Clinical Research Coordinator jobs at Nationwide Children's Hospital

Dr. Kristen Fox seeks a Clinical Research Program Coordinator to join her research program on health behaviors, psychosocial functioning, and healthcare experiences of adolescents and young adults with congenital heart disease. The candidate will play an integral role in supporting Dr. Fox's program of research, including implementing a NIH-funded randomized clinical trial evaluating a mobile health intervention. Key duties include coordinating trial start-up activities, overseeing day-to-day operations of the trial, and supervising research coordinators. Opportunities exist to contribute to research products. This position requires in-person work. Flexibility to work some evenings/weekends for recruitment and data collection as needed is required. The position is available immediately. Summary: Coordinates and manages the department/center's research portfolio. Maintains working knowledge of projects in process as well as funded projects including grant budgets and IRB protocols. Coordinates subcontracts with other sites and the Sponsored Projects Office, develops and implements processes across multiple study sites, and maintains documents to ensure effective, efficient and compliant project progress. Job Description: Essential Functions: Responsible for administrative management, organization of, and participation in program meetings and teleconferences, including scientific meetings with corporate and non-profit partners, teaching conferences, grand rounds, journal club, research seminars, and CME programs. Works with Sponsored Projects Officer to manage program and project funds and dissemination of funding to collaborations sites in addition to the subcontracts with other sites. Provides funding opportunity notifications to PI's. Collaborates with department/center investigators in the development of IRB protocols, grant submissions and scientific publications. Coordinates personnel needs for the program and projects; oversees and organizes training. Track projects and initiatives to ensure they move forward based on both timelines and budget; report to PI when progress is lacking and identifies needed action. May be responsible for administrative management of multiple protocols; plays a central role in the communication between NCH/RI and site; will act as liaison with other departments necessary to complete program projects (i.e., Data Management, Biostats, Medical Writing, Regulatory Compliance, etc.). Manages and oversees IRB process for program projects and associated sites, ensuring sites are submitting accurate and timely IRB submissions, and maintain associated regulatory documents. Helps facilitate creation of source documents that ensure systematic data collection and/or aid in protocol execution and management and record keeping. Collects and controls research data and subject information from sites as needed/requested; tracks screening and enrollment data across multiple sites/multiple projects. Provides monitoring, review and tracking of clinical data and preparation of study specific documents according to FDA regulations QA process implementation, maintenance and documentation; data entry; and maintenance of regulatory documents for multiple sites; multiple protocols. Work with principal investigators at each site to establish multi-site monitoring plans for investigator-initiated projects. Education Requirement: Bachelor's degree preferred or Associate degree with two years clinical research experience or project management experience. Certifications: ACRP or SOCRA certification, preferred. Skills: Demonstrated leadership skills Strong organizational skills Exceptional interpersonal, written and verbal communication Ability to filter information, discern importance and initiate plan for project completion Self-directed, results driven with the ability to manage workload. Ability to work independently and as part of a team. Working knowledge of data management software. Experience: Two years clinical research experience or project management experience. Physical Requirements: OCCASIONALLY: Bend/twist, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Reaching above shoulder, Squat/kneel FREQUENTLY: Sitting, Standing, Walking CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing - Far/near Additional Physical Requirements performed but not listed above: (not specified) "The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"

Behavioral Health Unit Full Time 36 Hours/week Nights 7p-730a every other weekend and holiday Onsite Assists manager in the daily operations at the unit level, in collaboration with interdisciplinary teams. Assesses, plans, implements, and evaluated delivery of patient care on assigned unit and shift. Contributes to development and evaluations of assigned nursing personnel. Assists and provides nursing care utilizing specialized knowledge, judgement and skill. Responsibilities: 1. Provides leadership and direction regarding unit goals and work environment by assisting nurse manager in his/her duties. 2. Demonstrates personal and professional accountability for self and staff. 3. Maintains unit safety for staff and patients. 4. Participates in performance improvement. 5. Participates in and supports staff recruitment and retention efforts. 6. Uses critical thinking to provide patient care management through staffing plan development, managing daily shift staffing, and delegation of resources. 7. Supports and assists within human resource management, including but not limited to coaching, time keeping, development and evaluation of nursing personnel. 8. Supports patient care and staffing needs throughout the Akron Children's Hospital enterprise. 9. Promotes a positive work environment and staff engagement. 10. Serves as a clinical resource to the interdisciplinary team. 11. Demonstrates the knowledge and skills necessary to provide care for the physical, psychological, social, educational and safety needs of the patients served. 12. Other duties as required. Other information: Technical Expertise 1. Proficiency in MS Office [Outlook, Excel, Word] or similar software is required. 2. Valid Ohio license. 3. Current Health Care Provider BLS training from the American Heart Association is required. 4. See the Department of Nursing Resuscitation Requirements and training policy #2102 for specific department requirements. 5. Relevant professional nursing certification, preferred. Education and Experience 1. Education: Graduate from an accredited School of Nursing, BSN required, or current enrollment in a BSN program with program completion required within 2 years of assuming position. 2. Certification: May differ based on department/unit 3. Years of experience: Minimum two years relevant clinical experience with demonstrated management and leadership abilities is required. 4. Years of experience supervising: Previous charge nurse or other leadership experience is required. 5. Strong leadership skills including communication/organizational skills, time management, coping skills, motivation, problem solving, autonomy, and supporting teams is required. Full Time FTE: 0.900000 Status: Onsite

