Clinical research coordinator jobs in Bismarck, ND - 28 jobs

PXL is hiring a Clinical Scientist! **Job Purpose:** The Clinical Scientist (CS) assists the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies (e.g., adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, protocol deviation management). **Key Accountabilities** May include but not limited to the following: Clinical Trial Operational Delivery - May support a single study or multiple studies - May lead a study with limited scope (e.g., Survival Follow-up) - Liaises with cross-functional lines as appropriate - May interact with internal and external stakeholders (study sites, committees, etc.) in support of clinical study objectives Compliance with Parexel Standards - Complies with required training curriculum - Completes timesheets accurately as required - Submits expense reports as required - Updates CV as required - Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: - Demonstrated oral and written communication skills - MS Office Suite Experience Required- including Word, Excel, and Power Point - Proficient in written and spoken English - Proficient in local language (as applicable) - Willingness to travel as required for key company meetings Knowledge and Experience: - Pharmaceutical experience beneficial but not required - Therapeutic Area (TA) specific experience beneficial - 2 years medical monitoring experience preferred Education: - Bachelors/Masters/PhD in Life Sciences with 2+ years relevant career experience - If no degree in Life Sciences, must have significant experience in clinical development (>5 years) \#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.

**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!_

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_

Work Setup: On-site Schedule: Part-time (24 hours per week) Shape the Future of Medicine with IQVIA! Are you passionate about advancing healthcare and improving patient outcomes? Join IQVIA as a Clinical Research Coordinator (CRC) and play a vital role in supporting clinical research studies that drive innovation. This hands-on position combines clinical procedures, recruitment activities, and compliance to ensure the highest standards of care. About IQVIA IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services. We partner with top pharmaceutical, biotechnology, and medical device companies to accelerate innovation and improve lives. Our team blends scientific expertise with cutting-edge technology to deliver insights that transform clinical trials and healthcare worldwide. What You'll Do Perform complex clinical procedures, including ECG, spirometry, sample collection, and vital signs Phlebotomy required Coordinate clinical research studies and ensure compliance with protocols and Good Clinical Practice (GCP) Prepare study materials, set up equipment, and manage logistical activities Recruit, screen, and orient volunteers while prioritizing their safety and well-being Collect and accurately record clinical data in case report forms (CRFs) Collaborate with investigators and monitors to resolve queries and maintain data quality Act as a volunteer advocate and maintain a safe environment in line with Health and Safety policies Focus on Recruitment and Pre-ICF Activities: Pre-screening & recruitment support including chart reviews, referral management, and community outreach Make eCRF entries, corrections, and queries Investigator Site File maintenance Regulatory experience would be a plus What We're Looking For High School Diploma or equivalent education and experience Minimum 1 year of relevant clinical research experience (preferred) Working knowledge of clinical trials, GCP principles, and medical terminology Strong attention to detail and ability to build effective working relationships Advanced-level experience supporting site lead CRC with patient visits, data entry/query resolution, and prescreening physician referrals for eligibility Experience working in both research and clinical settings Please note: This position is not eligible for sponsorship. #LI-CES #LI-DNP #LI-HCP #ONSITE 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 is $35.00-$42.00 per hour. 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.

