Clinical research associate jobs in Bismarck, ND

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_

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Job Description * Please note: Candidates must live within or be willing to relocate to the Sioux Falls, SD, Area to perform the duties of this role. Primary Function of Position The Clinical Territory Associate (CTA) is a 24+ month developmental role that will partner with the Sioux Falls, SD, team to gain knowledge in all aspects of our business to include technical, clinical, and sales. Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager) * Assists sales representatives with surgeon trainings, hospitals robotic development, and overall territory management * Guides technical in-services for customers to include OR staff, surgeons, etc. * Sells benefits of advanced technology to existing robotic users to contribute to team overall quotas * Gains experience in goal setting, mapping, and attaining in preparation for quota bearing role to follow CTA position * Manages administrative tasks: reporting of sales/procedures, outcomes of sales activities, submission of expense reports Qualifications Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job) * Minimum 1-year leadership (military) experience or 1 year of outside sales experience required * Ability to travel up to 25%, and work nights and weekends as needed Required Education and Training (As applicable - Specific education and training that an individual must possess in order to successfully perform in job) * Bachelor's degree required Working Conditions (As applicable - Any physical requirements for the job. If not applicable, state "none") * None Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have) * Proven record of success * Ambition and exceptional work ethic * Ability to excel in a high-energy, fast-paced environment * Excellent interpersonal skills and persuasive communication skills * Proven ability to work effectively as part of a team Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. We provide market-competitive compensation packages, inclusive of base pay + commission, benefits, and equity. The on target earnings for this position are listed.

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: Sanford Med Ctr Fargo Location: Fargo, ND Address: 5225 23rd Ave S, Fargo, ND 58104, USA Shift: 10 Hours - Night Shifts Job Schedule: Full time Weekly Hours: 35.00 Salary Range: $53.00 - $87.50 Pay Info: Sign on Bonus: $15,000 with a commitment Department Details The schedule for this position consists of a 7-day on, 7-day off rotation, with work hours from 10:00 PM to 8:00 AM, Wednesday through Tuesday. Sanford Pharmacy Services are available 24 hours per day, seven days per week in the inpatient setting. The pharmacy team is involved in outpatient and inpatient departments and work under established P&T protocols as well as collaborative practice agreements. Pharmacy services at Sanford Medical Center also include involvement in cardiology, dialysis, internal medicine, intensive care, emergency care, medication reconciliation, medication delivery to bedside, OR pharmacy, transplant, and an antimicrobial stewardship program. Sanford Medical Center Fargo is a teaching hospital where the pharmacist has the opportunity to precept pharmacy residents and students. Job Summary Review prescriptions to assure accuracy, to ascertain the needed ingredients, and to evaluate their suitability. Provide information and advice regarding drug interactions, side effects, dosage, and proper medication storage. In a medical center or institutional setting, the Pharmacist reviews and interprets provider orders, provides drug information, assists in problem solving, and provides other aspects of pharmaceutical care. Duties may consist of unit dose dispensing, IV Admixtures, outpatient prescriptions, navigating the electronic medical record, compounding, and working with automated dispensing devices. The Pharmacist utilizes appropriate age-related patient information to assess the pharmaceutical needs of patients, which may include provision of pharmaceutical care to neonatal, pediatric, adolescent, adult, and geriatric patients. The Pharmacist follows all established regulations and standards that govern the practice of pharmacy. May be required to act as a shift supervisor under direct or indirect supervision by department managers. Demonstrates good written and verbal communication skills. Must be able to learn and utilize new technology as the profession of pharmacy evolves. Provides oversight and clinical supervision for pharmacy services and pharmacy support personnel. Pharmacy services at Sanford Health may include involvement in acute care surgery, neurology, cardiology, pediatrics, oncology, infusion services, intensive care, general medicine, dialysis, transplant, antimicrobial stewardship, and medication reconciliation. May include decentralized clinical functions, such as direct patient interaction/interdisciplinary team rounding, chart reviews, customer or patient counseling, collecting accurate medication list. May also include centralized clinical functions, such as checking and dispensing medications and overseeing the clinical functions of the IV room. Qualifications In a medical center or institutional setting: Graduate of an accredited School of Pharmacy. Must have a thorough knowledge of drugs and their actions; knowledge of state and local regulations. Hospital experience or residency preferred. License must be in good standing by the State Board of Pharmacy in state(s) of practice and/or possess multi-state licensure privileges as required by position. 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-0199286 Job Function: Allied Health Featured: No