6 Medical Full Time 36 hours/week Nights 7p-730a Onsite Assists manager in the daily operations at the unit level, in collaboration with interdisciplinary teams. Assesses, plans, implements, and evaluated delivery of patient care on assigned unit and shift. Contributes to development and evaluations of assigned nursing personnel. Assists and provides nursing care utilizing specialized knowledge, judgement and skill. Responsibilities: 1. Provides leadership and direction regarding unit goals and work environment by assisting nurse manager in his/her duties. 2. Demonstrates personal and professional accountability for self and staff. 3. Maintains unit safety for staff and patients. 4. Participates in performance improvement. 5. Participates in and supports staff recruitment and retention efforts. 6. Uses critical thinking to provide patient care management through staffing plan development, managing daily shift staffing, and delegation of resources. 7. Supports and assists within human resource management, including but not limited to coaching, time keeping, development and evaluation of nursing personnel. 8. Supports patient care and staffing needs throughout the Akron Children's Hospital enterprise. 9. Promotes a positive work environment and staff engagement. 10. Serves as a clinical resource to the interdisciplinary team. 11. Demonstrates the knowledge and skills necessary to provide care for the physical, psychological, social, educational and safety needs of the patients served. 12. Other duties as required. Other information: Technical Expertise 1. Proficiency in MS Office [Outlook, Excel, Word] or similar software is required. 2. Valid Ohio license. 3. Current Health Care Provider BLS training from the American Heart Association is required. 4. See the Department of Nursing Resuscitation Requirements and training policy #2102 for specific department requirements. 5. Relevant professional nursing certification, preferred. Education and Experience 1. Education: Graduate from an accredited School of Nursing, BSN required, or current enrollment in a BSN program with program completion required within 2 years of assuming position. 2. Certification: May differ based on department/unit 3. Years of experience: Minimum two years relevant clinical experience with demonstrated management and leadership abilities is required. 4. Years of experience supervising: Previous charge nurse or other leadership experience is required. 5. Strong leadership skills including communication/organizational skills, time management, coping skills, motivation, problem solving, autonomy, and supporting teams is required. Full Time FTE: 0.900000 Status: Onsite

The Clinical Research Informatician is a bridge between clinicians/researchers and data. They blend their knowledge of clinical workflow, terminology, and practices with an understanding of health information technology to advance clinical and translational research towards improved patient care. The Clinical Informatician will play an integral role focused on creating, testing, implementing, and maintaining applications and data for clinical areas. Responsibilities include acting as a liaison between clinicians/researchers and data stewards, interfacing with stakeholders on informatics software development, maintenance, and operations, and creating streamlined workflows for the exploitation of healthcare data. Minimum Education Bachelor's Degree In Health Information Management or Health Informatics OR B.S. in clinical field (nursing, etc.) and certification in Health Informatics OR B.S. in informatics, computer science, statistics, biomedical engineering artificial intelligence AND certification in Health Informatics required. Master's Degree preferred. Minimum Experience/Accountabilities Minimum 4 years' experience in clinical research Minimum 4 years' experience in clinical informatics Minimum 4 years' experience in information technology and/or in academic healthcare setting Experience with clinical operations, Health Information Management, or care management. Experience with clinical definitions, ontologies, dictionaries, and taxonomies required. Experience with clinical standards and coding. Experience with KPIs as they relate to clinical areas. Experience implementing new technologies in clinical areas. General clinical experience accepted, including experience as an MD, NP, PA, or RN. Experience serving as a liaison between clinicians/researchers and IT. Experience interpreting healthcare data using self-service tools or programming languages such as SQL and Python. Accountabilities: Collect, organize, curate, and document healthcare information within the data warehouse. Apply experience with clinical information and workflows to the development of informatics tools, applications, analyses, and procedures. Develop, modify, test, and implement applications and algorithms for the collection, organization, and analysis of healthcare data. Assist in the development of presentations, scientific publications, and grant proposals. Apply insights gained from research to improve patient care or healthcare operations. Ability to interact directly with and interpret healthcare data using self-service tools or coding languages, such as SQL and Python Ability to liaison between clinical stakeholders and Enterprise Data & AI technical team members Expertise in analyzing and optimizing clinical workflows, leveraging IT to enhance efficiency, accuracy, and patient outcomes through targeted interventions and system improvements. Collaborate with software vendors and IT service providers to ensure that their products and services are tailored to meet the unique operational needs of the healthcare facility, optimizing performance and compliance. Other duties as assigned.

Senior Clinical Research Coordinator Full-Time - Day Shift Advance the Future of Clinical Research Are you passionate about clinical research and ready to take your expertise to the next level? At University Health, we're seeking a Senior Clinical Research Coordinator to lead and support high-impact studies that shape the future of patient care. This is a unique opportunity to bring your clinical insight and research experience to a role that supports innovation, compliance, and excellence in human subject research. What You'll Do As a Senior Clinical Research Coordinator , you'll play a vital leadership role in the coordination and review of complex human subject research protocols. You will: Evaluate and provide expert clinical and risk assessment on research protocols and procedures Assist the Director with implementing a robust Human Subjects Protection Program Serve as a departmental representative to internal and external research committees, including IRB and OHRP Coordinate, monitor, and educate staff on best practices in research compliance and study execution Support grant applications, budgeting, and program planning across diverse research initiatives What We're Looking For Education & Experience: Required: Bachelor's of Science in Nursing (BSN) from an accredited institution Minimum 3 years of clinical research experience Working knowledge of research methods and federal regulations for human subject research Must possess or qualify to obtain CCRP or CCRA certification within 6 months of hire Core Competencies: Strong leadership and judgment in confidential, regulatory, and ethical matters Ability to navigate complex research protocols with a sharp eye for detail Confident representing the department in multi-institutional settings Excellent communication, planning, and coordination skills Why Join Us? At University Health, you'll be part of a team that is passionate about research, innovation, and improving patient outcomes. We offer: A dynamic, collaborative, and mission-driven environment Opportunities to lead and influence policy at the institutional and national levels A commitment to professional development and clinical research excellence The chance to make a real impact on groundbreaking studies and healthcare transformation Ready to Elevate Clinical Research? Bring your skills, passion, and vision to a team that's shaping the future of healthcare research. Apply today to become our Senior Clinical Research Coordinator.

