health related, or business administration program and three years clinical research experience. + Or a licensed as a practical nurse (LPN) and two years clinical research experience. + Or a Bachelor's degree in a scientific, health related, or business administration related program and one year of clinical research experience. + Or a Master's degree, MD or PhD in a scientific, health related or business administration program. This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher. PREFERRED QUALIFICATIONS: + Clinical trials + Experience recruiting and enrolling adults in research studies + Intervention research experience + Live in metro-Atlanta area + 2 years research experience + Highly organized + Strong written and oral communication skills + Reliable transportation NOTE: Position tasks are required to be performed in-person at an Emory University location; working remote is not an option. Emory reserves the right to change this status with notice to employee. **Additional Details** Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: ************ (V) | ************ (TDD). Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call ************ (Voice) | ************ (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination. **Connect With Us!** Connect with us for general consideration! **Job Number** _157733_ **Job Type** _Regular Full-Time_ **Division** _School Of Public Health_ **Department** _SPH: Epidemiology_ **Job Category** _Clinical Research_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Emory Campus-Clifton Corridor_ **Remote Work Classification** _No Remote_ **Health and Safety Information** _Working with human blood, body fluids, tissues, or other potentially infectious materials_

**Discover Your Career at Emory University** Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. **Description** KEY RESPONSIBILITIES: + Independently manages significant and key aspects of a large clinical trial or all aspects of one or more small trials, or research projects. + Trains and provides guidance to less experienced staff. + Oversees data management for research projects. + Interfaces with research participants and resolves issues related to study protocols. + Authorizes purchases for supplies and equipment maintenance. + Determines effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. + Periodically audits operations including laboratory procedures to ensure compliance with applicable regulations; provides leadership in identifying and implementing corrective actions/processes. + Monitors IRB submissions and responds to requests and questions. + Interfaces with study sponsors, monitors and reports SAEs; resolves study queries. + Provides leadership in determining, recommending, and implementing improvements to policies/processes. + Assists in developing grant proposals and protocols. + With appropriate credentialing and training may perform phlebotomy, specimens collection or diagnostics. + Employees in this classification may be required to work with, take specific precautions against and/or be immunized against potentially hazardous agents. + Transports and processes biological specimens (training provided). + May perform some supervisory duties. + Performs emergency CPR. + Performs related approved responsibilities as required. QUALIFICATIONS: + High School Diploma or GED and seven years of clinical research experience. + Or two years of college in a scientific, health related or business administration program and five years of clinical research experience + Or licensed as a Practical Nurse (LPN) and four years of clinical research experience + Or bachelor's degree in a scientific, health related or business administration program and three years clinical research experience + Or master's degree, MD or PhD in a scientific, health related or business administration program and one year of clinical research experience Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred. This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher. Must have transportation and be able to work at Emory University Hospital (primary site) and/or Emory University Hospital Midtown. NOTE: Position tasks are required to be performed in-person at an Emory University location; working remote is not an option. Emory reserves the right to change this status with notice to employee. **Additional Details** Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: ************ (V) | ************ (TDD). Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call ************ (Voice) | ************ (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination. **Connect With Us!** Connect with us for general consideration! **Job Number** _157509_ **Job Type** _Regular Full-Time_ **Division** _School Of Medicine_ **Department** _SOM: Anesthesiology: Admin_ **Job Category** _Clinical Research_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Emory University Hospital_ **Remote Work Classification** _N/A or Other_ **Health and Safety Information** _Working with human blood, body fluids, tissues, or other potentially infectious materials_

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The Senior Clinical Trial Specialist (Sr. CTS) is responsible for providing operational support for the day-to-day execution of clinical trials, following established SOPs, GCP and applicable regulatory requirements in the execution of all activities; proactively identifying and resolving operational project issues; and participating in process improvement initiatives as required. Major Duties/Responsibilities * Ensures timely and accurate study-related communication to clinical personnel (eg, internal and external study teams, consultants and investigative site personnel); prepares and disseminates clinical trial correspondence, newsletters, and IND safety letters (working with project clinician); and assists with the creation of study-specific manuals, tools, and templates * Participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; acts as liaison between vendors and sites (eg, assists sites with laboratory sample queries) * Coordinates specified clinical trial meetings (eg, investigator meetings, study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes * Sets up, tracks, collects and maintains audit-ready clinical trial documentation and study status in an electronic system; manages and tracks regulatory/IRB/IEC documentation, IND safety letter distribution, confidentiality disclosure agreements, and other clinical trial documents; performs initial QC of electronic data feeds; generates, reviews and distributes reports; assists with quality assurance audits and resolution of audit findings * Participates in study design and execution by contributing operational experience and expertise: provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; posts and maintains study-related information on external websites when applicable * Ensures that necessary study supplies are available as per study