Clinical research associate jobs in Chandler, AZ - 140 jobs

With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us! As a global leader we're looking for a Senior **Lead Clinical Research Associate (CRA)** to drive success as part of our Non-interventional Study team. Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinical research, and driving groundbreaking projects on a global scale! **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. **Required Experience** + **Education** : Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinical research experience. + **Clinical research expertise** : At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies. + **Communication skills** : Outstanding spoken and written proficiency in English (C1 level minimum).Additional languages are considered a strong asset. + **Technical proficiency** : Comfort with MS Office, EDC, CTMS exprience and willingness to learn and handle various technical systems and tools. + **Personal qualities** : Exceptional organizational and problem-solving skills, strong cross-culturalteamwork, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment. + **Financial management:** Experience reviewing site contracts, budget and invoices. + **Attention to detail** : Ability to work independently with careful, precise, and thorough execution of complex tasks. **Responsibilities** **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. Disclaimer: **Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.** **Range and benefit information provided in this posting are specific to the stated locations only** US: Hiring Range in USD from: $70,600 to $141,200 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC3 **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

**Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Job Summary and Responsibilities The Gregory W. Fulton ALS and Neuromuscular Disease Center is seeking a Clinical Research Specialist to join our team. Multiple Openings! The ALS Center was founded to integrate high quality care with cutting edge research for neuromuscular disorders including ALS Pompe disease Spinal Muscular Atrophy Myasthenia Gravis among others. Over the past several years the ALS Center researchers have conducted over 20 sponsored and investigator initiated clinical trials for ALS and Neuromuscular disorders with new research projects continually added across time. Clinical Research Specialist Position Duties: Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA) Office for Human Research Protections (OHRP) Good Clinical Practices (GCP) Institutional Review Board (IRB) HIPAA regulations and institutional requirements which include but are not limited to the following duties: * Knowledge of regulatory requirements and institutional requirements when conducting study protocol(s). * Assists with participant recruitment including pre-screening potential participant follow-up and collaboration with Investigators. * With the Investigators coordinates research subject informed consent and enrollment into appropriate research studies. * Coordinates and/or performs a variety of procedures/tests including but not limited to laboratory tests/phlebotomy vital signs ECG outcomes assessments cognitive evaluations as well as other needs as outlined in the study protocol(s). * Obtains medical history medical records and all other procedures outlined in the study protocol(s) within the allowed timelines. * Responds to patient inquiries via phone or in person in a timely manner. * Processing and shipment of laboratory samples collected as outlined in the study protocol(s). * Provides participant education with the Investigators research pharmacists and other members of the research study team such as study specific procedures diary/study log proper dosage/administration and specific restrictions as outlined in the study protocol(s). * Completes case report forms data entry and maintains source documentation for all study participants. * Prepares for participant visits including scheduling and source document creation. * Triages tracks and reports adverse events and deviations to the Investigator as well as the sponsor and IRB in accordance to their requirements. * Coordinates research monitor visits and responds to all data queries in a timely manner. Position is onsite in Phoenix, AZ Job Requirements Requirements: Minimum 2 years related experience required. Competent in computer skills including the Microsoft Office products required. Associates degree in related field or an equivalent combination of relevant education and/ or job-related experience in lieu of degree required. Preferred: Three (3) years clinical research experience preferred Bachelors Degree in related field preferred. Where You'll Work Hello humankindness Located conveniently in the heart of Phoenix, Arizona,St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved. We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Joseph's Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Joseph's is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital's patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph's. U.S News & World Report routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital. St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies. Look for us on Facebookand follow us on Twitter. For the health of our community ... we are proud to be a tobacco-free campus.

Job DescriptionSalary: Negotiable based on experience Clinical Research Finance & Billing Specialist Location: Phoenix, Arizona (Part-Time) Department: Finance & Operations Reports To: President (or delegated executive) Research Axsendo Clinical Research is a fast-growing, multi-site clinical research network focused on advancing Neurology, Cardiology, Metabolic Disease, Vaccines, and Medical Device innovation. With active operations across several markets, we support a high volume of clinical trials and are expanding our financial operations infrastructure to match our growth. We are seeking a part-time Clinical Research Finance & Billing Specialist to support accurate, compliant, and efficient financial workflows across the organization. Position Overview The Clinical Research Finance & Billing Specialist is responsible for managing study-related billing, sponsor invoicing, payment reconciliation, participant reimbursements, and financial activities tied directly to clinical trial operations. This role ensures Axsendo maintains accurate financial tracking across all active studies while supporting seamless communication between clinical operations, investigators, sponsors, CROs, and our outsourced accounting team. This is a part-time position designed for an experienced clinical research financial professional who can operate independently and bring structure, accuracy, and oversight to multi-site billing workflows. Key Responsibilities Clinical Research Billing & Study Financial Operations Prepare and manage sponsor invoicing for visit-based billing, screen failures, pass-through items, milestone payments, and other budgeted items Maintain detailed accounts receivable tracking and follow up on outstanding sponsor payments Process and reconcile participant reimbursement payments according to study protocol and sponsor requirements Review and track PI payments, investigator stipends, and ensure accurate allocation per CTA and budget Monitor budget-to-actuals for assigned studies and support financial forecasting for active protocols Assist in ensuring billing compliance with CTAs, budgets, and clinical protocol requirements Coordination With Outsourced Accounting Firm Serve as the internal point of contact for the outsourced accounting/tax firm Provide timely documentation, coding, and financial details for monthly close Review reconciliations, journal entries, and financial statements prepared by the outsourced firm Support cost classification, accrual validation, and GAAP-aligned reporting processes Internal Controls & Compliance Maintain financial SOPs tied to study billing, receivables, reimbursements, and sponsor payments Verify compliance with sponsor contracts, internal financial processes, and clinical research guidelines Support audit preparation, monitoring visits, and financial documentation requests Maintain confidentiality and secure handling of financial and research-sensitive information Systems & Process Support Utilize CTMS financial modules, participant payment systems, and sponsor portals for billing workflows Identify and recommend process improvements across billing, reconciliation, and study budget tracking Support site operations with financial reporting needs related to enrollment, forecasting, and study activation Qualifications Education Bachelors degree in Accounting, Finance, Business, Health Administration, or related field preferred Experience Minimum 3 years of clinical research financial experience required (pharma, medical device, CRO, or research site) Hands-on experience with study budgets, sponsor invoicing, and participant/stipend payments Experience working with CTMS financial tools strongly preferred Prior collaboration with outsourced accounting teams is a plus Technical Skills Strong Excel skills Proficiency with CTMS financial modules and payment platforms Familiarity with EMR/EDC billing triggers preferred Working knowledge of GAAP Core Competencies High attention to detail and accuracy Ability to manage multiple studies and deadlines in a fast-paced environment Strong communication with both operations and accounting teams High integrity and confidentiality Solution-oriented mindset with an understanding of clinical research workflows Employment Type Part-Time (approximately 1525 hours per week, depending on study volume) Compensation Competitive hourly rate commensurate with experience (If you want, I can provide a recommended Phoenix market range for this role) Why Join Axsendo Play a key role in supporting a growing multi-market clinical research organization Work collaboratively with clinical and accounting teams across multiple therapeutic areas Flexible part-time schedule with meaningful impact and the ability to grow into a full-time role A positive, professional culture centered on service, reliability, and operational excellence

