Clinical research coordinator jobs in Utah - 165 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.

**Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs **Description:** _Remote_ Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation. _This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._ Salary: $130,000 - $150,000/ yr. w2 **Responsibilities:** **Responsibilities** + Lead development of clinical study protocols, case report forms, and associated study documents. + Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee. + Contribute scientific input into study design, endpoints, and overall clinical strategy. + Review and interpret clinical data to support study reports, publications, and regulatory submissions. + Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams. + Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews. + Ensure scientific consistency across programs and alignment with regulatory and clinical goals. + Support the development of data collection tools and ensure clarity, accuracy, and completeness. + Assist with medical writing elements related to clinical reports and study documentation. **Experience Requirements:** **Experience Requirements** + Electrophysiology and Pulse Field Ablation experience required. + Background supporting clinical studies in industry or academia. + Strong understanding of clinical research methods and safety reporting. + Ability to evaluate and interpret clinical data. + Strong scientific writing skills and attention to detail. + Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions. + Excellent communication and analytical capabilities. + Prior experience as a Clinical Scientist in medical devices preferred. + Experience with Class III devices or IDE studies preferred. + Experience contributing to regulatory submissions or interacting with health authorities preferred. + Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred. **Education Requirements:** **Education Requirements** + MS, PhD, or MD. **_Recruitment Transparency Notice_** **_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._** _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._ _W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._ _Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._ _About Eliassen Group:_ _Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._ _Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._ _Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_

in Salt Lake City, Utah Are you ready to accelerate your career in clinical research? Join Avacare, a dynamic Site Management Organization (SMO) where Clinical Research Coordinators (CRCs) gain unparalleled exposure to diverse trials, hands-on responsibilities, and a collaborative team environment. Why Avacare? At Avacare, CRCs wear more hats than in traditional research settings. You'll gain experience across multiple therapeutic areas, manage complex protocols, and take ownership of key trial activities - from patient recruitment and informed consent to regulatory documentation and site audits. This breadth of responsibility not only strengthens your core CRC skills but also prepares you for future roles in clinical operations, monitoring, and beyond. What You'll Gain: Broadened Skill Set: Manage 2-6 trials of varying complexity, perform clinical procedures, and lead study coordination from start to finish. Professional Growth: Work closely with investigators, sponsors, and monitors while mentoring junior staff and contributing to internal training. Collaborative Culture: Be part of a supportive team that values initiative, adaptability, and continuous learning. Global Impact: Experience the synergy of working within a local SMO backed by the resources and reach of a global CRO. Qualifications: Clinical Skills: Hands-on experience in obtaining vital signs, performing phlebotomy, conducting ECGs, and processing lab specimens. Site Operations Knowledge: Solid understanding of site operations and the drug development process. Experience: CRC I: Minimum of 1-3 years in clinical research setting at a clinical investigative site working with participants. CRC II: Minimum of 3 years as a Clinical Research Coordinator in a clinical investigative site working with participants. Communication & Documentation: Strong written and verbal communication skills, with attention to detail and time management. Technical Proficiency: Comfortable using CTMS, eCRFs, and Microsoft Office tools. Whether you're early in your CRC journey or ready to take the next step, Avacare offers a unique environment where your contributions matter and your career can flourish. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $36,600.00 - $91,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Job DescriptionSalary: At Numinus... Healing Happens Here! Join our team and play an integral role in helping individuals achieve mental wellness. Numinus has an esteemed team of medical professionals dedicated to the clinical research in the use of psychedelic-assisted psychotherapy. This research is changing the future of how we treat mental illnesses. Its pretty exciting here at Numinus and wed love for you to join our team! Numinus values diversity and strives to create an inclusive work environment. We respect and celebrate individuals for their differences and encourage applicants from all backgrounds to apply. We are looking for someone who is highly motivated, organized, and able to work independently to join our team. This Research Site Manager position will be in our Draper Clinics. (in-person not remote) Responsibilities Ensuring that the clinical trials are conducted in accordance with ethical principles and within regulatory requirements Collaborate with Principle Investigator, Director of Research Operations, Regulatory and Recruitment teams to ensure the smooth running of clinical trials Supervising the collection, storage and processing of data to maintain integrity and accuracy In conjunction with Regulatory and Clinical Trial Project Mgr., coordinate and oversee clinical studies from initiation to closeout With