timelines: sources clinical trial supplies through external vendors (eg, case report forms, study manuals, lab kits); manages, reviews and tracks drug shipment, destruction, and return; coordinates internal lab sample supply set-up and shipment * Maintains ongoing communication with site staff to resolve issues (eg, data queries, study management), support the staff, oversee the efficient conduct of the trial, and ensure continued compliance * May also be responsible for acting as a central point of communication between Puma and investigative sites for all assigned clinical trial-related activities to assure trials are conducted on time and budget, while fully compliant with ICH GCP and the SOPs in effect. In this role, the Sr. CTS may be responsible for: * Conducting on-site visits consistent with the applicable Clinical Monitoring Plan and SOPs for site qualification, site initiation, routine monitoring, site close-out and other site visits (eg, booster), as requested * Overseeing site recruitment, implementing appropriate contingency plans, as needed * Assessing site performance and conducting training/re-training when necessary to ensure site compliance with the protocol, applicable regulations and Puma expectations * Writing confirmation letters, follow-up letters and site visit reports that conform with guidelines and timelines stated in the applicable Clinical Monitoring Plan and SOPs * Mentors more junior staff * Manages study team meetings in absence of Clinical Trial Manager * Performs other tasks, as assigned by the manager/designee to promote the efficient conduct of the trial Skills & Abilities * Clear and timely communication, both written and verbal * Ability to handle a moderate volume of highly complex tasks within an established timeframe * Strong organizational skills and ability to prioritize * Ability to build relationships within the team, across departments, and with external contacts (eg, vendors, site staff) * Proactively identify and resolve/escalate project-related operational issues * Ability to work independently on routine assignments, and take over new assignments based on previous experience * Familiarity with word processing, spreadsheet and document management systems Travel Travel required up to 25%. Education & Professional Experience Required: * Bachelor's degree or equivalent combination of education/experience, preferably in science or a health-related field * Strong understanding of GCP, ICH and knowledge of regulatory requirements * Minimum one year prior Clinical Trial Specialist experience or commensurate Preferred: * One year of clinical research experience or health-related experience (eg, study coordinator, data management, nursing) * Completion of Puma Field Monitoring Course or equivalent, as required for field monitoring activities * Oncology experience * Global trial experience Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Physical Demands The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Compensation Range The salary range for this role is $90,000 - $100,000 per year. Higher compensation may be available for someone with advanced skills and/or experience. At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. #LI-Remote

Department: 36962 Wake Forest University Health Sciences - Cardiology: Adult Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: Full time- On site position Pay Range $26.10 - $39.15 Under departmental direction, coordinates activities to support multiple research studies of all phases. Serves as the principal administrative liaison for assigned studies with the ability to manage a workload that includes studies of increased complexity. Develops and maintains recordkeeping systems and procedures to ensure compliance with study protocols and all appropriate regulations. Attends clinic as needed to perform activities including, but not limited to: assist the research team with recruitment activities, administer questionnaires and answer any questions about future appointments. Responsible for the compilation, registration and submission of data, as required by the Sponsor. EDUCATION/EXPERIENCE Bachelor's degree with two years; experience in clinical research; or an equivalent combination of experience and education. LICENSURE, CERTIFICATION, and/or REGISTRATION SOCRA or ACRP Certification preferred. Must complete the CITI certification for Human Subject Research if not already completed. All additional required WakeOne training for research coordinators. ESSENTIAL FUNCTIONS 1. Works under the direction of the Study Investigators or Clinical Research Nurse Manager with minimal supervision. 2. Plays an active role in recruitment of patients to study. 3. Performs protocol specific duties required per the research protocol. 4. Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families. 5. Fulfills sponsor requirements related to reportable information including adverse events, unanticipated problems, and other information required by the sponsor protocol. 6. Abstracts data from the medical record and completes paper and electronic case report forms, including responding to any requests for data clarification, and maintains all necessary source documents. 7. Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner. 8. Provides staff relief as required to meet the needs of the department. Participates in scheduled team/department meetings. Participates in quality improvement projects on an on-going basis. 9. May mentor new and less experienced staff. 10. Follows established Wake Forest Baptist and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality. 11. Performs other related duties as assigned or requested. SKILLS/QUALIFICATIONS Excellent interpersonal, oral, and written communication skills Excellent reading comprehension Strong organizational skills EPIC/WakeOne proficiency to include appropriate documentation of research notes Proficient in the use of OnCore/WISER Clinical Trial Management System Basic computer skills Fosters/promotes a positive image and professional appearance Sensitivity to intercultural relations Sensitivity to the maintenance of confidentiality Knowledge of Microsoft Products WORK ENVIRONMENT Clean, comfortable, office environment Our Commitment to You: Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including: Compensation Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training Premium pay such as shift, on call, and more based on a teammate's job Incentive pay for select positions Opportunity for annual increases based on performance Benefits and more Paid Time Off programs Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability Flexible Spending Accounts for eligible health care and dependent care expenses Family benefits such as adoption assistance and paid parental leave Defined contribution retirement plans with employer match and other financial wellness programs Educational Assistance Program About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.

