Clinical research associate jobs in Rapid City, SD - 28 jobs

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. 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_

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

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: $27.50 - $44 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 to the research process. Job Description 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. 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 ************************.

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.

Worker Type: Regular Work Shift: Primarily days with possible weekends/evenings/holidays (United States of America) Highlights 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 Responsible for providing leadership and oversight to ensure high-quality strategic implementation of clinical cancer research that will expand the Avera Cancer Institute research program. Directs and supervises research activities within the Avera Cancer Institute to provide high quality research to grow and support research across the oncology service line and increase referrals for research studies. In addition, is responsible for the functions of research areas and development/enhancement of relationships with internal/external customers involved in research that lead to bringing new research opportunities to Avera. What you will do Directs and supervises research at Avera Cancer Institute and supports activities that include but not limited to all phase clinical trials and research administrative support staff. Directly responsible and accountable for the core operations/function of each area as it relates to research policies, procedures and protocols, regulatory compliance, performance improvement, business plans, fundraising, financial/budgetary management, staff orientation and competency. In collaboration with the Clinical Vice President of Oncology and Vice President of Oncology, completes strategic and operational planning. Promotes growth of research operations that allow the organization to expand, enrich and advance the field of oncology research. Facilitates staff and resources to reinforce the vision of the Avera Cancer Institute and health system. As a member of the leadership team, serves as a role model of the leadership principles resulting in positive communication and problem solving. Ensures lines of communication are open with staff, promoting high employee morale and a professional, healthful work environment. Serves as a clinical investigator by identifying, designing, managing, and directing investigator-led oncology clinical trials through positive collaborations with physicians, research staff, and pharmaceutical companies and other cooperative groups or organizations. Stewards growth in the relationships between Avera, physician partners, academic institutions and other collaborators across the United States and the world in the field of research through academic and professional appointments. Partners with leadership, medical director(s), and scientific personnel to acquire external funding at various levels to underpin high quality research and service activity. Works in conjunction with the Avera Foundation to develop and execute fundraising plans for designated research projects. Maintains an accurate and acute knowledge of industry regulations and compliance standards. Knows and addresses to applicable laws and regulations. Reviews and updates departmental policies, protocols and practices to reflect current regulations. In collaboration with the Avera Compliance assures the development and maintenance of research compliance with respect to protocols. Maintains professional affiliations and enhances professional growth and development to keep current in the latest trends in research administration. Responsibilities include interviewing, hiring, developing, training, and retaining employees; planning, assigning, and leading work; appraising performance; rewarding and coaching employees; addressing complaints and resolving problems. 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 Minimum 3 years related management experience Proven leadership success in implementing and guiding early phase oncology clinical research development Preferred Education, License/Certification, or Work Experience: Master's MBA, MHA or equivalent Doctorate (PHD) or equivalent with related postdoctoral experience A track record of obtaining extramural funding 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 **************** .

Worker Type: Regular Work Shift: Primarily days with possible weekends/evenings/holidays (United States of America) Highlights 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 Responsible for providing leadership and oversight to ensure high-quality strategic implementation of clinical cancer research that will expand the Avera Cancer Institute research program. Directs and supervises research activities within the Avera Cancer Institute to provide high quality research to grow and support research across the oncology service line and increase referrals for research studies. In addition, is responsible for the functions of research areas and development/enhancement of relationships with internal/external customers involved in research that lead to bringing new research opportunities to Avera. What you will do * Directs and supervises research at Avera Cancer Institute and supports activities that include but not limited to all phase clinical trials and research administrative support staff. * Directly responsible and accountable for the core operations/function of each area as it relates to research policies, procedures and protocols, regulatory compliance, performance improvement, business plans, fundraising, financial/budgetary management, staff orientation and competency. In collaboration with the Clinical Vice President of Oncology and Vice President of Oncology, completes strategic and operational planning. * Promotes growth of research operations that allow the organization to expand, enrich and advance the field of oncology research. * Facilitates staff and resources to reinforce the vision of the Avera Cancer Institute and health system. As a member of the leadership team, serves as a role model of the leadership principles resulting in positive communication and problem solving. Ensures lines of communication are open with staff, promoting high employee morale and a professional, healthful work environment. * Serves as a clinical investigator by identifying, designing, managing, and directing investigator-led oncology clinical trials through positive collaborations with physicians, research staff, and pharmaceutical companies and other cooperative groups or organizations. * Stewards growth in the relationships between Avera, physician partners, academic institutions and other collaborators across the United States and the world in the field of research through academic and professional appointments. * Partners with leadership, medical director(s), and scientific personnel to acquire external funding at various levels to underpin high quality research and service activity. * Works in conjunction with the Avera Foundation to develop and execute fundraising plans for designated research projects. * Maintains an accurate and acute knowledge of industry regulations and compliance standards. Knows and addresses to applicable laws and regulations. Reviews and updates departmental policies, protocols and practices to reflect current regulations. In collaboration with the Avera Compliance assures the development and maintenance of research compliance with respect to protocols. Maintains professional affiliations and enhances professional growth and development to keep current in the latest trends in research administration. * Responsibilities include interviewing, hiring, developing, training, and retaining employees; planning, assigning, and leading work; appraising performance; rewarding and coaching employees; addressing complaints and resolving problems. 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 * Minimum 3 years related management experience * Proven leadership success in implementing and guiding early phase oncology clinical research development Preferred Education, License/Certification, or Work Experience: * Master's MBA, MHA or equivalent * Doctorate (PHD) or equivalent with related postdoctoral experience * A track record of obtaining extramural funding 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 ****************.

