Clinical research associate jobs in Beaverton, OR

The OHSU Knight Cancer Institute, known as one of the pioneers in personalized cancer medicine, is an international leader in research and cancer treatment. Driven by its mission to end cancer as we know it, the institute is building upon its expertise in targeted treatments to advance the early detection of cancer when the disease is most treatable. Every Knight Cancer employee is expected to embody our guiding principles: * We act BOLDLY-Breakthroughs require pushing the boundaries of science, exploring new frontiers, and thinking differently * We SUPPORT each other-Respect leads to trust, which leads to excellence * We work as a CONNECTED team-We must leverage our collective brain power to conquer cancer because no one individual can do it alone Function/Duties of Position We are seeking a full-time Clinical Research Associate to serve as Project Director (PD) of a clinical research study in people with cancer, specifically cancer survivorship, treatment-related toxicities and rehabilitation strategies. The PD will work directly with the PI, Lab Manager, and Intervention Supervisor to execute all aspects of the clinical research, with particular oversight for recruitment and data collection. This person is responsible for day-to-day project management duties and will be responsible for overseeing elements of the project that may include: participant recruitment and retention, development of study recruitment materials and procedures, regulatory compliance, data quality and management, intervention delivery, budget management, progress reporting and dissemination. Day-to-day research responsibilities include overseeing research assistants/student trainees on scheduling of participants for appointments, overseeing collection, entry and quality of data, communicating with study participants as needed, purchasing research supplies, and working in partnership with the members of the study team to maintain scientific quality across all studies. They will also be writing data summaries, project reports, and possibly presenting research findings at scientific meetings. We expect the Clinical Research Associate to work with the team to identify and resolve research issues, develop research ideas, and disseminate results. The ideal candidate is ambitious and eager to contribute to the PI's program of research, has strong communication skills both within a team environment and with participants, has strong organizational skills, and can demonstrate a commitment to maintaining the integrity and quality of data collection in a research environment. Must be able to work and lead independently, including maintaining oversight of study timelines, benchmarks, milestones, and deliverables. A positive, solution-oriented mindset is required! The person hired must be CPR/First Aid certified or be willing to obtain this prior to the position's start date. This is a grant funded position for up to one year but may be extended depending on project needs and funding. Oversee study timelines and benchmarks: Oversee and manage research grants and maintain oversight and delegation of study timelines, benchmarks, milestones, and deliverables. Organize and run investigator meetings. Coordinate activities between research sites Oversee recruitment: develop and maintain recruiting strategies, lead recruiting functions, accrue near/at target sample for studies Maintain regulatory documents / compliance: maintain all IRB and related documentation, submit modifications and annual reports; assure all internal regulatory documentation are obtained, stored and secured according to protocol; assure compliance with all regulatory policies and procedures Oversee data collection systems and activities: strive for high compliance and retention in the study, maintain study data bases, perform regular data checks, clean data in preparation for statistical analysis Assist with data analysis, abstract/manuscript preparation and progress reports: conduct simple descriptive data analysis; work with statistical team on analysis planning and execution; contribute to manuscript preparation through construction of tables, figures and text; prepare annual progress reports for sponsor Oversee research assistant team: Train and supervise Research Assistants in participant recruitment and data management, including data quality control, preliminary analysis and reports. Required Qualifications Education & experience: * Master's Degree in relevant field AND 3 years of clinical research coordination experience OR * Bachelor's Degree in relevant field AND 5 years of clinical research Coordination experience * 3 years of relevant experience Knowledge, skills, and abilities: * Ability to attend to details and complete assignments with minimal direction * Prior experience in human research studies (recruitment, data collection) * Ability to work with PI and lab manager and other project directors to independently carry out research and related work * Ability to communicate clearly and consistently, demonstrate a high level of professionalism and interact well with collaborators, participants, and medical staff * Proficiency in Microsoft (Office Word, Excel, Outlook, and other MS office programs) * Excellent verbal and written communication skills in English language * First Aid/CPR Certified Preferred Qualifications * Master's Degree or higher in exercise science, health promotion, nutrition, health education, nursing or related field required * Prior experience conducting clinical research at OHSU. * Experience recruiting participants in a clinic setting. * Experience/familiarity with clinical assessments including physical performance (mobility, balance, etc.). * Experience using EPIC, REDCap, and eIRB. * Oncology experience Additional Details Apply online. Please be sure to upload a Cover Letter and Resume/CV. Please include a cover letter and names and contact information for 3 professional references. We offer a variety of benefits on top of joining a thriving organization: * Medical, dental and vision coverage at no or low cost to employees * Covered 100% for full-time employees and 88% for dependents * Several retirement plans to choose from with contributions from OHSU * 25 days a year of paid time off * 8 days of sick time off * Commuter subsidies * Tuition reimbursement * Access to group life insurance, disability insurance and other supplemental benefits * Annual Merit Increase * Growth/Development Opportunities * Employee discounts to local and major businesses #linkedin #indeed #knightcancerjobs #knightresearchandlabjobs #knightclinicalresearchjobs All are welcome Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at ************ or *************.

The OHSU Knight Cancer Institute, known as one of the pioneers in personalized cancer medicine, is an international leader in research and cancer treatment. Driven by its mission to end cancer as we know it, the institute is building upon its expertise in targeted treatments to advance the early detection of cancer when the disease is most treatable. Every Knight Cancer employee is expected to embody our guiding principles: We act BOLDLY-Breakthroughs require pushing the boundaries of science, exploring new frontiers, and thinking differently We SUPPORT each other-Respect leads to trust, which leads to excellence We work as a CONNECTED team-We must leverage our collective brain power to conquer cancer because no one individual can do it alone Function/Duties of Position We are seeking a full-time Clinical Research Associate to serve as Project Director (PD) of a clinical research study in people with cancer, specifically cancer survivorship, treatment-related toxicities and rehabilitation strategies. The PD will work directly with the PI, Lab Manager, and Intervention Supervisor to execute all aspects of the clinical research, with particular oversight for recruitment and data collection. This person is responsible for day-to-day project management duties and will be responsible for overseeing elements of the project that may include: participant recruitment and retention, development of study recruitment materials and procedures, regulatory compliance, data quality and management, intervention delivery, budget management, progress reporting and dissemination. Day-to-day research responsibilities include overseeing research assistants/student trainees on scheduling of participants for appointments, overseeing collection, entry and quality of data, communicating with study participants as needed, purchasing research supplies, and working in partnership with the members of the study team to maintain scientific quality across all studies. They will also be writing data summaries, project reports, and possibly presenting research findings at scientific meetings. We expect the Clinical Research Associate to work with the team to identify and resolve research issues, develop research ideas, and disseminate results. The ideal candidate is ambitious and eager to contribute to the PI's program of research, has strong communication skills both within a team environment and with participants, has strong organizational skills, and can demonstrate a commitment to maintaining the integrity and quality of data collection in a research environment. Must be able to work and lead independently, including maintaining oversight of study timelines, benchmarks, milestones, and deliverables. A positive, solution-oriented mindset is required! The person hired must be CPR/First Aid certified or be willing to obtain this prior to the position's start date. This is a grant funded position for up to one year but may be extended depending on project needs and funding. Oversee study timelines and benchmarks: Oversee and manage research grants and maintain oversight and delegation of study timelines, benchmarks, milestones, and deliverables. Organize and run investigator meetings. Coordinate activities between research sites Oversee recruitment: develop and maintain recruiting strategies, lead recruiting functions, accrue near/at target sample for studies Maintain regulatory documents / compliance: maintain all IRB and related documentation, submit modifications and annual reports; assure all internal regulatory documentation are obtained, stored and secured according to protocol; assure compliance with all regulatory policies and procedures Oversee data collection systems and activities: strive for high compliance and retention in the study, maintain study data bases, perform regular data checks, clean data in preparation for statistical analysis Assist with data analysis, abstract/manuscript preparation and progress reports: conduct simple descriptive data analysis; work with statistical team on analysis planning and execution; contribute to manuscript preparation through construction of tables, figures and text; prepare annual progress reports for sponsor Oversee research assistant team: Train and supervise Research Assistants in participant recruitment and data management, including data quality control, preliminary analysis and reports. Required Qualifications Education & experience: Master's Degree in relevant field AND 3 years of clinical research coordination experience OR Bachelor's Degree in relevant field AND 5 years of clinical research Coordination experience 3 years of relevant experience Knowledge, skills, and abilities: Ability to attend to details and complete assignments with minimal direction Prior experience in human research studies (recruitment, data collection) Ability to work with PI and lab manager and other project directors to independently carry out research and related work Ability to communicate clearly and consistently, demonstrate a high level of professionalism and interact well with collaborators, participants, and medical staff Proficiency in Microsoft (Office Word, Excel, Outlook, and other MS office programs) Excellent verbal and written communication skills in English language First Aid/CPR Certified Preferred Qualifications Master's Degree or higher in exercise science, health promotion, nutrition, health education, nursing or related field required Prior experience conducting clinical research at OHSU. Experience recruiting participants in a clinic setting. Experience/familiarity with clinical assessments including physical performance (mobility, balance, etc.). Experience using EPIC, REDCap, and eIRB. Oncology experience Additional Details Apply online. Please be sure to upload a Cover Letter and Resume/CV. Please include a cover letter and names and contact information for 3 professional references. We offer a variety of benefits on top of joining a thriving organization: Medical, dental and vision coverage at no or low cost to employees Covered 100% for full-time employees and 88% for dependents Several retirement plans to choose from with contributions from OHSU 25 days a year of paid time off 8 days of sick time off Commuter subsidies Tuition reimbursement Access to group life insurance, disability insurance and other supplemental benefits Annual Merit Increase Growth/Development Opportunities Employee discounts to local and major businesses #linkedin #indeed #knightcancerjobs #knightresearchandlabjobs #knightclinicalresearchjobs All are welcome Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at ************ or *************.