Department: 36412 Wake Forest University Health Sciences - Pulmonology Clinic Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: Position will support Pulmonary Critical Care Research Program at Atrium Health Wake Forest Baptist Medical Center. Pay Range $23.65 - $35.50 JOB SUMMARY Under general supervision, responsible for the compilation and collection of data, recruitment of subjects, and general coordination of clinical studies. EDUCATION/EXPERIENCE Bachelor's degree in a related field of study or an equivalent combination of experience and education. Experience in a medical and/or research setting. Paramedical or other clinical experience. LICENSURE, CERTIFICATION, and/or REGISTRATION Registered Record Administrator preferred. ESSENTIAL FUNCTIONS 1. Assists principal investigator and other health professionals in troubleshooting various problems related to the management of the clinical study. Assists in all aspects of the data collection process. 2. Performs technical procedures on clinical subjects under the direction of the principal investigator or his/her designee. 3. Assists with recruitment of patients for the clinical study including tracking the sources of patient referrals. Follow-up with sources of patient referrals including referring doctors, various Medical Center labs, and other sources. 4. Maintains appropriate patient records as necessary. This includes charting the condition of the patient and determining their continued eligibility in the study. 5. Obtains and interprets pertinent data from medical records as needed to understand past and present condition of the patients. 6. Performs day-to-day administrative and clerical duties such as designing brochures, stationary and data forms. Creates reports and graphs pertinent to the study including presentation of the results of the study. 7. May supervise other personnel including volunteers as assigned. 8. Assists in development of suitable codes and data collection forms for computerization. 9. Consults and cooperates with all faculty, coordination centers, sponsors, and health professionals involved in the clinical study. 10. Performs other related duties incidental to the work described herein. SKILLS/QUALIFICATIONS Understanding of medical and/or scientific terminology Strong oral, written, and interpersonal communication skills WORK ENVIRONMENT Clean, well-lit, office environment, clinic Our Commitment to You: Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including: Compensation Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training Premium pay such as shift, on call, and more based on a teammate's job Incentive pay for select positions Opportunity for annual increases based on performance Benefits and more Paid Time Off programs Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability Flexible Spending Accounts for eligible health care and dependent care expenses Family benefits such as adoption assistance and paid parental leave Defined contribution retirement plans with employer match and other financial wellness programs Educational Assistance Program About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.