Leadership, Regulatory and Project Mgr. teams, ensure all clinical studies are conducted in accordance with regulatory requirements and study protocols Manage resources, timelines, and quality of clinical research coordinators Training and mentoring clinical research coordinators Oversees administrative duties related to study CRC personnel including orientation, assuring core competencies, basic certifications, safety/responsible conduct of research education; conducts performance reviews. Responsible for immediate supervision and performance of the assigned site including conducting performance reviews as well as coaching, counseling, and implementing disciplinary action if needed. Oversee data management and analysis, and ensure data integrity (EDC-Source) and query resolution. Other Site Management Duties as assigned SKILLS Exceptional leadership and communication skills with experience in clinical research. Knowledge of business and management principles. Ability to direct, manage, implement, and evaluate department operations as it relates to CRC team. Ability to effectively plan, delegate and/or supervise the work of others. Ability to lead, motivate, develop, and train others. Strong knowledge of clinical research processes and protocols, including study design, budgeting, and data collection Strong interpersonal and communication skills to establish productive relationships with research teams, sponsors, and regulatory bodies Problem-solving skills to effectively deal with issues that may arise during the clinical trial process Leadership skills and the ability to manage and motivate a team of clinical research coordinators and daily Site operations Qualifications Proven work experience as a Clinical Research Site Manager 5-7 Years Clinical Research Experience as a CRC with a focus on managing clinical trials Deep knowledge of Good Clinical Practice (GCP) guidelines, FDA regulations, and other applicable regulatory requirements Experience in clinical trials and knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines Familiarity with clinical data management systems and procedures Strong leadership, project management, and team coordination skills Excellent analytical, decision-making, and problem-solving skills Certified Clinical Research Coordinator (CCRC) certification preferred. Experience performing clinical assessments, including but not limited to obtaining vital signs EKGs, blood draws, processing/shipping lab specimens. Reports to the Director of Clinical Research Operations Salaried Position Monday-Friday and other times as needed Salary is based upon candidate experience and qualifications, as well as market and business considerations. Benefits: 401(k) matching Medical, Dental, Vision, & Life insurance Flexible spending account Paid time off starting at 4 weeks per year

Job Description The Clinical Research Coordinator (CRC) is a specialized, independent research professional who ensures oversight and compliance of both system-wide and local SHC clinical research activities. Reporting to the Clinical Research Program Manager or (local Hospital Administrator / Clinic Director) and Research Programs Office at SHC International Headquarters, the CRC provides support in accordance with SHC's policies and procedures, SHC's hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. The CRC works closely with the Chief of Staff, SHC scientific and medical staff and other research personnel to ethically recruit and consent SHC's vulnerable pediatric subjects and to appropriately collect and safeguard data. Overall, the CRC is the site's primary liaison among research participants, the local investigator(s) and study sponsor(s). This position's main responsibilities are to help ensure proper study conduct, subject safety, and the quality of data and data safeguards. Shriners Salt Lake City has an opportunity for a Clinical Research Coordinator II to join our team! Responsibilities Maintains a contemporary knowledge of clinical research regulatory requirements. Has a working knowledge of the complex clinical research process, from protocol development to implementation Responsible for tracking all aspects of projects including all study, investigator and Institutional Review Board (IRB) information, patient recruitment activity, and financial management Works closely with investigators, research leadership, study sponsor and regulatory agencies to conduct and report the results of clinical research Coordinates the collection, statistical analysis and dissemination of data results throughout a clinical study. Evaluates protocols under consideration for feasibility, including the process for data collection, entry, storage and reporting Safeguards all participants involved in a research study supported and approved by Shriners Children's Facilitates the local site's research programs and projects through collaborative, timely communications and teamwork Provides expertise consultation and mentorship to site staff, residents, students, and volunteers with respect to research processes, Good Clinical Practices, and regulations governing clinical research. Interacts with other departments in a professional and timely manner to facilitate research coordination. Note: This is not an all-inclusive list of this job's responsibilities. The incumbent may be required to perform other related duties and participate in special projects as assigned. Qualifications Required Without a Bachelor's degree, 5 or more years of specific job-related experience in the administration of clinical research 3 or more years Clinical research experience, e.g. experience with site management, study management, IRBs, and federal regulations regarding clinical research compliance Preferred Bachelor's Clinical Research, science or other healthcare related field Master's Clinical Research, science or other healthcare related field Experience in the coordination of intergroup or multi-site clinical studies CCRP or CCRC certification

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#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.