The OHSU Knight Cancer Institute, known as one of the pioneers in personalized cancer medicine, is an international leader in research and cancer treatment. Driven by its mission to end cancer as we know it, the institute is building upon its expertise in targeted treatments to advance the early detection of cancer when the disease is most treatable. Every Knight Cancer employee is expected to embody our guiding principles: We act BOLDLY-Breakthroughs require pushing the boundaries of science, exploring new frontiers, and thinking differently We SUPPORT each other-Respect leads to trust, which leads to excellence We work as a CONNECTED team-We must leverage our collective brain power to conquer cancer because no one individual can do it alone Function/Duties of Position We are seeking a full-time Clinical Research Associate to serve as Project Director (PD) of a clinical research study in people with cancer, specifically cancer survivorship, treatment-related toxicities and rehabilitation strategies. The PD will work directly with the PI, Lab Manager, and Intervention Supervisor to execute all aspects of the clinical research, with particular oversight for recruitment and data collection. This person is responsible for day-to-day project management duties and will be responsible for overseeing elements of the project that may include: participant recruitment and retention, development of study recruitment materials and procedures, regulatory compliance, data quality and management, intervention delivery, budget management, progress reporting and dissemination. Day-to-day research responsibilities include overseeing research assistants/student trainees on scheduling of participants for appointments, overseeing collection, entry and quality of data, communicating with study participants as needed, purchasing research supplies, and working in partnership with the members of the study team to maintain scientific quality across all studies. They will also be writing data summaries, project reports, and possibly presenting research findings at scientific meetings. We expect the Clinical Research Associate to work with the team to identify and resolve research issues, develop research ideas, and disseminate results. The ideal candidate is ambitious and eager to contribute to the PI's program of research, has strong communication skills both within a team environment and with participants, has strong organizational skills, and can demonstrate a commitment to maintaining the integrity and quality of data collection in a research environment. Must be able to work and lead independently, including maintaining oversight of study timelines, benchmarks, milestones, and deliverables. A positive, solution-oriented mindset is required! The person hired must be CPR/First Aid certified or be willing to obtain this prior to the position's start date. This is a grant funded position for up to one year but may be extended depending on project needs and funding. Oversee study timelines and benchmarks: Oversee and manage research grants and maintain oversight and delegation of study timelines, benchmarks, milestones, and deliverables. Organize and run investigator meetings. Coordinate activities between research sites Oversee recruitment: develop and maintain recruiting strategies, lead recruiting functions, accrue near/at target sample for studies Maintain regulatory documents / compliance: maintain all IRB and related documentation, submit modifications and annual reports; assure all internal regulatory documentation are obtained, stored and secured according to protocol; assure compliance with all regulatory policies and procedures Oversee data collection systems and activities: strive for high compliance and retention in the study, maintain study data bases, perform regular data checks, clean data in preparation for statistical analysis Assist with data analysis, abstract/manuscript preparation and progress reports: conduct simple descriptive data analysis; work with statistical team on analysis planning and execution; contribute to manuscript preparation through construction of tables, figures and text; prepare annual progress reports for sponsor Oversee research assistant team: Train and supervise Research Assistants in participant recruitment and data management, including data quality control, preliminary analysis and reports. Required Qualifications Education & experience: Master's Degree in relevant field AND 3 years of clinical research coordination experience OR Bachelor's Degree in relevant field AND 5 years of clinical research Coordination experience 3 years of relevant experience Knowledge, skills, and abilities: Ability to attend to details and complete assignments with minimal direction Prior experience in human research studies (recruitment, data collection) Ability to work with PI and lab manager and other project directors to independently carry out research and related work Ability to communicate clearly and consistently, demonstrate a high level of professionalism and interact well with collaborators, participants, and medical staff Proficiency in Microsoft (Office Word, Excel, Outlook, and other MS office programs) Excellent verbal and written communication skills in English language First Aid/CPR Certified Preferred Qualifications Master's Degree or higher in exercise science, health promotion, nutrition, health education, nursing or related field required Prior experience conducting clinical research at OHSU. Experience recruiting participants in a clinic setting. Experience/familiarity with clinical assessments including physical performance (mobility, balance, etc.). Experience using EPIC, REDCap, and eIRB. Oncology experience Additional Details Apply online. Please be sure to upload a Cover Letter and Resume/CV. Please include a cover letter and names and contact information for 3 professional references. We offer a variety of benefits on top of joining a thriving organization: Medical, dental and vision coverage at no or low cost to employees Covered 100% for full-time employees and 88% for dependents Several retirement plans to choose from with contributions from OHSU 25 days a year of paid time off 8 days of sick time off Commuter subsidies Tuition reimbursement Access to group life insurance, disability insurance and other supplemental benefits Annual Merit Increase Growth/Development Opportunities Employee discounts to local and major businesses #linkedin #indeed #knightcancerjobs #knightresearchandlabjobs #knightclinicalresearchjobs All are welcome Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at ************ or *************.

Absci is a clinical-stage biotechnology company advancing novel therapeutics using generative AI. Our Integrated Drug Creation™ platform combines cutting-edge AI models with a synthetic biology data engine, enabling the rapid design of innovative therapeutics that address challenging therapeutic targets. Absci is a global company headquartered in Vancouver, WA, and maintains offices in New York City, Switzerland, and Serbia. Learn more at ************* or follow us on LinkedIn (@absci), X (@Abscibio), and YouTube. Lead Clinical Trial Manager Vancouver, WA (Onsite), Remote/Hybrid (US-based) We are seeking a dynamic Clinical Research Operations Manager to lead our clinical research initiatives and manage the operational aspects of our clinical trials. This pivotal role combines the scientific expertise of clinical research with the organizational skills of operations management to ensure the efficient and effective execution of studies across various therapeutic areas meeting regulatory standards and company objectives. The ideal candidate will have a strong background in the life sciences, a deep understanding of clinical trial processes, and experience in regulatory affairs to oversee both the scientific and logistical elements of clinical research. Responsibilities: Develop and maintain effective working relationships with cross-functional teams, external partners (CROs, vendors), and study sites to ensure collaboration and alignment on trial objectives. Manage Contract Research Organizations (CROs) to ensure that all clinical operations are carried out in alignment with the study's goals, budget, and timelines. Ensure robust patient recruitment and retention strategies are in place and effectively executed. Author, review, and maintain Standard Operating Procedures (SOPs) related to clinical research and operations ensuring high quality, compliance with the study protocol and regulatory requirements across all trials. Support design, implementation, and oversight of clinical trials from concept through completion, ensuring adherence to protocols, regulatory requirements, and ethical standards. Identify potential risks and implement contingency plans. Ensure accurate data collection, documentation, and record-keeping. Support analysis and interpretation of clinical data, prepare reports, and communicate findings to internal stakeholders and regulatory agencies. Stay informed about industry developments, regulatory changes, and advancements in clinical research methodologies to inform trial design and execution strategies. Responsible for the integrity, confidentiality, and security of all research data. Qualifications: Bachelors Degree in life sciences, pharmacology or related field a must Advanced degree (MSc., Ph.D., PharmD, MD) in life sciences, pharmacology, or related field preferred Minimum of 2-3 years of experience in phase 1 clinical research and operations within the pharmaceutical or biotechnology industry, with experience in immunology and/or dermatology studies being a plus. Good working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and other regulatory requirements in clinical research. Familiarity with the IND and CTA filing process. Exceptional organizational, communication, and leadership skills, with the ability to manage multiple projects and teams in a fast-paced environment. Strong analytical and problem-solving abilities, with a meticulous attention to detail. Demonstrated capability to work collaboratively across various departments and with external partners to achieve objectives. Ability to work in a fast-paced environment and manage multiple projects simultaneously. Ability to travel up to 20% per month as needed to oversee clinical trials at investigator sites, onsite meetings with vendors, and conferences The salary range for this position is $145,000- $165,000/year. Competitive equity package applies. Pay offered may vary depending on job-related knowledge, skills, and experience. In addition to equity, compensation packages include a wide range of medical, dental, and vision benefits andthe ability to participate in our employee stock purchase plan. Absci offers highly competitive salaries and benefits, including medical, dental, vision insurance, unlimited vacation, parental leave, breakfast and lunch for onsite employees, employee assistance program, voluntary life and disability insurance, annual bonus potential, and 401(k) with a generous company match. Legal authorization to work in the United States is required. Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, sexual orientation, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, marital status, or any characteristic protected under applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should request the recruiter or hiring manager or contact ****************.