Job DescriptionSalary: Recruitment Specialist TL;DR The Recruitment Specialist plays a key role in supporting patient enrollment for ongoing clinical trials. You are the frontline in connecting potential participants to important research opportunities! With your excellent communication skills and attention to detail, youll contact patients from recruitment rosters, provide them with trial information, and help determine initial eligibility. Ideal for a pre-med or life sciences student looking to gain hands-on experience in clinical research. This is a part-time role with flexible shifts, with eligibility for hybrid work after completion of onboarding and training, demonstrated competency sign-off, and approval from management. What you will own & improve Patient outreach: Call patients from curated recruitment lists to inform them about active clinical trials and assess initial interest and eligibility. Pre-screening: Conduct structured phone screenings and accurately document responses for clinical team review. Data entry: Update tracking logs and recruitment dashboards to ensure accurate, real-time metrics. Scheduling support: Assist in coordinating next steps for interested participants, including scheduling pre-screen visits or connecting them with study staff. Communication flow: Collaborate with the recruitment team and site staff to flag barriers to enrollment and suggest improvements to patient outreach efforts. Follow-ups: Execute timely and professional follow-up calls with prospective patients to keep recruitment on track. What you already know Youre comfortable talking on the phone and engaging people from diverse backgrounds. Youre organized, proactive, and detail-orientedyou know that missing documentation can cause unwanted delay. You are a team player and know how to take direction while working independently. Youre excited by the idea that your calls can lead to someone gaining access to a potentially life-changing clinical trial. What you will learn How patient recruitment drives clinical research timelines and impacts study success. Real-world experience in clinical trials, patient communication, and eligibility pre-screening. How to work with patient data while maintaining compliance with HIPAA and GCP. CTMS and e-regulatory systems used across the clinical research industry. How to work with recruitment leadership to improve strategies and achieve enrollment goals. About the Team This role reports to the Director of Patient Recruitment & Strategy Part-time position: 2-4 weekday shifts/week (approx. 4 hours each) In-person onboarding and training required; hybrid work may be available after competency sign-off and management approval. Flexible hours and a supportive, mission-driven team environment Benefits at DocTrials Competitive salary | Flexible schedule | Company adventures Values at DocTrials Align Your Daily Priorities | Roll Out the Red Carpet | Be Obsessed About Learning Show Up Ready | What Can We Do? | Dont Panic Dont Work in a Bubble | Recognize the Gray | Have a Positive Purpose About Us DocTrials' culture is guided by our values and behavior. Our success depends on how much we care for each other, our customers, and our community. DocTrials is an alliance of physician sites specializing in the conduct of clinical studies within their private practices. Sites in the alliance work under DocTrials' core standard operating procedures and quality control measures that provide a methodology ensuring the highest quality control and best practice utilization across sites. This provides assurance and confidence to sponsors that they will achieve quality data in the most efficient and timely manner. DocTrials was founded with the primary goal of connecting patients and physicians with clinical trials across the US; aiding in the process to discover new therapies, bring hope, and find new treatment for disease.

Where You'll Work Hello humankindness Located conveniently in the heart of Phoenix, Arizona,St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved. We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Joseph's Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Joseph's is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital's patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph's. U.S News & World Report routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital. St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies. Look for us on Facebookand follow us on Twitter. For the health of our community ... we are proud to be a tobacco-free campus. Job Summary and Responsibilities The Gregory W. Fulton ALS and Neuromuscular Disease Center is seeking a Clinical Research Specialist to join our team. Multiple Openings! The ALS Center was founded to integrate high quality care with cutting edge research for neuromuscular disorders including ALS Pompe disease Spinal Muscular Atrophy Myasthenia Gravis among others. Over the past several years the ALS Center researchers have conducted over 20 sponsored and investigator initiated clinical trials for ALS and Neuromuscular disorders with new research projects continually added across time. Clinical Research Specialist Position Duties: Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA) Office for Human Research Protections (OHRP) Good Clinical Practices (GCP) Institutional Review Board (IRB) HIPAA regulations and institutional requirements which include but are not limited to the following duties: Knowledge of regulatory requirements and institutional requirements when conducting study protocol(s). Assists with participant recruitment including pre-screening potential participant follow-up and collaboration with Investigators. With the Investigators coordinates research subject informed consent and enrollment into appropriate research studies. Coordinates and/or performs a variety of procedures/tests including but not limited to laboratory tests/phlebotomy vital signs ECG outcomes assessments cognitive evaluations as well as other needs as outlined in the study protocol(s). Obtains medical history medical records and all other procedures outlined in the study protocol(s) within the allowed timelines. Responds to patient inquiries via phone or in person in a timely manner. Processing and shipment of laboratory samples collected as outlined in the study protocol(s). Provides participant education with the Investigators research pharmacists and other members of the research study team such as study specific procedures diary/study log proper dosage/administration and specific restrictions as outlined in the study protocol(s). Completes case report forms data entry and maintains source documentation for all study participants. Prepares for participant visits including scheduling and source document creation. Triages tracks and reports adverse events and deviations to the Investigator as well as the sponsor and IRB in accordance to their requirements. Coordinates research monitor visits and responds to all data queries in a timely manner. Position is onsite in Phoenix, AZ Job Requirements Requirements: Minimum 2 years related experience required. Competent in computer skills including the Microsoft Office products required. Associates degree in related field or an equivalent combination of relevant education and/ or job-related experience in lieu of degree required. Preferred: Three (3) years clinical research experience preferred Bachelors Degree in related field preferred.

