Clinical research coordinator jobs in Great Falls, MT

The Clinical Research Coordinator (CRC) facilitates and coordinates multiple clinical trials in accordance with Good Clinical Practice (GCP) under the direction of investigators and the director. The CRC ensures adherence to research standards set forth by the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), National Cancer Institute (NCI), and other regulatory agencies. Responsibilities include ensuring protocol compliance, recruiting and caring for study participants, documenting study activities, reporting adverse events, and maintaining effective collaboration with research teams, sponsors, and contract research organizations (CROs). Minimum Qualifications: Required Bachelor's Degree. Current American Heart Association BLS, or ability to complete within thirty (30) days of hire. Current Dangerous Goods Shipping certification, or ability to complete within thirty (30) days of hire. Current Good Clinical Practices/Human Subjects Research certifications, or ability to complete within seven (7) days of hire. Intermediate proficiency with Microsoft Office products. Preferred Master's Degree involving a research component or thesis project. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP). Current Phlebotomy Certification. Previous Clinical Research Coordinator (CRC) experience. Prior experience with EPIC EMR. Essential Job Functions: In addition to the essential functions of the job listed below, employees must have on-time completion of all required education as assigned per DNV requirements, Bozeman Health policy, and other registry requirements. Ensure compliance with research protocols, regulatory requirements, and institutional policies while preparing and submitting necessary documentation to Institutional Review Boards (IRB), study Sponsors, and CROs. Oversee participant recruitment, screening, Informed Consent, enrollment, and retention while maintaining effective communication and engagement with study participants, Sponsors, CROs, and department leadership. Coordinate study visits, monitor adherence to protocols, and collect and document study-related data, including adverse event reporting and resolution of data queries. Conduct and document clinical procedures such as ECGs, vital signs, spirometry, and biological specimen collection, processing, and shipping in accordance with study guidelines (Protocol, Lab manual, etc.) and Good Clinical Practice. Complete and maintain required regulatory documentation in the Investigator Site File and sponsor-provided/departmental vendor systems. Manage investigational product inventory, including training, dispensing, accountability, and compliance monitoring. Maintain data integrity through accurate entry into electronic data capture systems, tracking participant progress, and archiving essential study documents. Collaborate with investigators, nurses, and other healthcare professionals to optimize study execution and participate in site initiation visits, investigator meetings, and training sessions. Support operational and administrative activities, including inventory management, scheduling, correspondence, study progress reporting, and study closeout procedures. Knowledge, Skills, and Abilities Demonstrates sound judgement, patience, and maintains a professional demeanor at all times. Exercises tact, discretion, sensitivity and maintains confidentiality. Performs essential job functions successfully in a busy and stressful environment. Learns current and new computer applications and office equipment utilized at Bozeman Health. Strong interpersonal, verbal, and written communication skills. Analyzes, organizes, and prioritizes work while meeting multiple deadlines. Investigative Mindset - Strong ability to think critically. Strong emotional intelligence, interpersonal, teamwork, and public relations skills. Schedule Requirements This role requires regular and sustained attendance. The position may necessitate working beyond a standard 40-hour workweek, including weekends and after-hours shifts. On-call work may be required to respond promptly to organizational, patient, or employee needs. Physical Requirements Lifting (Rarely - 30 pounds): Exerting force occasionally and/or using a negligible amount of force to lift, carry, push, pull, or otherwise move objects or people. Sit (Continuously): Maintaining a sitting posture for extended periods may include adjusting body position to prevent discomfort or strain. Stand (Occasionally): Maintaining a standing posture for extended periods may include adjusting body position to prevent discomfort or strain. Walk (Occasionally): Walking and moving around within the work area requires good balance and coordination. Climb (Rarely): Ascending or descending ladders, stairs, scaffolding, ramps, poles, and the like using feet and legs; may also use hands and arms. Twist/Bend/Stoop/Kneel (Occasionally): Twisting, bending, stooping, and kneeling require flexibility and a wide range of motion in the spine and joints. Reach Above Shoulder Level (Occasionally): Lifting, carrying, pushing, or pulling objects as necessary above the shoulder, requiring strength and stability. Push/Pull (Occasionally): Using the upper extremities to press or exert force against something with steady force to thrust forward, downward, or outward. Fine-Finger Movements (Continuously): Picking, pinching, typing, or otherwise working primarily with fingers rather than using the whole hand as in handling. Vision (Continuously): Close visual acuity to prepare and analyze data and figures and to read computer screens, printed materials, and handwritten materials. Cognitive Skills (Continuously): Learn new tasks, remember processes, maintain focus, complete tasks independently, and make timely decisions in the context of a workflow. Exposures (Rarely): Bloodborne pathogens, such as blood, bodily fluids, or tissues. Radiation in settings where medical imaging procedures are performed. Various chemicals and medications are used in healthcare settings. Job tasks may involve handling cleaning products, disinfectants, and other substances. Infectious diseases due to contact with patients in areas that may have contagious illnesses. *Frequency Key: Continuously (100% - 67% of the time), Repeatedly (66% - 33% of the time), Occasionally (32% - 4% of the time), Rarely (3% - 1% of the time), Never (0%). The above statements are intended to describe the general nature and level of work being performed by people assigned to the job classification. They are not to be construed as a contract of any type nor an exhaustive list of all job duties performed by individuals so classified. 77387225 Clinical Research Studies