Join Our Campus Community! Thank you for your interest in joining the University of Wyoming. Our community thrives on the contributions of talented and driven individuals who share in our mission, vision, and values. If your expertise and experience align with the goals of our institution, we would be thrilled to hear from you. We encourage you to apply and become a valued member of our vibrant campus community today! Why Choose Us? At the University of Wyoming, we value our employees and invest in their success. Our comprehensive benefits package is designed to support your health, financial security, and work-life balance. Benefits include: Generous Retirement Contributions: The State contributes 14.94% of your gross salary, and you contribute 3.68%, totaling 18.62% toward your retirement plan. Exceptional Health & Prescription Coverage: Enjoy access to medical, dental, and vision insurance with competitive employer contributions, that include 4 deductible options to suit your needs. Paid Time Off: Benefit from ample vacation, sick leave, paid holidays, and paid winter closure. Tuition Waiver: Employees and eligible dependents can take advantage of tuition waivers, supporting continuous education and professional growth. Wellness and Employee Assistance Programs: Stay healthy with wellness initiatives, counseling services, and mental health resources. At the University of Wyoming, we are committed to creating a supportive and enriching workplace. To learn more about what we offer, please refer to UW's Benefits Summary. JOB TITLE: Annual Giving Coordinator - Institutional Advancement and UW Foundation JOB PURPOSE: Manage the social media and technology-based fundraising for the department of Annual Giving. Assist with the administration and implementation of annual giving programs. Serve as a key member of the Annual Giving team, supporting traditional functions of fundraising in the department. ESSENTIAL DUTIES AND RESPONSIBILITIES: Daily execution of annual giving technology-based fundraising functions, such as solicitations through email, text to give, online giving, crowdfunding and other industry-recognized venues. Provide leadership in innovative technology-based fundraising, such as Crowdfunding. Manage the process of print-based solicitations as well as stewardship of annual giving donors. Manage the annual giving schedules and projects. Coordinate processes through which annual giving projects are recorded, tracked and reported with department on shared drive and through appropriate email reporting. SUPPLEMENTAL FUNCTIONS: May make recommendations for current expenditures and ongoing budget planning; may manage funds for assigned areas of responsibility. Receive training and have the ability to serve as the backup supervisor for the Cowboy Call center in the absence of the Call Center Manager. COMPETENCIES: Teamwork Attention to Detail Analysis/Problem Identification Initiative Adaptability Consistency MINIMUM QUALIFICATIONS: Education: Bachelor's Degree, or equivalent combination of education and experience. Experience: 1 year work-related experience Required licensure, certification, registration or other requirements: None DESIRED QUALIFICATIONS: Education: Bachelor's Degree Experience: 2 years progressively responsible work-related experience Assimilates and applies information in a timely manner. Demonstrated success in exceeding goals with a commitment to high personal performance and teamwork. Excellent written communication and interpersonal skills with the ability to collaborate effectively with diverse teams and stakeholders. Strong attention to detail, organizational skills, and ability to manage multiple competing priorities accurately and reliably. Ability and propensity to leverage new technologies, tools, and best practices to improve program results. Demonstrated ability to work autonomously and take initiative while also being a collaborative team player. REQUIRED APPLICATION MATERIALS: Complete the online application. The department additionally requests candidates upload the following document(s) for a complete application: Cover letter Resume or C.V. Contact information for four work-related references (references will only be contacted if you are selected as a finalist for the position). **Due to a current system limitation, you may only be prompted to upload your resume/CV and a Cover Letter. To ensure your application is complete, we recommend you put all of your application materials into one file with your cover letter. However, if you're experiencing any issues in doing so, please send any additional application materials to ****************, and a recruiter will manually add them to your application packet. To help us process your application more efficiently, please include the 6-digit job ID number (located at the bottom of the job posting) in your email. This position will remain open until filled. Complete applications received by 1/5/2026 will receive full consideration. WORK LOCATION: On-campus: This position provides vital support to campus customers, and the successful candidate must be available to work on campus. WORK AUTHORIZATION REQUIREMENTS: The successful candidate must be eligible to work in the United States. Sponsorship for H-1B work authorization or work visa is not available for this position. HIRING STATEMENT/EEO: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. In compliance with the ADA Amendments Act (ADAAA), if you have a disability and would like to request an accommodation to apply for a position, please contact us at ************ or email ****************. ABOUT LARAMIE: The University of Wyoming is located in Laramie, a charming town of 30,000 residents nestled in the heart of the Rocky Mountain West. The state of Wyoming continues to invest in its only 4-year university, helping to make it a leader in academics, research, and outreach with state-of-the-art facilities and strong community ties. We invite you to learn more about Laramie by visiting the About Laramie website. Located in a high mountain valley near the Colorado border, Laramie offers both outstanding recreational opportunities and close proximity to Colorado's Front Range and the metropolitan Denver area. Laramie's beautiful mountain landscape offers outdoor enjoyment in all seasons, with over 300 days of sunshine annually. For more information about the region, please visit ************************

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

**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!_

**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.

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 Sioux Falls, SD and Worthington, MN sites 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 ************************.

**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. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled

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. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. 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_

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 the Sponsor's 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. **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 the Sponsor's 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 Site Care Partner 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 Site Care Partner 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 the Sponsor's credibility, scientific leadership and in order to facilitate their 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 **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#LI-LO1 \#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.

**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:** $24.00 - $38.50 **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 about the research process. 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 Sioux Falls, SD and Worthington, MN sites 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. **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-0244375 **Job Function:** Research **Featured:** No

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.

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_