Shriners Children's is an organization that respects, supports, and values each other. Named as the 2025 best mid-sized employer by Forbes, we are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidenced based practice, experience, innovation, and critical thinking. Our compassion, integrity, accountability, and resilience define us as leaders in pediatric specialty care for our children and their families. All employees are eligible for medical coverage on their first day! In addition, upon hire all employees are eligible for a 403(b) and Roth 403 (b) Retirement Saving Plan with matching contributions of up to 6% after one year of service. Employees in a FT or PT status (40+ hours per pay period) will also be eligible for paid time off, life insurance, short term and long-term disability and the Flexible Spending Account (FSA) plans and a Health Savings Account (HSA) if a High Deductible Health Plan (HDHP) is elected. Additional benefits available to FT and PT employees include tuition reimbursement, home & auto, hospitalization, critical illness, pet insurance and much more! Coverage is available to employees and their qualified dependents in accordance with the plans. Benefits may vary based on state law. Job Overview The Clinical Research Coordinator (CRC) is a specialized, independent research professional who ensures oversight and compliance of both system-wide and local SHC clinical research activities. Reporting to the Clinical Research Program Manager or (local Hospital Administrator / Clinic Director) and Research Programs Office at SHC International Headquarters, the CRC provides support in accordance with SHC's policies and procedures, SHC's hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. The CRC works closely with the Chief of Staff, SHC scientific and medical staff and other research personnel to ethically recruit and consent SHC's vulnerable pediatric subjects and to appropriately collect and safeguard data. Overall, the CRC is the site's primary liaison among research participants, the local investigator(s) and study sponsor(s). This position's main responsibilities are to help ensure proper study conduct, subject safety, and the quality of data and data safeguards. Shriners Salt Lake City has an opportunity for a Clinical Research Coordinator II to join our team! Responsibilities * Maintains a contemporary knowledge of clinical research regulatory requirements. Has a working knowledge of the complex clinical research process, from protocol development to implementation * Responsible for tracking all aspects of projects including all study, investigator and Institutional Review Board (IRB) information, patient recruitment activity, and financial management * Works closely with investigators, research leadership, study sponsor and regulatory agencies to conduct and report the results of clinical research * Coordinates the collection, statistical analysis and dissemination of data results throughout a clinical study. Evaluates protocols under consideration for feasibility, including the process for data collection, entry, storage and reporting * Safeguards all participants involved in a research study supported and approved by Shriners Children's * Facilitates the local site's research programs and projects through collaborative, timely communications and teamwork * Provides expertise consultation and mentorship to site staff, residents, students, and volunteers with respect to research processes, Good Clinical Practices, and regulations governing clinical research. Interacts with other departments in a professional and timely manner to facilitate research coordination. Note: This is not an all-inclusive list of this job's responsibilities. The incumbent may be required to perform other related duties and participate in special projects as assigned. Qualifications Required * Without a Bachelor's degree, 5 or more years of specific job-related experience in the administration of clinical research * 3 or more years Clinical research experience, e.g. experience with site management, study management, IRBs, and federal regulations regarding clinical research compliance Preferred * Bachelor's Clinical Research, science or other healthcare related field * Master's Clinical Research, science or other healthcare related field * Experience in the coordination of intergroup or multi-site clinical studies * CCRP or CCRC certification

Job Posting Title: Research Program Coordinator, Woolfolk Center, Moody College of Communication ---- Hiring Department: Department of Speech, Language, and Hearing Sciences ---- All Applicants ---- Weekly Scheduled Hours: 40 ---- FLSA Status: Exempt ---- Earliest Start Date: Immediately ---- Position Duration: Expected to Continue Until Dec 31, 2027 ---- Location: UT MAIN CAMPUS ---- Job Details: General Notes The Research Coordinator will work closely with the Associate Director of the Woolfolk Center to establish and maintain a collaborative research team across several testing sites. Key responsibilities of this position include developing and managing proposals for the Institutional Review Board regarding human subjects research, creating project and team schedules, overseeing project budgets, preparing funding proposals, and ensuring the smooth operation of the center. The ideal candidate will exhibit strong attention to detail, effective decision-making and critical thinking skills, excellent communication abilities, a proactive approach, strong interpersonal skills, and adept problem-solving capabilities. This is a 2 year position with continuation