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology - it is all we do - combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking - we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients. Position Summary: The Senior Clinical Trial Manager (Sr. CTM) position oversees and performs day-to-day site management activities, after site activation, on clinical research trials. The Sr. CTM acts as the site liaison between the Project Manager and a group of Clinical Research Associates (CRAs) assigned to a given clinical trial, and with collaboration from the team, ensures the clinical site portion of a trial is always inspection ready. This role also performs leadership activities and provides operational support to department heads. Essential Functions: Leadership: * Support and mentor CTM I and II while providing clinical site management oversight on a trial and relational basis. * Assist other departments or functional areas including Finance, Business Operations, Clinical Development, Site Engagement, Data Services, Data Management, Vendor Management, and Quality Assurance by serving a subject matter expert in site management. * Support Principal CTM with performance metrics, operational efficiencies, process improvements, resourcing and utilization, training, and other tasks as needed or assigned. General: * Ensure compliance with FDA and ICH GCP regulations, Sponsor guidelines, and all internal controlled documents. * Ensure accurate time completion on a weekly basis in accordance with trial budgets and scopes. * Assist with the development and implementation of TD2 clinical policies, SOPs, working guidelines, training manuals, and informal processes. Trial: * Effectively communicate with project and senior management on strategies to grow site services business at TD2. * Collaborate with cross-functional team members and trial sites throughout all trial phases. * Review protocol, amendments, plans, manuals, and other trial documents as necessary. * Develop trial Patient Recruitment, Enrollment, and Retention Plans. Ensure individual site profiles appendixes are completed and support site triage and services upon activation. * Prepare and review site-related reports (e.g., enrollment, deviation logs, monitoring trackers, and interim monitoring). * Provide site metrics as needed for decision making purposes. * Lead regular Investigator meetings, create agendas, review meeting minutes, update Project Log, and ensure distribution as agreed upon with the Sponsor. * Work with the Project Manager and Sponsor to proactively identify site risks, developing mitigation and contingency planning. * Participate in Sponsor meetings and Internal Team meetings, serving as subject matter expert in site management including enrollment, and reviewing agendas, minutes, and the Project Log as needed for site information. Quality: * Represent TD2 during quality audits with specific focus on site management activities at TD2. * Immediately escalate any site, patient, or trial safety or conduct concerns to project manager and department leadership for awareness and assistance. Site Management: * Develop and maintain Sponsor and site relationships that result in repeat business. * Serve as primary liaison between sites, Project Manager, CRAs, or other designated team members for site non-compliance and issue resolution (e.g., recruitment, enrollment, documentation, data entry timeliness, query follow-up, investigational product (IP), laboratory samples and kit logistics, and general miscommunications). * In collaboration with the CRAs, proactively identify site issues and coordinate personnel retraining to avoid major deviation occurrences or recurrences. * Review and approve interim monitoring trip reports initially completed by CRA or designated individual. * Track projected versus actual enrollment, providing solution-based site support and customized interventions to boost patient recruitment, screening, enrollment, and retention. * Work with site personnel to proactively address potential or actual barriers to patient recruitment, screening, enrollment, and retention, collaborating with Site Engagement or other designated individuals. * Responsible for site budgets, regulatory submissions and approvals, site ICF revisions, site document distribution, and site training with protocol amendments. * Responsible for the post site-activation site milestone tracking in the detailed trial timeline. Monitor and coordinate the efforts of the key site milestones to ensure they are met on time. IP, Supplies, and Specimen Management: * Serve as main contact for site clinical trial supplies IP, communicating with respective vendors for coordination and inventory reconciliation, not including budget or change orders. Perform other related duties as assigned. Job Requirements: * Minimum of a Bachelor's degree in a life science, or health related with Master's degree preferred. Experience may be substituted for education at TD2's discretion. * Minimum of 6 years' experience in research. * Minimum 4 years' experience in oncology research trials from biotechnology/pharmaceutical, clinical research organization, and/or site setting. * Experience in other complex therapeutic areas, such as rare and orphan diseases, cardiac, or AME trials, as well TD2 performance and work experience, may be substituted at TD2's discretion. * Evidence of understanding aspects of clinical trials. Required Specialized/Technical Skills: * Understanding of oncology clinical trials with strong knowledge of the clinical drug development process. * Familiarity and training in all aspects of clinical trial research, including GCP/ICH guidelines. * Understanding of CRA activities and responsibilities. * Ability to train and lead the work of others. * Excellent communication, written and interpersonal skills. * Strong ability to perform individually, work collaboratively with team members, and build excellent relationships with Sponsors, sites, and other TD2 team members. * Possess strategic thinking, contingency planning, problem-solving and dispute resolution skills. * Good organization and multi-tasking skills in a fast-paced environment. * High-level skills in communication, judgement, problem-solving, persuading, and negotiating. * Strong computer skills, including Microsoft Excel, Word, and PowerPoint. * Experience using required electronic systems (e.g., CTMS, TMF, EDC) * Ability to travel approximately 15% (dependent on Sponsor/trial requirements). TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran's status, gender, sexual orientation, gender identity, or gender expression. #LI-TD2

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow-because at LivaNova, we don't just treat conditions - we aspire to alter the course of lives. The Associate Clinical Project Manager will be involved and assist with the management and execution of clinical studies in accordance with the applicable domestic and international government regulations, Clinical Investigation Plans, and Standard Operating Procedures. Additionally they will assist with the development of effective clinical trial strategies, preliminary project timelines, and budgets for clinical project(s) to ensure successful product development and worldwide marketing efforts. General Responsibilities * Coordinate project deliverables such as team meetings, project budgets and timelines, and systems to track study metrics. * Assist Clinical Management with the development and planning of clinical study strategies, design, protocols, and other study-related documents and tools. * Oversee and provide clinical input for the design of the Case Report Forms and electronic databases. * Assist with and coordinate preparation of regulatory applications, amendments, questions from the authorities, supplements, reports, and advisory panel presentations needed to conduct studies and approve products. * Assist and drive clinical site selection, activation, management and any close-out activities throughout the conduct of the study including all necessary documentation. * Prepare and give clinical presentations to physicians, clinical study staff, agents and distributors, as required. * Monitor or co-monitor clinical study sites to ensure compliance with the approved study protocol, plans and objectives which may include reviewing clinical monitoring reports. * Assure clinical studies are adequately managed to meet the protocol objectives and schedules. * If applicable, support Data Monitoring Committees (also called Data Safety Monitoring Boards) and other committees/consultants established to support the studies. * Assist data management staff with clinical data review and collection of data from sites to maintain integrity by reviewing protocol deviations, adverse events, data inconsistencies, outliers, other issues as identified. * Develops and executes risk based study management process and plan according to study-specific risk indicators and thresholds. * Assist with management of study vendors for compliance to study plans, objectives and vendor contracts, including task management of labs and/or CROs, if applicable. * Helps to ensure sponsor and site compliance to domestic and international government regulations and guidelines. * Effectively communicate with LivaNova study management, participating sites, and any vendors on issues, questions and/or study updates. * Create, update, and maintain site administrative files and trial master files (electronic and/or paper) to ensure audit-readiness at all times. * Maintain accurate and up-to date study tracking documents (eg enrollment, regulatory approvals and renewals, payments) and systems (eg CTMS, EDC). * For premarket studies, instruct warehouse and field staff in clinical device distribution and recovery. Maintain device accountability plan and report. * Coordinates and assists with the data review, analysis and preparation of the clinical study reports and coordinates their deliveries. * Coordinates closeout of sites/study, archive study documents. Skills and Experience * Minimum prior work experience of 4+ years as a Clinical Research Nurse or equivalent role supporting clinical trial project management at a medical device/drug company, clinical research site, or CRO. * Knowledge of international regulations and guidelines (ISO14155/GCP) and clinical study design and implementation. * Working knowledge of medical terminology. * Capability and willingness to learn device function. * Ability to interface effectively with medical professionals. * Strong analytical and organization skills, with excellent attention to detail and accuracy. * Project oversight and tracking capability. * Good oral and written communication skills. * Ability to work autonomously with excellent organizational skills and ability to prioritize assignments while handling various projects simultaneously. * Experience with electronic data capture (EDC) and clinical trial management systems (CTMS). * Demonstrated ability to perform in a team environment. * Ability to travel as necessary to clinical centers to establish and manage clinical studies. * Experience as a Project Coordinator/Manager is a plus. Education * Minimum Bachelor's Degree in Nursing (a Master's Degree in Nursing is also accepted for candidates who did not complete an undergraduate nursing program). Travel Requirements * This position requires regular business travel of 25% or more of the time. Pay Transparency * A reasonable estimate of the annual base salary for this position is $95,000 - $105,000 + discretionary annual bonus. Pay ranges may vary by location. Employee benefits include: * Health benefits - Medical, Dental, Vision * Personal and Vacation Time * Retirement & Savings Plan (401K) * Employee Stock Purchase Plan * Training & Education Assistance * Bonus Referral Program * Service Awards * Employee Recognition Program * Flexible Work Schedules Welcome to impact. Welcome to innovation. Welcome to your new life.