Bookmark this Posting Print Preview | Apply for this Job Posting Details Posting Details Logo Institution South Dakota State University Working Title Research Coordinator Posting Number NFE02945P Department SDSU-West River Ag Center-AES Physical Location of Position (City) Rapid City Posting Text South Dakota State University (SDSU) is seeking a motivated and highly organized individual to play a key role in advancing livestock and rangeland research at the Cottonwood Field Station. This position is central to keeping research programs and projects running smoothly and efficiently - from coordinating project and personnel needs to supporting fieldwork, technology, and student involvement. Based at the West River Research and Extension facility in Rapid City, this role offers the opportunity to work closely with faculty, students, and station staff while contributing to impactful, on‑the‑ground research across western South Dakota. This position is located in Rapid City, South Dakota. This position is a 12 Month, full-time, benefits-eligible position. Must be authorized to work in the U.S. Sponsorship is not available for this position. KEY RESPONSIBILITIES: * Coordinate, organize, and provide on-the-ground supervision and support of livestock and rangeland research projects at the Cottonwood Field Station. * Provide operational leadership by managing logistics and ensuring research sites and facilities are fully prepared. * Maintain accurate, up-to-date research protocols and ensure consistent adherence. * Support and coordinate high-quality data collection, data management, and data curation. * Manage, maintain, and troubleshoot research equipment, technologies, and station systems. * Provide proactive supervision, guidance, and mentorship to undergraduate and graduate students involved in research activities. * Directly supervise research intern(s) assigned to Cottonwood. * Collaborate closely with administration, faculty and students based at the West River Research and Extension facility. * Travel regularly to the Cottonwood Field Station to oversee project implementation, coordinate with station management, and provide on-site support. BENEFITS: SDState offers a wide range of excellent benefits including medical, dental, and flexible benefits, retirement plans, compensation packages, paid holidays, and vacation leave. We offer a generous retirement plan that includes 6% matching, 10 hours of annual leave each month, 9.34 hours of sick leave each month, and eleven paid holidays. Employees also have access to internal and state-sponsored training as well as reduced tuition for state-supported courses at all State of South Dakota academic institutions. Relocation benefits are available per university's guidelines. QUALIFICATIONS: MINIMUM QUALIFICATIONS: * Master's degree in Animal Science or closely related field completed within 6 months of start date. * At least 1 year of related experience * Demonstrated experience in livestock research, production systems, and/or applied animal management PREFERRED QUALIFICATIONS: * Demonstrated experience writing scientific manuscripts. * Demonstrated experience with precision livestock technologies. APPLICATION PROCESS: SDState accepts applications through an on-line employment site. To apply, visit: ***************************** search by the position title, view the job announcement, and click on "apply for this job." This system will guide you through the electronic application form. This employment site will also require the attachment of a cover letter, which should specifically address how the candidate meets the qualifications as outlined in the advertisement, resume, and a reference page with the contact information for three professional references. Email applications will not be accepted. Please contact SDState Human Resources at ************** if you require assistance with this process. Any offer of employment is contingent on the university's verification of credentials and other information required by law and/or university policies, including but not limited to, successful completion of a criminal background check. SDState is a tobacco free environment. It is the policy of the University to maintain a drug-free environment and to thereby establish, promote, and maintain a safe and healthy working and learning environment for employees and students. This position is subject to South Dakota State University's Drug and Alcohol Testing Policy 4:14. Posting Date 01/12/2026 Closing Date 02/02/2026 Open Until Filled No First Consideration Date Advertised Salary The starting rate of pay for this position is $58,000. Duration of the Term 12 months If Other, describe duration Appointment Percent 100 Work Hours Generally 8-5, weekdays Typical Hours Worked Per Week Appointment Type Regular Faculty Status No Scope of Search External (includes Internal) If internal, define scope of search This position requires Travel, Valid Drivers License If other, please indicate Department Description and Cultural Expectations SDState is the state's largest, most comprehensive university with over $94 million annual research expenditures, more than 200 academic programs and an enrollment of approximately 12,000 students. The university is part of a dynamic community for families, students, young professionals, and retirees, which offers an abundance of attractions and activities. SDSU West River Research and Extension in Rapid City is the western front door to SDSU and the College of Agriculture, Food and Environmental Sciences. It is here that academics, research, Extension, and professionalism come together to provide South Dakota, especially western South Dakota, with the agricultural resources and expertise that can give rise to personal, professional, and community success. Equal Employment Opportunity Statement South Dakota State University promotes access to and opportunities for all to receive the benefit of and participate in education, research, and service and is especially interested in candidates that can contribute to this land-grant access mission. SDSU is an equal opportunity employer. All qualified applicants will receive consideration without regard to, and SDSU prohibits unlawful discrimination of all legally protected classes in the offering of all educational programs and employment. Arrangements for accommodations required by disabilities can be made by emailing **************. Individuals with concerns regarding discrimination should contact: Equal Opportunity Officer/Title IX Coordinator, Human Resources, Morrill Hall 100, SDSU, Brookings, SD 57007. Phone: **************. Contact Information For questions on the position, contact search committee chair, [Amanda Blair at ************************ or ************. Working Conditions Cognitive Requirements Please check the appropriate response that describe the cognitive requirements for this position. Analyzing, Comprehend, Frequent Change, Logic, Memory, Multiple Priorities, Multiple Stimuli, Pace-fast, Perform calculations, Reading, Reasoning, Verbal Communication, Written Communication Protective Clothing/Equipment Please check the appropriate response for this position's use of the following protective clothing or equipment. Ear Protection (including earplugs), Eye Protection, Latex Gloves If other protection is used please identify Physical Requirements Please designate the physical requirements of this position Balancing, Carrying, Crawling, Crouching, Driving, Fine Finger Manipulation (keyboarding, pipefitting, bench work, etc), Grasping, Kneeling, Lifting Above Waist, Lifting Below Waist, Lifting light, Lifting moderate, Pushing/Pulling, Reaching, Sitting for sustained periods of time, Squatting, Standing for sustained periods of time, Use Both Hands, Use of Either Hand, Independently, Walking, Wrist Movement (twisting or rotating) Describe any of the conditions selected Field work; working with equipment; working with livestock; desk work; supplies. Sensory Requirements Please check the appropriate response that describe the sensory requirements for this position. Depth Perception, Distant Vision, Hearing, Near Vision, Peripheral Vision, Speaking, Vision (With and without corrective lenses) Working Conditions & Exposures Working Conditions or Exposures (or potential exposures) that this position may encounter during the course of the work day. Animal Handling, Changes of Temperature, Exposure or Potential Exposure to Blood/Body Fluids, Exposure to Dust, Exposure to Noise, Extreme Cold, Extreme Heat >100F, Extreme Weather Conditions (wind, rain, snow, humidity), Walking/Standing on rough or uneven surfaces (gravel, rocks, etc), Walking/Standing on wood, metal or concrete, Work in confined/congested spaces (tunnels), Work in narrow aisles/passageways, Working Around Machinery Please describe, in more detail, any of the conditions checked above Working with livestock and livestock handling facilities; outdoors work year-around Working Environment Check the appropriate box(es) that best describes the environment in which the primary function of the position is performed. Animal Research Farm, Farm or Grassland Environment, Outdoors Environment If you have indicated Other Environment, if work tasks involve one or more of the above, or if further explanation is necessary, please use the space provided. Working outdoors; working with beef cattle. Supplemental Questions Required fields are indicated with an asterisk (*). * * Where did you hear about this position? * LinkedIn * SDBOR Employment Site * South Dakota Department of Labor * Employee Referral * Department Announcement / Inside State * Handshake * Job Board (Indeed, Monster, ZipRecruiter) - Please specify * Industry Conference * Search Engine - Please specify * Employment Agency - Please specify * Newspaper - Please specify * HigherEdJobs.com * Chronicle of Higher Education * Social Media (Facebook, Instagram, LinkedIn) - Please specify * Radio - Please specify * APLU * List Servs - Please specify * Alumni * Other - Please specify Documents Needed to Apply Required Documents * Resume * Cover Letter * Reference List Optional Documents

