Clinical research associate jobs in Missoula, MT - 12 jobs

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

Under the supervision of the RED Service Centers Director, the Research Asset Program Coordinator will be responsible for maintaining inventory of all capital research equipment housed at MSU-Bozeman, from equipment acquisition to disposal. The individual in this position will have decision-making ability to lead major projects and improve processes within asset management, with the ultimate goal of enhancing University compliance with federal asset requirements. Duties and Responsibilities In collaboration with Property Management and with minimal oversight, maintain an accurate and detailed inventory of all capital research equipment housed at MSU-Bozeman in accordance with State, Federal and University policies, subject to State, Federal and internal audits. Review of capital research expenditures through purchase orders, invoice approval queues, and purchasing card purchases for MSU-Bozeman. Work with Property Management staff and supervisor to make updates to the Property Management Procedures manual and prepare documentation to respond to equipment audits. Conduct physical inventories in research laboratories and service centers. Act as a liaison between researchers/service centers and Property Management to review requests for disposal of capital research equipment; determine best means for disposal and coordinate with Facilities Services regarding removal of items. Collaborate with Facilities, Sustainability, Office of Sponsored Programs, departments and service centers for relocation of capital research equipment within or outside of the university via Property Asset Redistribution Request forms. Assist RED Service Centers Director with developing and maintaining a University-wide shared research equipment list within the service center management platform. Support RED Service Centers (i.e. Core Facilities) with maintenance of fee-for-service research equipment listings within the service center management platform. Coordinate with RED Service Centers Director to avoid redundancy in capital research equipment purchases. Required Qualifications - Experience, Education, Knowledge & Skills Property management experience or general business experience or research lab experience which includes maintaining, processing and verifying detailed records with a high degree of accuracy or an equivalent combination of education and/or experience. Demonstrated experience using software for performing detailed and accurate data entry. Demonstrated experience providing a high level of customer service in a positive, professional and helpful manner to a various range of individuals. Preferred Qualifications - Experience, Education, Knowledge & Skills Bachelor's degree in science-related field and/or familiarity with laboratory settings. Relevant knowledge of state and university business property management procedures, policies, and regulations. Relevant knowledge of federal property guidelines and documentation requirements. The Successful Candidate Will Demonstrate excellent organizational skills, including the ability to prioritize tasks, multi-task, keep detailed records and think analytically. Demonstrate competence organizing and prioritizing multiple work assignments and meeting deadlines in a timely manner in a busy environment. Demonstrate ability to interpret, explain and maintain compliance with policies and procedures. Communicate effectively with co-workers and the public, both in person, over the phone and via email. Consistently exercise initiative and good judgement. Maintain confidentiality of records and information. Position Special Requirements/Additional Information This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts Montana State University's rights to assign or reassign duties and responsibilities to this job at any time. Physical Demands To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or with reasonable accommodations. The requirements listed above are representative of the knowledge, skill, and or ability required. This position has supervisory duties? No

