Clinical Research Coordinator jobs at Banner Health

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.

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.

The Opportunity The Roche/Genentech Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late stage development (Phase 1b-3) clinical strategies and plans to deliver medically differentiated therapies that provide meaningful improvement to patients. The Clinical Scientist supports the molecule/study/project team for effective and efficient Clinical Development Plan (CDP) execution. This includes contributing to clinical documentation, supporting training of study site personnel, acting as a point-of-contact for questions and enquiries to clinical studies, conducting ongoing medical/safety data reviews, and providing clinical science input into study reporting. Clinical Scientists perform their responsibilities with considerable guidance and direction from more experienced Clinical Scientists and Medical Directors. This position is located on-site in San Francisco, CA. Key Responsibilities You will provide support in developing and/or preparing clinical science information for inclusion into the CDP. You will contribute (with guidance from the Lead Clinical Scientist) to protocol/ICF (writing or amendment), construct appropriate CRFs and coordinate these items cross-functionally as needed; you will contribute (with guidance) to internal/external clinical presentations and communications (e.g. investigator meetings, study site interactions, patient information, study newsletters); You will present at appropriate internal meetings, e.g. Study Leadership Team and may contribute to abstracts, posters, content for scientific meetings. You will work with Lead Clinical Scientists/Medical Directors/Clinical Directors and cross-functional groups to execute the Medical Data Review Plan, data interpretation and contribute to study reporting. You will contribute (with guidance) to Clinical Trial Application (CTA)/Ethics Committee (EC) written interactions, briefing packs, written responses to Health Authority (HA) questions, clinical science data/preparations for HA interactions and clinical data input to regulatory submissions. You will have the opportunity to contribute to exploratory safety analyses and be involved in cross franchise initiatives You will work in a collaborative environment with internal and external stakeholders; you have the ability to work cross functionally with early development stakeholders (specifically in gRED and/or pRED) especially in preclinical sciences, discovery sciences and/or developmental sciences, You have provide the necessary support with governing laws, regulations, guidelines and Roche SOPs on global clinical trial execution is required and some knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulation. Who You Are Required You hold a bachelor's Degree focused in Biology, Biomedical Sciences and/or other relevant Life Science areas; Advanced Clinical/Science Degree is highly preferred (e.g. PhD, PharmD, MSN, MPH, etc). You have 1-2 years of clinical development, industry experience, with demonstrated expertise in both early and late stage R&D drug development, including discovery sciences. You have a good understanding of the multidisciplinary functions involved in drug development; including ICF, CST and Safety Data Review activities. Preferred You have the ability to independently carry out the majority of the study conduct responsibilities; you have worked across various therapeutic areas in drug development You have demonstrated experience with protocol review and assessment. You have proven ability to work effectively and efficiently within cross-functional teams, e.g. Study Leadership Team/CSL with therapeutic area-relevant clinical trial experience or clear ability to adapt with transferable skills You have strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location San Francisco, CA is $124,800.00 - $205,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

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 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

It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. As the Study Coordinator you will plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trial sponsor and study team. You will lead the execution of trials for the research team You will plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out You will confirm patient eligibility and discuss discrepancies with nursing staff and physicians You will verify study procedures are performed within the protocol specified window You will participate in teleconferences with sponsors to update on patients including research visits, toxicity, and overall response. Responsible for sending notification out to department before and after calls to update study staff You will present in weekly protocol meeting to investigators, research staff, and management You will provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria You will update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments You will create study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable) You will ensure study specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes You will investigate root cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions You will ensure pharmacy has Investigative Product and supplies You will interface with laboratory technician for lab kits and processing You will track and report adverse events, serious adverse events, protocol waivers, deviations and violations You will participate in monitor visits for each assigned trial at each monitoring visit You will review and comment on monitor letters within 5 business days of receipt and insures resolution of open items You will review source documentation and queries for missing documentation You will collect, complete and enter data into study-specific case report forms or electronic data capture systems within the contractually agreed upon timeframe You will maintain case report forms tracking management database You will review trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance You will assist in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events You will assist in external sponsor audit and US FDA inspection preparation, conduct, and close out processioning You will review and responds to audit findings and escalates issues You will maintain and archive study documentation and correspondence per company policy You will reports patient visit and data entry information in financial tracking system. You will provide required metrics to leadership You will initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects You will adhere to professional standards and SOP's established for clinical research You will assist internal quality team in preparation for sponsor and US FDA audit teams You should have for this role: An understanding of clinical trial data. Knowledge of FDA guidelines and GCP is required. The ability to work independently in a fast paced environment. Interpersonal skills, detailed-oriented and meticulous. Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel Bachelor Degree is preferred At least one year of experience in healthcare, research or other science related field At least one year of experience planning and managing clinical trial process Pay range $29.33/hr - $35.00/hr About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings. We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