Careers With Purpose Sanford Health is one of the largest and fastest-growing not-for-profit health systems in the United States. We're proud to offer many development and advancement opportunities to our nearly 50,000 members of the Sanford Family who are dedicated to the work of health and healing across our broad footprint. Facility: Cancer Center Building Location: Sioux Falls, SD Address: 1309 W 17th St, Sioux Falls, SD 57104, USA Shift: 8 Hours - Day Shifts Job Schedule: Full time Weekly Hours: 40.00 Salary Range: $27.50 - $44 Department Details * Attire is either business casual or navy blue scrubs; lab coats are also provided by the department * Flexibility for things like appointments/kid drop off * Ability to WFH 1x per week after 6 months * Collaborative team approach and supportive management team * Opportunities for continued learning and professional development * Emphasis on employee wellbeing through annual events and team building activities Job Summary Provides an opportunity to learn daily and contribute to treatments of the future. Enthusiasm for learning required, along with participation in educating patients, physicians, nurses and other personnel to the research process. Advanced nursing position that involves clinical patient contact, research study coordination and study data management. Must be able to organize complex components of clinical trials, including test ordering, procedure scheduling and insurance pre-authorization for participants, if applicable. Clinical skills that may be required include, but not limited to: patient assessment for adverse events and assistance with, or completion of, study related procedures as detailed in the research protocol (ex: injections, phlebotomy, or infusions), within the applicable state scope of practice. Demonstrate a desire and ability to strictly adhere to all levels of institutional, state and federal regulations and established research protocols, and the ability to collaborate with physician investigators to ensure safe and compliant investigational treatment or intervention and follow-up. Attend investigator meetings and coordinate pre-study site visits. Monitor enrollment goals and modify recruitment plan as needed. Ensure the completion of all screening, eligibility and enrollment procedures. Work with pharmacy to dispense study articles and provide subject education. Clarify questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations and study procedures. Review inclusion/exclusion criteria to assure subject eligibility and review with physician investigator. Review study protocol, informed consent form and follow-up procedures with potential study subjects. Schedule subjects for follow-up visits to review diaries and questionnaires. Ensure appropriate specimen collection, batching and shipping as required. Document and maintain all study-related procedures, processes and events. Document protocol deviations and exemptions and record accurate and timely data. Maintain accurate source documentation for all case report entries and input data for submission. Required to use appropriate nursing assessment skills to evaluate patient condition in response to study intervention. Collect data regarding patient condition for review by the physician investigator. Prepare case report forms and source documents for sponsor review. Abstract data from medical records, clinic, consultation and referral notes for preparation of study forms and flow sheets. Communicate effectively with subjects, research team, Institutional Review Board (IRB) and sponsor representatives. Occasional local travel between sites and student supervision may be required. Qualifications Graduate from a nationally accredited nursing program preferred, including, but not limited to, Commission on Collegiate Nursing Education (CCNE), Accreditation Commission for Education in Nursing (ACEN), and National League for Nursing Commission for Nursing Education Accreditation (NLN CNEA). Currently holds an unencumbered RN license with the State Board of Nursing where the practice of nursing is occurring and/or possess multistate licensure if in a Nurse Licensure Compact (NLC) state. Obtains and subsequently maintains required department specific competencies and certifications. Benefits Sanford Health offers an attractive benefits package for qualifying full-time and part-time employees. Depending on eligibility, a variety of benefits include health insurance, dental insurance, vision insurance, life insurance, a 401(k) retirement plan, work/life balance benefits, and a generous time off package to maintain a healthy home-work balance. For more information about Total Rewards, visit *********************************** . Sanford is an EEO/AA Employer M/F/Disability/Vet. If you are an individual with a disability and would like to request an accommodation for help with your online application, please call ************** or send an email to ************************ . Sanford Health has a Drug Free Workplace Policy. An accepted offer will require a drug screen and pre-employment background screening as a condition of employment. Req Number: R-0244377 Job Function: Research Featured: No