Are you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. **Job Description** **Responsibilities** + Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities. + Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions). + Support adoption of new technology or clinical applications through advocacy and evidence. + Participate in customer presentations regarding use of Interventional products for institution research purposes. + Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs. + Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations + Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns. + Grow technology leadership mindshare through joint scientific presentations and publications. + Install/upgrade research equipment and software & prototypes + Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures + Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products. + Study new technology concepts and leverage expertise to move initiatives forward. Note: + No sponsorship available for this role now or in the future to work in the United States.. **Qualifications** + PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field. + 3+ years of experience in Interventional healthcare industry or research. + Knowledge of Interventional procedures, anatomies, clinical practice. + Excellent written and verbal communication skills. + Excellent customer relationship management and collaboration skills. + Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas. + Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task. + Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. + Able to individually lead complex projects with autonomy, rigor, drive & competence + Ability to travel ( + Quality, Compliance, and Continuous Improvement focus **Desired Characteristics** + 5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics. + Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) + Demonstrated record of innovation and development. + History of publications, clinical/non-clinical experiments, knowledge in statistics + Programming / Image processing experience + Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our **total rewards** are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. \#LI-BR3 \#LI-Remote We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. **Additional Information** GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. **Relocation Assistance Provided:** No

Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary General Summary/Overview Statement: The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact. Principal Duties and Responsibilities: The following regulatory duties will be performed under general supervision by the Clinical Research Manager: · Maintain and organize study specific regulatory binders · Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB · Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study · Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required · Submit Data and Safety Monitoring Reports · Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process · Collect, complete, and submit essential regulatory documents to various regulatory entities · Participate in monitoring visits and file all monitoring visit correspondence · Ensure appropriate documentation of delegation and training for all study staff members · Maintain screening and enrollment logs Skills/Abilities/Competencies Required · Careful attention to detail · Good organizational skills · Ability to follow directions · Good communication skills · Computer literacy · Working knowledge of clinical research protocols Qualifications Education: Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials: n/a Experience: Knowledge, Skills and Abilities: - Careful attention to detail. - Good organizational skills. - Ability to follow directions. - Computer literacy. - Working knowledge of clinical research protocols. Additional Job Details (if applicable) Working Conditions: · Duties will be performed remotely Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary General Summary/Overview Statement: The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact. Principal Duties and Responsibilities: The following regulatory duties will be performed under general supervision by the Clinical Research Manager: * Maintain and organize study specific regulatory binders * Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB * Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study * Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required * Submit Data and Safety Monitoring Reports * Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process * Collect, complete, and submit essential regulatory documents to various regulatory entities * Participate in monitoring visits and file all monitoring visit correspondence * Ensure appropriate documentation of delegation and training for all study staff members * Maintain screening and enrollment logs Skills/Abilities/Competencies Required * Careful attention to detail * Good organizational skills * Ability to follow directions * Good communication skills * Computer literacy * Working knowledge of clinical research protocols Qualifications Education: Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials: n/a Experience: Knowledge, Skills and Abilities: * Careful attention to detail. * Good organizational skills. * Ability to follow directions. * Computer literacy. * Working knowledge of clinical research protocols. Additional Job Details (if applicable) Working Conditions: * Duties will be performed remotely Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

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

NATIONAL LEADERS IN PEDIATRIC CARE Ranked among the top 10 pediatric hospitals in the nation, Children's Hospital Los Angeles (CHLA) provides the best care for kids in California. Here world-class experts in medicine, education and research work together to deliver family-centered care half a million times each year. From primary to complex critical care, more than 350 programs and services are offered, each one specially designed for children. The CHLA of the future is brighter than can be imagined. Investments in technology, research and innovation will create care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a perfect match for every patient. And together, CHLA team members will turn health care into health transformation. Join a hospital where the work you do will matter-to you, to your colleagues, and above all, to our patients and families. The work will be challenging, but always rewarding. It's Work That Matters. Overview Schedule: Monday-Friday Purpose Statement/Position Summary: As a certified research professional, handles clinical trial administration for all protocol phases. Serves as a resource for study team members and principal investigators and assists with subject recruitment, data collection, scheduling of study-related activities and follow-up with enrolled subjects. Assists in quality assurance/control of data resulting from studies. Provides cross-coverage for other CRCs within the department. Trains new staff. Develops procedures related to clinical trial coordination. In addition, this role supports complex clinical trials involving Bone Marrow Transplant (BMT), CAR-T cell therapy, and stem cell therapies, which require specialized coordination and regulatory oversight. Responsibilities include managing investigational product logistics, monitoring patient safety and adverse events, and ensuring compliance with FDA and institutional protocols. The Clinical Research Coordinator III collaborates closely with transplant physicians, cellular therapy teams, and external sponsors to facilitate high-impact research aimed at improving outcomes for pediatric patients with hematologic malignancies and other life-threatening conditions. Minimum Qualifications/Work Experience: 5+ year experience in clinical trial coordination with 2+ years pediatric clinical trials experience. Preferred Experience: * In-depth knowledge of BMT clinical workflows, including donor matching, conditioning regimens, engraftment monitoring, and post-transplant complications. * Experience with pediatric BMT populations and familiarity with transplant-related adverse event reporting. * Proficiency in managing regulatory documentation for BMT trials, including IND submissions and FDA correspondence. Education/Licensure/Certification: Bachelor's degree or Associate degree in related scientific field. ACRP Certified Clinical Research Coordinator (CCRC) or SOCRA Certified Clinical Research Professional (CCRP) required. *Candidates with a medical degree are exempt from certification requirement. Pay Scale Information $75,712.00-$129,792.00 CHLA values the contribution each Team Member brings to our organization. Final determination of a successful candidate's starting pay will vary based on a number of factors, including, but not limited to education and experience within the job or the industry. The pay scale listed for this position is generally for candidates that meet the specified qualifications and requirements listed on this specific job description. Additional pay may be determined for those candidates that exceed these specified qualifications and requirements. We provide a competitive compensation package that recognizes your experience, credentials, and education alongside a robust benefits program to meet your needs. CHLA looks forward to introducing you to our world-class organization where we create hope and build healthier futures. Children's Hospital Los Angeles (CHLA) is a leader in pediatric and adolescent health both here and across the globe. As a premier Magnet teaching hospital, you'll find an environment that's alive with learning, rooted in care and compassion, and home to thought leadership and unwavering support. CHLA is dedicated to creating hope and building healthier futures - for our patients, as well as for you and your career! CHLA has been affiliated with the Keck School of Medicine of the University of Southern California since 1932. At Children's Hospital Los Angeles, our work matters. And so do each and every one of our valued team members. CHLA is an Equal Employment Opportunity employer. We consider qualified applicants for all positions without regard to race, color, religion, creed, national origin, sex, gender identity, age, physical or mental disability, sexual orientation, marital status, veteran or military status, genetic information or any other legally protected basis under federal, state or local laws, regulations or ordinances. We will also consider for employment qualified applicants with criminal history, in a manner consistent with the requirements of state and local laws, including the LA City Fair Chance Ordinance and SF Fair Chance Ordinance. Qualified Applicants with disabilities are entitled to reasonable accommodation under the California Fair Employment and Housing Act and the Americans with Disabilities Act. Please contact CHLA Human Resources if you need assistance completing the application process. Our various experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA. Clinical Research Office Staff