The Clinical Research Coordinator (CRC) is responsible for managing and coordinating all aspects of clinical research studies conducted within the organization. This role ensures compliance with study protocols, regulatory requirements, and ethical standards while supporting investigators and research teams in delivering high-quality data and patient care. The CRC recruits and screens study participants, obtains informed consent, schedules and conducts study visits, collects and maintains accurate research data, and serves as a key liaison among sponsors, investigators, and clinical staff. Strong organizational skills, attention to detail, and the ability to manage multiple projects simultaneously are essential to success in this role. QUALIFICATIONS RN, MA, LPN, or other medical license/certification required Clinical trial/research experience required Bachelor's, master's, or other advanced degree in healthcare preferred Requirements KNOWLEDGE, SKILLS AND ABILITIES: Holds themselves accountable and takes ownership of their job duties Ability to relate sensitively to patients' needs Excellent verbal and written skills; strong customer service expertise Maintains confidentiality by being discrete and using sound judgment Ability to establish credibility with physicians, staff, and patients Ability to multi-task; resourceful and well organized; takes initiative Always mindful of quality improvement and cost-efficient care High energy team player who maintains a positive attitude toward providers, peers and patients ESSENTIAL DUTIES AND RESPONSIBILITIES: Screen & enroll subjects in studies & manage their participation according to ethical, regulatory, & protocol-specific requirements Obtain informed consent from trial subjects before performing any study related procedures Develop organizational aids & checklists to facilitate patient recruitment and the collection of complete & accurate study data Maintain the regulatory and study files for each research project Communicate with the Ethics Committee as appropriate Assure proper handling of the investigational product Report adverse events to the IRB and sponsor, as appropriate Meet with sponsor representatives to discuss planned and ongoing studies Oversee study start up through closure and reporting of results Participate in quality assurance activities of the sponsor, other regulatory, and accrediting agencies Supervise other clinical research personnel, as appropriate Participate as appropriate in the training of individuals recruited as members of the research team Manage the business aspects of studies, including developing and negotiating study budgets, facilitating the contract review process to assure that provisions on publication, intellectual property, indemnification, records retention, and data ownership are appropriately negotiated with the sponsor Design appropriate recruitment strategies and track study enrollment Accurate and timely data entry

Department: 37371 Wake Forest University Health Sciences - Comprehensive Cancer Center Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: 40 hours per week M-F. No weekends. No holidays. 2 remote days allowed upon completion of 90-day orientation. Pay Range $23.65 - $35.50 Job Summary Under thedirection of the Study Investigators and Disease Group Chair, mentorship of experienced clinical studies coordinator staff, supervision of the Nurse Team Leader and the leadership of the Director of Clinical Protocol and Data Management, the Clinical Studies Coordinator I coordinates activities to support research studies. Able to manage low complexity trials after completion of orientation. Assignments are gradually adjusted to add increased responsibility based on demonstrated competency. Mentored by an experienced clinical research coordinator II or III, serves as the principle administrative liaison for assigned studies. Follows and maintains recordkeeping systems and procedures to ensure compliance with study protocols and all appropriate regulations. Attends clinic as needed to perform activities including, but not limited to: assist the research team with recruitment activities, administer questionnaires, and answer any questions about future appointments. Responsible for the compilation, registration and submission of data, as required by the Sponsor. Education/Experience Bachelor's degree in a related field of study or an equivalent combination of experience and education. Experience in a medical and/or research setting. Paramedical experience or other clinical experience. Licensure, Certification and/or Registration SOCRA or ACRP certification preferred Must complete the CITI certification for Human Subject Research if not already completed All additional required WakeOne training for research coordinators Essential Functions Study Conduct * Works under the supervision of the Study Investigators, Disease Group Chair and the direction of the Administrative Director of Clinical Protocol and Data Management. * Works in conjunction with a clinical studies coordinator mentor and the oversight of a Nurse Team Leader to gradually assume more responsibility and workload * Assists in the recruitment of patients to study by helping to identify potential eligible patients who are scheduled to be seen in the clinic and communicating the information to the Study Team. * Performs protocol specific duties required per the research protocol, including but not limited to: * Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families. * Confirms and documents subject eligibility. * As part of the team, ensures all protocol procedures are ordered and completed as specified in the protocol. * Randomizes subjects using interactive voice response systems or other systems as applicable. * Administers standardized tools or questionnaires, such as Quality of Life assessments, if appropriately credentialed. * Assembles lab kits and other supplies in preparation to obtain required biospecimen samples and transports to appropriate laboratories for processing; ships samples externally per International Air Transport Association (IATA) requirements. * Optimizes the safety of research subjects by monitoring and reporting any adverse events to the investigators and other members of the study team. * Participates in required teleconferences, on site meetings and off site investigator meetings, as required. Regulatory Compliance and Documentation. * Fulfills sponsor requirements related to reportable information, including: adverse events, unanticipated problems, other information required by the sponsor protocol. Data Management * Abstracts data from the medical record and completes paper and electronic case report forms, including responding to any requests for data clarification, and maintains all necessary source documents. * Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner. Personnel Management * Provides staff relief as required to meet the needs of the department. * Participates in scheduled team/department meetings. * Participates in quality improvement projects on an on-going basis. Follows established Wake Forest Baptist and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality. Performs other related duties as assigned or requested. Skills and Qualifications Knowledge of medical terminology. Exposure to clinical trials or related health field is preferred. Excellent oral/written communication and organizational skills. Excellent reading comprehension. Foster/promote a positive image and professional appearance. Sensitivity to intercultural relations. Sensitivity to the maintenance of confidentiality. Ability to use Microsoft products, access data in computer data bases, compile data, and research information. Proofread documents. Troubleshoot problems. Our Commitment to You: Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including: Compensation * Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training * Premium pay such as shift, on call, and more based on a teammate's job * Incentive pay for select positions * Opportunity for annual increases based on performance Benefits and more * Paid Time Off programs * Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability * Flexible Spending Accounts for eligible health care and dependent care expenses * Family benefits such as adoption assistance and paid parental leave * Defined contribution retirement plans with employer match and other financial wellness programs * Educational Assistance Program About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.