The Fourth Year Coordinator will report directly to the Director of Clinical Education and Clinical Dean. The coordinator will be responsible for collecting and processing the clinical rotations forms, maintaining rotation schedules, and the data necessary to maintain the fourth-year clinical rotation student files. Responsibilities * Serve as a liaison between the student and the Department of Clinical Education. Serve as the initial/primary point of contact for the student(s). * Communicates with students and clinical sites regarding student schedules and student performance evaluations * Communicates with individual preceptors to coordinate rotation opportunities. * Regularly follow-up with students regarding missing student performance evaluations. * Responds to a high volume of emails in a timely manner * Assures that all matters reported by students and/or the clinical rotation sites/ hospital are communicated to the Director of Clinical Education and Clinical Dean. * Verifies and completes onboarding paperwork for clinical rotations across various platforms and applications * Establishes and maintains student tracking software (New Innovations) for student schedules. * Participates in annual department review of forms and manuals. * Responsible for form/documentation review and editing. * Conducts and attends meetings with students regarding rotations, academic and residency advisement * Creates detailed spreadsheets tracking student information, clinical site details and residency information * Collaborates and assists in administrative processes for the department with: * Registrar: Submits course registration and completes course add/drop forms * Grade Coordinator: Communicates changes in schedules * Assessment Coordinator: Communicates online remote elective requests for registration. * Health Assessment Coordinator: Monitors and follows up with students regarding health packet requirements. * Work within the team environment. * Other duties or responsibilities as assigned. Qualifications Education/Experience * Some college training preferred or related administrative experience. Knowledge/Skills/Abilities * Strong analytical skills * Well organized * Able to prioritize tasks * Proficiency in Microsoft Office Suite including Word, Excel, PowerPoint, Outlook, and Adobe Acrobat Maximum Salary Minimum Salary

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

The Fourth Year Coordinator will report directly to the Director of Clinical Education and Clinical Dean. The coordinator will be responsible for collecting and processing the clinical rotations forms, maintaining rotation schedules, and the data necessary to maintain the fourth-year clinical rotation student files. Responsibilities Serve as a liaison between the student and the Department of Clinical Education. Serve as the initial/primary point of contact for the student(s). Communicates with students and clinical sites regarding student schedules and student performance evaluations Communicates with individual preceptors to coordinate rotation opportunities. Regularly follow-up with students regarding missing student performance evaluations. Responds to a high volume of emails in a timely manner Assures that all matters reported by students and/or the clinical rotation sites/ hospital are communicated to the Director of Clinical Education and Clinical Dean. Verifies and completes onboarding paperwork for clinical rotations across various platforms and applications Establishes and maintains student tracking software (New Innovations) for student schedules. Participates in annual department review of forms and manuals. Responsible for form/documentation review and editing. Conducts and attends meetings with students regarding rotations, academic and residency advisement Creates detailed spreadsheets tracking student information, clinical site details and residency information Collaborates and assists in administrative processes for the department with: Registrar: Submits course registration and completes course add/drop forms Grade Coordinator: Communicates changes in schedules Assessment Coordinator: Communicates online remote elective requests for registration. Health Assessment Coordinator: Monitors and follows up with students regarding health packet requirements. Work within the team environment. Other duties or responsibilities as assigned. Qualifications Education/Experience Some college training preferred or related administrative experience. Knowledge/Skills/Abilities Strong analytical skills Well organized Able to prioritize tasks Proficiency in Microsoft Office Suite including Word, Excel, PowerPoint, Outlook, and Adobe Acrobat

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.