NATIONAL LEADERS IN PEDIATRIC CARE Ranked among the top 10 pediatric hospitals in the nation, Children's Hospital Los Angeles (CHLA) provides the best care for kids in California. Here world-class experts in medicine, education and research work together to deliver family-centered care half a million times each year. From primary to complex critical care, more than 350 programs and services are offered, each one specially designed for children. The CHLA of the future is brighter than can be imagined. Investments in technology, research and innovation will create care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a perfect match for every patient. And together, CHLA team members will turn health care into health transformation. Join a hospital where the work you do will matter-to you, to your colleagues, and above all, to our patients and families. The work will be challenging, but always rewarding. It's Work That Matters. Overview Position Summary: The Clinical Research Coordinator II, as a certified research professional, handles clinical trial administration for all protocol phases. Children's Hospital Los Angeles is seeking a Clinical Research Coordinator II (CRC II) to support an innovative study aimed at improving survivorship care transitions for young adult childhood cancer survivors (CCS), particularly those experiencing health-related social needs (HRSN). This position is ideal for a certified research professional with experience in clinical trials involving pediatric, adolescent, and young adult populations, and a strong commitment to advancing health equity. The CRC II will be responsible for ensuring regulatory compliance, maintaining high-quality data, and facilitating effective communication among study participants, healthcare providers, and key stakeholders. Will serve as a resource for study team members and principal investigators and assists with subject recruitment, data collection, scheduling of study-related activities and follow-up with enrolled subjects. Assists in quality assurance/control of data resulting from studies. Provides cross-coverage for other CRCs within the department. Finally, the CRC II will contribute to the study's implementation and evaluation using the RE-AIM framework. Minimum Qualifications: 3+ year experience in clinical trial coordination with 1+ years pediatric clinical trials experience. * Strong organizational skills * Experience in clinical trials involving pediatric, adolescent, and young adult populations Education/Licensure/Certifications: Bachelor's degree or associates degree in related scientific field. ACRP Certified Clinical Research Coordinator (CCRC) or SOCRA Certified Clinical Research Professional (CCRP). *Candidates with a medical degree are exempt from certification requirement. Pay Scale Information $68,640.00-$116,563.00 CHLA values the contribution each Team Member brings to our organization. Final determination of a successful candidate's starting pay will vary based on a number of factors, including, but not limited to education and experience within the job or the industry. The pay scale listed for this position is generally for candidates that meet the specified qualifications and requirements listed on this specific job description. Additional pay may be determined for those candidates that exceed these specified qualifications and requirements. We provide a competitive compensation package that recognizes your experience, credentials, and education alongside a robust benefits program to meet your needs. CHLA looks forward to introducing you to our world-class organization where we create hope and build healthier futures. Children's Hospital Los Angeles (CHLA) is a leader in pediatric and adolescent health both here and across the globe. As a premier Magnet teaching hospital, you'll find an environment that's alive with learning, rooted in care and compassion, and home to thought leadership and unwavering support. CHLA is dedicated to creating hope and building healthier futures - for our patients, as well as for you and your career! CHLA has been affiliated with the Keck School of Medicine of the University of Southern California since 1932. At Children's Hospital Los Angeles, our work matters. And so do each and every one of our valued team members. CHLA is an Equal Employment Opportunity employer. We consider qualified applicants for all positions without regard to race, color, religion, creed, national origin, sex, gender identity, age, physical or mental disability, sexual orientation, marital status, veteran or military status, genetic information or any other legally protected basis under federal, state or local laws, regulations or ordinances. We will also consider for employment qualified applicants with criminal history, in a manner consistent with the requirements of state and local laws, including the LA City Fair Chance Ordinance and SF Fair Chance Ordinance. Qualified Applicants with disabilities are entitled to reasonable accommodation under the California Fair Employment and Housing Act and the Americans with Disabilities Act. Please contact CHLA Human Resources if you need assistance completing the application process. Our various experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA. CRSO

