Weights and Research Coordinator
Clinical research coordinator job in Portland, OR
R+L Carriers has immediate opportunities for a W&R Coordinator. To Ensure R&L Carriers receives the appropriate revenue on shipments, the W&R Coordinator will review shipments as they pass across their respective docks to verify the accuracy of the actual class of the shipment compared to that of the bill of lading information.
Weights and Research Coordinator
Full-Time Monday-Friday, Various shifts
Come and experience the difference with R+L Carriers
Earn 1 week of vacation after 90 days of employment
60-65k a year.
Requirements:
Any type of LTL experience preferred but not required
Ability to self-motivate and self-manage
Willingness to learn
Analytical skills
Computer proficiency
Able to work in a fast-paced environment
Excellent Benefits
PTO available after the first 90 calendar days of employment
and enjoy an excellent benefits package that includes are very own employee resorts
Click here to learn more about our employee resorts
Auto-ApplyClinical Research Associate ll - Oncology (Oregon)
Clinical research coordinator job in Oregon City, 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
Clinical Research Associate
Clinical research coordinator job in Portland, 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 *************.
Auto-ApplyClinical Research Associate
Clinical research coordinator job in Portland, 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 *************.
Auto-ApplyLead Clinical Trial Manager
Clinical research coordinator job in Vancouver, WA
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 ****************.
Auto-ApplyClinical Research Associate
Clinical research coordinator job in Portland, 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 *************.
Auto-ApplyResearch Coordinator for GI located in NE Portland, Oregon
Clinical research coordinator job in Portland, OR
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.
Clinical Research Associate II/Sr. Clinical Research Associate - FSP
Clinical research coordinator job in Salem, OR
***Oncology experience strongly preferred ***Preference for candidates based in the Midwest, West Coast, Northeast & North Carolina The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
**Monitoring Responsibilities and Study Conduct:**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk:**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Skills:**
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
+ Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Ability to travel 60-80%
+ Valid driver's license and passport required
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
\#LI-LO1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Clinical - Clinical Research
Clinical research coordinator job in Portland, OR
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
PRN Clinical Research Coordinator Position
Clinical research coordinator job in Portland, OR
Join a Growing Team Where You Can Make a Difference - Clinical Research Coordinator Opportunity (Portland, Oregon)
Axsendo Clinical Research is seeking a motivated and detail-oriented Clinical Research Coordinator to join our nimble, patient-focused team on a part-time or PRN basis, with potential for transition to full-time based on performance and project needs.
If you're in the Portland, Oregon area and looking for a refreshing alternative to the structured pace of a large academic medical center or corporate setting, Axsendo offers an opportunity to work in a collaborative, agile environment where your voice is heard, and your contributions truly matter.
What We're Looking For:
A strong interest in clinical research, with a focus on improving patient care.
Detail-oriented and proactive mindset.
Flexibility and readiness to adapt to evolving project needs.
Willingness to travel within the Portland area (minimal travel required).
Why Join Axsendo?
Smaller, people-first company culture that values initiative and collaboration.
Opportunities to learn and grow within a supportive environment.
Ability to make an impact without the layers of bureaucracy found in larger organizations.
If you're ready to take the next step in your clinical research career with a company that values your contributions and promotes growth, we'd love to hear from you.
Key Responsibilities:
Assist in the planning, execution, and monitoring of clinical trials.
Coordinate and manage study-related activities, including patient recruitment and scheduling.
Ensure compliance with regulatory requirements and study protocols.
Collect, maintain, and manage study data and documentation.
Collaborate with investigators, sponsors, and study team members.
Participate in training and orientation of new staff and study volunteers.
Conduct site visits and assist with patient follow-ups as needed.
Prepare and administer IP
Unblinded experience a plus.
Qualifications:
Previous experience in clinical research or a healthcare setting is a plus.
Strong organizational and multitasking skills.
Excellent communication and interpersonal abilities.
Proficient in Microsoft Office and data management software.
Must be willing to travel within the Phoenix area as needed.
Benefits:
Opportunity for professional growth and development.
Potential for transition to a full-time role based on project needs and performance.
Clinical Research Coordinator
Clinical research coordinator job in Portland, OR
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.
Auto-ApplySpecialist, Clinical Business Operations, Oncology
Clinical research coordinator job in Salem, OR
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA).
+ Assist with the entry of Contractual Agreements into an electronic document repository.