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow-because at LivaNova, we don't just treat conditions - we aspire to alter the course of lives. The Associate Clinical Project Manager will be involved and assist with the management and execution of clinical studies in accordance with the applicable domestic and international government regulations, Clinical Investigation Plans, and Standard Operating Procedures. Additionally they will assist with the development of effective clinical trial strategies, preliminary project timelines, and budgets for clinical project(s) to ensure successful product development and worldwide marketing efforts. General Responsibilities Coordinate project deliverables such as team meetings, project budgets and timelines, and systems to track study metrics. Assist Clinical Management with the development and planning of clinical study strategies, design, protocols, and other study-related documents and tools. Oversee and provide clinical input for the design of the Case Report Forms and electronic databases. Assist with and coordinate preparation of regulatory applications, amendments, questions from the authorities, supplements, reports, and advisory panel presentations needed to conduct studies and approve products. Assist and drive clinical site selection, activation, management and any close-out activities throughout the conduct of the study including all necessary documentation. Prepare and give clinical presentations to physicians, clinical study staff, agents and distributors, as required. Monitor or co-monitor clinical study sites to ensure compliance with the approved study protocol, plans and objectives which may include reviewing clinical monitoring reports. Assure clinical studies are adequately managed to meet the protocol objectives and schedules. If applicable, support Data Monitoring Committees (also called Data Safety Monitoring Boards) and other committees/consultants established to support the studies. Assist data management staff with clinical data review and collection of data from sites to maintain integrity by reviewing protocol deviations, adverse events, data inconsistencies, outliers, other issues as identified. Develops and executes risk based study management process and plan according to study-specific risk indicators and thresholds. Assist with management of study vendors for compliance to study plans, objectives and vendor contracts, including task management of labs and/or CROs, if applicable. Helps to ensure sponsor and site compliance to domestic and international government regulations and guidelines. Effectively communicate with LivaNova study management, participating sites, and any vendors on issues, questions and/or study updates. Create, update, and maintain site administrative files and trial master files (electronic and/or paper) to ensure audit-readiness at all times. Maintain accurate and up-to date study tracking documents (eg enrollment, regulatory approvals and renewals, payments) and systems (eg CTMS, EDC). For premarket studies, instruct warehouse and field staff in clinical device distribution and recovery. Maintain device accountability plan and report. Coordinates and assists with the data review, analysis and preparation of the clinical study reports and coordinates their deliveries. Coordinates closeout of sites/study, archive study documents. Skills and Experience Minimum prior work experience of 4+ years as a Clinical Research Nurse or equivalent role supporting clinical trial project management at a medical device/drug company, clinical research site, or CRO. Knowledge of international regulations and guidelines (ISO14155/GCP) and clinical study design and implementation. Working knowledge of medical terminology. Capability and willingness to learn device function. Ability to interface effectively with medical professionals. Strong analytical and organization skills, with excellent attention to detail and accuracy. Project oversight and tracking capability. Good oral and written communication skills. Ability to work autonomously with excellent organizational skills and ability to prioritize assignments while handling various projects simultaneously. Experience with electronic data capture (EDC) and clinical trial management systems (CTMS). Demonstrated ability to perform in a team environment. Ability to travel as necessary to clinical centers to establish and manage clinical studies. Experience as a Project Coordinator/Manager is a plus. Education Minimum Bachelor's Degree in Nursing (a Master's Degree in Nursing is also accepted for candidates who did not complete an undergraduate nursing program). Travel Requirements This position requires regular business travel of 25% or more of the time. Pay Transparency A reasonable estimate of the annual base salary for this position is $95,000 - $105,000 + discretionary annual bonus. Pay ranges may vary by location. Employee benefits include: Health benefits - Medical, Dental, Vision Personal and Vacation Time Retirement & Savings Plan (401K) Employee Stock Purchase Plan Training & Education Assistance Bonus Referral Program Service Awards Employee Recognition Program Flexible Work Schedules Welcome to impact. Welcome to innovation. Welcome to your new life.

Clyde & Co is seeking an insurance defense trial and litigation associate with 0 to 3 years of experience to join our Phoenix office. This practice is focused on the defense of a myriad of high exposure litigation across the nation, including trials, trial monitoring, and parachute trials. This practice includes catastrophic injury cases, bodily injury, complex business and commercial litigation, premise liability, bad faith and fraud, UM/UIM, class action and mass tort, and trucking and transportation matters. The ideal candidate has litigation and trial experience, is proactive, motivated, and organized and possesses superior oral argument, research and writing skills. The Associate will interact with our clients, participate in and try cases, and monitor cases and trials. Responsibilities In this role you will: Manage a caseload of 25-30 matters; Take depositions, attending hearings, and mediations as required; Draft and submit pleadings, discovery, motions and briefs; Monitor trials, evaluate trial record for errors to be raised on appeal; Conduct legal research using Westlaw/Lexis/Nexis; Review and analyze documents and materials for production; Review and analyze briefs and trial transcripts and develop arguments for appeals; Evaluate insurance policies and analyze claims for potential coverage issues; Actively investigate claims and prepare case handling strategies; Actively and effectively report to our insurance carrier clients and insureds; Prepare cases for trial/mediation and participate in trial/mediation Education and Experience Admission to the Arizona bar Litigation experience Experience taking depositions Excellent academic credentials Skills and Ability Exceptional legal writing and communication skills; Strong interpersonal skills: Ability to manage and prioritize multiple projects; Ability to identify and resolve problems quickly. This role may require out of state travel for trial and trial monitoring. Benefits offered include student loan reimbursement; flexible time off; medical, dental, and vision insurance; 401K Safe Harbor contribution; Life/AD&D Disability; Flexible Spending Account; Supplemental Medical Accident Insurance; Supplemental Critical Illness Insurance; Employee Assistance Program; Pet Insurance; Commuter Benefits. Clyde & Co is a leading global law firm, helping organizations successfully navigate risk and maximize opportunity in the sectors that underpin global trade and commercial activity. When you work at Clyde & Co, you join a team of 490 partners, 2,400 lawyers, 3,200 legal professionals and 5,500 people in nearly 70 offices and associated offices worldwide. Our values are the principles that guide the decisions we make, unite us in our endeavors and strengthen our delivery, for both our clients and our firm. We work as one, excel with clients, celebrate difference and act boldly. We are committed to operating in a responsible way by progressing towards a diverse and inclusive workforce that reflects the communities and clients it serves. The Firm When you work at Clyde & Co, you join a team of 500 partners, 2,400 lawyers, 3,200 legal professionals and 5,500 people in nearly 70 offices and associated offices worldwide. Our values are the principles that guide the decisions we make, unite us in our endeavours and strengthen our delivery, for both our clients and our firm. We work as one, excel with clients, celebrate difference and act boldly. We are committed to operating in a responsible way by progressing towards a diverse and inclusive workforce that reflects the communities and clients it serves. We are devoted to providing an environment in which everyone can realise their potential, using its legal and professional skills to support its communities. We do this through pro bono work, volunteering and charitable partnerships, and minimising the impact it has on the environment, including through our commitment to the SBTi Net-Zero standard and the setting of ambitious emissions reduction targets. Our Commitment Clyde & Co is proud to be an equal opportunities employer. Our values encourage us to support fairness, celebrate diversity and prohibit all forms of discrimination in the workplace to allow everyone to excel at work. Therefore, we welcome and encourage all applications from suitably qualified individuals, regardless of background or identity. Learn more about our interview process. A Note on Privacy Please take a moment to read our privacy notice.. This describes what personal information Clyde & Co (we) may hold about you, what it's used for, how it's obtained, your rights and how to contact us as a data subject. If you are submitting a candidate as a Recruitment Agency Partner, it is an essential requirement and your responsibility to ensure that candidates applying to Clyde & Co are aware of this privacy notice. This is the job description as constituted at present; however, Clyde & Co reserves the right to reasonably amend it in accordance with the changing needs of the business.