dependent on funding. Purpose To coordinate the daily operations of the research projects at the Woolfolk Center for Language Disorders Research. Responsibilities Support the Associate Director in day-to-day coordination and communication regarding program activities. Manage the calendars for the research program - including scheduling and communicating with research staff and participants for research activities. Maintain research records and ensure fidelity of data collection using REDCap and other systems. Assist in generating and maintaining data files for analysis. Assist in the development and submission of proposals and revisions to the Institutional Review Board (IRB). Coordinate participant recruitment by engaging with families and community partners to enhance recruitment efforts and maintain lasting relationships with participants. Assist with fiscal management of the center including budgeting, reimbursements, and processing payments. Required Qualifications Bachelor's degree and three years of experience coordinating or administering a research and/or clinical program or Master's degree and 1 year of experience coordinating or administering such a program. Excellent written and verbal communication skills. Demonstrated organizational and time management skills with attention to detail. Ability to manage multiple tasks and deadlines in a fast-paced environment. Demonstrated ability to work independently and collaboratively. Relevant education and experience may be substituted as appropriate. Preferred Qualifications Experience coordinating a research project Experience with REDCap Strong organizational and project management skills Training in the field of speech-language pathology Salary Range $50,000+ depending on qualifications Working Conditions Monday - Friday 8-5. Occasional weekend evening work for community events for recruitment This position may be considered for a hybrid work environment. Required Materials Resume/CV 3 work references with their contact information; at least one reference should be from a supervisor Letter of interest Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded. Once your job application has been submitted, you cannot make changes. Important for Current university employees and contingent workers: As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questions presented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above. ---- Employment Eligibility: Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval. ---- Retirement Plan Eligibility: The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length. ---- Background Checks: A criminal history background check will be required for finalist(s) under consideration for this position. ---- Equal Opportunity Employer: The University of Texas at Austin, as an equal opportunity/affirmative action employer, complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions. ---- Pay Transparency: The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. ---- Employment Eligibility Verification: If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form. You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. Failure to do so will result in loss of employment at the university. ---- E-Verify: The University of Texas at Austin use E-Verify to check the work authorization of all new hires effective May 2015. The university's company ID number for purposes of E-Verify is 854197. For more information about E-Verify, please see the following: E-Verify Poster (English and Spanish) [PDF] Right to Work Poster (English) [PDF] Right to Work Poster (Spanish) [PDF] ---- Compliance: Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP-3031. The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701.

Clinical Study Coordinator - Full Time, Benefits - Salt Lake City, Utah (UT) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Study Coordinator to join our diverse and dynamic team in Salt Lake City, Utah (UT). As a Clinical Study Coordinator at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing Collaborating with cross-functional teams to develop and implement clinical trial protocols. Coordinating and overseeing the execution of clinical studies, ensuring adherence to protocols and regulatory requirements. Managing study timelines, budgets, and resources effectively. Facilitating communication between investigative sites, sponsors, and internal teams. Ensuring data accuracy and completeness through regular monitoring and quality control activities. Your profile Bachelor's degree in a relevant scientific discipline. Proven experience as a Clinical Study Coordinator or in a similar role. Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements. Strong organizational and multitasking skills. Excellent communication and interpersonal abilities. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Clinical Study Coordinator - Full Time, Benefits - Salt Lake City, Utah (UT) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a **Clinical Study Coordinator** to join our diverse and dynamic team in **Salt Lake City, Utah (UT)** . As a Clinical Study Coordinator at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. **What you will be doing** + Collaborating with cross-functional teams to develop and implement clinical trial protocols. + Coordinating and overseeing the execution of clinical studies, ensuring adherence to protocols and regulatory requirements. + Managing study timelines, budgets, and resources effectively. + Facilitating communication between investigative sites, sponsors, and internal teams. + Ensuring data accuracy and completeness through regular monitoring and quality control activities. **Your profile** + Bachelor's degree in a relevant scientific discipline. + Proven experience as a Clinical Study Coordinator or in a similar role. + Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements. + Strong organizational and multitasking skills. + Excellent communication and interpersonal abilities. **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply

Clinical Study Coordinator - Full Time, Benefits - Salt Lake City, Utah (UT) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Study Coordinator to join our diverse and dynamic team in Salt Lake City, Utah (UT). As a Clinical Study Coordinator at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing * Collaborating with cross-functional teams to develop and implement clinical trial protocols. * Coordinating and overseeing the execution of clinical studies, ensuring adherence to protocols and regulatory requirements. * Managing study timelines, budgets, and resources effectively. * Facilitating communication between investigative sites, sponsors, and internal teams. * Ensuring data accuracy and completeness through regular monitoring and quality control activities. Your profile * Bachelor's degree in a relevant scientific discipline. * Proven experience as a Clinical Study Coordinator or in a similar role. * Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements. * Strong organizational and multitasking skills. * Excellent communication and interpersonal abilities. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Clinical Study Coordinators Helps with the logistical and administrative aspect of clinical trials and studies, ensuring adherence to protocols and regulatory requirements. Help facilitate participant recruitment, consent processes, and documentation management. Coordinate study visits, monitor adverse events, and maintain accurate records for successful study outcomes. Learn more about the great benefits of working for University of Utah: benefits.utah.edu The department may choose to hire at any of the below job levels and associated pay rates based on their business need and budget. Responsibilities Clinical Study Coordinator, I Helps with the logistical and administrative aspects of clinical trials and studies, ensuring adherence to protocols and regulatory requirements. Help facilitate participant recruitment, consent processes, and documentation management. Coordinate study visits, monitor adverse events, and maintain accurate records for successful study outcomes. Requires a bachelor's (or equivalency) up to 2 years of directly related work experience or a master's (or equivalency) degree. This is an Entry-Level position in the General Professional track. Job Code: P51731 Grade: P10 Clinical Study Coordinator, II Coordinate fundamental technical and administrative details in clinical trials or research studies with some supervision. Assist Principal Investigators in achieving study objectives by implementing and completing study protocols and procedures. Review protocols for clarity and subject safety, addressing concerns with the PI and sponsor. Participate in recruitment and consent processes. Maintain detailed and accurate study documentation. Coordinate study visits and ensure the availability of necessary resources. Report and track adverse events with guidance. Complete and audit CRFs for accuracy. Assist in preparing and submitting IRB documents. Ensure proper collection, processing, and shipment of specimens. Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience. This is a Developing-Level position in the General Professional track. Job Code: P51732 Grade: P11 Expected Pay Range: $24,722 to $56,715 Clinical Study Coordinator, III Coordinate technical and administrative details of clinical trials or research studies, assisting Principal Investigators in implementing and completing study protocols and procedures. Assess protocol clarity and subject safety, review inclusion/exclusion criteria, and address concerns with the PI and sponsor. Participate in meetings, advising on assignments and timelines. Obtain informed consent, medical history, and demographics, and maintain accurate documentation. Coordinate facility and equipment availability for study visits. Report adverse events, including serious AEs, to the IRB and sponsor. Document protocol deviations, reconcile test article accountability, and prepare summary reports. Complete, audit, correct, and relay CRFs to the sponsor. Assist with negotiating contract budgets and terms, maintain documents per FDA guidelines, manage IRB documents, and ensure proper specimen collection, processing, and shipment. Perform Clinical Research Assistant functions as needed. Requires a bachelor's (or equivalency) + 6 years or a master's (or equivalency) + 4 years of directly related work experience. This is a Career-Level position in the General Professional track. Job Code: P51733 Grade: P12 Minimum Qualifications EQUIVALENCY STATEMENT : 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience). Department may hire employee at one of the following job levels: Clinical Study Coordinator, I: Requires a bachelor's (or equivalency) up to 2 years of directly related work experience or a master's (or equivalency) degree. Clinical Study Coordinator, II: Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience. Clinical Study Coordinator, III : Requires a bachelor's (or equivalency) + 6 years or a master's (or equivalency) + 4 years of directly related work experience.