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.

Job Description The Clinical Research Program Manager (CRPM) is a specialized, independent research professional who is responsible for operational management, overseeing all local SHC clinical research activities. Reporting to the Hospital Administrator and Research Programs Office at SHC International Headquarters, the CRPM provides support and leadership in accordance with SSHC'spolicies and procedures, SHC's hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. The CRPM works closely with the Chief of Staff, SHC scientific and medical staff and other research personnel to ethically recruit and consent SHC's vulnerable pediatric subjects and to appropriately collect and safeguard data. overall, the CRPM is the site's primary liaison among research participants, local study staff, the local investigator(s) and study sponsor(s). This position's main responsibilities are to help ensure proper study conduct, subject safety, and the quality of data and data safeguards. This position will provide management for the day-to-day operations of the clinical research program, ensure competent and standardized staff practices, and coordinate strategies to enhance interdisciplinary communication and collaboration. For those sites at which there is more than one Clinical Research Coordinator (CRC), the CRPM is responsible for direct oversight and reporting for these CRC's. Shriners Portland is looking for a full time Clinical Research Program Manager to join our amazing team! Schedule: Full time 1.0 FTE Responsibilities Accountable for the site's research activities. Facilitates the local site's research programs and projects through collaborative, timely communications and teamwork Works effectively with SHC leadership to ensure the research mission is upheld. Maintains a contemporary knowledge of clinical research regulatory requirements Takes a leadership role in implementation of process development and improvement changes, as needed Provides support, direction, supervision an mentoring for any site clinical research coordinators promoting exemplary study conduct, subject safety, and the generation of accurate and complete substantiated data within SHC's data safeguards Has an extensive working knowledge of the complex clinical research process, from protocol development to implementation, including experience with clinical trials Supports the implementation of approved research protocols, ensures studies are conducted in compliance with the approved protocol Coordinates the collection, statistical analysis and dissemination of data results throughout a clinical study Safeguards all participants involved in a research study supported and approved by Shriners Children's, maintains patient safety and privacy throughout the study Note: This is not an all-inclusive list of this job's responsibilities. The incumbent may be required to perform other related duties and participate in special projects as assigned. Qualifications Required Without a Bachelor's degree, 5 or more years of specific job-related experience in the administration of clinical research 3 or more years Clinical research experience, e.g. experience with site management, study management, IRB's, and federal regulations regarding clinical research compliance Preferred Bachelor's Clinical Research, science or other healthcare related field Master's Clinical Research, science or other healthcare related field Experience in the coordination of intergroup or multi-site clinical studies CCRP or CCRC certification

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_

Make an Impact at The Oregon Clinic! Premium Benefits, Competitive Pay, and Inspiring Purpose Join us at The Oregon Clinic as a full-time (40 hours per week) or part-time (20-29 hours per week) Research Coordinator. Work alongside a collaborative team of patient-focused colleagues and physicians in our thriving Gastroenterology East Clinic located in Northeast Portland. Each patient receives the highest value care tailored to their needs. Every person at TOC makes a difference in our mission of delivering world-class care with kindness and empathy. As a member of our team, you have the opportunity to make a valuable impact within the local community and our ecosystem of care. By providing patients and internal and external stakeholders with a consistent, efficient, and easy experience, you'll help ensure that patients at The Oregon Clinic Gastroenterology East Clinic receive the highest value care tailored to their needs. Using excellent customer service and communications skills, your primary duties in this role include: * The primary concern of all research department personnel is the protection and care of the patient as a study subject. * Provides professional care; assesses, plans, implements, and evaluates the care rendered to patients under the supervision of the physician. * Works closely with the Clinic Supervisor or Director to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and regulatory perspective. * Assists in the evaluation of study protocols to determine feasibility and budgetary issues, including contract requirements. * Establishes and maintains working relationships with local and central IRBs. * Obtains study-specific documents and process requirements from the sponsor and ensures all requirements are documented and implemented consistently throughout the trial. May provide regulatory feedback and guidance on study documents. * Processes laboratory samples as directed. Maintains inventory of supplies and arranges equipment maintenance. * Updating records as needed. * Other duties as assigned. Salary: Hiring range, based on experience and credentials: $29.68-$44.52 per hour. Workdays: This role is located at the Gateway Medical Office Building. Typical hours are Monday-Friday, (8:00 a.m.-5:00 p.m.) Must live in Portland area or SW Washington Qualifications that support success in this role are based on education, experience and values including: * Bachelor's Degree in a related field or equivalent healthcare experience. * Minimum of two (2) years' experience in clinical research coordination is strongly preferred. Previous GI or Hepatology research experience is a plus! * Skill in phlebotomy is preferred. * Current CPR/BLS within 60 days of hire. ACLS may be required by specialty. * Prior Electronic Medical Record (EMR) experience is preferred. Epic experience is a plus! * Experience with Microsoft Office Suite and Excel is required. * Ability to travel to developmental/promotional activities and within the research community. * Demonstrated ability to initiate, work independently, and effectively multitask. * Excellent attendance and work ethic. * Positive attitude and desire to be a team player. * Ability to communicate professionally and effectively with patients, physicians, and other team members. * A commitment to patient-focused care, privacy, and safety. This description is intended to provide only basic guidelines for meeting job requirements. Responsibilities, knowledge, skills, abilities and working conditions may change as needs evolve. Make an impact in patient-focused healthcare. Look forward to coming to work and feel good about the work you do - apply today! Premium Benefits: * Healthcare: Part-time Employees are 50% and Full-time Employees are 100% covered Medical, Dental, and Prescription Insurance * Financial Wellbeing: Generous 401(k) plan and Flexible Spending Account options * Work-Life Balance: Paid Time Off plus 9 paid holidays annually * Wellness Support: Robust wellness program and employee assistance services * Commuter Benefits: 70% of Tri-Met transit pass covered * Additional Perks: Employee discounts and optional benefits like Pet Insurance Patients and peers recognize The Oregon Clinic as a top regional healthcare provider and employer. We are: * Guided by our values of dedicating to excellence, compassionate and joyful connection, inclusive collaboration, listening humbly, and leading with integrity. * The largest physician-owned, multi-specialty medical and surgical practice in Oregon, with a team of 1,500 team members across 30 specialties, and our business office. * Dedicated to providing the highest value care tailored to the needs of each unique patient. * Proud to be consistently ranked by our employees as a Top 10 Workplace by The Oregonian. Our Commitments: * Diversity, Equity, & Inclusion: We are more than an Equal Opportunity Employer. We welcome and embrace differences and a diversity of backgrounds. Our goal is for patients, physicians, and team members to see and feel diversity, equity, safety, and inclusion in all aspects of their interactions with TOC clinics and administration. * A safe workplace: We are an alcohol and drug-free workplace for the safety of our patients and employees. Offers are contingent on successful completion of drug and background screenings.