About Us: Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment. Title: Clinical Research Coordinator III (Phase I) Compensation: $33 - $39 per hour, depending on experience Location: Chandler, AZ Schedule: Full-time, 40 hours, Monday-Friday, 7am - 4pm Essential job functions/duties Reasonable accommodation may be made to enable individuals with disabilities to perform these essential functions. Develop and implement strategies to achieve Site Goals for participant engagement, enrollment, and retention. Build and maintain relationships with clinical teams, and other stakeholders at your facility Identify and monitor barriers to enrollment and retention, and develop solutions to overcome them. Assist with training new staff members and assisting the site manager as needed. Ensure local strategies are successful through regular assessment and evaluations. Under the direction of the Principal Investigator or sub-investigator, manage the conduct of clinical research activities. Responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs. May assume responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner. Collects and records clinical research data, assists in patient assessments, scheduling, maintain study files, study supplies and study medication accountability. Keep the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators and ensuring status of each patient is accurate. Develop management systems and prepare for study initiation. Conduct study required procedures within study specific guidelines/timeline and document in real time. Documentation may be electronic or on paper depending on the trial. All “wet ink” documents will be filed in a binder or folder to pass off to the oncoming staff or clinical research coordinator. Record data and study documentation. Record data as directed using the appropriate media or platform. Follow procedures for access and security for electronic data entry. After proper training and delegation this position will be required to perform all study related procedures required on their shift and in preparation for the next shift. The procedures may include performing ecgs, vital signs, administering subject home medication, administering IP (Investigational Product/study drug) under direction of pharmacy staff, administer questionnaires as required per protocol, start iv's after, draw and process blood per lab manual, urine collection, keep intake and output sheets, collect and process bodily secretions per study guidelines. Other duties as assigned to keep in compliance with protocol requirements and data collection. Answer phone calls and direct appropriately. Order subject meals and ensure they eat per protocol requirements. Ensure subject and staff meals are within company guidelines. Manage study-related activities, subject compliance and documentation. Screen and enroll study subjects. Document all adverse events as required per protocol. Investigator and/or clinical coordinator should be notified in a timely manner of any potential adverse reactions. Management of site activities during audits and inspections. Prepare for quality assurance audits and regulatory inspections as needed. Act as contact person before, during and after audits and inspections. If new subjects check in to the unit during your shift, ensure all bags are checked for prohibited items. If these items are found, they should be confiscated and locked in a secure area for the safety of all subjects and staff. This will include cigarettes and lighters, pocket knives, subject home meds, etc. Perform all duties according to established policies, procedures, regulatory requirements, as well as applicable professional standards. Training in BLS/ACLS per company policy. Call 911 if emergency situation arises and notify the investigator immediately. Notify investigator or other delegated staff of any changes in subject status or reports of complaints by subject. Administer over-the-counter medication under direction of investigator. Assist subject with hygiene needs as required. Keep rooms clean and change bed linen as needed. Take subjects on walks outside and attend during smoking breaks. Keep stock of snacks, sodas, water, etc. Order or provide list of needed supplies to Phase 1 staff member. Keep drawers, closets stocked with needed supplies. Knowledge/Skills/Abilities Required Training (appropriate to anticipated duties - Medical Assistant, associates, undergraduate, graduate degree or equivalent, study-specific training, other as applicable to assigned responsibilities). Experience and training in the conduct of clinical research (specific experience and/or training in clinical research, including IRB submissions, reporting and source documentation, trial management). A thorough understanding of regulatory requirements, principles of GCP and biomedical research ethics. Interpersonal and communication skills-interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects and referral sources. Education, credentials, and/or trainings required High School Diploma or GED required. BLS and ACLS training required. Bachelor's degree preferred. 4+ years of experience in clinical research field Medical Assistant certification or diploma from an accredited program preferred. Professional certification in Phlebotomy from a recognized program preferred. Supervisory responsibilities None. Work environment Clinic / office setting Physical demands Able to lift at least 30 lbs. Able to sit for long periods (at least 50%). Able to type and do computer work for long periods. Travel Requirements Some interoffice travel may be required with use of company vehicle or mileage reimbursement. Work authorization requirements Must have valid documentation and authorization to work in the U.S. -- visa sponsorship or visa transfer is not offered now or in the future Benefits & Perks: Health, Dental, Vision (with HSA plans and employer contribution) 3 weeks PTO 5 days Sick Time 7 Company holidays + 2 Half-days 401K with up to 6% company match Short & Long Term Disability Educational Assistance Shared company vehicles for required travel EEO statement It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate. Notice to Staffing Agencies: It is our policy that any and all contact with third party staffing or recruitment vendors come through our Talent Acquisition Team directly. We have an established and preferred network of contracted partners that we engage if and when we deem it necessary. We request that staffing agencies refrain from repeatedly contacting our hiring managers or employees directly. Unsolicited resumes, onsite solicitations, and inquiries will not be considered or responded to. Overly persistent and pushy inquires may also be blocked across our network as spam. Thank you for your understanding and cooperation.

***Relocation assistance is NOT available for this position. Candidates must currently reside within commuting distance or be able to relocate independently as well as be prepared to begin employment within 2-4 weeks of receiving an offer*** Ironwood Cancer & Research Centers has beautiful state-of-the-art integrated Cancer and Women's Centers, with locations strategically located throughout the Valley. Each one provides a superior cancer care environment with a full spectrum of cancer related services for patients. Our multi-disciplinary team approach includes surgical oncology, medical oncology, radiation oncology, women's centers, diagnostic imaging services, integrative services including social work and nutrition, and genetic counseling. Mission Statement : To serve the community by providing quality, comprehensive cancer care which respects the values and needs of each individual. Overview : We are looking for a qualified and experienced Research Coordinator. Manages and coordinates all aspects of conducting clinical trials within Ironwood Physicians, PC facilities, both clinically and administrative/regulatory. Required to have in-depth knowledge of protocol requirements and ensures that studies are properly conducted in conformance with the protocol guidelines, departmental standards and good clinical practices as set forth by federal regulations and international guidelines. Schedule: Full-time, Monday through Friday day shift position and located in our Mesa (Arbor) location. Essential Duties and Responsibilit ies include: Acts as liaison between investigators, other study staff, primary care providers, IRB and sponsor. Reviews studies for clinical and operational feasibility, along with the Investigator and Director of Research. Screens, consents, enrolls and follows study subjects ensuring protocol compliance and close monitoring while subjects are on study utilizing Research Nurses' oversight for help with clinical decision making. Responsible for all data and source documentation, adverse experience reporting, and will assist Regulatory Specialist in the maintenance of complete regulatory files. Develops screening/enrollment/follow up mechanisms. Ensures that randomization procedures and blinding procedures, as applicable, are followed as per protocol guidelines. Schedules and performs patient procedures, assessments, evaluations and testing as required by the protocol, including but not limited to blood sample collection, processing and shipping, ECG, vital signs, etc., as applicable. Knowledge and Skills : Excellent clinical and functional skills. Organized and detail oriented. Data entry experience a plus. Proficiency in Microsoft Office, Word, Outlook, and Internet. Ability to use office equipment, computer. Education and Experience : Associate or Bachelor's Degree. Clinical experience in Oncology or other acute care. Prior research and phlebotomy experience. Current IATA, Human subjects protection training or GCP training highly desirable. We offer a competitive salary and a comprehensive benefit package including health/dental/vision and life insurance, 401K, and a caring work environment. We are an E.O.E. Please visit our website at ******************** "Outsmarting Cancer One Patient at a Time"