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_

You'll want to join Billings Clinic for our outstanding quality of care, exciting environment, interesting cases from a vast geography, advanced technology and educational opportunities. We are in the top 1% of hospitals internationally for receiving Magnet Recognition consecutively since 2006. And you'll want to stay at Billings Clinic for the amazing teamwork, caring atmosphere, and a culture that values kindness, safety and courage. This is an incredible place to learn and grow. Billings, Montana, is a friendly, college community in the Rocky Mountains with great schools and abundant family activities. Amazing outdoor recreation is just minutes from home. Four seasons of sunshine! You can make a difference here. About Us Billings Clinic is a community-owned, not-for-profit, Physician-led health system based in Billings with more than 4,700 employees, including over 550 physicians and non-physician providers. Our integrated organization consists of a multi-specialty group practice and a 304-bed hospital. Learn more about Billings Clinic (our organization, history, mission, leadership and regional locations) and how we are recognized nationally for our exceptional quality. Your Benefits We provide a comprehensive and competitive benefits package to all full- and part-time employees (minimum of 20 hours/week), including Medical, Dental, Vision, 403(b) Retirement Plan with employer matching, Defined Contribution Pension Plan, Paid Time Off, employee wellness program, and much more. Click here for more information or download the Employee Benefits Guide. Magnet: Commitment to Nursing Excellence Billings Clinic is proud to be recognized for nursing excellence as a Magnet-designated organization, joining only 97 other organizations worldwide that have achieved this honor four times. The re-designation process happens every four years. Click here to learn more! Pre-Employment Requirements All new employees must complete several pre-employment requirements prior to starting. Click here to learn more! Clinical Research Coordinator (0.5 FTE) - Diabetes Research DIABETES RESEARCH (BILLINGS CLINIC 1045 N 30TH BUILDING) req10965 Shift: Day Employment Status: Part-Time (.5 - .74) Hours per Pay Period: 0.50 = 40 hours every two weeks (Exempt) Starting Wage DOE: $0.00 - 0.00 Coordinates, manages, and oversees assigned clinical research studies involving human participants by performing a wide range of clinical, regulatory, and administrative responsibilities. Works collaboratively with participants, staff, and sponsoring organizations to ensure studies are conducted safely, ethically, and in compliance with all applicable regulatory requirements. Essential Job Functions * Supports and models behaviors consistent with the mission and philosophy of Billings Clinic and department/service. * Reviews and interprets study protocols to develop comprehensive study manuals that ensure consistent adherence by all staff. •Provides collaboration, training, and guidance to internal and external Billings Clinic staff on protocol procedures to support compliance and uphold high standards of research quality. * Exceptional attention to detail to ensure accurate data collection, precise documentation, and strict adherence to study protocols and regulatory requirements. * Prepares and submits regulatory documents to pharmaceutical companies and institutional review boards (IRBs). * Creates and implements participant screenings and obtains informed consent from participants, adhering to regulatory requirements and the rights of the participant in research. * Ensure participants are fully informed of the study's procedures, potential risks, and benefits, obtaining and documenting informed consent in accordance with ethical and regulatory standards. * Coordinates information and documentation systems and processes to meet the needs for conducting clinical research studies including screening logs, participant information lists, study specific source documents, phone logs, drug logs, and any others as needed. * Facilitates participant education regarding the role of a research subject, and the specific requirements of the research protocol they participate in. Provides participant with appropriate teaching materials to help facilitate understanding and compliance. * Creates, collects and documents research data in both paper and electronic source documents and case report forms. Develops, implements, and maintains required regulatory documentation, and prepares for and participates in study monitoring visits and audits. * Communicates clearly and professionally with participants, investigators, study teams, and regulatory bodies to ensure effective coordination and compliance throughout the research process. * Engages in regular interactions with study participants to monitor their health, provide support, and ensure adherence to study protocols, including dispensing and counting medications, obtaining biological samples, and performing other protocol-required procedures. * Reports adverse events per FDA, IRB, and sponsor guidelines. Notifies appropriate physician as necessary, and follows up on adverse events as required. * Identifies needs and sets goals for own growth and development; meets all mandatory organizational and departmental requirements. * Maintains competency in all organizational, departmental and outside agency environmental, employee or patient safety standards relevant to job performance. * Performs other duties as assigned or needed to meet the needs of the department/organization. Supports and models behaviors consistent with Billings Clinic's mission, vision, values, code of business conduct and service expectations. Meets all mandatory organizational and departmental requirements. Maintains competency in all organizational, departmental and outside agency standards as it relates to the environment, employee, patient safety or job performance. Minimum Qualifications Education * Minimum 4 Year / Bachelors Degree Experience * 3-5 years hospital or medical experience Certifications and Licenses * Current Montana license as a Registered Nurse or Registered Dietician At hire * Healthcare Provider CPR Certification At hire Billings Clinic is Montana's largest health system serving Montana, Wyoming and the western Dakotas. A not-for-profit organization led by a physician CEO, the health system is governed by a board of community members, nurses and physicians. Billings Clinic includes an integrated multi-specialty group practice, tertiary care hospital and trauma center, based in Billings, Montana. Learn more at ****************************** Billings Clinic is committed to being an inclusive and welcoming employer, that strives to be kind, safe, and courageous in all we do. As an equal opportunity employer, our policies and processes are designed to achieve fair and equitable treatment of all employees and job applicants. All employees and job applicants will be provided the same treatment in all aspects of the employment relationship, regardless of race, color, religion, sex, gender identity, sexual orientation, pregnancy, marital status, national origin, age, genetic information, military status, and/or disability. To ensure we provide an accessible candidate experience for prospective employees, please let us know if you need any accommodations during the recruitment process.