**We are more than a health system. We are a belief system.** We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities. ** Summary:** The Clinical Consultant Research works in collaboration with the Principal Investigator (PI) to coordinate assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and federal regulations. This position performs basic day to day activities related to clinical research studies including: recruit and screen participants, obtains informed consent, educate participants regarding study requirements, event reporting, collection of and organizes research data and complete case report forms. This position applies basic level of understanding to the ability to perform a variety of tasks under direct supervision in a range of different type of clinical studies. **Responsibilities And Duties:** Study Planning and Coordination Assists with implementation and coordination of research studies and projects. Accountable to PI for study specific responsibilities. Works closely with PI and direct supervisor to organize, plan and carry out the research in an efficient and timely manner. Assists with protocol feasibility, resource requirements and study planning activities including leading internal training to implement the protocol and avoid deviations. Assists with recruitment procedures for potential participants and oversees the enrollment of the clinical trial as directed by the PI. Ensures that study parameters are correctly applied prior to a research participant enrolling in a study and during the research participant's visits and assessments. Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time Attends investigator's meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives. Participates in in-house protocol meetings to review study-related procedures, staffing and visit flow. Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant's responsibilities in the study. Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events. Accurately records and extracts data from source documentation onto required data collection forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation. Prepares study documents for archiving according to timelines, following closeout visits activities Responsible for in-depth knowledge of protocol requirements and GCP guidelines. Performs other related duties as assigned or required. Patient Care Assists nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants. Assists nursing and clinical staff and utilizes knowledge of disease processes to observe, report adverse events, and protocol violations / deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant. Quality and Compliance Assists in audit preparedness activities for OHRI. Assists with monitoring visits on site or remotely and is available during visits for corrections, questions, etc. Maintains study records according to sponsor and/or regulations. Keep records in a secure location. Reporting Assist in the development of reporting metrics. Generates reports and reviews to ensure validity of data. Provide ad hoc reports. Communication Demonstrates effective communications skills. Communicates information in a timely and accurate manner. Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies. Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers. Uses various media forms to maximize communication success. Demonstrates teamwork characteristics. Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects. Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level. Works with research staff to effectively communicate patient process for each trial for the life of the study. Advise, communicate and reinforce standard practices, regulations to following regarding research study participation. Other Attends relevant training courses on policy and compliance. Ensures assigned training is complete and meets internal qualifications. Responsible for completing all necessary training for their position. Maintain familiarity with evolving regulatory and compliance context. Other duties as assigned. **Minimum Qualifications:** Associate's Degree **Additional Job Description:** Ability to prioritize assigned work Strong verbal and written communication skills, as well as customer service skills and ability to problem solve, prioritize and manage multiple tasks Strong computer skills, including thorough knowledge of systems (EMR, Microsoft) **Work Shift:** Day **Scheduled Weekly Hours :** 40 **Department** Heart & Vascular Research Clinical Services Join us! ... if your passion is to work in a caring environment ... if you believe that learning is a life-long process ... if you strive for excellence and want to be among the best in the healthcare industry Equal Employment Opportunity OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment

**We are more than a health system. We are a belief system.** We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities. ** Summary:** The Clinical Consultant Research works in collaboration with the Principal Investigator (PI) to coordinate assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and federal regulations. This position performs basic day to day activities related to clinical research studies including: recruit and screen participants, obtains informed consent, educate participants regarding study requirements, event reporting, collection of and organizes research data and complete case report forms. This position applies basic level of understanding to the ability to perform a variety of tasks under direct supervision in a range of different type of clinical studies. **Responsibilities And Duties:** Study Planning and Coordination Assists with implementation and coordination of research studies and projects. Accountable to PI for study specific responsibilities. Works closely with PI and direct supervisor to organize, plan and carry out the research in an efficient and timely manner. Assists with protocol feasibility, resource requirements and study planning activities including leading internal training to implement the protocol and avoid deviations. Assists with recruitment procedures for potential participants and oversees the enrollment of the clinical trial as directed by the PI. Ensures that study parameters are correctly applied prior to a research participant enrolling in a study and during the research participant's visits and assessments. Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time Attends investigator's meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives. Participates in in-house protocol meetings to review study-related procedures, staffing and visit flow. Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant's responsibilities in the study. Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events. Accurately records and extracts data from source documentation onto required data collection forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation. Prepares study documents for archiving according to timelines, following closeout visits activities Responsible for in-depth knowledge of protocol requirements and GCP guidelines. Performs other related duties as assigned or required. Patient Care Assists nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants. Assists nursing and clinical staff and utilizes knowledge of disease processes to observe, report adverse events, and protocol violations / deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant. Quality and Compliance Assists in audit preparedness activities for OHRI. Assists with monitoring visits on site or remotely and is available during visits for corrections, questions, etc. Maintains study records according to sponsor and/or regulations. Keep records in a secure location. Reporting Assist in the development of reporting metrics. Generates reports and reviews to ensure validity of data. Provide ad hoc reports. Communication Demonstrates effective communications skills. Communicates information in a timely and accurate manner. Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies. Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers. Uses various media forms to maximize communication success. Demonstrates teamwork characteristics. Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects. Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level. Works with research staff to effectively communicate patient process for each trial for the life of the study. Advise, communicate and reinforce standard practices, regulations to following regarding research study participation. Other Attends relevant training courses on policy and compliance. Ensures assigned training is complete and meets internal qualifications. Responsible for completing all necessary training for their position. Maintain familiarity with evolving regulatory and compliance context. Other duties as assigned. **Minimum Qualifications:** Bachelor's Degree (Required) **Additional Job Description:** required from a four year college or university **SPECIALIZED KNOWLEDGE** Ability to prioritize assigned work Strong verbal and written communication skills, as well as customer service skills and ability to problem solve, prioritize and manage multiple tasks Strong computer skills, including thorough knowledge of systems (EMR, Microsoft) **DESIRED ATTRIBUTES** One year of relevant work or academic experience preferred Prior experience in a medical environment preferred Clinical Research Coordinator Certification (or equivalent approved Clinical Research Certification) One or more years of direct human subjects research Clinical knowledge in assigned therapeutic area or program **MAJOR DUTIES/RESPONSIBILITIES & ESSENTIAL FUNCTIONS** **Study Planning and Coordination** Assists with implementation and coordination of research studies and projects. Accountable to PI for study specific responsibilities. Works closely with PI and direct supervisor to organize, plan and carryout the research in an efficient and timely manner. Assists with protocol feasibility, resource requirements and study panning activities including leading internal training to implement the protocol and avoid deviations. Assist with recruitment procedures for potential participants and oversee the enrollment of the clinical trial as directed by the PI. Ensures that study parameters are correctly applied prior to a research participant enrolling a study and during the research participant's visits and assessments. Extracts and records physical findings, laboratory data and other details essential to each study onto the required data collection forms accurately and within the designated time period Attends investigator's meetings, pre-study site visits which may require travel, study initiation visits, and all other study-related visits by monitors or Sponsor representatives. Participate in in-house protocol meetings to review study-related procedures, staffing and visit flow. Participates in the ongoing Informed Consent process with the Investigator to ensure that research participants and their families (if applicable) have their questions answered and understand the consent form, as well as participant's responsibilities in the study. Responsible for giving participant instructions and serves as the primary contact for subjects by being available to handle study specific questions, concerns or events. Accurately records and extracts data from source documentation onto report forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation. After closeout visits have been conducted, prepares study documents for archiving according to timelines. Responsible for in-depth knowledge of protocol requirements and GCP guidelines. Performs other related duties as assigned or required. **Patient Care** Assists nursing and clinical staff and applies skills and knowledge to facilitate the care of research participants. Assists nursing and clinical staff and utilizes knowledge of disease processes to observe and report adverse events and protocol violations / deviations in a timely and accurate manner to the Investigator to ensure the health, safety and welfare of the participant. **Quality and Compliance** Assists in audit preparedness activities for OHRI. Assists with monitoring visits on site and is available during visits for corrections, questions, etc. Maintains study records according to sponsor and/or regulations. Keep records in a secure location. **Reporting** Assist in the development of reporting metrics. Generates reports and reviews to ensure validity of data. Provide ad hoc reports. **Communication** Demonstrates effective communications skills. Communicates information in a timely and accurate manner. Functions as a liaison with sponsor and investigator regarding the preparation, execution and completion of studies. Adapts communication skills in response to various situations including those related to differences in culture, age, education and other communication barriers. Uses various media forms to maximize communication success. Demonstrates teamwork characteristics. Ability to manage time, prioritize and follow up on projects as necessary taking into consideration the need for flexibility when working on multiple projects. Participates in meetings with OHRI, PI and clinical teams to review patient status at a detailed level. Work with research staff to effectively communicate patient process for each trial for the life of the study. Advise, communicate and reinforce standard practices, regulations to following regarding research study participation. **Other** Attends relevant training courses on policy and compliance. Ensures assigned training is complete and meets internal qualifications. Responsible for completing all necessary training for their position. Maintain familiarity with evolving regulatory and compliance context. Other duties as assigned. **Work Shift:** Day **Scheduled Weekly Hours :** 40 **Department** Heart & Vascular Research Clinical Services Join us! ... if your passion is to work in a caring environment ... if you believe that learning is a life-long process ... if you strive for excellence and want to be among the best in the healthcare industry Equal Employment Opportunity OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment

Job Description Responsibilities Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, we are Radiology Forward . With dynamic cross-training and advancement opportunities in a team-focused environment, the core of our success is its people with the commitment to a better healthcare experience. When you join us as a Clinical Research Coordinator, you will be joining a dedicated team of professionals who deliver quality, value, and access in the 21st century and align all stakeholders- patients, providers, payors, and regulators to achieve the best clinical outcomes. You Will: Works with broad spectrum of health care providers for many disease types, physicians, nurses, other research coordinators, imaging techs and support staff Read and interpret research study protocols in order to define the procedures that will be provided to the clinical research site Translate the designated study procedures into a plan for operational implementation Must be able to articulate study process and produce study flow and source documents that are instructive to the technical and clerical staff Maintain impeccable records of all interactions with clients and companies Assures confidentiality of patient's records and study related materials that are provided under non-disclosure agreements by the research site, pharmaceutical company, or imaging vendor Assist the scheduling team with any problems or difficulties to achieve patient study time lines Maintains accurate study files Provides each imaging site with binders and assists them with relevant information in order to procure correct imaging for each study Visits multiple imaging centers in California to ensure training and study compliance. Attends on site pre study and site initiation visits as needed Adjusts schedule to ensure site visits and training sessions can be accomplished Must be able to problem solve and resolve data queries in a timely manner Work environment is organized and functions efficiently You Are: Genuinely passionate about customer service and exercise sound judgement and an ability to remain professional in all situations Able to demonstrate high level of attention to detail, excellent organizational skills and have the ability to multitask Able to thrive in a fast-paced environment, have a knack for prioritizing work with a structured approach, and enjoy providing world class customer service To Ensure Success In This Role, You Must Have: High school graduate (some college preferred) MA certificate, or at least 2 years in a clinical setting or imaging center At least 2 years in a research environment with study operations responsibilities Bachelor's degree or higher may substitute for experience We Offer: Comprehensive Medical, Dental and Vision coverages. Health Savings Accounts with employer funding. Wellness dollars 401(k) Employer Match Free services at any of our imaging centers for you and your immediate family.

The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants. Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned. Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation. Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46). Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information. Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable. Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights. Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times. Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed. Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed. Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner. Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research. Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections. Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed. Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution. Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial. Adheres to the USRC Research quality assurance program guidelines. Travel to Investigator Meetings or similar research related meetings is required. Travel may be required between dialysis facilities or nephrology practices within the community. Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications. May provide training and oversight of Clinical Research Coordinators and/or Research Assistants. Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization. Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures. Participate in staff meetings as required. Regular and reliable attendance is required for the job. Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization. Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures. Regular and reliable attendance is required for the job.