We are currently seeking candidates who are specifically looking for part-time hours. If you are in need of part-time work, we encourage you to apply for this position. Contract Duration: Open-ended contract (expected duration is 3-6 months) Job Type: Part-time 24 hours per week (Monday-Friday) - during normal business hours Start Date: ASAP Job Description: We are seeking a part-time, onsite Clinical Research Coordinator (CRC) with experience in clinical research to support an ongoing Pneumococcal Disease clinical trial. The ideal candidate will be able to work independently and act as one of the main CRCs for this study. Key Responsibilities: * Community Outreach: Visiting clinics and hospitals to educate medical professionals and patients about the clinical trial, distributing study materials, posting recruitment materials, and maintaining online portals to track metrics. * Referral Physician Networking: Building relationships between clinical researchers and community physicians to facilitate patient recruitment for clinical trials. * General Support: Assist with any other study-related efforts as deemed necessary by the site. Qualifications: * Minimum of one year of experience as a Clinical Research Coordinator or Community Outreach Coordinator * Community outreach experience required * Reliable transportation * Proficiency with electronic medical records (EMR) and electronic data capture (EDC) systems Pay and Benefits The pay range for this position is $25.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Provo,UT. Application Deadline This position is anticipated to close on May 12, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study. To consistently embody AMR Clinical's Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Clinical Research Coordinator reports to the Site Manager/Team Lead. Classification: Non-Exempt Primary Responsibilities: Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures. Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols. Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution. Establish understanding of SOP's and implement the SOP's Gain understanding of the pharmaceutical drug per clinical trial. Develop detailed knowledge of protocol and procedures per clinical research study. Communicate effectively with study sponsors, CROs, monitors/CRA's, IRBs, laboratories, and clinical personnel within the research industry. Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study. Establish and maintain patient rapport. Clinical data collection (vital signs, EKG recording, weight, height, etc.) Obtain medical records and review as required. Phlebotomy Specimen collection, processing, and storage Transporting clinical specimens to the laboratory. Educate subjects on diaries and oversees compliance with diary completion. Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.) Responsible for completing patient phone call visits in accordance to the standard protocol period. Ensure documentation follows ALCOA standards and is completed in a timely manner. Ensure all necessary documents are completed, signed and dated. Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required. Manage study inventory and order supplies as needed. Prepare and assist study monitors during onsite visits. Maintain familiarity with all ongoing clinical research studies. Travel to Investigator meetings as needed. Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties Position may require occasional weekend and/or overtime hours. Other duties as assigned Desired Skills and Qualifications: 1 year of experience in clinical research. Completion of formal medical training, educational program, or healthcare experience Strong medical terminology Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.). Ability to work independently and lead study-related tasks. Ability to multi-task in a high-paced evolving environment. Exceptional listening, written, and verbal communication skills as well. Demonstrate proficiency in office equipment and software programs. Excellent organizational and task management skills. Ability to be ambulatory most of the workday. Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination. AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor. ** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Schedule: 3 day shifts per week, 6 am - 6 pm, days vary. Essential Responsibilities and Duties: Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Monitors, and reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes. Assists the CTM in planning, creating processes, trainings and development of staff. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must have proper experience and demonstrate mastery of Clinical Research Coordinator I position. High school graduate or equivalent; Bachelors Degree, preferred CCRC certification preferred 2-3 years of experience in the medical field, preferred Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

This position assists in managing clinical research studies of Intermountain Healthcare and is responsible for the efficient coordination of clinical studies by working closely with clinical investigators, physicians, department managers and others. **Essential Functions** + Collect, process, maintain, and ship study samples, ensuring proper stewardship of lab kits and shippers. Safely operate laboratory equipment when applicable. + Understand assigned protocols and effectively communicate project details to patients, caregivers, and principal investigators. + Screen participants for eligibility, obtain patient consent, and develop recruitment strategies. + Monitor participant progression and manage patient visits to ensure protocol compliance. + Coordinate clinical patient information and assist physicians or residents with gathering clinical data. + Comply with training on clinical research coordination, FDA Good Clinical Practices (GCP), and standard operating procedures. + Safely operate laboratory equipment and maintain research records in compliance with policies and regulations. + Perform other duties as assigned, such as data entry, expense tracking, patient chart reviews, and source document creation, with moderate supervision. **Skills** + Organizational Skills + Communication Skills + Team Oriented + Compassionate + High Reading Comprehension + Administrative Skills + Self-starter + Critical Thinking Skills **Job Specific** + Schedule is Monday - Friday 8am -5pm. + occasional need for early start or later evening. + Potential for 1 day work remote (if there is work that can be done remote) **Minimum Qualifications** + Experience in a role requiring the ability to demonstrate proficiency with Microsoft and database applications. + Experience using laboratory protocol, systems, and documentation techniques. + Demonstrated experience in a healthcare, academics or research related setting or research related setting working with patients. **Preferred Qualifications** + Bachelor's Degree or higher from an accredited institution. + Prior experience in a clinical research setting. + Expertise or prior experience in the clinical area applicable to this research role (ie cardiology, pulmonary, oncology, women and newborn, etc. + **Previous experience running an Investigational drug study is preferred.