**Worker Type:** Regular **Work Shift:** Day Shift (United States of America) **Pay Range:** is listed below. Actual pay rate dependent upon experience._ $24.00 - $36.50 Highlights** **This position will support projects in the maternal and child health studies at Avera Research Institute. This includes supporting the ECHO study (Environmental influences on Child Health Outcomes), which is a longitudinal, observational study following pregnant women and their children to understand how environmental exposures in the prenatal and early childhood time frame affect health outcomes for children later in life.** **_We are seeking individuals who have a strong interest in working with this study's_** **_population of pregnant women and children, and have an interest in public health_** **.** **_This position is not intended for individuals seeking clinical research_** **_experience as it is not a part of a clinical trial._** **Learn more about the Avera Research Institute at the link below:** ************************************************************************** **You Belong at Avera** **Be part of a multidisciplinary team built with compassion and the goal of Moving Health Forward for you and our patients. Work where you matter.** **A Brief Overview** An advanced position that contributes to the overall operations of one or more research studies. The CRC is responsible for implementation of the study protocol, recruitment plan, study visits, data, study assessments, and other tasks outlined in the protocol. This position requires close collaboration with the study team and investigator to ensure safe and compliant research procedures and follow-up per the established research protocol. This position will work directly with research participants, physicians, nurses, community stakeholders, and health/social service organizations. This position has opportunities for ongoing learning and contribution to research that is focused on improving health and wellbeing of individuals and the community. **What you will do** + Coordinates research studies per Good Clinical Practices guidelines, FDA regulations, and approved protocols. + Understands and adheres to Standard Operating Procedures (SOPs). Ability to develop or improve SOPs, help guides, and other team resources. + Acquires detailed knowledge of assigned research protocols and ability to conduct study required processes, procedures, and assessments. Ability to prepare, utilize, and review Case Report Forms. Collects and manages data, Case Report Forms, and timely entry into the electronic data capture system. + Collects and assists with processing all laboratory specimens to include centrifuging, separating, measuring, storing, shipping, and distributing to appropriate testing areas. Maintains inventory of laboratory supplies and study kits. + Screens, recruits, and enrolls study participants using study's eligibility criteria. Preforms the informed consent, answering all participant questions, and obtaining appropriate sign-off. + Ensures the adherence to ethical practices during the conduct of clinical trials in order to protect the rights and well-being of patients and the collection of quality data. + Ensures validity of research results by ensuring timely, accurate, and complete data documentation, reporting deviations, violations, and serious adverse events. + Develops relationships with referring physicians, clinical staff, and ancillary departments to facilitate compliance with and accrual to clinical trials. **Essential Qualifications** The individual must be able to work the hours specified. To perform this job successfully, an individual must be able to perform each essential job function satisfactorily including having visual acuity adequate to perform position duties and the ability to communicate effectively with others, hear, understand and distinguish speech and other sounds. These requirements and those listed above are representative of the knowledge, skills, and abilities required to perform the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions, as long as the accommodations do not cause undue hardship to the employer. **Required Education, License/Certification, or Work Experience:** + Bachelor's From a four year college or university within the health and science field **Preferred Education, License/Certification, or Work Experience:** + 1-3 years Human Research + 1-3 years Laboratory or clinical **Expectations and Standards** + Commitment to the daily application of Avera's mission, vision, core values, and social principles to serve patients, their families, and our community. + Promote Avera's values of compassion, hospitality, and stewardship. + Uphold Avera's standards of Communication, Attitude, Responsiveness, and Engagement (CARE) with enthusiasm and sincerity. + Maintain confidentiality. + Work effectively in a team environment, coordinating work flow with other team members and ensuring a productive and efficient environment. + Comply with safety principles, laws, regulations, and standards associated with, but not limited to, CMS, The Joint Commission, DHHS, and OSHA if applicable. **Benefits You Need & Then Some** Avera is proud to offer a wide range of benefits to qualifying part-time and full-time employees. We support you with opportunities to help live balanced, healthy lives. Benefits are designed to meet needs of today and into the future. + PTO available day 1 for eligible hires. + Up to 5% employer matching contribution for retirement + Career development guided by hands-on training and mentorship _Avera is an Equal Opportunity Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, Veteran Status, or other categories protected by law. If you are an individual with a disability and would like to request an accommodation for help with your online application, please call ************** or send an email to_ _****************_ _._ At Avera, the way you are treated as an employee translates into the compassionate care you deliver to patients and team members. Because we consider health care a ministry, you can live out your faith, uphold the dignity and respect of all persons while not compromising high-quality services. Join us in making a positive impact on moving health forward. The policy of Avera to provide opportunities for all qualified employees or applicants without regard to disability and to provide reasonable accommodations for all employees or applicants who may be disabled. Avera is committed to ensuring compliance in accordance with the Americans with Disability Act. For assistance, please contact HR Now at ************. Additional Notices: For TTY, dial 711 Avera is an Equal Opportunity/Affirmative Action Employer: Minority/Female/Disabled/Veteran/Sexual Orientation/Gender Identity.

