Clinical research associate jobs in Gresham, OR

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (******************************* . Job Description The CRA II advances AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for patients, and leveraging advanced capabilities to drive industry-leading performance. The CRA II partners with investigators and site staff to build meaningful, effective engagements that position AbbVie as the sponsor of choice in clinical trials. The role focuses on site clinical research by ensuring proper trial conduct, while continually working to improve data integrity, compliance, overall study performance, and the customer experience. Responsibilities: + Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie's positioning. + Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership. + Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects. + Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy. + Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance. + Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. + May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager. + Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. + Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach. + Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators. + Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. + Ensures audit and regulatory inspection readiness at assigned clinical site at all times. + Manages investigator payments as per executed contract obligations, as applicable. Qualifications Minimum Qualifications: + Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. (CRA experience) + Familiar with risk-based monitoring approach, onsite and offsite monitoring. Preferred Qualifications: + Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred. + Knowledge of appropriate therapeutic area indications (oncology) is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials. + Experience as a study coordinator Other Required Skills: + Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies. + Demonstrate strong cross-functional collaboration skills among internal and external stakeholders. + Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. + Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site. + Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training. + Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues. + Acts with integrity in accordance with AbbVie code of business conduct and leadership values. + Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: + The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. + We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. + This job is eligible to participate in our short-term incentive programs. + This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: ************************************************************* Salary: $82,500 - $157,500

Monitors investigator sites with a risk-based monitoring approach: applies root Functions cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections. Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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.

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_

Excel is seeking highly skilled healthcare professionals for travel assignments across the United States. As a Travel Healthcare Professional, you will have the opportunity to work in diverse healthcare settings, providing essential medical care while exploring new locations and cultures. Key Responsibilities: Provide direct patient care in accordance with healthcare facility policies and procedures. Collaborate with interdisciplinary teams to ensure comprehensive patient care. Maintain accurate patient medical records and documentation. Adhere to infection control standards and other regulatory requirements. Educate patients and their families on healthcare plans and treatments. Qualifications: Active state licensure in [specify relevant states] (e.g., RN, LPN, PT, OT). Minimum [number] years of experience in [specialty]. BLS/CPR certification (ACLS, PALS, or others as required by specialty). Excellent communication and interpersonal skills. Ability to adapt to different environments and work independently. Why Choose Excel Medical Staffing: Trusted partner with a proven track record in healthcare staffing. Competitive compensation package including hourly wages and stipends. Access to a wide range of healthcare facilities and specialties. Personalized support throughout your assignment. Opportunity to enhance your skills and build a diverse professional portfolio.

Title: Clinical Research Responsibilities: Serve as the primary liaison between the site, study participants, investigators, and sponsors. Coordinate and conduct study visits per protocol, ensuring accurate and timely data collection and documentation. Obtain and document informed consent in compliance with ethical and regulatory standards. Screen and enroll participants according to eligibility criteria; maintain recruitment logs. Maintain accurate, complete, and up-to-date source documentation and electronic data capture (EDC). Manage investigational products including receipt, storage, accountability, and administration oversight. Monitor participants for adverse events and ensure timely reporting to all required parties. Perform or coordinate study-related procedures such as vital signs, ECGs, blood draws, and lab sample processing/shipping. Schedule subject visits and follow-up calls; manage calendars and visit reminders. Assist with regulatory submissions, IRB documentation, and correspondence with sponsors and monitors. Support patient retention and engagement efforts, including participation in recruitment events and community outreach. Train or mentor new CRCs or ancillary staff as needed. Maintain compliance with all SOPs, GCP guidelines, and applicable local/federal regulations. Requirements: Bachelor s degree in a health, science, or related field preferred, but not required. Alternatively, an associate degree with 2+ years of relevant CRC experience, or equivalent combination of education and experience. 0 2+ years of experience coordinating clinical trials required (more preferred). Medical assistant, LPN, phlebotomy, or similar clinical background is a plus. Strong understanding of ICH GCP, clinical trial phases, and FDA/IRB regulatory requirements. Proficiency in data entry systems (e.g., EDC, CRIO) and Microsoft Office Suite. Excellent organizational, time management, and communication skills. Ability to manage multiple tasks and prioritize effectively under pressure. High attention to detail and commitment to quality and compliance. Ability to work independently and collaboratively within a cross-functional team. Please reference Job number: 265118

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: $26.53-$39.79 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.