Under the supervision of the Medical Office Administrator, the Clinical Research Coordinator oversees the day to day functions of multiple clinical research studies. This role is responsible for interfacing with the Principal Investigator, Patient, Sponsor, and the IRB. This position is directly responsible to ensure that all documentation is timely and accurate and works closely with the PI to ensure strict compliance to study protocols (GCP/ICH). Providence caregivers are not simply valued - they're invaluable. Join our team at Providence Medical Foundation and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and retain the best people, we must empower them. Required Qualifications: + Coursework/Training - Completion of an accredited Medical or Phlebotomy training program or equivalent educ/experience. Preferred Qualifications: + Graduate of a Vocational School or college. + Coursework/Training - Biohazardous Material packaging training. + F02 AMG Clinical Trials: Required to have College Degree. + Phlebotomy Certificate (for department SJuHMG Clinical Trials) upon hire. + 2 years - Experience in a Clinical Research setting. 3 years preferred. Why Join Providence? Our best-in-class benefits are uniquely designed to support you and your family in staying well, growing professionally, and achieving financial security. We take care of you, so you can focus on delivering our Mission of caring for everyone, especially the most vulnerable in our communities. About Providence At Providence, our strength lies in Our Promise of "Know me, care for me, ease my way." Working at our family of organizations means that regardless of your role, we'll walk alongside you in your career, supporting you so you can support others. We provide best-in-class benefits and we foster an inclusive workplace where diversity is valued, and everyone is essential, heard and respected. Together, our 120,000 caregivers (all employees) serve in over 50 hospitals, over 1,000 clinics and a full range of health and social services across Alaska, California, Montana, New Mexico, Oregon, Texas and Washington. As a comprehensive health care organization, we are serving more people, advancing best practices and continuing our more than 100-year tradition of serving the poor and vulnerable. The amounts listed are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities. Providence offers a comprehensive benefits package including a retirement 401(k) Savings Plan with employer matching, health care benefits (medical, dental, vision), life insurance, disability insurance, time off benefits (paid parental leave, vacations, holidays, health issues), voluntary benefits, well-being resources and much more. Learn more at providence.jobs/benefits. Applicants in the Unincorporated County of Los Angeles: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Unincorporated Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act." Requsition ID: 403768 Company: Providence Jobs Job Category: Research Job Function: Clinical Support Job Schedule: Full time Job Shift: Multiple shifts available Career Track: Clinical Support Department: 7520 RESEARCH PROJECTS CA HERITAGE SERVICES Address: CA Orange 1100 W Stewart Dr Work Location: St Joseph Hospital-Orange Workplace Type: On-site Pay Range: $33.05 - $51.30 The amounts listed are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities.

The Assistant Clinical Research Coordinator comprises an integral part of the research team. Working under the PI, he/she is responsible for conducting the study in accordance with federal regulations. Some responsibilities of the Clinical Research Coordinator include: 1. Preparing for study initiation 2. Obtaining physician signatures 3. Recruiting subjects 4. Screening and scheduling subjects 5. Getting voluntary subject consent 6. Teaching subjects about protocol expectations for them 7. Performing study/protocol procedures in a detailed, accurate manner 8. Maintaining study files 9. Tracking subjects, avoiding lost-to-follow-up 10. Documenting an adverse event 11. Processing and shipping lab work 12. Maintaining communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel 13. Completing case report forms (CRF's) for PI review and approval 14. Helping study monitors with CRA corrections 15. Maintaining study-specific supplies 16. Preparing for study closure and archiving Knowledge of Spanish and / or Phlebotomy Training will be an added advantage.

SUMMARY/JOB PURPOSE: The Senior Clinical Trials Specialist, Clinical Operations, role coordinates the activities associated with the evaluation, initiation, and management of oncology clinical trials. This role provides operational support to the Study Delivery Lead (SDL) by managing assigned study activities and clinical sites, providing CRO oversight, and maintaining accurate study documentation. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Review study documents to manage oncology clinical trials, determine operational risks, and develop mitigation plans to address risks proactively * Responsible for clinical sites within assigned geographical region, and assist with managing/overseeing external vendors within a specific scope (e.g., Lab), as assigned by SDL * Provide CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc. * Participate in meetings with CROs and cross-functional study teams to proactively work to mitigate project risks and resolve issues * Assist with review and development of study documents and plans (e.g. Protocol, Informed Consent Form (ICF), Vendor Oversight Plan, eCRF Guidelines, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals) * Review compound-specific ICF and develop study-specific ICF templates * Assist Study Delivery Team (SDT) and CRO in feasibility assessments and site selection * Responsible for study start-up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, and regulatory documents * Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites * May coordinate the preparation, conduct, and presentations at Investigator Meetings * Review monitoring visit reports for completeness, accuracy, and adherence to the protocol * Coordinate clinical drug/supply reconciliation with oversight of CRO and site reconciliation * May conduct UAT for EDC / IRT and data listing review of EDC data for analysis * Compile and review appendices for preparation of clinical study reports * Review and/or create study documents (e.g. newsletters, and various study / site trackers) * Assist in the coordination of Study Delivery Team (SDT) meetings, prepare agenda, draft and finalize minutes, and track action items to completion * Maintain internal document management system and submit to TMF ensuring Regulatory and Essential/Important documents, and communication are filed timely and appropriately * May assist in materials preparation for strategic governance discussions as required SUPERVISORY RESPONSIBILITIES: * None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: * BS/BA/BSN in biological sciences or related field and a minimum of 5 years of related experience; or, * MS/MA/MSN in biological sciences or related field and a minimum of 3 years of related experience; or, * Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: * Typically requires a minimum of 5 years of related experience in life sciences, including 3 years in experience in clinical research Knowledge/Skills: * Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation * Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures * Experience with development of prospective site-selection criteria * Familiar with medical terminology, and basic concepts of clinical research * Ability to deal with time demands, incomplete information or unexpected events * Experience in interactions with outside vendors, e.g., CROs and contract labs * Demonstrated ability to write and present clearly using on scientific and clinical issues terminology * Applies technical standards, principles, theories, concepts and techniques * Advanced computer skills * Good organizational and planning skills * Strong interpersonal skills and communication skills (both written and oral) * Ability to work effectively in a team/matrix environment * Ability to understand technical, scientific and medical information * Demonstrated success in problem-solving * Self-motivation, eagerness to grow professionally and commitment to self-development JOB COMPLEXITY: * Works on assigned problems of moderate scope with analysis of situation or data required. * Exercises judgment within defined procedures and practices to determine appropriate action. * Builds productive internal and external working relationships. * Uses professional concepts and company policies and procedures to solve a variety of routine problems. * Demonstrated professional collaboration skills * Capable of identifying task-related challenges and prioritizing activity accordingly DESIRED BEHAVIORS: * Resilient in the context of a rapidly changing environment * Organized with a systematic approach to prioritization * Works independently to meet objectives and completes tasks within established timelines. * Expresses curiosity, asks questions and shares perspective, appropriately EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS: * We drive for results, so patients can survive and thrive. * We are resilient in the face of adversity, and tireless in advancing our science. * We celebrate our long history of prolific drug discovery and rigorous drug development. * We unite to launch innovative medicines for difficult-to-treat cancers. * We exist to give people hope - one drug, one patient at a time. * We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY: * Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way), * Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results) * Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS: * Travel may be required up to 20% in support of clinical study activities #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $108,500 - $153,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