Worker Type: Regular Work Shift: Day Shift (United States of America) Pay Range: is listed below. Actual pay rate dependent upon experience. $24.00 - $36.50 Highlights This position will support projects in the maternal and child health studies at Avera Research Institute. This includes supporting the ECHO study (Environmental influences on Child Health Outcomes), which is a longitudinal, observational study following pregnant women and their children to understand how environmental exposures in the prenatal and early childhood time frame affect health outcomes for children later in life. We are seeking individuals who have a strong interest in working with this study's population of pregnant women and children, and have an interest in public health. This position is not intended for individuals seeking clinical research experience as it is not a part of a clinical trial. Learn more about the Avera Research Institute at the link below: ********************************************************************** You Belong at Avera Be part of a multidisciplinary team built with compassion and the goal of Moving Health Forward for you and our patients. Work where you matter. A Brief Overview An advanced position that contributes to the overall operations of one or more research studies. The CRC is responsible for implementation of the study protocol, recruitment plan, study visits, data, study assessments, and other tasks outlined in the protocol. This position requires close collaboration with the study team and investigator to ensure safe and compliant research procedures and follow-up per the established research protocol. This position will work directly with research participants, physicians, nurses, community stakeholders, and health/social service organizations. This position has opportunities for ongoing learning and contribution to research that is focused on improving health and wellbeing of individuals and the community. What you will do * Coordinates research studies per Good Clinical Practices guidelines, FDA regulations, and approved protocols. * Understands and adheres to Standard Operating Procedures (SOPs). Ability to develop or improve SOPs, help guides, and other team resources. * Acquires detailed knowledge of assigned research protocols and ability to conduct study required processes, procedures, and assessments. Ability to prepare, utilize, and review Case Report Forms. Collects and manages data, Case Report Forms, and timely entry into the electronic data capture system. * Collects and assists with processing all laboratory specimens to include centrifuging, separating, measuring, storing, shipping, and distributing to appropriate testing areas. Maintains inventory of laboratory supplies and study kits. * Screens, recruits, and enrolls study participants using study's eligibility criteria. Preforms the informed consent, answering all participant questions, and obtaining appropriate sign-off. * Ensures the adherence to ethical practices during the conduct of clinical trials in order to protect the rights and well-being of patients and the collection of quality data. * Ensures validity of research results by ensuring timely, accurate, and complete data documentation, reporting deviations, violations, and serious adverse events. * Develops relationships with referring physicians, clinical staff, and ancillary departments to facilitate compliance with and accrual to clinical trials. Essential Qualifications The individual must be able to work the hours specified. To perform this job successfully, an individual must be able to perform each essential job function satisfactorily including having visual acuity adequate to perform position duties and the ability to communicate effectively with others, hear, understand and distinguish speech and other sounds. These requirements and those listed above are representative of the knowledge, skills, and abilities required to perform the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions, as long as the accommodations do not cause undue hardship to the employer. Required Education, License/Certification, or Work Experience: * Bachelor's From a four year college or university within the health and science field Preferred Education, License/Certification, or Work Experience: * 1-3 years Human Research * 1-3 years Laboratory or clinical Expectations and Standards * Commitment to the daily application of Avera's mission, vision, core values, and social principles to serve patients, their families, and our community. * Promote Avera's values of compassion, hospitality, and stewardship. * Uphold Avera's standards of Communication, Attitude, Responsiveness, and Engagement (CARE) with enthusiasm and sincerity. * Maintain confidentiality. * Work effectively in a team environment, coordinating work flow with other team members and ensuring a productive and efficient environment. * Comply with safety principles, laws, regulations, and standards associated with, but not limited to, CMS, The Joint Commission, DHHS, and OSHA if applicable. Benefits You Need & Then Some Avera is proud to offer a wide range of benefits to qualifying part-time and full-time employees. We support you with opportunities to help live balanced, healthy lives. Benefits are designed to meet needs of today and into the future. * PTO available day 1 for eligible hires. * Up to 5% employer matching contribution for retirement * Career development guided by hands-on training and mentorship Avera is an Equal Opportunity Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, Veteran Status, or other categories protected by law. If you are an individual with a disability and would like to request an accommodation for help with your online application, please call ************** or send an email to ****************.