**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.

Mom/Babe Clinical Coordinator (RN) Status/FTE: FT / 0.8 FTE Shift length: 8 hours Start Time: Variable Unit: OB/Gyn Schedule Requirements (including weekends, holidays): Mon-Friday, no weekends. Required qualifications: Current state RN License Bachelor's degree in nursing from accredited school BLS for Healthcare Provider and ACLS upon hire Three (3) to Five (5) years in Mother/Baby or L&D Proficient in English, verbal and written communication skills, and computer skills required Preferred qualifications: Master's degree in nursing preferred Recent Charge Nurse experience Additional Information/Department information: The Clinical Coordinator (Focus: Mom/Babe) is a competent professional nurse who possesses advanced knowledge, skills and abilities, as well as leadership capabilities. Under the supervision of the Department Director, the Clinical Coordinator functions as a shift leader providing day-to-day management of the departments to which s/he is assigned. The Clinical Coordinator may also design, organize, implement, and evaluate generalized, as well as focused adult learning activities and programs that facilitate the professional growth, skill development, and competency of direct clinical nursing care providers in arenas providing adult acute care. The role includes responsibilities for this functional area of patient care services and that of a resource person, consultant, collaborator, facilitator-instructor, role model, and evaluator. This individual assists in communication of organizational and division-level vision and goals, educates a team of skilled staff, and ensures cost effective and efficient use of allocated resources for optimum outcomes Hiring Manager and contact information: Pamela Pearson, ************************* Your experience matters At Community Medical Center, we are driven by a profound commitment to prioritize your well-being so you can provide exceptional care to others. Here, you're not just valued as an employee, but as a person. As a registered nurse (RN) joining our team, you're embracing a vital mission dedicated to making communities healthier . Join us on this meaningful journey where your skills, compassion, and dedication will make a remarkable difference in the lives of those we serve. Connect with our RN recruiting specialist Not ready to complete an application, or have questions? Please contact Derek Palmer by texting or calling via phone ************. How you'll contribute You'll make an impact by utilizing your specialized plan-of-care intervention and serving as a patient-care innovator. You will shape exceptional patient journeys every day and leverage your skills and our cutting-edge technology to directly impact patient wellbeing. What we offer Fundamental to providing great care is supporting and rewarding our team. In addition to your base compensation, this position also offers: Comprehensive medical, dental, and vision plans, plus flexible-spending and health- savings accounts Competitive paid time off and extended illness bank package for full-time employees Income-protection programs, such as life, accident, critical-injury insurance, short- and long-term disability, and identity theft coverage Tuition reimbursement, loan assistance, and 401(k) matching Employee assistance program including mental, physical, and financial wellness Professional development and growth opportunities About our Health System Community Medical Center is a 151-bed hospital located in Missoula, MT, and is part of Lifepoint Health, a diversified healthcare delivery network committed to making communities healthier with acute care, rehabilitation, and behavioral health facilities from coast to coast. From your first day to your next career milestone-your experience matters. EEOC Statement “Community Medical Center is an Equal Opportunity Employer. Community Medical Center is committed to Equal Employment Opportunity for all applicants and employees and complies with all applicable laws prohibiting discrimination and harassment in employment.” COVID-19 Update: Community Medical Center is hiring top talent, but we also have a mission of Making Communities Healthier, which means keeping our community safe and to reduce the risk of exposure. We have modified our conditions of employment to include COVID-19 vaccination unless a documented medical or religious exemption is approved. This position is subject to Drug and Alcohol Testing according to MT Law 39-2-205-39-2-211.