SUMMARY/JOB PURPOSE: The Senior Clinical Trials Specialist, Clinical Operations, role coordinates the activities associated with the evaluation, initiation, and management of oncology clinical trials. This role provides operational support to the Study Delivery Lead (SDL) by managing assigned study activities and clinical sites, providing CRO oversight, and maintaining accurate study documentation. ESSENTIAL DUTIES AND RESPONSIBILITIES: · Review study documents to manage oncology clinical trials, determine operational risks, and develop mitigation plans to address risks proactively · Responsible for clinical sites within assigned geographical region, and assist with managing/overseeing external vendors within a specific scope (e.g., Lab), as assigned by SDL · Provide CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc. · Participate in meetings with CROs and cross-functional study teams to proactively work to mitigate project risks and resolve issues · Assist with review and development of study documents and plans (e.g. Protocol, Informed Consent Form (ICF), Vendor Oversight Plan, eCRF Guidelines, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals) · Review compound-specific ICF and develop study-specific ICF templates · Assist Study Delivery Team (SDT) and CRO in feasibility assessments and site selection · Responsible for study start-up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, and regulatory documents · Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites · May coordinate the preparation, conduct, and presentations at Investigator Meetings · Review monitoring visit reports for completeness, accuracy, and adherence to the protocol · Coordinate clinical drug/supply reconciliation with oversight of CRO and site reconciliation · May conduct UAT for EDC / IRT and data listing review of EDC data for analysis · Compile and review appendices for preparation of clinical study reports · Review and/or create study documents (e.g. newsletters, and various study / site trackers) · Assist in the coordination of Study Delivery Team (SDT) meetings, prepare agenda, draft and finalize minutes, and track action items to completion · Maintain internal document management system and submit to TMF ensuring Regulatory and Essential/Important documents, and communication are filed timely and appropriately · May assist in materials preparation for strategic governance discussions as required SUPERVISORY RESPONSIBILITIES: · None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: · BS/BA/BSN in biological sciences or related field and a minimum of 5 years of related experience; or, · MS/MA/MSN in biological sciences or related field and a minimum of 3 years of related experience; or, · Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: · Typically requires a minimum of 5 years of related experience in life sciences, including 3 years in experience in clinical research Knowledge/Skills: · Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation · Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures · Experience with development of prospective site-selection criteria · Familiar with medical terminology, and basic concepts of clinical research · Ability to deal with time demands, incomplete information or unexpected events · Experience in interactions with outside vendors, e.g., CROs and contract labs · Demonstrated ability to write and present clearly using on scientific and clinical issues terminology · Applies technical standards, principles, theories, concepts and techniques · Advanced computer skills · Good organizational and planning skills · Strong interpersonal skills and communication skills (both written and oral) · Ability to work effectively in a team/matrix environment · Ability to understand technical, scientific and medical information · Demonstrated success in problem-solving · Self-motivation, eagerness to grow professionally and commitment to self-development JOB COMPLEXITY: · Works on assigned problems of moderate scope with analysis of situation or data required. · Exercises judgment within defined procedures and practices to determine appropriate action. · Builds productive internal and external working relationships. · Uses professional concepts and company policies and procedures to solve a variety of routine problems. · Demonstrated professional collaboration skills · Capable of identifying task-related challenges and prioritizing activity accordingly DESIRED BEHAVIORS: · Resilient in the context of a rapidly changing environment · Organized with a systematic approach to prioritization · Works independently to meet objectives and completes tasks within established timelines. · Expresses curiosity, asks questions and shares perspective, appropriately EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS: · We drive for results, so patients can survive and thrive. · We are resilient in the face of adversity, and tireless in advancing our science. · We celebrate our long history of prolific drug discovery and rigorous drug development. · We unite to launch innovative medicines for difficult-to-treat cancers. · We exist to give people hope - one drug, one patient at a time. · We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY: · Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way), · Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results) · Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS: · Travel may be required up to 20% in support of clinical study activities #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $108,500 - $153,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.