** **Physical Requirements** + Ongoing need for employee to see, read and understand information, labels, assess patient needs, operate monitors, identify equipment and supplies. + Frequent interactions with patient care providers, patients, and visitors that require employee to verbally communicate as well as hear and understand spoken information, alarms, needs, and issues quickly and accurately. + Manual dexterity of hands and fingers to manipulate complex and delicate equipment with precision and accuracy. This includes frequent computer use and typing for documenting patient care, accessing needed information, etc. + Expected to bend, lift, and carry patient files, documents, equipment, and supplies. + Remain sitting or standing for long periods of time while interacting with others or to perform work on a computer, telephone, or other equipment. + For roles requiring driving: Expected to drive a vehicle which requires sitting, seeing and reading signs, traffic signals, and other vehicles. **Location:** Intermountain Health Intermountain Medical Center **Work City:** Murray **Work State:** Utah **Scheduled Weekly Hours:** 40 The hourly range for this position is listed below. Actual hourly rate dependent upon experience. $25.02 - $39.41 We care about your well-being - mind, body, and spirit - which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged. Learn more about our comprehensive benefits package here (***************************************************** . Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. At Intermountain Health, we use the artificial intelligence ("AI") platform, HiredScore to improve your job application experience. HiredScore helps match your skills and experiences to the best jobs for you. While HiredScore assists in reviewing applications, all final decisions are made by Intermountain personnel to ensure fairness. We protect your privacy and follow strict data protection rules. Your information is safe and used only for recruitment. Thank you for considering a career with us and experiencing our AI-enhanced recruitment process. All positions subject to close without notice.

Title: Research Nurse Hours: Part Time Joule is currently looking to hire a part-time Registered Nurse or LPN. In this role, you will be conducting home visits with patients enrolled in a clinical research study. Each visit will last approximately two hours and will take place in the patients' homes. The ideal/preferred visit time is earlier in the day, before noon. You will primarily be working with male participants in the Logan UT area. Responsibilities + Perform Visual Skin Assessment & Draize Scoring + Confirmation of necessary study supplies + Instruct participant to complete PROMIS Sleep (per treatment schedule or upon treatment discontinuation, whichever comes first) + Conduct device training with participants + Pre-weigh overnight pads (if applicable) + Ensure participants wear investigational device + Measure urine output + Post-weigh overnight pads + Document device adherence issues or dislodgment + Instruct participant to complete End of Treatment Participant Experience Questionnaire (per treatment schedule or upon treatment discontinuation, whichever comes first) + Complete End of Treatment Disposition (per treatment schedule or upon treatment discontinuation, whichever comes first) + Complete End of Study Disposition + Instruct participant to complete End of Study Preference Survey (per treatment schedule or upon treatment discontinuation, whichever comes first) + Collect and return unused devices, dispose of used study products + AE and SAE reviews, Device Deficiencies (if applicable) Requirements: + Nursing/care experience + Licensed valid/active (must be an LPN or RN) + Technically savvy (iPads/tablet, EDC, file transfer site) + Availability to make Home visits and calls. The ideal/preferred visit time is earlier in the day, before noon. + Excellent, effective interpersonal and professional communication skills + Strong organizational and time management skills, and ability to work independently with minimal supervision System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #LI-AD3 Ref: #568-Clinical System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

This is a quality improvement/research nurse liaison position responsible for driving research/quality improvement project implementation and assisting with care coordination for the UQuAL Hospitalist Team. The research/quality improvement role is to serve as an embedded team member who can lead daily research project implementation (e.g., daily reminders about project activities) and gather frontline, real-time data (e.g., observation , surveys) as well as share critical nursing expertise about project feasibility. The first funded research project (funded by the National Academy of Medicine; ************************************* ) will be exploring diagnostic communication between the emergency and inpatient clinician care teams and helping to build a tool to improve communication of diagnostic uncertainty. Additional projects will be determined in collaboration with the UQuAL Hospitalist Team leadership. The clinical role is to round with the UQuAL Hospitalist Team and facilitate interdisciplinary communication, patient care transitions, and help educate trainees on system procedures and resources. All of these roles will be in collaboration with existing nursing infrastructure. This