Provide study coordinator/data management/regulatory specialist support to the Clinical Trials Office (CTO). Manage independent assignment, providing excellent customer support and guidance in the clinical trials arena. Responsibilities: * Assure all study requirements are met and documented and meet both internal and external regulations in accordance with protocol guidelines. * Maintain logs, including tracker submissions and update the CTO Oncore database in a timely manner according to CTO SOPs. * Design systems for coordinating, compiling and submission of data; design workflow processes and participate in quality assurance measures; coordinate site visits. * Manage all patient and/or protocol data as assigned and respond to queries in a timely fashion. * Schedule and participate in monitoring visits and participate in multidisciplinary team program meetings as required. * Bachelor's degree required or equivalent combination of education and experience. * Medical and/or science experience/education preferred. * Clinical research certification preferred. Equal Opportunity Employer of Minorities/Females/Disabled/Veterans Additional Information * Schedule: Full-time * Requisition ID: 25007200 * Daily Work Times: 8am-4:30pm * Hours Per Pay Period: 80 * On Call: No * Weekends: No

The Clinical Coordinator is responsible for implementing and supporting WRHS clinical applications and departments. Excellence in Practice: Primary responsibilities involve assuring the overall successful implementation and operation of WRHS's clinical modules. Serves as the day-to-day contact person for the end-users of clinical modules during implementation and for ongoing maintenance thereafter. Identifies and assists in the resolution of issues arising in the clinical modules and issues that overlap the clinical departments relating to the set up and operation of WRHS's information system. Trains users in the use of clinical and other assigned applications. Tests and oversees the testing of all software updates/new releases for the clinical modules. Assists in maintaining system security through role based user access and auditing of clinical applications. Documents, tracks and follows up on all reported problems and enhancement requests; maintains procedural and operational documentation for the clinical modules. Maintains a general knowledge of computer operations and other applications to serve as a departmental team member. Keeps supervisor informed about the status of work done and work outstanding. Communicates effectively with supervisor and users about the status of issues and projects. Essential Job Requirements: Education: Bachelor degree in a computer-related or clinical field. Experience: The candidate should possess expert knowledge of and significant experience in a clinical field, experience working in or supporting electronic health record, and general healthcare operations License Requirements: None Physical Requirements: Must be capable and willing to safely lift computer equipment weighing at least 65 pounds. Work requires active movement such as walking, standing, and bending. Normal working hours: 8am-5pm Starting salary range: $24.21 - $29.86 Powered by JazzHR Ef3NZubpRb

Clinical Nurse Coordinator At RestorixHealth, our mission is simple…to restore health and improve the quality of life - and access to care - for patients with wounds. The Full Time Clinical Nurse Coordinator is a dual role consisting of Registered Nurse and Marketing Coordinator. The Registered Nurse (RN) provides direct patient care and coordination of care for patients through assessment and team collaboration in evaluation, planning and implementing evidence based holistic wound care. The Marketing Coordinator is responsible for developing and maintaining community relationships with current and future referral sources through direct referral source interaction and education of medical communities on services provided and patient eligibility. The ideal Nurse Coordinator is flexible and cooperative in fulfilling role obligations, and willing to continue coordination of care efforts even during non-clinical hours. The Nurse Coordinator will receive ongoing training and will be provided with additional resources to help you be successful in your role. Take your passion for enhancing the lives of patients and turn it into a career, join the RestorixHealth Team and APPLY TODAY! What We Offer: Monday - Friday schedule, no weekends Internal ongoing educational/training opportunities Competitive compensation Continuous coaching & mentorship Overall Expectations: Ensure staff demonstrates competency in core and center-specific clinical skills, and that continuing education and certificates are maintained and up to date Review wound healing center activities and recommend process flow changes in, or better utilization of, facilities, services, and staff Establishes weekly contacts with host facilities' administration and medical staff. Adheres to our and host facility regulatory and accrediting standards policies/procedures Maintains open communication with Senior Management, Regional Director, Program Director, Clinical Team, host facility staff, providers, and business office staff to ensure continuity of care Actively participates in all Quality Management measures, and ensures all measures are turned in by designated deadlines Develops patient specific wound care plan and regularly reviews wound progress. Follows up with lab and diagnostic results, communicates to provider and patient, and documents accurately Ensures accuracy, legibility, and completion of all staff documentation and adheres to daily chart check and correction policy Qualifications: Valid Registered Nurse license in the state of employment Current BLS and ACLS certification through the American Heart Association Minimum of 3 years of nursing experience, wound care clinic experience or a combination of both Ability to function competently and independently to provide the highest quality of nursing practice At RestorixHealth, we grow talent. When you join our team, you have the opportunity to develop your career based on your strengths and potential, including the possibility to move functionally, geographically, laterally, and vertically. This is a career destination for engaged, caring, passionate and talented people who want to make a difference. We are the leader in the development and management of comprehensive wound healing and Amputation Prevention Center facilities. RestorixHealth is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, or marital status. INDHP