Shriners Children's is an organization that respects, supports, and values each other. Named as the 2025 best mid-sized employer by Forbes, we are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidenced based practice, experience, innovation, and critical thinking. Our compassion, integrity, accountability, and resilience define us as leaders in pediatric specialty care for our children and their families. All employees are eligible for medical coverage on their first day! In addition, upon hire all employees are eligible for a 403(b) and Roth 403 (b) Retirement Saving Plan with matching contributions of up to 6% after one year of service. Employees in a FT or PT status (40+ hours per pay period) will also be eligible for paid time off, life insurance, short term and long-term disability and the Flexible Spending Account (FSA) plans and a Health Savings Account (HSA) if a High Deductible Health Plan (HDHP) is elected. Additional benefits available to FT and PT employees include tuition reimbursement, home & auto, hospitalization, critical illness, pet insurance and much more! Coverage is available to employees and their qualified dependents in accordance with the plans. Benefits may vary based on state law. Job Overview The Clinical Research Program Manager (CRPM) is a specialized, independent research professional who is responsible for operational management, overseeing all local SHC clinical research activities. Reporting to the Hospital Administrator and Research Programs Office at SHC International Headquarters, the CRPM provides support and leadership in accordance with SSHC'spolicies and procedures, SHC's hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. The CRPM works closely with the Chief of Staff, SHC scientific and medical staff and other research personnel to ethically recruit and consent SHC's vulnerable pediatric subjects and to appropriately collect and safeguard data. overall, the CRPM is the site's primary liaison among research participants, local study staff, the local investigator(s) and study sponsor(s). This position's main responsibilities are to help ensure proper study conduct, subject safety, and the quality of data and data safeguards. This position will provide management for the day-to-day operations of the clinical research program, ensure competent and standardized staff practices, and coordinate strategies to enhance interdisciplinary communication and collaboration. For those sites at which there is more than one Clinical Research Coordinator (CRC), the CRPM is responsible for direct oversight and reporting for these CRC's. Shriners Portland is looking for a full time Clinical Research Program Manager to join our amazing team! Schedule: Full time 1.0 FTE Responsibilities * Accountable for the site's research activities. Facilitates the local site's research programs and projects through collaborative, timely communications and teamwork * Works effectively with SHC leadership to ensure the research mission is upheld. Maintains a contemporary knowledge of clinical research regulatory requirements * Takes a leadership role in implementation of process development and improvement changes, as needed * Provides support, direction, supervision an mentoring for any site clinical research coordinators promoting exemplary study conduct, subject safety, and the generation of accurate and complete substantiated data within SHC's data safeguards * Has an extensive working knowledge of the complex clinical research process, from protocol development to implementation, including experience with clinical trials * Supports the implementation of approved research protocols, ensures studies are conducted in compliance with the approved protocol * Coordinates the collection, statistical analysis and dissemination of data results throughout a clinical study * Safeguards all participants involved in a research study supported and approved by Shriners Children's, maintains patient safety and privacy throughout the study Note: This is not an all-inclusive list of this job's responsibilities. The incumbent may be required to perform other related duties and participate in special projects as assigned. Qualifications Required * Without a Bachelor's degree, 5 or more years of specific job-related experience in the administration of clinical research * 3 or more years Clinical research experience, e.g. experience with site management, study management, IRB's, and federal regulations regarding clinical research compliance Preferred * Bachelor's Clinical Research, science or other healthcare related field * Master's Clinical Research, science or other healthcare related field * Experience in the coordination of intergroup or multi-site clinical studies * CCRP or CCRC certification

Snapscale is seeking an Intermediate US Clinic Operation Specialist to join our dynamic team from Mexico. This role is crucial for optimizing clinic operations in the United States, ensuring efficient workflow, compliance with healthcare regulations, and enhancing patient satisfaction. The ideal candidate will possess a blend of operational expertise and a deep understanding of the healthcare environment, allowing them to support our clinics and their staff effectively. Responsibilities: Manage daily clinic operations to ensure efficient workflow and adherence to established protocols. Collaborate with clinic staff to identify areas for improvement and implement operational best practices. Monitor compliance with healthcare regulations and internal policies, ensuring all operations align with legal requirements. Assist in the development and implementation of training programs for clinic personnel, enhancing operational efficiency. Analyze clinic performance metrics and generate reports to provide insights on operational effectiveness. Act as a liaison between clinics and corporate management, communicating challenges and proposing solutions. Support the scheduling and coordination of patient appointments, ensuring optimal patient flow and satisfaction. A minimum of 3 years of experience in clinic operations or healthcare management. Strong understanding of healthcare regulations and compliance standards specific to the US. Proven ability to analyze data and generate actionable insights to improve operational efficiency. Excellent communication and interpersonal skills, with the ability to collaborate across diverse teams. Proficiency in clinic management software and Microsoft Office Suite. Ability to work independently and manage multiple tasks in a fast-paced environment. Ability to converse in Spanish fluently.

Job DescriptionSalary: $28.00 - $34.00 Hourly Clinical Research Coordinator II Location: Portland, Oregon (Part-Time, On-Site) Research Axsendo Clinical Research is a rapidly growing, multi-market clinical research organization specializing in Neurology, Cardiology, Metabolic Disease, Vaccines, and Medical Devices. Our Portland site is expanding and we are seeking a skilled, service-minded Clinical Research Coordinator II to join our team. This role is ideal for experienced coordinators who can independently execute study visits, support study startup, maintain high-quality documentation, and contribute to a best-in-class patient and sponsor experience. Position Overview The Clinical Research Coordinator II manages the day-to-day execution of assigned clinical trials with a high level of autonomy. This includes conducting study visits, supporting investigators, ensuring protocol compliance, maintaining audit-ready documentation, and collaborating with sponsors/CROs. The ideal candidate has strong operational discipline, excellent patient communication skills, and the ability to execute visits with speed, accuracy, and professionalism. Key Responsibilities Patient & Protocol Management Independently conduct study visits, including consenting, assessments, vital signs, questionnaires, sample collection, and follow-up Read, interpret, and maintain full working knowledge of assigned research protocols Conduct pre-screening and EMR-based feasibility reviews to identify eligible candidate patients Coordinate eligibility discussions with the Principal Investigator Obtain and document informed consent in accordance with ICH-GCP and site SOPs Prevent out-of-window procedures and ensure all required assessments occur per protocol schedule Safety & Regulatory Compliance Report Adverse Events (AEs) and Serious Adverse Events (SAEs) to the IRB and sponsor as required Maintain complete, accurate, and ALCOA-compliant source documentation Ensure accurate Investigational Product (IP) management and accountability Collect and process laboratory specimens per protocol, including preparing shipments and completing lab documentation Maintain up-to-date temperature logs, accountability logs, and essential documentation Data & Documentation Excellence Complete timely and accurate EDC entries and resolve queries promptly Understand and accurately use all study-related data collection instruments Ensure all Case Report Forms (CRFs) and patient tracking logs are complete and accurate Maintain audit-ready source, regulatory, and IP documentation at all times Monitoring & Sponsor Interaction Prepare for monitoring visits by organizing source documents, resolving outstanding action items, and addressing prior queries Support monitors during visits and coordinate any required follow-up Maintain consistent communication with sponsors and CROs regarding data, queries, and operational needs Operational Coordination Plan and prepare subject visits, coordinating room availability, equipment, and supplies Work closely with site administration to ensure clinic readiness Collaborate with investigators, sub-investigators, and cross-functional team members to support seamless study execution Qualifications Minimum 12 years of direct clinical research experience required Demonstrated ability to independently conduct study visits and manage multiple protocols Strong understanding of ICH-GCP, safety reporting, sample handling, and data quality standards Experience with EMR, EDC, CTMS, and electronic source systems Strong communication skills and a service-oriented, patient-centered mindset Superior organizational skills with the ability to manage multiple competing priorities Ability to remain calm, timely, and precise during high-volume or fast-paced clinic days Preferred Qualifications Phlebotomy and EKG training Certified Medical Assistant (CMA) or clinical credential Medical terminology proficiency Bilingual (Spanish/English) a strong plus Experience in cardiology, neurology, metabolic disease, or device trials Why Join Axsendo Opportunity to contribute to a growing research organization with expanding multi-market operations Exposure to diverse therapeutic areas and complex study portfolios A supportive team culture centered around excellence, integrity, and professional growth Continued training and advancement opportunities within Axsendos clinical operations pathway