Clinical Research Coordinator I (Glendale, AZ) (Multiple Positions) Posting Number req24921 Department All of Us Research Program Department Website Link ***************************************************************** Location Greater Phoenix Area Address Phoenix, AZ USA Position Highlights University of Arizona Health Sciences (UAHS) is seeking a Clinical Research Coordinator to join the All of Us Research Program at the University of Arizona and Banner Health. All of Us is a national research program funded by the National Institutes of Health (NIH). It seeks to enroll one million or more individuals from across the United States with an emphasis on Pediatric Participants. The aim is to help speed up medical research and advance precision medicine. The All of Us Research Program at the University of Arizona and Banner Health will contribute significantly to the development of this database by engaging, enrolling, and retaining 100,000 or more participants in our region. As a Clinical Research Coordinator for All of Us, you will assist with participant recruitment, enrollment, education, retention and data collection by engaging with individuals in various clinical settings. You will be presenting an overview of the program mission and goals, conducting eligibility screenings and informed consent procedures, and collecting physical measurements and biospecimens (blood and urine). You will be responsible for ensuring participants understand what is expected of them and addressing any questions or concerns. In addition, Clinical Research Coordinators are responsible for accurate collection and timely entry of data into various program platforms, processing of biospecimens, scheduling and follow-up communication with participants, longitudinal participant retention, and overall compliance with program procedures. You will work closely with your supervisor, your coworkers, and the clinical team(s) at your assigned site to coordinate and implement program recruitment, enrollment and retention procedures. Your home site will be Banner Thunderbird Medical Center in Glendale, AZ, but you may be asked to float to other Banner facilities in the Phoenix metro area as needed. Community outreach events at off-site locations may occur in the evenings and on weekends. Reliable transportation is necessary. Outstanding U of A benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; U of A/ASU/NAU tuition reduction for the employee and qualified family members; retirement plans; access to U of A recreation and cultural activities; and more! The University of Arizona has been recognized for our innovative work-life programs. For more information about working at the University of Arizona and relocations services, please click here. Duties & Responsibilities Participant Recruitment & Enrollment: * Assisting with participant recruitment by engaging with individuals in various clinical and nonclinical settings and presenting an overview of the program mission and goals. * Create daily recruitment lists via Cerner. * Uses good Clinical Practice (GCP) and University of Arizona procedures and other applicable rules, regulations and policies to conduct eligibility screening, informed consent process, and survey completion. * Handles scheduling of prospective participants for research visits and procedures. Engages in administrative tasks including phone call, email, SMS, in-person, etc.(including reminder communications). * Completing enrollment visit according to core protocol, standard operating procedures (SOP), and best practices including data collection, physical measurements, and biospecimen collection (blood and urine). * Ensure proper collection, processing, and handling of biospecimens. * Coordinate with department, supervisor, coworkers and on-site clinical team(s) to help ensure recruitment, clinical research, and related activities are performed in accordance with protocol and standard operating procedures. * Sanitize and stock carts daily with enrollment tools and supplies. Participant Retention: * Develop a longitudinal relationship with Baseline Participants through frequent communication via phone call, email, SMS, in-person, etc. * Engage with participants in clinical and nonclinical settings. * Navigate retention platforms including HealthPro, REDCap, Cerner, and Program Management Toolkit (PMT). * Support participants with accessing their accounts by overcoming technology / digital barriers through education and strong communication abilities. Technology Documentation & Miscellaneous: * Ensure data is accurately captured and entered into program platforms including REDCap, Cerner, HealthPro, and PMT. * Verify captured data across systems to ensure accurate medical records are transferred to the NIH. * Complete inventory evaluations as needed. Knowledge, Skills, and Abilities: * Must possess excellent interpersonal skills; able to build rapport with strangers and communicate effectively with various individuals. * Must be willing to be trained in phlebotomy and biospecimen collection. * Must be willing to work in a clinical setting. * Ability to handle confidential and sensitive information. Knowledge of HIPAA. * Ability to navigate technology platforms such as Cerner and REDCap * Knowledge of and familiarity with policies associated with confidentiality and informed consent. This job posting reflects the general nature and level of work expected of the selected candidate(s). It is not intended to be an exhaustive list of all duties and responsibilities. The institution reserves the right to amend or update this description as organizational priorities and institutional needs evolve. Minimum Qualifications * Bachelor's degree or equivalent advanced learning attained through experience required. * 1 year of relevant work experience. Preferred Qualifications * Bilingual English/Spanish * Experience working in clinical research or clinical trials FLSA Exempt Full Time/Part Time Full Time Number of Hours Worked per Week 40 Job FTE 1.0 Work Calendar Fiscal Job Category Research Benefits Eligible Yes - Full Benefits Rate of Pay $47,356 - $59,195 Compensation Type salary at 1.0 full-time equivalency (FTE) Grade 6 Compensation Guidance The Rate of Pay Field represents the University of Arizona's good faith and reasonable estimate of the range of possible compensation at the time of posting. The University considers several factors when extending an offer, including but not limited to, the role and associated responsibilities, a candidate's work experience, education/training, key skills, and internal equity. The Grade Range represent a full range of career compensation growth over time. The university offers compensation growth opportunities within its career architecture. To learn more about compensation, please review our Applicant Compensation Guide and our Total Rewards Calculator. Career Stream and Level PC1 Job Family Clinical Research Job Function Research Type of criminal background check required: Name-based criminal background check (non-security sensitive) Number of Vacancies 2 Target Hire Date Expected End Date Contact Information for Candidates Sarah Siebenaler | *************************** Open Date 1/20/2026 Open Until Filled Yes Documents Needed to Apply Resume and Cover Letter Special Instructions to Applicant Please note: If invited to interview, please be prepared to provide three (3) professional references. Notice of Availability of the Annual Security and Fire Safety Report In compliance with the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act (Clery Act), each year the University of Arizona releases an Annual Security Report (ASR) for each of the University's campuses. These reports disclose information including Clery crime statistics for the previous three calendar years and policies, procedures, and programs the University uses to keep students and employees safe, including how to report crimes or other emergencies and resources for crime victims. As a campus with residential housing facilities, the Main Campus ASR also includes a combined Annual Fire Safety report with information on fire statistics and fire safety systems, policies, and procedures. Paper copies of the Reports can be obtained by contacting the University Compliance Office at ********************.