**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_ _****************_ _._ At Avera, the way you are treated as an employee translates into the compassionate care you deliver to patients and team members. Because we consider health care a ministry, you can live out your faith, uphold the dignity and respect of all persons while not compromising high-quality services. Join us in making a positive impact on moving health forward. The policy of Avera to provide opportunities for all qualified employees or applicants without regard to disability and to provide reasonable accommodations for all employees or applicants who may be disabled. Avera is committed to ensuring compliance in accordance with the Americans with Disability Act. For assistance, please contact HR Now at ************. Additional Notices: For TTY, dial 711 Avera is an Equal Opportunity/Affirmative Action Employer: Minority/Female/Disabled/Veteran/Sexual Orientation/Gender Identity.

Worker Type: Regular Work Shift: 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 ****************.

Job DescriptionThe Senior Research Associate PDP & Mfg. plays a critical role as a cGMP scientist and operator, supporting the development and manufacturing of investigational drug products for plasma fractionation immunotherapies. This position is responsible for ensuring compliance with Good Manufacturing Practices (GMP) regulations and regulatory guidelines throughout all phases of product development, from research to commercial-scale production. Duties and Responsibilities (Include but are not limited to): Assist in writing and updating related SOPs, records, protocols, reports. Maintain accurate records of activities. Perform bench-scale protein purification. Lead purification needs for reagent production. Work towards optimizing purification methods and protocols for increased yield and purity. Create purification methods in chromatography software programs. Perform statistical analysis as needed. Collaborate with the Supervisor to execute projects to meet timelines. Support the training of associates in purification activities. Purify and Filling product as needed based on Clinical needs. Assist other research associates in purification activities. Assist with Shipping, Receiving, and Ordering related to PDP & Manufacturing. Assist with cleaning activities as needed in the Cleanrooms and Bench area. Perform calibrations and maintenance events on equipment related to PDP and Manufacturing. Other duties as assigned. Requirements: Education/Experience/Skills: Bachelor's degree and minimum 3 years of relevant experience or a combination of experience and Master's or Doctorate degree in a relevant field. Certification in Quality by Design is a plus. Demonstrated proficiency in Microsoft Office applications Word, Excel, PowerPoint, Outlook Familiarity with chromatography software, preferably Cytiva UNICORN. Basic computer programming knowledge to support use of UNICORN software. Mathematical skills to consist of addition, subtraction, multiplication, division and ability to perform basic statistical analysis, including mean, median, range, mode, standard deviation calculations and related analysis. Ability to calculate dilutions and molarity. Strong time management and organizational skills. Demonstrated ability to effectively work independently with minimal supervision. Excellent verbal and written communications skills and a collaborative approach work. Physical Demands: While performing the duties of this job, the employee is regularly required to walk, stand, sit and must regularly lift and/or move up to 10 pounds. Able to wear aseptic gowning for extended periods of time. Employee may be required to wear a PAPR or Respirator for cleaning. Working Environment and Travel: Duties will be performed in normal laboratory, and cleanroom environment. Work in aseptic setting, ISO5 environment. Travel is not typically required for this position. ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990. SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets Powered by JazzHR qEPfeND0iG