ALIVATION RESEARCH, LLC Integrated Health Center | Next Level You Lincoln, NE 68526 A leader in integrated Mental Healthcare for over 20 years with Pharmacy, Primary Care, Aesthetics and Research divisions all in one location, where ideas and opinions are valued and expected, seeks a Clinical Research Assessment Coordinator to join our expanding Behavioral Health Research Team promoting an innovative culture, putting the patient's health and well-being first. CORE VALUES: Drive | Passion | Humility | Openness | Discipline JOB TITLE: Clinical Research Assessment Coordinator STATUS: Regular Full-Time If you have a perceptive passion to promote research studies in a collaborative team environment, with an innate learning desire that resonates with our core values to deliver and enhance the best patient care, we would like to meet you. Ultimately, you will assume an important role in the promotion of clinical research performing all activities involved in conducting clinical studies in a safe and therapeutic physical environment, specifically the patient visits rating scales and assessments for the research trials. TALENT: Eager, determined to achieve success, and committed to making a difference every day Compassionate and care deeply about our patients and their experience Love what you do and where you work Not afraid to ask questions and grow as a professional Ability to have open, honest conversations with patients and team members Self-motivated Integrity belief in everything you do KEY RESPONSIBILITIES: (Job Description Available Upon Demand) Implements and supports the practice mission and strategic vision within respective departments. Handles confidential information requiring professional discretion and compliance with protected health information, data integrity and security policies. Implements Phase I, II, III and IV pharmaceutical, device, and non-interventional research trials in accordance with GCP guidelines. Recruit patients to participate in research studies in person, over the phone, and through community outreach and/or events: This includes explaining the study design, purpose, and requirements, as well as pre-screening for eligibility and answering any questions the patient may have. Schedules patient visits: This includes coordinating provider schedules and research schedules. Conducts patient visits while observing all protocol and GCP requirements and guidelines. Dispenses and receives study medication. Monitors adverse events and concomitant medications at each visit. Performs rating scales and assessments during the patient visits (especially those in which a MD, PhD, Masters, or equivalent degree is required). Performs/assists with safety assessments during the patient visits, including height, weight, blood pressure, temperature, respiratory, ECG, blood draw and urine collection. Completes all data entry required after each visit: This includes answering sponsor queries. Manages a caseload of various studies and be able to organize and submit all required documents for each specific study to the sponsor, IRB, study team, and any other applicable parties. Assists with maintaining and organizing regulatory documents for research trials. Submits all required documentation to study team, sponsor and IRB. Maintains patient and regulatory master files to assure audit readiness. Attend periodic investigator meetings out-of-state. Demonstrates adaptability to changing work demands in terms of priorities that necessitate personal initiative. Demonstrates excellent interpersonal skills, strong active listening skills, verbal, and written communication skills, patience and trustworthiness to effectively share knowledge with Chief Medical Officer, Neuroscience Clinical Research Manager and patients. Other clinical or administrative duties as assigned to meet practice needs. QUALIFICATIONS: MD (No License Required), PhD, Masters or Equivalent Degree in Mental Health Field Required | Knowledge of FDA Regulations and GCP Guidelines | Proficient Medical Terminology | Basic Life Support (BLS) Certification or In Process | Electronic Data Capture Systems | ECG Machine | Electronic Manometer | Thermometer | Scale | Familiar with EMR & PM Systems | Familiar with Microsoft Platforms EXPERIENCE: 3 years experience conducting clinical research studies| Previous experience in Psychiatric Treatment preferred. Previous experience administering some or all of the following rating scales and assessments required: ABC-I, ADHD-RS-IV, ACDS, AIMS, AISRS, ASRS, ATRQ, BARS, BPRS+, CAPS-5, CADSS, CDRS-R, CGI-I/CGI-S, C-SSRS, CY-BOCS, HAM-A, HAM-D, HDRS-21, Ishihara Color Blindness Test, K-SADS, Kaufmann Brief Intelligence Test, LEC-5, MADRS, MINI-KID, MINI, MMSE, MoCA, PAC, PANSS, PARS, Peds-QL, PHQ-9, PPVT, PROMIS, PWC-20, QIDS-SR, SAS, SIGH-D-17, SNAP-IV, S-STS, SCID, Tanner Staging, TOVA, UKU, YGTSS, Y-BOCS, YMRS COMPENSATION: Competitively Based COMPREHENSIVE BENEFITS PACKAGE: Clinic-Owned, Innovative Aesthetics Environment Discounted Primary Care Office Visits for Employees Amazing Team Culture No On-Call Shifts No Nights or Weekends Corporate Employee Discounts Free Parking 120 Hours PTO Seven Paid Holidays Health Insurance (Employee Premium Allotment) Dental Insurance Vision Insurance Short-Term & Long-Term Disability Insurance Paid Life Insurance Policy Employee Assistance Program (EAP) Health Savings Account 401(k) Matching Retirement Plan EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER: The Practice provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