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 ************

The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk:** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

You'll want to join Billings Clinic for our outstanding quality of care, exciting environment, interesting cases from a vast geography, advanced technology and educational opportunities. We are in the top 1% of hospitals internationally for receiving Magnet Recognition consecutively since 2006. And you'll want to stay at Billings Clinic for the amazing teamwork, caring atmosphere, and a culture that values kindness, safety and courage. This is an incredible place to learn and grow. Billings, Montana, is a friendly, college community in the Rocky Mountains with great schools and abundant family activities. Amazing outdoor recreation is just minutes from home. Four seasons of sunshine! You can make a difference here. About Us Billings Clinic is a community-owned, not-for-profit, Physician-led health system based in Billings with more than 4,700 employees, including over 550 physicians and non-physician providers. Our integrated organization consists of a multi-specialty group practice and a 304-bed hospital. Learn more about Billings Clinic (our organization, history, mission, leadership and regional locations) and how we are recognized nationally for our exceptional quality. Your Benefits We provide a comprehensive and competitive benefits package to all full- and part-time employees (minimum of 20 hours/week), including Medical, Dental, Vision, 403(b) Retirement Plan with employer matching, Defined Contribution Pension Plan, Paid Time Off, employee wellness program, and much more. Click here for more information or download the Employee Benefits Guide. Magnet: Commitment to Nursing Excellence Billings Clinic is proud to be recognized for nursing excellence as a Magnet-designated organization, joining only 97 other organizations worldwide that have achieved this honor four times. The re-designation process happens every four years. Click here to learn more! Pre-Employment Requirements All new employees must complete several pre-employment requirements prior to starting. Click here to learn more! Clinical Coordinator - Medical Oncology MEDICAL ONCOLOGY (BILLINGS CLINIC CLINIC) req9740 Shift: Day Employment Status: Full-Time (.75 or greater) Hours per Pay Period: 1.00 = 80 hours every two weeks (Exempt) Starting Wage DOE: $38.96 - 48.71 The Clinical Coordinator assists the Manager and/or Director in providing leadership and management within the assigned department(s). May supervise nursing and non-nursing staff depending on the staff mix within an assigned department. However, non-RN Clinical Coordinators do not evaluate or oversee the practice of nursing - this would be coordinated with another RN Leader. The Clinical Coordinator is responsible and accountable for the coordination of the operational and clinical activities. Responsibilities include but are not limited to personal management to include clinical personnel selection, orientation/training, scheduling, development/mentoring, performance appraisals, coaching and counseling, disciplinary actions, patient care delivery, physician relationships, intradepartmental and interdepartmental activities, quality control and process improvement activities, regulatory compliance and fiscal control. Assists in the development of policies and procedures. In the absence of the Manager/Director, may assume responsibility and accountability for management of the assigned department(s). Essential Job Functions * Supports and models behaviors consistent with Billings Clinic's mission, vision, values, code of business conduct and service expectations. Meets all mandatory organizational and departmental requirements. Maintains competency in all organizational, departmental, and outside agency standards as it relates to the environment, employee, patient safety or job performance. * Assists the Clinic Manager in leading the day-to-day operation and coordination of patient care services. Assists the Clinic Manager in leading the clinic to improve patient, provider, and staff satisfaction. Identify and recommend solutions to clinic team members and office issues or problems. * Works with Medical Oncology department chair to prioritize and implement process improvements. * Works with Cancer Center Leads Team to collaborate on cross departmental functions and processes. * Adheres to Billings Clinic and departmental safety standards, policies and practices. Anticipates and identifies problems and safety issues, then initiates appropriate action in conjunction with manager. * Assists the Clinic Manager in the recruitment, retention, performance reviews and professional development related to clinical staff. Assists in setting realistic and measurable goals for clinical staff to achieve. * Works with Oncology Nursing Professional Specialists to arrange ongoing educational