+ Ensure all outsourcing decisions are properly documented, compliant, and audit-ready.
+ Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate.
+ Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements.
+ Perform other duties as requested.
**Key Core Competencies**
+ Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities
+ Ability to proactively identify and act on opportunities for operational efficiencies
+ Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude
+ Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution
+ Excellent written and oral communication skills
**Education and Experience**
+ BA/BS preferred with at least 2 years experience, or 5 years equivalent experience
+ Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles.
The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at **********************************************
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
Clinical Territory Associate
Clinical research coordinator job in Portland, OR
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
* Please note: Candidates must live within or be willing to relocate to the Portland, OR Area to perform the duties of this role.
Primary Function of Position
The Clinical Territory Associate (CTA) is a 24+ month developmental role that will partner with the Portland, OR team to gain knowledge in all aspects of our business to include technical, clinical, and sales.
Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager)
* Assists sales representatives with surgeon trainings, hospitals robotic development, and overall territory management
* Guides technical in-services for customers to include OR staff, surgeons, etc.
* Sells benefits of advanced technology to existing robotic users to contribute to team overall quotas
* Gains experience in goal setting, mapping, and attaining in preparation for quota bearing role to follow CTA position
* Manages administrative tasks: reporting of sales/procedures, outcomes of sales activities, submission of expense reports
Qualifications
Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job)
* Minimum 1-year leadership (military) experience or 1 year of outside sales experience required
* Ability to travel up to 25%, and work nights and weekends as needed
Required Education and Training (As applicable - Specific education and training that an individual must possess in order to successfully perform in job)
* Bachelor's degree required
Working Conditions (As applicable - Any physical requirements for the job. If not applicable, state "none")
* None
Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have)
* Proven record of success
* Ambition and exceptional work ethic
* Ability to excel in a high-energy, fast-paced environment
* Excellent interpersonal skills and persuasive communication skills
* Proven ability to work effectively as part of a team
Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
Mandatory Notices
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages, inclusive of base pay + commission, benefits, and equity. The on target earnings for this position are listed.
Clinical Associate
Clinical research coordinator job in Portland, OR
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Clinical Associate
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
Our Abbott story is one of delivering bold solutions in the face of complex healthcare challenges. At Abbott Electrophysiology (EP), we've been a leader for over 20 years, pioneering one of the first mapping systems, introducing the first contact force ablation catheter and creating a portfolio of products trusted in millions of procedures around the world. We have and will continue to redefine what's possible in an evolving and challenging EP landscape.
When you join Abbott EP, you become part of a passionate group of individuals who are dedicated to driving the EP space forward and helping people live longer, fuller lives. We are committed to building a foundation for our people to be successful, investing in their development and growth, and creating a diverse, inclusive culture that welcomes different perspectives, experiences and backgrounds.
What You'll Work On
Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager.
As a Clinical Associate on the U.S. Abbott EP team, you will provide clinical and technical support in a hospital setting, utilizing EP technology in the treatment of various cardiac arrhythmias. You will join a high-functioning, collaborative team, partnering closely with physicians and hospital staff to support the diagnosis and treatment of abnormal heart rhythms to achieve better patient outcomes. In this role, individuals will exercise independent judgment in planning, organizing, and performing day-to-day tasks. You will identify and routinely use the most effective, cost-efficient, and best business practices to execute processes, regularly communicating insights, feedback, and results to managers and team. Additional responsibilities include:
Gaining foundational knowledge of EP through a structured training program with a strong emphasis on hands-on learning and practical application.
Providing regional EP procedural case coverage in an Electrophysiology lab and/or operating room setting.
Acting as a clinical interface between the medical community and the business.
Demonstrating the ability to build and sustain credible clinical relationships with customers and sharing product expertise accordingly.
Demonstrating a thorough command of all EP products, including technical details, software utilization, and capabilities.
Providing engineering, sales, education, and clinical support on the safe and effective use of Abbott EP products, including cardiac mapping, diagnostic, and therapy systems.
Supporting EP Sales Representatives in the following areas:
Collaborating with sales personnel;
Facilitating regional training seminars;
Participating in clinical studies/data collection;
Troubleshooting; and,
Leading/supporting new product in-service trainings and/or demonstrations to physicians, nurses, and sales representatives.
Continuously develops engineering, sales and technical skills aligned with the overall territory strategy, including learning from senior sales personnel and management.