ALIVATION RESEARCH, LLC Integrated Health Center | Next Level You Lincoln, NE 68526 A leader in integrated Mental Healthcare for over 20 years with Pharmacy, Primary Care, Aesthetics and Research divisions all in one location, where ideas and opinions are valued and expected, seeks a versatile and compassionate candidate to join our vibrant Behavioral Health Research Team promoting an innovative culture, putting the patient's health and well-being first. CORE VALUES: Drive | Passion | Humility | Openness | Discipline JOB TITLE: Clinical Research Coordinator STATUS: Regular Full-Time If you have a passion for delivering excellent patient care as well as furthering science through pharmaceutical and device research studies, we would like to meet you. Ultimately, you will play an important role on our team as a coordinator who is entrusted with learning a variety of different Behavioral Health Research trials, maintaining documentation for research studies, engaging with sponsors, conducting research trial visits with patients, and maintaining effective communication with the research team and providers in the clinic. TALENT: Eager, determined to achieve success, and committed to making a difference every day. Compassionate and care deeply about our patients and their experience. Love what you do and where you work. Not afraid to ask questions and grow as a professional. Ability to have open, honest conversations with patients and team members. Self-motivated. Integrity belief in everything you do. KEY RESPONSIBILITIES: (Job Description Available Upon Demand) Supports and implements the practice mission and strategic vision within their respective departments. Handles confidential information requiring professional discretion and compliance with protected health information, data integrity and security policies. Implements Phase II, III and IV pharmaceutical, device, and non-interventional research trials in accordance with GCP guidelines. Recruitment of patients to participate in research studies in person and over the phone, schedules patient visits, prepares for patient visits, conducts patient visits, and completes all data entry required after each visit. Manages a caseload of patients on a variety of different studies. Perform/assist with safety assessments during the patient visits, including height, weight, blood pressure, temperature, respiratory, ECG, blood draw and urine collection. Complete all data entry required after each visit, including answering sponsor queries. Maintains excellent communication with manager, team members, sponsor, and the IRB. Meticulously documents all patient correspondence. Periodically attends investigator meetings out of state. Other clinical or administrative duties as assigned to meet practice needs. QUALIFICATIONS: High School Diploma | Bachelor's Degree or Medical Experience Preferred | Proficient Medical Terminology | Knowledge of GCP Regulations | Familiar with EMR Systems EXPERIENCE: Minimum Three Years Working In A Clinical Research Setting COMPENSATION: Competitively Based COMPREHENSIVE BENEFITS PACKAGE: Clinic-Owned, Innovative Aesthetic Environment Discounted Primary Care Office Visits for Employees Amazing Team Culture Company Sponsored Events No On-Call Shifts No Nights or Weekends Corporate Employee Discounts Free Parking 91 Hours PTO Seven Paid Holidays Health Insurance (Employee Premium Allotment) Dental Insurance Vision Insurance Short-Term & Long-Term Disability Insurance Paid Life Insurance Policy Employee Assistance Program (EAP) Health Savings Account 401(k) Matching Retirement Plan EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER: The Practice provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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.