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care. Job Description *Please note: Candidates must live within or be willing to relocate to the Bismarck, ND Area to perform the duties of this role. Primary Function of Position The Clinical Territory Associate (CTA) is a 24+ month developmental role that will partner with the Bismarck, ND team to gain knowledge in all aspects of our business to include technical, clinical, and sales. Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager) Assists sales representatives with surgeon trainings, hospitals robotic development, and overall territory management Guides technical in-services for customers to include OR staff, surgeons, etc. Sells benefits of advanced technology to existing robotic users to contribute to team overall quotas Gains experience in goal setting, mapping, and attaining in preparation for quota bearing role to follow CTA position Manages administrative tasks: reporting of sales/procedures, outcomes of sales activities, submission of expense reports Qualifications Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job) Minimum 1-year leadership (military) experience or 1 year of outside sales experience required Ability to travel up to 25%, and work nights and weekends as needed Required Education and Training (As applicable - Specific education and training that an individual must possess in order to successfully perform in job) Bachelor's degree required Working Conditions (As applicable - Any physical requirements for the job. If not applicable, state “none”) None Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have) Proven record of success Ambition and exceptional work ethic Ability to excel in a high-energy, fast-paced environment Excellent interpersonal skills and persuasive communication skills Proven ability to work effectively as part of a team Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. We provide market-competitive compensation packages, inclusive of base pay + commission, benefits, and equity. The on target earnings for this position are listed.

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

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

Dept: Operating Room Hours per pay period: 80 hours Schedule: 7:00-3:30pm Under general direction of unit manager, plans, organizes and oversees tasks related to the care and treatment of patients undergoing a surgical intervention in assigned department. Provides guidance and support to operating room staff in meeting individualized patient needs related to their surgical specialty. Provides motivation and assistance in the continuing education of personnel to their surgical specialty after basic instruction Essential Functions and Responsibilities: 1. Assists leadership in planning and prioritizing daily activities of personnel in the rotation of surgical specialty by demonstrating and applying clinical and operational knowledge of operating room care delivery in the assigned service line to maintain departmental and AORN standards. 2. During peak hours, will facilitate the flow of surgical patients through the surgical process by planning, implementing, coordinating room turnover and any other assigned tasks. 3. Assist in patient care in the OR, within scope of practice, as needed. 4. Communicates freely with charge nurse and manager identifying and making recommendations for the resolutions of problems and reporting and documenting any unusual incidents. 5. Demonstrates the ability to revise priorities as work demands or schedules change. 6. Assesses needs on a continuing basis to reflect current changes in department service lines. This means ongoing communication with physician staff and awareness of current literature. Updating physician preference cards as needed. 7. Assists the management team and in-service instructor in the development of long range plans for specialty area with physician cooperation. 8. Responsible for overseeing that appropriate supplies and equipment are available. Effectively utilizes resources, materials and equipment and participates in development of cost containment strategies. Educates personnel in cost containment methodology. 9. Communicates pertinent patient information to other health team members, concisely, accurately and comprehensively in both written and verbal format. 10. Recognizes and follows lines of authority/communication within the work setting and works within those limits. Knows when to defer decisions to others. 11. Participates in the in-service program of the Department, highlighting instrumentation and equipment of specialty area. Leads discussion; gives productive input in meetings. Participates and helps to conduct regular staff meetings according to institutional and departmental policy and submits minutes if requested. 12. Presents a minimum of two in-services a year. 13. Acts as a role model and as resource person to facilitate attainment of unit standards and goals. 14. Demonstrates adequate knowledge of rules and regulations of appropriate regulatory and government agencies that are directed toward the specialty. Assist in maintaining accreditation standard. 15. Encourages and provides opportunities for staff development (i.e., develops leadership potential, basic and advanced technical knowledge, interpersonal skills). 16. Identifies areas for personal and professional growth. 17. Assumes the responsibility for checking surgical boarding's for cases that require special equipment/supplies and obtain necessary items. Communicates all equipment/supply problems to appropriate personnel. 18. Within scope of practice, assists in the orientation and on-the-job training of Department staff rotating through the specialty surgery rotation. Precepts the patients care rendered by department staff as well as perceived skill levels. 19. Maintains open communication with Central Service Department (Sterile Processing) as related to specialty needs and instrumentation. 20. Understand equipment, safety and mechanics of laser equipment. 21. Maintains high level of comprehension of assigned surgical specialty including, but not limited to, specific procedural process, medications, instrumentation, supplies, and equipment as demonstrated by the upkeep of the physician/procedure preference sheets and the on-going communication and education to staff. 22. Performs other related job duties as requested. #LI-LM1 #L Qualifications: Required: * Graduate of an accredited Nursing or Surgical Technologist program. * Current State of Michigan Registered Nurse license or Surgical Technologist Certification from The National Board of Surgical Technology and Surgical Assisting (NBSTSA) * Three-years prior work experience, in an acute care setting, as a Reg Nurse or Surgical Technologist * BLS certification from American Heart Association (AHA), American Red Cross (ARC), or Canadian equivalent, is required before start date and valid at least 60 days beyond start date. Preferred: * Prior work experience in a related specialty care area. Equal Opportunity Employer of Minorities/Females/Disabled/Veterans Additional Information * Schedule: Full-time * Requisition ID: 25000334 * Daily Work Times: 7:00 am-3:30pm * Hours Per Pay Period: 80 * On Call: No * Weekends: No