Staying up-to-date on the latest industry developments, regulatory requirements, and maintains strong knowledge of company and competitor products, market trends, and strategic goals.
Providing management with feedback on market trends and customer insights to inform strategic decisions and guide next-generation product development.
Participating in occasional travel for in-person instruction and live procedure coverage.
Required Qualifications
Bachelors Degree or equivalent experience.
Verification that you will satisfy all vendor credentialing requirements, which may include vaccination for COVID-19. If you require a medical or religious accommodation from these requirements or if you would like to understand more about these requirements, please advise HR so that we can provide additional information and if needed, we can explore any needed accommodation(s).
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews.
The base pay for this position is
$50,000.00 - $100,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Support ServicesDIVISION:EP ElectrophysiologyLOCATION:United States of America : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 50 % of the TimeMEDICAL SURVEILLANCE:YesSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
Auto-ApplyClinical Appeals Coordinator
Clinical research coordinator job in Salem, OR
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
Clinical Coordinator
Clinical research coordinator job in Portland, OR
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.
Auto-ApplyClinical Associate Physician
Clinical research coordinator job in Portland, OR
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 *************.
Auto-ApplyClinical Territory Associate
Clinical research coordinator job in Portland, OR
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
*Please note: Candidates must live within or be willing to relocate to the Portland, OR Area to perform the duties of this role.
Primary Function of Position
The
Clinical Territory Associate
(CTA) is a 24+ month developmental role that will partner with the Portland, OR team to gain knowledge in all aspects of our business to include technical, clinical, and sales.
Essential Job Duties
(Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager)
Assists sales representatives with surgeon trainings, hospitals robotic development, and overall territory management
Guides technical in-services for customers to include OR staff, surgeons, etc.
Sells benefits of advanced technology to existing robotic users to contribute to team overall quotas
Gains experience in goal setting, mapping, and attaining in preparation for quota bearing role to follow CTA position
Manages administrative tasks: reporting of sales/procedures, outcomes of sales activities, submission of expense reports
Qualifications
Required Skills and Experience
(Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job)
Minimum 1-year leadership (military) experience or 1 year of outside sales experience required
Ability to travel up to 25%, and work nights and weekends as needed
Required Education and Training
(As applicable - Specific education and training that an individual must possess in order to successfully perform in job)
Bachelor's degree required
Working Conditions
(As applicable - Any physical requirements for the job. If not applicable, state “none”)
None
Preferred Skills and Experience
(As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have)
Proven record of success
Ambition and exceptional work ethic
Ability to excel in a high-energy, fast-paced environment
Excellent interpersonal skills and persuasive communication skills
Proven ability to work effectively as part of a team
Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
Mandatory Notices
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide market-competitive compensation packages, inclusive of base pay + commission, benefits, and equity. The on target earnings for this position are listed.
Clinical Research Associate ll - Oncology (Oregon)
Clinical research coordinator job in Oregon City, 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
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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
https://**************/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://**************/join-us/reasonable-accommodations.html
TI Sr Clinical Research Associate
Clinical research coordinator job in Portland, OR
The Knight Cardiovascular Institute Clinical Research Associate is responsible for various duties supporting clinical trials focused on the investigation of new drug, infusion, and gene therapies for treating patients with cardiac diseases including, hypertrophic cardiomyopathy, amyloidosis, and others encompassing an array of heart failure disease phenotypes supporting the Cardiomyopathy research team directed by Dr. Masri. This position will have a strong understanding of the principles of clinical research and the regulatory responsibilities integral to the success of the work; they will be available to all coordinators and assistant coordinators for triaging daily questions.
The position is on point for all regulatory work, organizing and leading monitoring visits with sponsors, preparation and execution of activities needed during an FDA audit, and working with leadership on projects relating to study start-up. They also serve as a mentor to junior research staff in the group, is on point for collaborating with leadership in organizing the training and onboarding of new coordinators within the group, as well as developing standardized workflows and SOP's for the program. Lastly, this position is also responsible for analyzing and interpreting complex research data and assisting the principle investigator in publication development.
The Clinical Research Associate is the primary liaison for patients receiving experimental research procedures on a clinical trial and is responsible for the triage of patient needs and identification, reporting of, and follow-up of adverse events. They have a strong understanding of the connection and differences between clinical care and protocol visits conducted for research subjects. This position will primarily support our Hypertrophic Cardiomyopathy and Amyloid research team within the division of Cardiology, they may be reassigned secondary duties to support other sections within the Cardiovascular Medicine Clinical Trials Unit and Knight Cardiovascular Institute. This is an onsite role with limited hybrid opportunities.