At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. Clinical Research Coordinator (CRC) 📍 Location: Portland, OR | 🏥 Site Name: Summit Research Network | 🕒 Full-Time | 🧪 Clinical Research With decades of experience, Summit Research Network provides the most advanced clinical research, including our Memory Health Center, to help develop better treatments and better future health for individuals with psychiatric, dementia, age-related memory issues, and many other health conditions. Together with Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. Type: Regular Full-time Employee Schedule: Mondays through Thursdays, Location: Onsite in Portland, OR (no capabilities for remote or hybrid work) Reports to: Site Director Benefits: Our benefits package for full-time employees includes health insurance (medical, dental, and vision), Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA), Paid Time Off (PTO), a variety of disability, accident, and life insurance options, as well as many more. 💼 What We Offer Competitive pay + annual performance incentives Medical, dental, and vision insurance 401(k) plan with company match Paid time off (PTO) and company holidays A mission-driven culture focused on advancing medicine and improving patient outcomes 🚀 Why Join Us? You'll be part of a growing, mission-driven organization that values its people. At our core, we're committed to bringing innovative medical treatments to patients faster-while creating an environment where employees thrive. If you're passionate about clinical research and ready to make a difference, we'd love to hear from you. Responsibilities: Coordinate all aspects of assigned clinical trials from site initiation to study close-out Conduct subject visits and ensure timely, accurate documentation following ALCOA-C standards Maintain compliance with study protocols, GCP/ICH guidelines, FDA regulations, IRB policies, and company SOPs Manage subject recruitment, informed consent, and retention strategies Ensure timely data entry and resolution of EDC queries Report and follow up on all adverse events, serious adverse events, and deviations Collaborate with investigators, lab teams, sponsors/CROs, and internal stakeholders Prepare for and participate in monitoring visits, audits, and inspections Maintain regulatory documentation and ensure proper training is completed for all study amendments and systems Execute study procedures such as phlebotomy, ECGs, and sample processing within scope (as trained) Attend investigator meetings and provide cross-functional support as needed Maintain working knowledge of study protocols, laboratory manuals, equipment calibration, and inventory control Requirements: High school diploma or GED required; Bachelor's Degree preferred Industry-sponsored trial experience strongly preferred At least one full year of experience coordinating clinical trials phases 2-4 required Familiarity with electronic data capture (EDC), IVRS, and other trial platforms Deep understanding of FDA, ICH-GCP regulations, and clinical trial procedures Proficiency in medical terminology and clinical documentation practices Strong interpersonal, verbal, and written communication skills Organized, detail-oriented, and capable of managing multiple priorities Proficient in Microsoft Office and other clinical research systems 📬 Apply now to become a part of a team that's changing the future of healthcare-one trial at a time.

Posting Date 09/09/20256828 Se Foster Rd, Portland, Oregon, 97206-4546, United States of America DaVita is seeking a Clinical Coordinator who is looking to give life in an outpatient dialysis center. You can make an exceptional difference in the lives of our patients and their families dealing with end-stage renal failure or chronic kidney disease. Do you desire to deliver care in an empathetic, compassionate way - the way you'd want your own care to be? If you haven't considered Nephrology before, read on as we think that you should. DaVita - which is Italian for "giving life" - is working to provide quality service to patients, partners, and teammates. Our mission is to be the Provider, Partner, and Employer of Choice. Some details about this position: At least 6 months dialysis RN experience is required. Coordinate ESRD patient care and services (trend lab values, track metrics on vital signs, weight, outcome management, etc.)• Ensure you and your clinical team are delivering the highest level of care to our patients by ensuring their safety, comfort, and well-being. Training may take place in a facility or a training clinic other than your assigned home clinic Potential to float to various clinics during and after your training You must have a flexible schedule and be able to work mornings, evenings, weekends, and holidays What you can expect: Build meaningful and long term relationships with patients and their family in an intimate outpatient setting. Be a part of a team that supports and relies on each other in a positive environment. Staff RNs are a central part of a small interdisciplinary team of clinicians. Deliver care to patients who are often dealing with multiple co-morbidities which require unique treatment plans and the ability to leverage a broad range of nursing skills and knowledge. Oversee a group of patients with the support of PCTs to conduct patient observations, measuring stats and machine set up. You will work with your head, heart and hands each day in a fast paced environment. What we'll provide: DaVita Rewards package connects teammates to what matters most including: Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out Support for you and your family: family resources, EAP counseling sessions, access Headspace , backup child and elder care, maternity/paternity leave, pet insurance, and more Paid training Requirements: Current Registered Nurse (RN) license in the state of practice Current CPR certification required At least 18 months of registered nursing experience Dialysis Charge RN readiness approval by Clinical Nurse Manager or RN-licensed FA/GFA required Certified Nephrology Nurse (CNN) or Certified Dialysis Nurse (CDN) preferred Intensive Care Unit (ICU), Critical Care Unit (CCU), Emergency Room (ER), or Medical Surgical (Med Surg) experience is preferred Associates Degree in Nursing (A.D.N) from accredited school of nursing required; Bachelor of Science in Nursing (B.S.N) preferred; three-year diploma from accredited diploma program may be substituted for nursing degree Current CPR certification required Completed training approved by the medical director and the governing body as required by CMS guidelines prior to operating the water treatment system Supervisory experience preferred; willingness, desire, and ability to supervise required Basic computer skills and proficiency in MS Word and Outlook required DaVita is a clinical leader! We have the highest percentage of facilities meeting or exceeding CMS's standards in the government's two key performance programs. We expect our nurses to commit to improving patient health through clinical goal setting and quality improvement initiatives. Ready to make a difference in the lives of patients? Take the first step and apply now. #LI-EQ1 At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. This position will be open for a minimum of three days. For location-specific minimum wage details, see the following link: DaVita.jobs/WageRates Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at *********************************** Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.

The Department of Obstetrics and Gynecology at Oregon Health & Science University (OHSU) is seeking a Maternal Fetal Medicine physician to provide clinical care to patients primarily in our regional medical partner program in Salem, Oregon. The Clinical Associate is a critical component of the group practice model and will support outpatient and inpatient consultative Maternal Fetal Medicine services. This position will also work in conjunction with team members as need arises, including General Ob/Gyn, Nurse Midwives, Family Medicine, and advanced practice providers. Function/Duties of Position Clinical Primary responsibility to include staffing outreach clinics at local and regional sites. Primary location will be Salem, Oregon. Provide consultative staffing for Maternal-Fetal Medicine services, including inpatient consultation and outpatient ultrasound, consultation, genetic counseling and diagnostic procedures. Serve as a liaison between Salem Hospital and OHSU MFM including but not limited to development and distribution of outpatient clinical guidelines/pathways, oversight of complex patients and the ultrasound program, scheduling efficiencies, quality assessment and improvements, and partnership with OHSU MFM division and hospital-based obstetricians in patient care, including patient transfer to OHSU when appropriate. Required Qualifications MD degree Oregon licensure, and Completion of maternal-fetal medicine fellowship. Candidate Applicants must have the potential for academic accomplishment. Be board-certified or board-eligible in Obstetrics and Gynecology, and in Maternal-Fetal Medicine. Obtain medical privileges at our regional medical partner program in Salem, Oregon and OHSU. Additional Details Upload cover letter and resume. Please be sure to include months and years (MM/YYYY format) to the resume for jobs/experience. All are welcome Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at ************ or *************.