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA 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 SrCRA 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 SrCRA 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 ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, SrCRAs 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 always inspection ready. + 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 ICHGCP, 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 Scientific Liaisons (MSLs) as directed by LSAD or line manager **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 (Desirable):** + 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 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-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.

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_

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

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care. Job Description * Please note: Candidates must live within or be willing to relocate to the Bismarck, ND Area to perform the duties of this role. Primary Function of Position The Clinical Territory Associate (CTA) is a 24+ month developmental role that will partner with the Bismarck, ND team to gain knowledge in all aspects of our business to include technical, clinical, and sales. Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager) * Assists sales representatives with surgeon trainings, hospitals robotic development, and overall territory management * Guides technical in-services for customers to include OR staff, surgeons, etc. * Sells benefits of advanced technology to existing robotic users to contribute to team overall quotas * Gains experience in goal setting, mapping, and attaining in preparation for quota bearing role to follow CTA position * Manages administrative tasks: reporting of sales/procedures, outcomes of sales activities, submission of expense reports Qualifications Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job) Minimum 1-year leadership (military) experience or 1 year of outside sales experience required * Ability to travel up to 25%, and work nights and weekends as needed Required Education and Training (As applicable - Specific education and training that an individual must possess in order to successfully perform in job) * Bachelor's degree required Working Conditions (As applicable - Any physical requirements for the job. If not applicable, state "none") * None Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have) * Proven record of success * Ambition and exceptional work ethic * Ability to excel in a high-energy, fast-paced environment * Excellent interpersonal skills and persuasive communication skills * Proven ability to work effectively as part of a team Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. We provide market-competitive compensation packages, inclusive of base pay + commission, benefits, and equity. The on target earnings for this position are listed.

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

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Job Description *Please note: Candidates must live within or be willing to relocate to the Sioux Falls, SD, Area to perform the duties of this role. Primary Function of Position The Clinical Territory Associate (CTA) is a 24+ month developmental role that will partner with the Sioux Falls, SD, team to gain knowledge in all aspects of our business to include technical, clinical, and sales. Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager) Assists sales representatives with surgeon trainings, hospitals robotic development, and overall territory management Guides technical in-services for customers to include OR staff, surgeons, etc. Sells benefits of advanced technology to existing robotic users to contribute to team overall quotas Gains experience in goal setting, mapping, and attaining in preparation for quota bearing role to follow CTA position Manages administrative tasks: reporting of sales/procedures, outcomes of sales activities, submission of expense reports Qualifications Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job) Minimum 1-year leadership (military) experience or 1 year of outside sales experience required Ability to travel up to 25%, and work nights and weekends as needed Required Education and Training (As applicable - Specific education and training that an individual must possess in order to successfully perform in job) Bachelor's degree required Working Conditions (As applicable - Any physical requirements for the job. If not applicable, state “none”) None Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have) Proven record of success Ambition and exceptional work ethic Ability to excel in a high-energy, fast-paced environment Excellent interpersonal skills and persuasive communication skills Proven ability to work effectively as part of a team Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. We provide market-competitive compensation packages, inclusive of base pay + commission, benefits, and equity. The on target earnings for this position are listed.