The Clinical Quality Improvement Coordinator works directly with the Director of Quality & Informatics, supporting the development, implementation, and oversight of the CPR, Inc. Quality and Utilization Management Program. This role combines quality management expertise with licensed clinical oversight to ensure compliance with regulatory requirements, promote continuous quality improvement, and support clinical operations across multiple service lines. At CPR, we are committed to making diversity, equity, inclusion, and belonging an integral part of our daily operations. We strive to hire and retain talented, diverse, and creative individuals, and we are dedicated to ensuring equitable treatment by promoting fairness and respect at every level of our organization. Knowledge and Skills Licensed behavioral health clinician with strong knowledge of quality improvement, compliance, and utilization management practices in a healthcare setting. Understanding of best clinical practices and evidence-based treatment models for behavioral health. Familiarity with federal and state regulations, including Board of Medical Facilities Licensing (BMFL), Arizona Health Care Cost Containment System (AHCCCS), Centers for Medicare and Medicaid Services (CMS), HIPAA, and other healthcare quality and compliance standards. Ability to work effectively both independently and collaboratively. Excellent problem-solving skills utilizing creativity, resourcefulness, timeliness, and technical knowledge. Strong written and verbal communication skills. Proficiency with electronic medical record systems and competency in both computer and phone applications (including Apple products). Exceptional multi-tasking and organizational skills to manage multiple, competing priorities. Primary Duties and Responsibilities Clinical Oversight and Staffing Support Provide staffing coverage to various service lines, including TCP, Crisis, Public Safety, and occasionally SMI programs. Offer clinical oversight during audits, investigations, and when responding to staff questions related to clinical issues. Serve as a licensed clinical resource for interdisciplinary teams as needed. Quality Improvement and Compliance Conduct internal chart reviews and audits across multiple departments. Review clinical documentation for adherence to medical necessity and level of care criteria. Develop and implement documentation improvement plans following external audits. Maintain and manage the log of all CPR complaints and Incident, Accident, and Death (IAD) reports. Complete Quality of Care (QOC) concern medical requests and reviews. Assist in reviewing, investigating, and documenting internal and external complaints. Participate in all external audits and support the development and implementation of Performance Improvement Plans. Ensure HIPAA compliance across the agency and perform annual HIPAA Risk Assessments. Training and Education Assist in onboarding new CPR staff related to Quality and Utilization Management processes. Facilitate QPR suicide prevention training approximately once per quarter (or as needed) for clinicians and client-facing staff. Support ongoing agency-wide clinical training initiatives in collaboration with the Director of Quality & Informatics. Other Responsibilities Contribute to Targeted Investment initiatives and other special projects as assigned. Perform other duties as necessary to meet the objectives of the position. Qualifications and Education Requirements Master's degree in a Behavioral Health field. Active, behavioral health license in the State of Arizona. Minimum of two years of post-graduate experience in a clinical setting, with preference for candidates with quality management or utilization management experience.

Details Department: RSRCH-GRNT | Clinical Research Admin Shift: Mon-Fri, Days, 8am-5pm Posting #: 947836 Employee Type: Full-Time This position is responsible for the coordination of a variety of research projects from pre-study implementation through study closure and will work independently in the acquisition of specimens; extraction and entry of patient data; maintenance of complete and accurate subject data and regulatory documentation; and analysis of data per protocol. This position provides administrative / regulatory support (recruiting, interviewing and scheduling study participants, processing IRB and other regulatory documents) to specific clinical departments in accordance with all federal, state, regulatory agency, and specific institutional requirements. Position Duties * Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), and institutional guidelines, which includes the following duties: 1. Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, and procedures for all research activities in designated area 2. Responsible for the completion and submission of documents to the appropriate IRB and institutional committees on an ongoing basis 3. Maintains compliance with current and accurate documentation in the regulatory binders as required by regulations and sponsors 4. With the principal investigator, explains the study purpose, parameters, and requirements of the studies to the participants * Completes all tasks required by study sponsors. 1. Provides regulatory documents to sponsor in timely manner 2. Completes case report forms, data entry, and maintains source documentation for all study participants 3. Tracks and reports adverse events per sponsor and institutional guidelines 4. Coordinates research monitor visits and responds to all data queries * Coordinates the process for opening new studies. 1. Obtains needed background material(s) on proposed research projects; presents findings and information to principal investigator 2. Completes feasibility questionnaires 3. Circulates the confidentiality disclosure and trial agreements to the appropriate parties 4. Creates study budgets and works with management to determine financial feasibility and resources necessary to conduct the trial 5. Assists in development of workflow procedures for study team based on specific protocol * Participates in recruitment and selection of study participants. Coordinates research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met. * Coordinates and schedules a variety of medical procedures/tests including, but not limited to, laboratory tests, blood pressure readings, imaging studies, psychological evaluations, and cardiac and/or pulmonary function tests as needed by the study protocol(s). * In conjunction with the principal investigator, research pharmacist, and other members of the research study team, provides study specific education to the participant and their family. This may include study specific procedures, diary/study log documentation, proper dosage/administration, and disease treatment. * Reviews monthly financial reports, including study participant billing, expenditures, and revenue. Maintains inventory level of all supplies and equipment, initiates requisitions for replacement items, and maintains equipment to provide for continuous operational efficiency. * Participates in a variety of professional development programs to ensure understanding of most current methodologies, practices, and philosophies as applied to the relevant patient population and research area. * Performs miscellaneous job related duties as requested.

Full-time Description JOB DESCRIPTION: CLINICAL RESEARCH COORDINATOR II POSITION DESCRIPTION: The Clinical Research Coordinator II (CRC) reports to the Director of Research and is responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs. The CRC collects and records clinical research data, assists in patient assessments, scheduling, maintain study files, study supplies and study medication accountability. RESPONSIBILITIES: Responsible for up to 10 studies and expected to perform 20-40 visits a month. Knowledge of all active protocols and disease indications within the company, and providing information about these protocols to staff and patients. Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources. The CRC is responsible for meeting recruitment goals for each study. The methodology of recruitment will include, but is not limited to daily chart review, hosting recruitment breakfasts, advertising when funds are available, referrals from rheumatologists and other AARA staff and may include attending health fairs and community outreach. Keeping the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators, and ensuring status of each patient is accurate. Responsible for chain of custody and accurate accountability of investigation product and devices. Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following: Informed Consent Obtaining patient medical history and medication lists Phlebotomy and basic laboratory tests Processing & shipping labs for central and local labs Patient education and training ECG Administer questionnaires and assessments Vital signs Collect information for adverse event reporting Assist with joint counts and other efficacy assessments Data Entry and Query Resolution Study drug administration, including injections Tracking study supply inventory and reordering when necessary Schedule patient visits in appropriate electronic systems Documenting all patient visits and communications in progress notes Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed. Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program. Ensures uniform implementation of protocols by completing required training documentation in a consistent, accurate and timely manner. Assists in regulatory functions, including but not limited to preparing appropriate Institutional Review Board (IRB) forms, processing updated informed consents, protocols, correspondence, and regulatory filing in an accurate and timely manner. Responsible for administrative duties including filing documents related to subjects participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc. Serves as a liaison to all physicians, AARA employees, and third party vendors. Participates in monitoring visits from sponsor provided appointees, ensures monitors are able to meet/speak with PI and ensures all concerns are addressed in a timely manner. Ensure the delegation logs are correct and only delegated site staff are performing duties as listed on the delegation log for any given study. Ensures that primary referring physicians receive timely progress notes on the patient's diagnosis and treatment. May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner. Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards. Provides all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum. Maintaining office supply inventory while keeping an organized office space. Travel as necessary for Investigator Meetings and other AARR sites. Requirements Qualifications: Bachelor's Degree or equivalent 1 year experience as a clinical research coordinator Must have in-depth knowledge of medical procedures and clinical terminology Possess strong organizational skills Ability to develop and maintain strong professional relationships with all providers and research subjects Excellent working knowledge of ICH-GCP Guidelines and all Federal regulations Excellent verbal and written communication skills Ability to lift 20 pounds Willing and able to travel for Investigator Meetings and other AARR sites Salary: $65,000-$75,000 annual salary plus bonus Salary Description 65,000-75,000 annual