Clinical Nurse Coordinator At RestorixHealth, our mission is simple…to restore health and improve the quality of life - and access to care - for patients with wounds. The Full Time Clinical Nurse Coordinator is a dual role consisting of Registered Nurse and Marketing Coordinator. The Registered Nurse (RN) provides direct patient care and coordination of care for patients through assessment and team collaboration in evaluation, planning and implementing evidence based holistic wound care. The Marketing Coordinator is responsible for developing and maintaining community relationships with current and future referral sources through direct referral source interaction and education of medical communities on services provided and patient eligibility. The ideal Nurse Coordinator is flexible and cooperative in fulfilling role obligations, and willing to continue coordination of care efforts even during non-clinical hours. The Nurse Coordinator will receive ongoing training and will be provided with additional resources to help you be successful in your role. Take your passion for enhancing the lives of patients and turn it into a career, join the RestorixHealth Team and APPLY TODAY! What We Offer: Monday - Friday schedule, no weekends Internal ongoing educational/training opportunities Competitive compensation Continuous coaching & mentorship Overall Expectations: Ensure staff demonstrates competency in core and center-specific clinical skills, and that continuing education and certificates are maintained and up to date Review wound healing center activities and recommend process flow changes in, or better utilization of, facilities, services, and staff Establishes weekly contacts with host facilities' administration and medical staff. Adheres to our and host facility regulatory and accrediting standards policies/procedures Maintains open communication with Senior Management, Regional Director, Program Director, Clinical Team, host facility staff, providers, and business office staff to ensure continuity of care Actively participates in all Quality Management measures, and ensures all measures are turned in by designated deadlines Develops patient specific wound care plan and regularly reviews wound progress. Follows up with lab and diagnostic results, communicates to provider and patient, and documents accurately Ensures accuracy, legibility, and completion of all staff documentation and adheres to daily chart check and correction policy Qualifications: Valid Registered Nurse license in the state of employment Current BLS and ACLS certification through the American Heart Association Minimum of 3 years of nursing experience, wound care clinic experience or a combination of both Ability to function competently and independently to provide the highest quality of nursing practice At RestorixHealth, we grow talent. When you join our team, you have the opportunity to develop your career based on your strengths and potential, including the possibility to move functionally, geographically, laterally, and vertically. This is a career destination for engaged, caring, passionate and talented people who want to make a difference. We are the leader in the development and management of comprehensive wound healing and Amputation Prevention Center facilities. RestorixHealth is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, or marital status. INDHP

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

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

**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!_

Sanford Health is one of the largest and fastest-growing not-for-profit health systems in the United States. We're proud to offer many development and advancement opportunities to our nearly 50,000 members of the Sanford Family who are dedicated to the work of health and healing across our broad footprint. Work Shift: 8 Hours - Day Shifts (United States of America) Scheduled Weekly Hours: 40Salary Range: $24.00 - $38.50 Union Position: No Department Details • Attire is either business casual or navy blue scrubs; lab coats are also provided by the department • Flexibility for things like appointments/kid drop off • Ability to WFH 1x per week after 6 months • Collaborative team approach and supportive management team • Opportunities for continued learning and professional development • Emphasis on employee wellbeing through annual events and team building activities Summary Provides an opportunity to learn daily and contribute to treatments of the future. Enthusiasm for learning required, along with participation in educating patients, physicians, nurses and other personnel about the research process. Job Description Organize complex components of various clinical trials, including the coordination of study-required testing and procedures, as well as investigational treatment for a variety of conditions and symptoms. Participate in listing and clarifying questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations and study procedures. Schedule and coordinate pre-study site visits. Monitor enrollment goals and modify recruitment plan as necessary. Maintain patient screening/enrollment logs and appropriately update sponsors, contract research organizations (CROs) and/or senior medical officers (SMOs). Assure the completion of all screening, eligibility and enrollment procedures. Conduct interviews to assess subject ability and willingness to follow and complete study procedures and visits. Follow randomization procedures per protocol. Schedule subjects for follow-up visits. Review diaries and questionnaires completed by subjects. Ensure appropriate specimen collection, batching and shipping as required. Collect source documents for sponsor or audit review. Assess subject compliance with the test article and follow-up visits. Abstract data from medical records, clinic, consultation and referral notes for preparation of study forms and flow sheets. Review inclusion/exclusion criteria to assure subject eligibility, and review with physician investigator for final sign-off. Review and verify required source documents in subject medical records to confirm study eligibility. Review study protocol, informed consent form and follow-up procedures with potential study subjects. Prepare case report forms for sponsor or audit review. Responsible for insurance pre-authorization for study participation, as applicable by study. Close collaboration with physician investigators required to ensure safe and compliant investigational treatment or intervention and follow-up per the established research protocol. Document and maintain all study-related procedures, processes and events by planning and design of new forms/source document tools to use in protocol implementation. Document protocol deviations and exemptions. Obtain and review original source documents as needed. Record accurate and timely data onto case report forms. Maintain source documentation for all case report entries, as applicable. Key in data for electronic submission, if applicable. Correct and edit case report form entries as appropriate. Resolve data queries. Ensure drug/device accountability by completing appropriate documentations per individual protocols. Schedule and participate in sponsor monitoring visits and audits to ensure compliance with regulatory requirements governing clinical research. Meet with monitors/auditors during routine visits to discuss case report form completion, query resolution and other protocol-related issues. Travel between the Sioux Falls, SD site and the Worthington, MN site may be required. Qualifications Bachelor's degree in biology, microbiology or related field. May consider graduates of an accredited school of practical nursing as a Licensed Practical Nurse (LPN) dependent on facility and department needs. Minimum three years of clinical or clinical research experience or six to eight years of relevant work experience required. If a Licensed Practical Nurse (LPN), currently holds an unencumbered LPN license with state nursing board and/or possess multi-state licensure privileges. Obtains and subsequently maintains required department specific competencies and certifications. Sanford is an EEO/AA Employer M/F/Disability/Vet. If you are an individual with a disability and would like to request an accommodation for help with your online application, please call ************** or send an email to ************************.