position will be within the School of Medicine and work under the UQuAL Hospitalist Team leadership. Essential Functions: · Research and Quality Improvement Functions o Attend UQuAL Meetings and report on UQuAL Hospitalist Team projects o Regular coordination with UQuAL Hospitalist Team Directors o Communicate with clinical research coordinators (CRCs) on UQuAL Hospitalist Team Projects o Provide expert nursing input on feasibility of UQuAL Hospitalist Team Projects o Help create and optimize study protocol documents and quick fact sheets o Ensure clinical team has access to all project-related fact sheets o Help educate clinical team on ongoing UQuAL Hospitalist Team Projects o Be available to answer questions on UQuAL Hospitalist Team Projects from clinical staff o Ensure appropriate consents are obtained and that studies adhere to study protocols o Collect primary data through structured observations, surveys, and interviews o Maintain up to date training in human subjects research and research compliance o Acquire additional QI or research training, depending on existing experience and training history · Clinical Functions o Round with UQuAL Hospitalist team on weekdays (one administrative day will be used for meetings, project coordination, developing project materials-including educational and protocol documents, basic data analysis, and completing relevant human subjects requirements) o When new team members rotate onto UQuAL Hospitalist team, orient them to UQuAL Hospitalist team purpose, activities, and ongoing quality initiatives o Assist with continuity of patient care o Facilitate interdisciplinary communication o Work with discharge pharmacy and discharge nursing to facilitate patient discharge including ensuring appropriate appointments are scheduled and communicating with the primary teams to ensure a smooth transition between inpatient and outpatient care o Help educate trainees on system procedures and resources o All of these roles with been done in collaboration with existing nursing infrastructure o Represent UQuAL Hospitalist Team at Nursing Quality, Acute Care Leadership Team, and acute care quality meetings Knowledge/skills/abilities · Outstanding communication and team-based care skills · Demonstrated critical thinking skills · Inquisitive nature and interest in learning many new skills · Experience with clinical research processes · Demonstrated teaching and leadership abilities · Ability to function both independently and as part of a team · Ability to provide safe and culturally inclusive care Qualifications · At least two years nursing experience, could include experience in care coordination · Prior training and experience in quality improvement or health services research methods · Current nursing license As a patient-focused organization, the University of Utah Health Sciences exists to enhance the health and well-being of people through patient care, research and education. Success in this mission requires a culture of collaboration, excellence, leadership, and respect. The Health Sciences Center seeks faculty and staff who are committed to the values of compassion, collaboration, innovation, responsibility, diversity, integrity, quality and trust that are integral to our mission. Responsibilities Assists in conducting weekly clinics that examine participating research patients, provide patient care follow-up, and evaluate their progress within the research project. Assists with the design of research projects by making recommendations on the feasibility of using certain protocols and treatment procedures. Determines patient eligibility for a specific research project. Performs patient education functions by informing patients and their families of possible implications that may arise by participating in specific research projects, and training them in the proper use of experimental drugs and/or devices. Gathers research results for evaluation to determine the efficacy of certain drugs, devices and/or test procedures. Analyzes the patient's condition and effectiveness of the particular protocol to determine other intervening factors in accounting for certain results. Provides educational training to other staff members to ensure that all medical personnel treating participating patients are accurately trained in the research protocols. Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis. Performs other patient care duties to include responding to emergency situations, answering questions, and following through with the patient to determine possible side effects of certain drugs and/or devices. Maintains investigational logs and records of drugs administered, medical devices monitored, and procedures followed. Prepares reports for companies and regulatory agencies. May assists in coordinating and initiating details of research projects including developing research protocols, evaluating and writing research results, obtaining and studying data from participating investigators, supplying study sites with needed materials, and making site visits. Orders drugs or medical devices from outside companies and maintains records of up-to-date inventory. Maintains an adequate knowledge to operate and care for highly technical equipment. Work Environment and Level of Frequency that may be required: Nearly Continuously: Office environment. Often: Infectious disease, oils ( there is air or skin exposure to oils or other cutting fluids ), hazards ( includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, or exposure to chemicals ). Physical Requirements and Level of Frequency that may be required Nearly Continuously: Hearing, listening, talking. Often: Repetitive hand motion (such as typing), walking, standing, sitting. Seldom: Bending, reaching overhead. Minimum Qualifications RN license in the state of Utah plus two years related experience required. Depending on area of assignment, CCRP , ACRP - CRC , SOCRA - CCRP certification may be required. A current Basic Life Support Health Care Provider Card certification or obtain one within 6 months of employment required. Demonstrated human relations and effective communication skills also required. The hiring department may also prefer experience in a specific area of nursing This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers, and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.