This position provides research project support to requesting department to ensure timelines and effectiveness in activation and completion of needed research projects. Responsible for routine to moderately complex project coordination / project management as well as communication and documentation as required by the research departments. **Please note that a video interview through Microsoft Teams will be required as well as potential onsite interviews and meetings** We are committed to offering flexible work options where approved and stated in the job posting. However, we are currently not considering candidates who reside or plan to reside in the following states: **California, Connecticut, Hawaii, Illinois, New York, Rhode Island, Vermont, and Washington** **Essential Functions** + **Research Support and Administration:** Support various clinical research studies and departments across the Intermountain system. Based on role, may coordinate (1) review of IRB/HRPP submissions and provide support to research oversight committees and research programs, coordinate review and oversee submission, or (2) centralized administrative and technical functions associated with grants, contracts and other agreements from external funding sources. + **Project Planning & Execution:** Define, develop, and execute clinical research project plans, including work plans and schedules. Identify needed resources, roles, and responsibilities for assigned studies. Facilitate feedback from key participants and participate as a team member when needed. + **Budget & Scope Management:** Develop comprehensive budget and scope documents for clinical research studies. Assist with business case and proposal development, including budget preparation and completion of required forms for internal and external routing. + **Study Requirements & Compliance:** Analyze study requirements to ensure sponsor and study requirements are met. Communicate impacts on existing studies to internal and external stakeholders. Look for cost-effective methods to facilitate study execution while meeting functional and regulatory requirements. + **Quality Assurance & Documentation:** Participate in quality assurance plans and reviews as requested. Document clinical research study deliverables, track and communicate timelines, and prepare reports and presentations on findings. Ensure completion of deliverables per specified deadlines. Support research billing by reviewing research accounts and reconciling invoices. + **Study Lifecycle Management:** Manage study startup, maintenance, and closeout activities. Provide support and guidance to Clinical Research study teams on study financials, and act as a source expert and liaison. As requested, provide support and back up as clinical research coordinator. + **Medicare Coverage Analysis:** Support the development of Medicare Coverage Analysis for clinical trials. Draft and prepare coverage analysis documents, review reimbursement guidelines, ensure correct billing, and provide coverage review. + **Auditing & Risk Management:** Coordinate project assessments and response planning. Communicate risks, develop and execute strategies, and lead auditing activities to ensure compliance with guidelines and regulations. **Skills** + Budgeting + Financial negotiation + Attention to detail + Multitasking + Clear written and verbal communication + Task Prioritization + Process Improvement + Critical thinking + Collaboration + Research **Physical Requirements** + Ongoing need for employee to see and read information, labels, monitors, etc. and to see to identify equipment and supplies and to utilize a wide variety of information including organizing and completing documentation and forms, accessing and entering computer information, and identifying needs and urgent issues. + Frequent interactions with providers, colleagues, customers, patients/clients, and visitors that require employee to verbally communicate as well as hear and understand spoken information, needs, and issues quickly and accurately. + Manual dexterity of hands and fingers to manipulate complex and delicate equipment with precision and accuracy. This includes frequent computer use and typing for documenting patient interactions, accessing needed information, operating telephones and other office equipment, including manipulating paper - requiring the ability to move fingers and hands. + Expected to bend, lift, and carry patient files, documents, equipment, and supplies. + Remain sitting or standing for long periods of time while interacting with others or to perform work on a computer, telephone, or other equipment. + For roles requiring driving: Expected to drive a vehicle which requires sitting, seeing and reading signs, traffic signals, and other vehicles. **Physical Requirements:** **Minimum Qualifications** + Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills; Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment. + Demonstrated experience working in a collaborative team environment. + Experience using word processing, spreadsheet, database, internet, e-mail, and scheduling applications. + Ability and willingness to travel within the Intermountain system and work from different locations as assigned. Occasional overnight travel may be required. + Clinical licensure, experience or certification may be required due to grant funding requirements. · Bachelor's Degree in a clinical or life science field, business, or healthcare operations. A degree must be obtained through an accredited institution. Education is verified. + Two (2) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures. **OR** + Three (3) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures. **Preferred Qualifications** + Experience in clinical research setting, including relevant study management experience. · Experience in a healthcare or hospital setting. **Location:** Intermountain Health Intermountain Medical Center **Work City:** Murray **Work State:** Utah **Scheduled Weekly Hours:** 40 The hourly range for this position is listed below. Actual hourly rate dependent upon experience. $27.65 - $43.55 We care about your well-being - mind, body, and spirit - which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged. Learn more about our comprehensive benefits package here (***************************************************** . Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. At Intermountain Health, we use the artificial intelligence ("AI") platform, HiredScore to improve your job application experience. HiredScore helps match your skills and experiences to the best jobs for you. While HiredScore assists in reviewing applications, all final decisions are made by Intermountain personnel to ensure fairness. We protect your privacy and follow strict data protection rules. Your information is safe and used only for recruitment. Thank you for considering a career with us and experiencing our AI-enhanced recruitment process. All positions subject to close without notice.

The Clinical Coordinator is responsible for securing and overseeing clinical sites for student clinical rotation experiences. This role involves close collaboration with the Program Director, Director of Registration, Clinical Instructors, and students to prepare, assign, and onboard both students and Clinical Instructors to their clinical rotations. Additionally, the Clinical Coordinator is tasked with identifying, evaluating, and establishing contracts with clinical sites on an ongoing basis. Qualifications of Clinical Coordinator: ● Excellent Communication Skills: Strong written and verbal communication skills to interact effectively with students, faculty, and clinical partners ● Organizational Skills: Ability to manage multiple tasks, schedules, onboarding, and clinical placements simultaneously with high attention to detail. ● Problem-Solving Abilities: Ability to resolve conflicts or issues that may arise in clinical placements or with students and faculty. ● Knowledge of Accreditation Standards: Familiarity with accreditation standards for nursing programs and clinical education, such as those from the Commission on Collegiate Nursing Education (CCNE), the Accreditation Commission for Education in Nursing (ACEN), Accrediting Bureau of Health Education Schools (ABHES), Oregon State Board of Nursing (OSBN). ● Technological Proficiency: Comfortable with using educational and scheduling software, databases, and office applications (e.g., Microsoft Office Suite,Google Sheets, student learning management systems (Canvas)). ● Leadership and Collaboration: Strong leadership skills and the ability to work collaboratively with faculty, clinical sites, and students. ● Time Management: Ability to prioritize tasks and manage time effectively to meet deadlines, especially when coordinating clinical rotations, creating clinical rotation spreadsheets, and onboarding students and Clinical Instructors. ● Adaptability: Ability to adjust to changes in clinical sites, student needs, and educational practices. ● Interpersonal Skills: Ability to build and maintain professional relationships with students, faculty, and healthcare facility staff. ● Experience in Policy Development: Prior involvement in policy creation, implementation, or review within a clinical or academic setting, preferably related to clinical education, healthcare regulations, or nursing programs. Responsibilities and Duties of Clinical Coordinator: Responsible for placement of students at clinical and practicum rotations. 1. Securing Clinical Placement Sites: * Identify and establish partnerships with healthcare facilities and clinical sites for student rotations. * Maintain and update a list of approved clinical sites. 2. Coordinating Clinical Rotations: * Collaborate with Program Director, Director of Registration, faculty, students, and clinical partners to assign clinical placements based on curriculum requirements and student needs. * Ensure that students are placed in appropriate clinical settings to meet their learning objectives. 3. Ensuring Compliance and Accreditation: * Ensure that clinical placements meet institutional, state, and accreditation standards. * Monitor compliance with regulatory and safety requirements at clinical sites. * Keep accurate records of contracts, agreements, evaluations, and surveys for accreditation purposes. 4*. Monitoring and Supporting Students:* * Provide ongoing support to students during their clinical rotation onboarding. * Address any concerns or issues related to student performance, clinical site conditions, or clinical partner relationships. * Facilitate communication between students, faculty, and clinical partners to ensure effective learning experiences. 5. Managing Schedules and Documentation: * · Coordinate clinical schedules for students and clinical partners, ensuring there are no conflicts or overlaps. * · Maintain accurate and up-to-date documentation on clinical placements, clinical partners, and clinical site agreements. 6. Collaboration and Communication: * Serve as the main point of contact for clinical sites, faculty, and students. * Facilitate regular communication between clinical sites and the nursing program to address any issues and ensure smooth operations. 7. Problem-Solving and Conflict Resolution: * Address and resolve any issues that may arise between students, faculty, or clinical sites. * Ensure that students have a positive and effective clinical experience by resolving challenges promptly. 8. Continuous Improvement: * Evaluate and improve clinical coordination processes for greater efficiency and effectiveness. * Gather feedback from students, faculty, and clinical partners to enhance the clinical education experience. 9. Scheduling and Logistics: * Expertise in developing policies around clinical placement scheduling, clinical partner onboarding, and the duration of clinical rotations. 10. Coordinate clinical site orientations and preceptor training. * Organize and conduct orientation sessions for students and faculty before they begin their clinical rotations. * Coordinating dates and times with the clinical site. * Ensuring all students and faculty attend the required orientations before starting their rotation. 11. Compliance and Documentation * Ensuring students submit required health records, immunizations, background checks, and drug screenings. * Tracking documentation renewals and communicating with students regarding due dates and clinical rotation clearance. * Confirming completion of any hospital-required training modules (e.g., OSHA, HIPAA, patient safety). 12. Stay updated on best practices and changes in nursing education. * Participate in monthly Student Max Consortium meetings. * Attend regular Oregon and Washington State Board of Nursing meetings and workshops. Job Type: Full-time Benefits: * 401(k) * Dental insurance * Health insurance * Life insurance * Paid time off * Tuition reimbursement * Vision insurance If you are interested in the position at Sumner College, please email your resume and cover letter to the HR Department at *******************************. In your email, be sure to indicate the position you are applying for. Thank you!