Department: 85056 Wake Forest University Health Sciences - Academic Clinical and Translational Science Institute (CTSI) Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: Weekdays Under general supervision, responsible for the compilation and collection of data, recruitment of subjects, and general coordination of clinical studies. EDUCATION/EXPERIENCE Bachelor's degree in a related field of study or an equivalent combination of experience and education. Experience in a medical and/or research setting. Paramedical experience or other clinical experience. LICENSURE, CERTIFICATION, and/or REGISTRATION Registered Record Administrator preferred SKILLS/QUALIFICATIONS * Understanding of medical and/or scientific terminology * Strong oral, written, and interpersonal communication skills ESSENTIAL FUNCTIONS * Assists principal investigator and other health professionals in troubleshooting various problems related to the management of the clinical study. Assists in all aspects of the data collection process. * Performs technical procedures on clinical subjects under the direction of the principal investigator or his/her designee. * Assists with recruitment of patients for the clinical study including tracking the sources of patient referrals. Follow-up with sources of patient referrals including referring doctors, various Medical Center labs, and other sources. * Maintains appropriate patient records as necessary. This includes charting the condition of the patient and determining their continued eligibility in the study. * Obtains and interprets pertinent data from medical records as needed to understand past and present condition of the patients. * Performs day-to-day administrative and clerical duties such as designing brochures, stationery and data forms. Creates reports and graphs pertinent to the study including presentation of the results of the study. * May supervise other personnel including volunteers as assigned. * Assists in development of suitable codes and data collection forms for computerization. * Consults and cooperates with all faculty, coordination centers, sponsors, and health professionals involved in the clinical study. * Performs other related duties incidental to the work described herein. WORK ENVIRONMENT Clean, well-lit, office environment and community settings Pay Range $23.65 - $35.50 Our Commitment to You: Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including: Compensation * Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training * Premium pay such as shift, on call, and more based on a teammate's job * Incentive pay for select positions * Opportunity for annual increases based on performance Benefits and more * Paid Time Off programs * Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability * Flexible Spending Accounts for eligible health care and dependent care expenses * Family benefits such as adoption assistance and paid parental leave * Defined contribution retirement plans with employer match and other financial wellness programs * Educational Assistance Program About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.

We are seeking an experienced Clinical Research Coordinator (CRC) Team Lead to join our dynamic research team. This role is pivotal in supporting clinical trials by working closely with the Principal Investigator (PI) and reporting directly to the Clinical Research Administrator. In addition to standard CRC responsibilities, the Team Lead will oversee site operations, provide guidance to coordinators, and assist with administrative duties to ensure compliance and efficiency in clinical research activities. Key Responsibilities Coordinate with PI, department, and administration to ensure compliance with federal regulations and sponsor policies. Assist PI with study feasibility assessments and protocol review. Prepare and maintain study materials, regulatory binders, and source documentation. Train and supervise CRCs and research assistants; maintain training logs. Develop and implement recruitment strategies in line with IRB requirements. Conduct informed consent processes and maintain accurate documentation. Manage investigational drug/device accountability and study supply inventory. Track enrollment, maintain timelines, and communicate effectively with sponsors and participants. Review and approve budget negotiations; attend weekly leadership meetings. Act as liaison between site coordinators and research leadership team. Qualifications Education: CRC certification required. Experience: Minimum 2 years as a Clinical Research Coordinator with site management experience. Skills: Strong organizational and problem-solving abilities. Excellent communication and interpersonal skills. Ability to interpret protocols and regulatory requirements. Proficiency in documentation and compliance standards. Additional Requirements Ability to work in a demanding environment with required occasional weekend work and travel. Physical ability to perform tasks such as sitting, bending, and lifting up to 25 lbs Benefits (Eligible for Fulltime Employees*) Med/Dent/Vision plus ancillary benefits Vacation/PTO 401k NOTE:This job description may not include all duties assigned to the employee and may be updated and modified by Management, without notice, according to operations at any given time.