Applicant must be a current Carroll College student enrolled in at least 6 credits to be eligible to apply. Department: United Way of the Lewis and Clark Area (UWLCA) Purpose of Job: At United Way we united resources, organizations, and people to transform our community for good. The Free Tax Clinics work study will assist taxpayers with scheduling and preparation for tax appointments as well as schedule and coordinate volunteers for the clinics. Duties and Responsibilities: Depending on the skills and interests of the successful applicant, the Free Tax Clinic position will assist our full-time team members with a range of tasks including: * Coordinate and schedule volunteers as needed for tax season clinics. Plan training and kickoff events. * Schedule and prepare taxpayers for their appointments. * Ensure all needed supplies are available for each clinic. * Help secures sponsorships for clinics by preparing outreach materials and tracking commitments. * Support creation of event marketing materials in coordination with United Way staff and partners. * Assist with social media promotion, website updates, and community outreach efforts. * Assist with weekly clinic set up. * Help with evaluation, follow up and thank you communications. Qualifications: * Commitment to advancing the common good in our community * Personal investment in your own professional growth * Communicate effectively on the phone, by email, in person, and in writing * Willing to talk to donors and supporters, teaching people about UWLCA, our community impact programs, and our partner agencies * Willing to be creative * Able to take direction and follow detailed procedures * Willing to work hard to get a job done Employment Specifications: Work-Study Only. Before applying, please contact Financial Aid if you are not positive you are eligible for work-study. Approximate Hours/Week: 8 to 10 hours per week Special Time/Schedule Requirements: Flexible Length of Employment: Academic Year Wage Rate: $13/hour To Apply Please Contact: Emily McVey - ********************** or ************

Days - 8 hr shifts JOB SUMMARY Assists the Sleep Center Manager in the day-to-day operations of the Sleep Center. The Sleep Center Coordinator oversees patient scheduling, monitors room utilization, maintains patient flow, educates patients on home sleep studies, and scores sleep studies as needed. Intervenes, as necessary, on issues relating to patient complaints, health care providers concerns, and operational issues. Ensures that clinical equipment is maintained and in adequate working order. Ensures the department meets or exceeds internal and external customer expectations and supports mission, vision, and values of St. Peter's Health. Assists the Manager with recommendations for long-term planning for Sleep Center growth, budgeting, and equipment needs. Administrative responsibilities include but are not limited to: staff scheduling, quality assurance and quality improvement, assists with staff selection, on-boarding, and retention, staff education and development, staff time and attendance, assists with regulatory compliance and accreditation, and assists Medical Director and Manager as needed. KNOWLEDGE/EXPERIENCE: Must have previous experience working in a sleep lab. Experience in a supervisory or coordinator role in a Sleep Lab or Respiratory Care department preferred. EDUCATION: A.S. or B.S. preferred in related field. LICENSE/CERTIFICATION/REGISTRY: Current Registered Polysomnography Technician (RPSGT) certification required and successful maintenance of certification required. Current BLS certification required and ability to successfully maintain certification required KNOWLEDGE/EXPERIENCE: Must have previous experience working in a sleep lab. Experience in a supervisory or coordinator role in a Sleep Lab or Respiratory Care department preferred. EDUCATION: A.S. or B.S. preferred in related field. LICENSE/CERTIFICATION/REGISTRY: Current Registered Polysomnography Technician (RPSGT) certification required and successful maintenance of certification required. Current BLS certification required and ability to successfully maintain certification required

**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.

Text to apply: ************ using code: Coordinator Clinic Coordinator ** Sign On Bonus Available. ** Join our I CARE team at Sidney Health Center for the competitive wages, benefit package, ability to obtain a wide variety of experience, family-like atmosphere, and great work life balance. Sidney Health Center is proud to be among a select few organizations who have been named a Top 100 Critical Access Hospital and named a Five Star Hospital and Nursing Home. Our pride shows! About Us Sidney Health Center is a not-for-profit community based medical center that has been serving people in the MonDak region for more than 100 years. Our passion for caring is shared by doctors, nurses and over 500 employees and volunteers. This commitment to caring is our allegiance to the community as we strive to provide Exceptional Care for Life while offering many services that are rarely found in like-size communities. From state-of-the-art imaging services to cancer care to a locally-owned air ambulance service, Sidney Health Center combines the modern medical amenities with a small-town agriculture-based community. The Position: Clinic Coordinator Employment Status: Full Time Hours per two-week pay-period: 72 Essential Job Functions: Scheduling clinic appointments Managing provider schedules Processing all incoming/outgoing referrals. Minimum Qualifications: High School Education or equivalent Knowledge of general computer usage and customer service Position Summary: Sidney Health Center is seeking a Clinic Coordinator to join our I CARE team in the Clinic setting. Essential duties of the position include scheduling clinic appointments, managing medical staff schedules and switchboard operations. If you enjoy serving others through purposeful work, Sidney Health Center is the place for you. The clinic team is critical to the continuum of health services. As a major employer in Richland County, Sidney Health Center offers competitive wages and a benefit package that supports a great work-life balance. Sidney Health Center (SHC) is an Equal Opportunity (EEO) employer. All persons of either sex, of all races, nationalities and religions, disabled or nondisabled, veteran or non, of all ages, as authorized by law, are encouraged to apply for any position at SHC for which they consider themselves qualified according to the position announcement.

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_