About Absci Absci is a clinical-stage biotechnology company advancing novel therapeutics using generative AI. Our Integrated Drug Creation platform combines cutting-edge AI models with a synthetic biology data engine, enabling the rapid design of innovative therapeutics that address challenging therapeutic targets. Absci is a global company headquartered in Vancouver, WA, and maintains offices in New York City, Switzerland, and Serbia. Learn more at ************* or follow us on LinkedIn (@absci), X (@Abscibio), and YouTube. Lead Clinical Trial Manager Vancouver, WA (Onsite), Remote/Hybrid (US-based) We are seeking a dynamic Clinical Research Operations Manager to lead our clinical research initiatives and manage the operational aspects of our clinical trials. This pivotal role combines the scientific expertise of clinical research with the organizational skills of operations management to ensure the efficient and effective execution of studies across various therapeutic areas meeting regulatory standards and company objectives. The ideal candidate will have a strong background in the life sciences, a deep understanding of clinical trial processes, and experience in regulatory affairs to oversee both the scientific and logistical elements of clinical research. Responsibilities: * Develop and maintain effective working relationships with cross-functional teams, external partners (CROs, vendors), and study sites to ensure collaboration and alignment on trial objectives. * Manage Contract Research Organizations (CROs) to ensure that all clinical operations are carried out in alignment with the study's goals, budget, and timelines. * Ensure robust patient recruitment and retention strategies are in place and effectively executed. * Author, review, and maintain Standard Operating Procedures (SOPs) related to clinical research and operations ensuring high quality, compliance with the study protocol and regulatory requirements across all trials. * Support design, implementation, and oversight of clinical trials from concept through completion, ensuring adherence to protocols, regulatory requirements, and ethical standards. * Identify potential risks and implement contingency plans. * Ensure accurate data collection, documentation, and record-keeping. * Support analysis and interpretation of clinical data, prepare reports, and communicate findings to internal stakeholders and regulatory agencies. * Stay informed about industry developments, regulatory changes, and advancements in clinical research methodologies to inform trial design and execution strategies. * Responsible for the integrity, confidentiality, and security of all research data. Qualifications: * Bachelors Degree in life sciences, pharmacology or related field a must * Advanced degree (MSc., Ph.D., PharmD, MD) in life sciences, pharmacology, or related field preferred * Minimum of 2-3 years of experience in phase 1 clinical research and operations within the pharmaceutical or biotechnology industry, with experience in immunology and/or dermatology studies being a plus. * Good working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and other regulatory requirements in clinical research. * Familiarity with the IND and CTA filing process. * Exceptional organizational, communication, and leadership skills, with the ability to manage multiple projects and teams in a fast-paced environment. * Strong analytical and problem-solving abilities, with a meticulous attention to detail. * Demonstrated capability to work collaboratively across various departments and with external partners to achieve objectives. * Ability to work in a fast-paced environment and manage multiple projects simultaneously. * Ability to travel up to 20% per month as needed to oversee clinical trials at investigator sites, onsite meetings with vendors, and conferences The salary range for this position is $145,000- $165,000/year. Competitive equity package applies. Pay offered may vary depending on job-related knowledge, skills, and experience. In addition to equity, compensation packages include a wide range of medical, dental, and vision benefits andthe ability to participate in our employee stock purchase plan. Absci offers highly competitive salaries and benefits, including medical, dental, vision insurance, unlimited vacation, parental leave, breakfast and lunch for onsite employees, employee assistance program, voluntary life and disability insurance, annual bonus potential, and 401(k) with a generous company match. Legal authorization to work in the United States is required. Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, sexual orientation, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, marital status, or any characteristic protected under applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should request the recruiter or hiring manager or contact ****************.

The Knight Cardiovascular Institute Clinical Research Associate is responsible for various duties supporting clinical trials focused on the investigation of new drug, infusion, and gene therapies for treating patients with cardiac diseases including, hypertrophic cardiomyopathy, amyloidosis, and others encompassing an array of heart failure disease phenotypes supporting the Cardiomyopathy research team directed by Dr. Masri. This position will have a strong understanding of the principles of clinical research and the regulatory responsibilities integral to the success of the work; they will be available to all coordinators and assistant coordinators for triaging daily questions. The position is on point for all regulatory work, organizing and leading monitoring visits with sponsors, preparation and execution of activities needed during an FDA audit, and working with leadership on projects relating to study start-up. They also serve as a mentor to junior research staff in the group, is on point for collaborating with leadership in organizing the training and onboarding of new coordinators within the group, as well as developing standardized workflows and SOP's for the program. Lastly, this position is also responsible for analyzing and interpreting complex research data and assisting the principle investigator in publication development. The Clinical Research Associate is the primary liaison for patients receiving experimental research procedures on a clinical trial and is responsible for the triage of patient needs and identification, reporting of, and follow-up of adverse events. They have a strong understanding of the connection and differences between clinical care and protocol visits conducted for research subjects. This position will primarily support our Hypertrophic Cardiomyopathy and Amyloid research team within the division of Cardiology, they may be reassigned secondary duties to support other sections within the Cardiovascular Medicine Clinical Trials Unit and Knight Cardiovascular Institute. This is an onsite role with limited hybrid opportunities. Function/Duties of Position The Senior Coordinator oversees all regulatory activities for each study in the program. This includes the following: IRB Protocol Management and Development * In collaboration leadership and based on sponsor protocol, develop and submit new IRB protocols for review. * Work in collaboration with coordinator teams and leadership to ensure timely closeout of all IRB protocols covering studies that have terminated * Work in collaboration with coordinator teams and leadership to ensure all IRB protocols are up to date, including updated staffing information, accurate term dates, and that amendments and continuing reviews are submitted timely when adjustments are needed. * Be the primary point of contact for IRB. Collaborate with study teams and leadership to submit changes, and address regulatory gaps with IRB protocols. Study Documentation * Monitor and ensure documentation storage meets FDA, institutional and sponsor guidelines. * Oversight and maintenance of all regulatory binders for each study * Ensure proper filing of all study correspondence between study team and sponsor for audit purposes * Ensure proper filing of all correspondence between IRB and study team for audit purposes * Ensure centralized documentation of all training certificates and medical license (if applicable) for study site staff and investigators for audit purposes * Ensure centralized documentation of all monitor visit reports. This includes site selection, site initiation, monitoring visits, and close-out reports * Audit Support/Preparation * Will develop in collaboration with leadership standardized auditing processes that includes a consistent methodology across all trials and allows for all critical components of study conduct to be reviewed. * In collaboration with leadership, identify at risk trials and perform an in-depth internal review. * Provide standardized reporting of all relevant findings, including possible action items and areas for retraining or process changes. * Learn FDA audit practices and work to identify and create strategies towards FDA audit in collaboration with leadership. Monitoring Visits * Work with the study teams to schedule and organize any documentation or data entry needed prior to the monitoring visit * Meet and provide any needed information or data to the monitor during the visit * Assist study teams in addressing any key deficiencies identified during a site monitoring visit. Provide report out to leadership on next steps. * Ensure all documentation post-visit is entered into EPIC and EDC * Responsible for direct sponsor correspondence regarding patient safety, responding to queries, reporting adverse events, conduction of visits, etc. Required Qualifications * Master's Degree in relevant field AND 3 years of clinical research coordination experience OR Bachelor's Degree in relevant field AND 5 years of clinical research Coordination experience * Strong interpersonal communication skills and excellent attention to detail * Critical thinking skills to anticipate and address potential problems * Very Strong understanding of Research Regulations and best practices * Strong knowledge of FDA regulations and audit preparation practices * Strong data abstraction and project management skills * Ability to prioritize multiple tasks at one time * Strong teaching skills with the ability to mentor junior staff * Must have excellent communication, analytical and organizational skills: both written and verbal. * Ability to work independently and as part of a team while being collaborative in resolving problems. * Must be proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint). * Must have demonstrated excellent customer service skills both on the phone and in person. * Demonstrated ability to work with a variety of diverse individuals and personalities. * Must possess energy and drive to coordinate multiple projects simultaneously. * Ability to use tact and diplomacy to maintain effective working relationships Preferred Qualifications * Masters degree * 5+ years of experience in coordinating clinical trials * Experience in coordinating trials in cardiovascular medicine * Experience managing regulatory activities for clinical trials * Previous experience at the Research Associate or Senior Coordinator level * Prior experience leading clinical research teams and mentoring junior staff Additional Details Location: Marquam Hill & South Waterfront Campus Schedule: Monday - Friday, 6am - 6pm primary business hours with variability depending on clinical schedules with occasional evenings & weekend work to meet project deadlines/goals. As salaried employee senior coordinators are expected to flex their time in conjunction with OHSU policy; this may mean working more than 40 hours in a week and then less another. Must be able to travel to all KCVI worksite locations, including potentially using the tram numerous times each day. Will work with human biological samples, including samples which may contain infectious disease. Research assistant Coordinator may be expected to travel to conferences, new study meetings. Clinical Research Assistant Coordinator is required to use Personal Protective Equipment (gloves, masks, etc.) as required to maintain a safe and healthy clinical research environment. Additional safety training may be required to work in clinical research. Position requires ability to focus in a busy cubicle environment with multiple distractions. Position requires successful completion of BLS certification. Due to the increased focused writing and focused attention on creation of sensitive study start-up regulatory materials this position is permitted to work remotely 1 day per week to complete this portion of the role. The other aspects of this role are patient facing on-site role. All obligations to clinical schedules and security of paper PHI and clinical trials regulations must be maintained at all times - this severely restricting the ability to conduct work remotely.#LI-CC1 All are welcome Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at ************ or *************.