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

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. Posted are the minimum and the maximum wage rates on the wage range for this position. The successful candidate's placement on the wage range for this position will be determined based upon relevant job experience and other applicable factors. These amounts 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.

At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer care-we're changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn't stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins. Position Summary A Clinical Research Coordinator -Biorepository provides operational and regulatory support for the Caris sponsored studies and collaborative Pharma studies ensuring activities are conducted per standard operating procedures and best practice principles. Responsibilities will include, but not limited to, study documentation maintenance, leading site onboarding activities, driving site engagement through routine status meetings/ touch points, study enrollment/ accrual reporting, specimen tracking, and inventory. Job Responsibilities Successfully execute site onboarding process in an effective and timely manner Develop and maintain a thorough understanding of study content, workflows, and procedures to successfully conduct the Site Initiation Visit meeting and offer ongoing site support. Liaison with study sites and regulatory document team to ensure regulatory documentation is up to date. Ensures proper regulatory, legal, and financial disclosure documentation are on file in accordance with standard operating procedures, data management plan and/or study protocol. Communicates cross functionally (internally and externally) on all research study operational changes; ensuring questions and issues are answered/addressed or provided to the appropriate group. Maintains workflows in accordance with approved Standard Operating Procedures (SOPs). Assists in process improvement within the department under the direction of manager. Reviews specimen requests for proper approvals, maintains documentation of chain of custody, and routes for fulfillment. Reviews associated specimen and subject submission documentation and verified accuracy of data entry. Continuously provides excellent customer service in an efficient and effective manner. Required Qualifications Associate degree with biological science coursework required. Candidates should have 1-2 years' experience in a Biorepository setting or Clinical Trial setting Proficient in Microsoft Office Suite, specifically Word, Excel, PowerPoint, Outlook, and general working knowledge of Internet for business use Preferred Qualifications BS degree or higher degree with biological science 3-5 years' experience Candidates should have experience with clinical trial regulatory documentation or TMF. Candidates should have a strong understanding of laboratory settings and processes and must be able to adapt to varied levels of workload in a dynamic environment. Laboratory Information Management System or Sample Management System experience. Customer service experience. Good Clinical Practice training, IATA training, and Human Subject Protection training. Physical Demands Ability to stand for more than 1 hour at a time, sit for more than 1 hour at a time. Ability to lift up to 30 lbs. Training Employee will be required to complete Good Clinical Practices, Human Subject Protection, HIPAA, and IATA training. All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. Other Weekend/evening/holiday work may be required depending on business need, however, is not to be the norm. Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification. This reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

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.

Job Description 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.

Job Details Experienced Scottsdale Office - Scottsdale, AZ Full Time MA Program Health CareDescription Women's health group, seeks an experienced Clinical Research Coordinator to care for patients in the West Phoenix area. Full-time opportunities available. Competitive pay. Great traditional and non-traditional benefits available, including six-week paid sabbaticals. SUMMARY A Research Assistant performs a variety of clinical study activities to assist the Investigator, Director, and Study Coordinator in the conduct of a clinical study. Various Medical Assistant job duties will be assigned as necessary. This is a full time position with data entry, research, and medical assistant job duties. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: (Other duties may be assigned as needed.) Maintain a neat and organized workspace, so as to enable a substitute to take over in the event of an absence. Be on time to work, appropriately attired for the work of WHR Confirm all patient visits for the following day. Participate in subject recruitment efforts as needed. Assist in clinical studies according to FDA regulations and ICH guidelines. Familiarize self with study protocol Strive to achieve results with as few errors as possible Be knowledgeable of the protocol, so that all study activities are completed correctly and completely. Schedule subject's visits within appropriate study visit windows. Complete the Case Report Forms accurately and completely in a timely manner. Maintain all required study documentation. Meet with Sponsors to discuss the conduct of the study and review study data. Be professional towards study subject and maintain confidentiality of study subject. Copy documents as needed for coordinators. Restock and clean exam rooms daily. Process and ship specimens in completion of this task. Keep packets stocked for every enrolling study for the coordinators. Mail out packets to patients as requested by the coordinators. Maintain and fax study logs for each protocol including study activity at the site. Correspond with subjects, monitors, pharmaceutical company personnel, lab personnel by fax, phone, mail, etc. Maintain a professional, yet friendly attitude when greeting patients. Ship and receive packets as needed for study staff. Ability to take and assess vitals ( i.e. blood pressure, pulse, height, weight, venipuncture..) Qualifications To perform this job successfully, an individual must be able to initiate and complete assigned tasks satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made available to individuals with disabilities to perform the essential functions. Ability to take and assess vitals ( i.e. blood pressure, pulse, height, weight, venipuncture..) EDUCATION and/or EXPERIENCE: Must have certification/degree/diploma in Medical Assisting. GCP training through CITI program. LANGUAGE ABILITY: Ability to ready and interpret (in English) all documents, such as protocols, informed consents, and laboratory/procedure manuals. Ability to write (in English) routine reports and correspondence. Ability to speak effectively before groups of subjects, customers, or employees of WHR. MATHEMATICAL ABILITY: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. REASONING ABILITY: Ability to solve practical problems and deal with a variety of variables in situations in which only certain standardization exists. Ability to interpret a variety of instructions furnished in written, oral, spreadsheet, or schedule form. OTHER REQUIREMENTS: Must maintain punctual attendance, absolute reliability, and be appropriately attired for the professional environment of WHR. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally required to walk and stand; frequently required to use hands; and regularly required to sit and talk or listen. May occasionally be required to lift up to 10 pounds. Experienced Clinical Research Coordinators/MA's are encouraged to apply