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_

PXL is hiring a Clinical Scientist! **Job Purpose:** The Clinical Scientist (CS) assists the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies (e.g., adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, protocol deviation management). **Key Accountabilities** May include but not limited to the following: Clinical Trial Operational Delivery - May support a single study or multiple studies - May lead a study with limited scope (e.g., Survival Follow-up) - Liaises with cross-functional lines as appropriate - May interact with internal and external stakeholders (study sites, committees, etc.) in support of clinical study objectives Compliance with Parexel Standards - Complies with required training curriculum - Completes timesheets accurately as required - Submits expense reports as required - Updates CV as required - Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: - Demonstrated oral and written communication skills - MS Office Suite Experience Required- including Word, Excel, and Power Point - Proficient in written and spoken English - Proficient in local language (as applicable) - Willingness to travel as required for key company meetings Knowledge and Experience: - Pharmaceutical experience beneficial but not required - Therapeutic Area (TA) specific experience beneficial - 2 years medical monitoring experience preferred Education: - Bachelors/Masters/PhD in Life Sciences with 2+ years relevant career experience - If no degree in Life Sciences, must have significant experience in clinical development (>5 years) \#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.

Sanford Health is one of the largest and fastest-growing not-for-profit health systems in the United States. We're proud to offer many development and advancement opportunities to our nearly 50,000 members of the Sanford Family who are dedicated to the work of health and healing across our broad footprint. Work Shift: 8 Hours - Day Shifts (United States of America) Scheduled Weekly Hours: 40Salary Range: $21.50 - $34.50 Union Position: No Department Details Following the mandatory in‑office training phase, a hybrid work arrangement may be permitted, subject to management discretion. Summary The Clinical Research Intake Coordinator is responsible for coordinating the intake, feasibility review, and selection processes for research studies and initiatives across the organization. This role serves as the primary point of contact for external partners, sponsors, investigators, leadership, and internal research teams from initial study or project inquiry through intake and selection decision. The Research Intake Coordinator ensures timely progression of research activities through required reviews, maintains accurate documentation and tracking, and supports effective communication and collaboration among stakeholders. Job Description Manage all communications related to research study and project inquiries. Serve as the primary point of contact for external partners, sponsors, internal research staff, investigators, and leadership from initial inquiry through intake and selection decision. Document all external and internal communications, study or project activity, and decisions in departmental databases and tracking systems in accordance with established workflows. Coordinate completion of research feasibility assessments, including the distribution, collection, and review of protocols, proposals, feasibility questionnaires, and supporting documentation. Facilitate leadership-level, scientific, and operational reviews by coordinating meetings, compiling materials, tracking feedback, and documenting outcomes. Ensure timely progression of studies and projects through intake, feasibility, and selection processes by monitoring milestones, following up on outstanding items, and escalating issues as appropriate. Support legal, regulatory, and contract-related communications by routing documents to appropriate stakeholders, tracking review status, and ensuring timely responses in accordance with institutional policies. Maintain organized and accurate records of research status, communications, and decisions to ensure transparency, compliance, and readiness for audit or reporting needs. Prepare and distribute research intake reports, dashboards, and summaries for leadership as needed. Support departmental operations by assisting with intake process improvements, maintaining research pipeline data, and contributing to efficient, compliant, and scalable research operations. Provide support for research-related conference and outreach activities, including meeting planning, travel coordination, and development of informational or marketing materials. Travel may be required for training, professional conferences, departmental retreats, and related activities. Other duties as assigned. Qualifications Bachelor's degree in research, business, healthcare administration, or other applicable field of study required. In lieu of degree, minimum of four years' applicable experience in clinical research or a specialized area like business, marketing or a similar field will be considered. Three years in administrative activities, clinical research, business, marketing, or similar environment required. Proficiency in Microsoft Office required; proficiency in Smartsheet or similar project tracking tools is highly recommended. Sanford is an EEO/AA Employer M/F/Disability/Vet. If you are an individual with a disability and would like to request an accommodation for help with your online application, please call ************** or send an email to ************************.