Full-time Description The Research Project Coordinator II is responsible for the successful planning and implementation for multiple ATSUs clinical and academic Research Support projects. Research Support projects and associated phases must be planned, monitored, and controlled, whereby they are delivered on time and following the respective research protocols. The Research Project Coordinator II is responsible for constant communications to all ATSU and external stakeholders. This includes but not limited to, senior leadership, professors, physicians, students, research participants, biostatisticians, etc. Duties & Responsibilities: The Research Project Coordinator II is responsible to effectively operate and troubleshoot research specific equipment, software, and hardware. This position must be very technology savvy. The Research Project Coordinator II is responsible for knowing, following, and update research project standard operating procedures. The Research Project Coordinator II is responsible for ensuring research project activities, contracts, and agreements execute accordance with ATSU, state and, federal laws, policies, and guidelines. Evening and weekend work will be required infrequently. Lead, plan, implement, and execute research projects to successfully meet research study objectives. Lead and assist with a variety of research program events. Effectively learn, operate, train, and troubleshoot research lab equipment, software, and hardware. Organize and lead research project status meetings with timely follow up to ensure deadlines are achieved. Effective written and oral communications with research project stakeholders. Provide consultation to principal investigator(s) and other key stakeholders (e.g., research team members, funders, regulatory bodies) on study-specific research processes. Research study data collection planning, including data management and data quality management. Processing collected data using project-specific procedures and technology. Recruit, screen, and enroll research participants. Ensure compliance with all regulatory activities and duties, at institutional, local, and/or national levels, including creating and submitting IRB applications and maintaining IRB approvals, communicating adverse events, maintaining procedural documentation, preparing for audits and monitoring visits from regulatory bodies. Ensure all contractual and legally binding agreements execute per ATSU, state, and federal (FDA, NIH, OHRP) policies. Effectively manage fiscal and physical research resources, including preparation and submission of required status reports. Effectively manage study finances including invoicing and resolving study subject compensation issues. Train, educate, mentor, and supervise research study personnel. Act as a liaison for research subjects, investigators, IRB, sponsors, funders, collaborators, and healthcare professionals, ensuring effective communication with all stakeholders. Coordinate academic research tests and testing protocol with the curriculum department and course instructors. Evening and weekend work will be required infrequently. Writing semi-annual and annual reports to regulatory bodies and funding agencies. Evaluating the feasibility of industry-sponsored pharmaceutical and device clinical trials. Develop study/project advertisement materials. Update Research Support intra-net (ATSU internal) web site. Experience & Education: Associate's degree or higher preferred. Three to five years experience in leading and organizing multiple research studies and projects effectively. Effective and confident speaking, writing, and presentation skills. Relevant experiences in clinical/academic/health sciences research. Strong attention to detail. Must posess strong initiative, use independent judgment, and be a team player. ATSU offers a comprehensive benefits package including medical, dental, and vision coverages, among more. If eligible, employee-elected benefits would begin the first of the month following hire date. For more information, please visit: atsu.edu/employment/benefits. A.T. Still University (ATSU) does not discriminate on the basis of race, color, religion, ethnicity, national origin, sex (including pregnancy), sexual orientation, age, disability, or veteran status in admission or access to, or treatment or employment in its programs and activities.

The Research Project Coordinator II is responsible for the successful planning and implementation for multiple ATSUs clinical and academic Research Support projects. Research Support projects and associated phases must be planned, monitored, and controlled, whereby they are delivered on time and following the respective research protocols. The Research Project Coordinator II is responsible for constant communications to all ATSU and external stakeholders. This includes but not limited to, senior leadership, professors, physicians, students, research participants, biostatisticians, etc. **Duties & Responsibilities:** + The Research Project Coordinator II is responsible to effectively operate and troubleshoot research specific equipment, software, and hardware. This position must be very technology savvy. + The Research Project Coordinator II is responsible for knowing, following, and update research project standard operating procedures. + The Research Project Coordinator II is responsible for ensuring research project activities, contracts, and agreements execute accordance with ATSU, state and, federal laws, policies, and guidelines. + Evening and weekend work will be required infrequently. + Lead, plan, implement, and execute research projects to successfully meet research study objectives. + Lead and assist with a variety of research program events. + Effectively learn, operate, train, and troubleshoot research lab equipment, software, and hardware. + Organize and lead research project status meetings with timely follow up to ensure deadlines are achieved. + Effective written and oral communications with research project stakeholders. + Provide consultation to principal investigator(s) and other key stakeholders (e.g., research team members, funders, regulatory bodies) on study-specific research processes. + Research study data collection planning, including data management and data quality management. + Processing collected data using project-specific procedures and technology. + Recruit, screen, and enroll research participants. + Ensure compliance with all regulatory activities and duties, at institutional, local, and/or national levels, including creating and submitting IRB applications and maintaining IRB approvals, communicating adverse events, maintaining procedural documentation, preparing for audits and monitoring visits from regulatory bodies. + Ensure all contractual and legally binding agreements execute per ATSU, state, and federal (FDA, NIH, OHRP) policies. + Effectively manage fiscal and physical research resources, including preparation and submission of required status reports. + Effectively manage study finances including invoicing and resolving study subject compensation issues. + Train, educate, mentor, and supervise research study personnel. + Act as a liaison for research subjects, investigators, IRB, sponsors, funders, collaborators, and healthcare professionals, ensuring effective communication with all stakeholders. + Coordinate academic research tests and testing protocol with the curriculum department and course instructors. + Evening and weekend work will be required infrequently. + Writing semi-annual and annual reports to regulatory bodies and funding agencies. + Evaluating the feasibility of industry-sponsored pharmaceutical and device clinical trials. + Develop study/project advertisement materials. + Update Research Support intra-net (ATSU internal) web site. **Experience & Education:** + Associate's degree or higher preferred. + Three to five years experience in leading and organizing multiple research studies and projects effectively. + Effective and confident speaking, writing, and presentation skills. + Relevant experiences in clinical/academic/health sciences research. + Strong attention to detail. + Must posess strong initiative, use independent judgment, and be a team player. ATSU offers a comprehensive benefits package including medical, dental, and vision coverages, among more. If eligible, employee-elected benefits would begin the first of the month following hire date. For more information, please visit: atsu.edu/employment/benefits . A.T. Still University (ATSU) does not discriminate on the basis of race, color, religion, ethnicity, national origin, sex (including pregnancy), sexual orientation, age, disability, or veteran status in admission or access to, or treatment or employment in its programs and activities. In demonstrating mutual respect for all members of the ATSU community, ATSU is an Equal Employment Opportunity (EEO). Meeting this mission requires serving together in mutual respect of one another's functions and each person's importance as an individual.

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.