Part-time Description Job Title: Clinical Research Coordinator (CRC) Department: Clinical Research Reports to: Clinical Manager Summary: The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the clinical Principal Investigator's (PI) direction. While the principal investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel, and other related aspects of the clinical study.Essential Duties and Responsibilities Rights, safety and well-being of patients prevail over science. Rights, safety and well-being of patients prevail over science. All available non-clinical and clinical information on any investigational agent can support the trial as designed. All trials are scientifically sound and clearly described. All clinical trials have current Institutional Review Board approval. Everyone involved in the clinical Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians. Trial is qualified by training, education and experience. Informed consent is given freely by every participant. All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification. Confidentiality of subjects is respected and protected. Investigational products maintain Good Manufacturing Practice in storage, manufacturing and handling. Systems to ensure quality are implemented in all aspects of the trial. Register participants to the appropriate coordinating center (if multi-site study) Complete study documentation and maintains study files in accordance with sponsor requirements and policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms and investigational material accountability forms. Retains all study records in accordance with sponsor requirements. Maintains effective and ongoing communication with sponsor, research participants, research director and PI during the course of the study. Competencies Required: Dependability and punctuality Planning and organizing Customer Service Multitasking Oral Communication Adaptability Problem solving Attention to Detail Ability to follow through Teamwork Professionalism Good written communication skills High energy Qualifications/Education/Experience: Qualifications: High school graduate or equivalent. Supervisory: The incumbent in the position will not supervise other employees. Education/Experience: Bachelor's degree in life science or related discipline and experience in clinical research is preferred. Skills/Abilities: Language Ability: Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization. Knowledge of modern equipment and the ability to maintain confidentiality, maintain physical effort, and distribute files. Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent, and to draw and interpret bar graphs. Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Computer Skills: Proficient in Microsoft Office, Outlook, Excel, PowerPoint, and Word; able to navigate the internet and intranet. Ability to learn the internal clinical outcome database and upload photographs from a camera. Environment Expectations: Work Environment: The incumbent in this position is not required to work under extreme conditions, but must be able to work around a moderate noise level, such as in an office environment. Physical Demands: The incumbent in this position typically has to stand approximately 20% of the time, walk 20% of the time, and sit 60%. In addition, this person talks or hears 100% of the time. Accountability: The Clinical Research Coordinator is accountable for the day-to-day operations of ensuring the clinical trial program runs smoothly, via phone messages, faxes to physicians and staff, database entry, billing entry, etc. Specific Individual Considerations: The designation of "essential functions" and "other duties" is for purposes of compliance with the Americans with Disabilities Act. This job description should not be construed to imply that these requirements are the only duties, responsibilities, and qualifications for this position. Incumbents may be required to follow any additional related instructions, acquire related job skills, and perform other related work as required. Incumbents in this position may be required to perform all or some of the above duties and responsibilities with varying concentration levels based on the incumbent's skill level and program needs. I have read and understand the contents of this position description. _____________________________ Signature Print Name Date Salary Description $20-22 per hour

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.