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.

You could be the one who changes everything for our 28 million members as a clinical professional on our Medical Management/Health Services team. Centene is a diversified, national organization offering competitive benefits including a fresh perspective on workplace flexibility. **Position Purpose:** Act as the liaison for all statewide appeals, fair hearings, review organizations, and other external type appeals. Responsible for ensuring that all appeal letters generated comply with both State and NCQA requirements. + Review clinical information for all appeals utilizing nationally recognized criteria to determine medical necessity of services requested. + Prepare reviews for cases that did not meet criteria + Gather, analyze and report verbal and written information regarding member and provider clinical appeals, including information follow up + Prepare response letters for member and provider clinical appeals and ensure letters are compliant with State and NCQA standards. + Maintain files and logs for all appeals + Coordinate with Medical Director(s) to clarify medical determinations or clinical rationale + Maintain current knowledge of NCQA and State regulations + Coordinate Fair Hearings with various internal departments and agencies + Performs other duties as assigned + Complies with all policies and standards **Education/Experience:** RN with 4+ years of clinical nursing and/or case management experience or LPN/LVN with 5+ years of clinical nursing or case management experience. Managed care or utilization review experience preferred. **License/Certification:** LPN, LVN, or RN license. **Texas Requirements:** RN license required within Utilization Management at Superior HealthPlan or LPC, LCSW or Psy D. licensure within UM Behavioral Health Appeals team. **Specialty Therapy Requirement:** Master's degree in area of specialty therapy or equivalent experience. 3+ years of experience providing therapy services in healthcare or home health settings. Managed care or utilization review experience preferred. **Licenses/Certifications:** Current state license in Physical Therapy, Occupational Therapy or Speech-Language Therapy. Speech-Language Therapist must have an active Certificate of Clinical Competence from the American Speech-Language-Hearing Association. **Corporate & Louisiana Healthcare Connections Requirements:** Current state RN, LPN, or LVN, LPC, LCSW, or Psy.D license. Pay Range: $33.03 - $59.47 per hour Centene offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors permitted by law, including full-time or part-time status. Total compensation may also include additional forms of incentives. Benefits may be subject to program eligibility. Centene is an equal opportunity employer that is committed to diversity, and values the ways in which we are different. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristic protected by applicable law. Qualified applicants with arrest or conviction records will be considered in accordance with the LA County Ordinance and the California Fair Chance Act

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 *************.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The CRA II advances AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for patients, and leveraging advanced capabilities to drive industry-leading performance. The CRA II partners with investigators and site staff to build meaningful, effective engagements that position AbbVie as the sponsor of choice in clinical trials. The role focuses on site clinical research by ensuring proper trial conduct, while continually working to improve data integrity, compliance, overall study performance, and the customer experience. Responsibilities: * Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie's positioning. * Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership. * Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects. * Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy. * Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance. * Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. * May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager. * Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. * Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach. * Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators. * Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. * Ensures audit and regulatory inspection readiness at assigned clinical site at all times. * Manages investigator payments as per executed contract obligations, as applicable. Qualifications Minimum Qualifications: * Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. (CRA experience) * Familiar with risk-based monitoring approach, onsite and offsite monitoring. Preferred Qualifications: * Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred. * Knowledge of appropriate therapeutic area indications (oncology) is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials. * Experience as a study coordinator Other Required Skills: * Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies. * Demonstrate strong cross-functional collaboration skills among internal and external stakeholders. * Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. * Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site. * Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training. * Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues. * Acts with integrity in accordance with AbbVie code of business conduct and leadership values. * Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. * This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************

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 *************.