opportunities for Medical Oncology Clinical Team. * Assists with interviews. Develops new employee orientation. Coordinates training and orientation of RN/LPN/MA in the Medical Oncology Clinic within scop of practice. * Analyze clinical practices and identify opportunities to increase quality, safety, effectiveness and efficiency. * Takes responsibility for own professional growth and development needs. Seeks additional training in system or workflow processes to further demonstrate skill expertise. * Ensure high quality clinical care by reviewing and researching concerns and complaints and recommend corrective action as appropriate. Assists Clinic Manager in addressing department specific safety nets and providing necessary follow-up. * Participate in quality improvement initiatives and assume responsibility for clinical team coaching and professional development without needing disciplinary actions. * Creates Medical Oncology clinical staff schedule monthly. Organize and assign staffing assignments, duties, and tasks to clinical team members. Monitor daily performance of clinical team members to ensure duties are completed accurately, efficiently, and timely. * Assist Clinic Manager in establishing physician and APP schedules including call days, outreach, and hospital coverage. * Assists in developing processes to increase new patient access and return patient access for patients. * Implements and documents safe patient care consistent with Billings Clinic and departmental values, goals, policies & procedures and according to scope of license. Ensure clinical policies and procedures comply with CoC, NAPBC, DNV, etc. Recommend policies and procedures as needed to ensure quality, compliance, accuracy, and cost efficiency. * Assist Medical Oncology RN/LPN/MA and providers with maintaining patient flow to ensure patients are seen timely and efficiently. * Assist Medical Oncology RN/LPN/MA as needed by returning patient voicemails, addressing message centers, completing prescription refills and prior authorizations, scheduling, and nursing tasks within LPN scope of practice. Serves as back-up for clinical team members as needed by working as a provider's primary nurse due to staffing shortages. * Conduct daily clinical staff huddles. * Will attend huddles with other departments of the Cancer Center (Navigation, Infusion Nurses, Infusion Pharmacy, Cancer Center Leads, etc.) to improve communication and effective collaboration. Assist Clinic Manager in coordinating provider meetings and developing agenda. * Maintain excellent communication and effective working relationships with patients, providers, clinical team, outreach sites, Cancer Center managers and administrators, the public and the community for continuity of high-quality patient care. Act as department liaison and first point of contact for other departments within the Cancer Center multidisciplinary care team. * Work as Carevive Program contact person for support needs. Triage Carevive alerts timely and effectively. Document within Careveive application. * Work at different outreach facility office locations as needed. * Performs other duties as assigned or needed to meet the needs of the department organization. Minimum Qualifications Education * Minimum Other Graduate of an accredited school of nursing as a Registered Nurse/Respiratory Therapist, Required * Minimum 4 Year / Bachelors Degree Bachelor of Science in Nursing (BSN) or Bachelor of Arts in Nursing (BAN) or BAS Respiratory Therapy, Preferred Certifications and Licenses * Current Montana state license as Registered Nurse/Respiratory Therapist, at hire * Healthcare Provider CPR certification required; Billings Clinic is Montana's largest health system serving Montana, Wyoming and the western Dakotas. A not-for-profit organization led by a physician CEO, the health system is governed by a board of community members, nurses and physicians. Billings Clinic includes an integrated multi-specialty group practice, tertiary care hospital and trauma center, based in Billings, Montana. Learn more at ****************************** Billings Clinic is committed to being an inclusive and welcoming employer, that strives to be kind, safe, and courageous in all we do. As an equal opportunity employer, our policies and processes are designed to achieve fair and equitable treatment of all employees and job applicants. All employees and job applicants will be provided the same treatment in all aspects of the employment relationship, regardless of race, color, religion, sex, gender identity, sexual orientation, pregnancy, marital status, national origin, age, genetic information, military status, and/or disability. To ensure we provide an accessible candidate experience for prospective employees, please let us know if you need any accommodations during the recruitment process.

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_

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