**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_

Worker Type: Regular Work Shift: Day Shift (United States of America) Pay Range: is listed below. Actual pay rate dependent upon experience. $20.50 - $36.50 Highlights This position requires relocation to Pierre, South Dakota. We are looking for either a Clinical Research Coordinator or Research Assistant This can be a Full Time or Part time Position. This position will support projects in the maternal and child health studies at Avera Research Institute. This includes supporting the ECHO study (Environmental influences on Child Health Outcomes), which is a longitudinal, observational study following pregnant women and their children to understand how environmental exposures in the prenatal and early childhood time frame affect health outcomes for children later in life. To learn more about some of the main projects, including the ECHO program, please click here: ************************* The requirements for this position is listed below. Research Assistant: High School Diploma or GED Clinical Research Coordinator: Clinical Research Coordinator: Bachelors from a four year college or university within the health and science field. The pay range for this position is listed below. Actual pay rate dependent upon experience. Research Assistant: $20.50 - $27.00 Clinical Research Coordinator: $24.00 - $36.50 You Belong at Avera Be part of a multidisciplinary team built with compassion and the goal of Moving Health Forward for you and our patients. Work where you matter. A Brief Overview An advanced position that contributes to the overall operations of one or more research studies. The CRC is responsible for implementation of the study protocol, recruitment plan, study visits, data, study assessments, and other tasks outlined in the protocol. This position requires close collaboration with the study team and investigator to ensure safe and compliant research procedures and follow-up per the established research protocol. This position will work directly with research participants, physicians, nurses, community stakeholders, and health/social service organizations. This position has opportunities for ongoing learning and contribution to research that is focused on improving health and wellbeing of individuals and the community. What you will do Coordinates research studies per Good Clinical Practices guidelines, FDA regulations, and approved protocols. Understands and adheres to Standard Operating Procedures (SOPs). Ability to develop or improve SOPs, help guides, and other team resources. Acquires detailed knowledge of assigned research protocols and ability to conduct study required processes, procedures, and assessments. Ability to prepare, utilize, and review Case Report Forms. Collects and manages data, Case Report Forms, and timely entry into the electronic data capture system. Collects and assists with processing all laboratory specimens to include centrifuging, separating, measuring, storing, shipping, and distributing to appropriate testing areas. Maintains inventory of laboratory supplies and study kits. Screens, recruits, and enrolls study participants using study's eligibility criteria. Preforms the informed consent, answering all participant questions, and obtaining appropriate sign-off. Ensures the adherence to ethical practices during the conduct of clinical trials in order to protect the rights and well-being of patients and the collection of quality data. Ensures validity of research results by ensuring timely, accurate, and complete data documentation, reporting deviations, violations, and serious adverse events. Develops relationships with referring physicians, clinical staff, and ancillary departments to facilitate compliance with and accrual to clinical trials. Essential Qualifications The individual must be able to work the hours specified. To perform this job successfully, an individual must be able to perform each essential job function satisfactorily including having visual acuity adequate to perform position duties and the ability to communicate effectively with others, hear, understand and distinguish speech and other sounds. These requirements and those listed above are representative of the knowledge, skills, and abilities required to perform the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions, as long as the accommodations do not cause undue hardship to the employer. Required Education, License/Certification, or Work Experience: Bachelor's From a four year college or university within the health and science field Preferred Education, License/Certification, or Work Experience: 1-3 years Human Research 1-3 years Laboratory or clinical Expectations and Standards Commitment to the daily application of Avera's mission, vision, core values, and social principles to serve patients, their families, and our community. Promote Avera's values of compassion, hospitality, and stewardship. Uphold Avera's standards of Communication, Attitude, Responsiveness, and Engagement (CARE) with enthusiasm and sincerity. Maintain confidentiality. Work effectively in a team environment, coordinating work flow with other team members and ensuring a productive and efficient environment. Comply with safety principles, laws, regulations, and standards associated with, but not limited to, CMS, The Joint Commission, DHHS, and OSHA if applicable. Benefits You Need & Then Some Avera is proud to offer a wide range of benefits to qualifying part-time and full-time employees. We support you with opportunities to help live balanced, healthy lives. Benefits are designed to meet needs of today and into the future. PTO available day 1 for eligible hires. Up to 5% employer matching contribution for retirement Career development guided by hands-on training and mentorship Avera is an Equal Opportunity Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, Veteran Status, or other categories protected by law. If you are an individual with a disability and would like to request an accommodation for help with your online application, please call ************** or send an email to **************** .