The Knight Cardiovascular Institute Clinical Research Associate is responsible for various duties supporting clinical trials focused on the investigation of new drug, infusion, and gene therapies for treating patients with cardiac diseases including, hypertrophic cardiomyopathy, amyloidosis, and others encompassing an array of heart failure disease phenotypes supporting the Cardiomyopathy research team directed by Dr. Masri. This position will have a strong understanding of the principles of clinical research and the regulatory responsibilities integral to the success of the work; they will be available to all coordinators and assistant coordinators for triaging daily questions. The position is on point for all regulatory work, organizing and leading monitoring visits with sponsors, preparation and execution of activities needed during an FDA audit, and working with leadership on projects relating to study start-up. They also serve as a mentor to junior research staff in the group, is on point for collaborating with leadership in organizing the training and onboarding of new coordinators within the group, as well as developing standardized workflows and SOP's for the program. Lastly, this position is also responsible for analyzing and interpreting complex research data and assisting the principle investigator in publication development. The Clinical Research Associate is the primary liaison for patients receiving experimental research procedures on a clinical trial and is responsible for the triage of patient needs and identification, reporting of, and follow-up of adverse events. They have a strong understanding of the connection and differences between clinical care and protocol visits conducted for research subjects. This position will primarily support our Hypertrophic Cardiomyopathy and Amyloid research team within the division of Cardiology, they may be reassigned secondary duties to support other sections within the Cardiovascular Medicine Clinical Trials Unit and Knight Cardiovascular Institute. This is an onsite role with limited hybrid opportunities. Function/Duties of Position The Senior Coordinator oversees all regulatory activities for each study in the program. This includes the following: IRB Protocol Management and Development In collaboration leadership and based on sponsor protocol, develop and submit new IRB protocols for review. Work in collaboration with coordinator teams and leadership to ensure timely closeout of all IRB protocols covering studies that have terminated Work in collaboration with coordinator teams and leadership to ensure all IRB protocols are up to date, including updated staffing information, accurate term dates, and that amendments and continuing reviews are submitted timely when adjustments are needed. Be the primary point of contact for IRB. Collaborate with study teams and leadership to submit changes, and address regulatory gaps with IRB protocols. Study Documentation Monitor and ensure documentation storage meets FDA, institutional and sponsor guidelines. Oversight and maintenance of all regulatory binders for each study Ensure proper filing of all study correspondence between study team and sponsor for audit purposes Ensure proper filing of all correspondence between IRB and study team for audit purposes Ensure centralized documentation of all training certificates and medical license (if applicable) for study site staff and investigators for audit purposes Ensure centralized documentation of all monitor visit reports. This includes site selection, site initiation, monitoring visits, and close-out reports Audit Support/Preparation Will develop in collaboration with leadership standardized auditing processes that includes a consistent methodology across all trials and allows for all critical components of study conduct to be reviewed. In collaboration with leadership, identify at risk trials and perform an in-depth internal review. Provide standardized reporting of all relevant findings, including possible action items and areas for retraining or process changes. Learn FDA audit practices and work to identify and create strategies towards FDA audit in collaboration with leadership. Monitoring Visits Work with the study teams to schedule and organize any documentation or data entry needed prior to the monitoring visit Meet and provide any needed information or data to the monitor during the visit Assist study teams in addressing any key deficiencies identified during a site monitoring visit. Provide report out to leadership on next steps. Ensure all documentation post-visit is entered into EPIC and EDC Responsible for direct sponsor correspondence regarding patient safety, responding to queries, reporting adverse events, conduction of visits, etc. Required Qualifications Master's Degree in relevant field AND 3 years of clinical research coordination experience OR Bachelor's Degree in relevant field AND 5 years of clinical research Coordination experience Strong interpersonal communication skills and excellent attention to detail Critical thinking skills to anticipate and address potential problems Very Strong understanding of Research Regulations and best practices Strong knowledge of FDA regulations and audit preparation practices Strong data abstraction and project management skills Ability to prioritize multiple tasks at one time Strong teaching skills with the ability to mentor junior staff Must have excellent communication, analytical and organizational skills: both written and verbal. Ability to work independently and as part of a team while being collaborative in resolving problems. Must be proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint). Must have demonstrated excellent customer service skills both on the phone and in person. Demonstrated ability to work with a variety of diverse individuals and personalities. Must possess energy and drive to coordinate multiple projects simultaneously. Ability to use tact and diplomacy to maintain effective working relationships Preferred Qualifications Masters degree 5+ years of experience in coordinating clinical trials Experience in coordinating trials in cardiovascular medicine Experience managing regulatory activities for clinical trials Previous experience at the Research Associate or Senior Coordinator level Prior experience leading clinical research teams and mentoring junior staff Additional Details Location: Marquam Hill & South Waterfront Campus Schedule: Monday - Friday, 6am - 6pm primary business hours with variability depending on clinical schedules with occasional evenings & weekend work to meet project deadlines/goals. As salaried employee senior coordinators are expected to flex their time in conjunction with OHSU policy; this may mean working more than 40 hours in a week and then less another. Must be able to travel to all KCVI worksite locations, including potentially using the tram numerous times each day. Will work with human biological samples, including samples which may contain infectious disease. Research assistant Coordinator may be expected to travel to conferences, new study meetings. Clinical Research Assistant Coordinator is required to use Personal Protective Equipment (gloves, masks, etc.) as required to maintain a safe and healthy clinical research environment. Additional safety training may be required to work in clinical research. Position requires ability to focus in a busy cubicle environment with multiple distractions. Position requires successful completion of BLS certification. Due to the increased focused writing and focused attention on creation of sensitive study start-up regulatory materials this position is permitted to work remotely 1 day per week to complete this portion of the role. The other aspects of this role are patient facing on-site role. All obligations to clinical schedules and security of paper PHI and clinical trials regulations must be maintained at all times - this severely restricting the ability to conduct work remotely. #LI-CC1 All are welcome Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at ************ or *************.