Function/Duties of Position
The Senior Coordinator oversees all regulatory activities for each study in the program. This includes the following:
IRB Protocol Management and Development
* In collaboration leadership and based on sponsor protocol, develop and submit new IRB protocols for review.
* Work in collaboration with coordinator teams and leadership to ensure timely closeout of all IRB protocols covering studies that have terminated
* Work in collaboration with coordinator teams and leadership to ensure all IRB protocols are up to date, including updated staffing information, accurate term dates, and that amendments and continuing reviews are submitted timely when adjustments are needed.
* Be the primary point of contact for IRB. Collaborate with study teams and leadership to submit changes, and address regulatory gaps with IRB protocols.
Study Documentation
* Monitor and ensure documentation storage meets FDA, institutional and sponsor guidelines.
* Oversight and maintenance of all regulatory binders for each study
* Ensure proper filing of all study correspondence between study team and sponsor for audit purposes
* Ensure proper filing of all correspondence between IRB and study team for audit purposes
* Ensure centralized documentation of all training certificates and medical license (if applicable) for study site staff and investigators for audit purposes
* Ensure centralized documentation of all monitor visit reports. This includes site selection, site initiation, monitoring visits, and close-out reports
*
Audit Support/Preparation
* Will develop in collaboration with leadership standardized auditing processes that includes a consistent methodology across all trials and allows for all critical components of study conduct to be reviewed.
* In collaboration with leadership, identify at risk trials and perform an in-depth internal review.
* Provide standardized reporting of all relevant findings, including possible action items and areas for retraining or process changes.
* Learn FDA audit practices and work to identify and create strategies towards FDA audit in collaboration with leadership.
Monitoring Visits
* Work with the study teams to schedule and organize any documentation or data entry needed prior to the monitoring visit
* Meet and provide any needed information or data to the monitor during the visit
* Assist study teams in addressing any key deficiencies identified during a site monitoring visit. Provide report out to leadership on next steps.
* Ensure all documentation post-visit is entered into EPIC and EDC
* Responsible for direct sponsor correspondence regarding patient safety, responding to queries, reporting adverse events, conduction of visits, etc.
Required Qualifications
* Master's Degree in relevant field AND 3 years of clinical research coordination experience OR Bachelor's Degree in relevant field AND 5 years of clinical research Coordination experience
* Strong interpersonal communication skills and excellent attention to detail
* Critical thinking skills to anticipate and address potential problems
* Very Strong understanding of Research Regulations and best practices
* Strong knowledge of FDA regulations and audit preparation practices
* Strong data abstraction and project management skills
* Ability to prioritize multiple tasks at one time
* Strong teaching skills with the ability to mentor junior staff
* Must have excellent communication, analytical and organizational skills: both written and verbal.
* Ability to work independently and as part of a team while being collaborative in resolving problems.
* Must be proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint).
* Must have demonstrated excellent customer service skills both on the phone and in person.
* Demonstrated ability to work with a variety of diverse individuals and personalities.
* Must possess energy and drive to coordinate multiple projects simultaneously.
* Ability to use tact and diplomacy to maintain effective working relationships
Preferred Qualifications
* Masters degree
* 5+ years of experience in coordinating clinical trials
* Experience in coordinating trials in cardiovascular medicine
* Experience managing regulatory activities for clinical trials
* Previous experience at the Research Associate or Senior Coordinator level
* Prior experience leading clinical research teams and mentoring junior staff
Additional Details
Location: Marquam Hill & South Waterfront Campus
Schedule: Monday - Friday, 6am - 6pm primary business hours with variability depending on clinical schedules with occasional evenings & weekend work to meet project deadlines/goals. As salaried employee senior coordinators are expected to flex their time in conjunction with OHSU policy; this may mean working more than 40 hours in a week and then less another.
Must be able to travel to all KCVI worksite locations, including potentially using the tram numerous times each day. Will work with human biological samples, including samples which may contain infectious disease. Research assistant Coordinator may be expected to travel to conferences, new study meetings. Clinical Research Assistant Coordinator is required to use Personal Protective Equipment (gloves, masks, etc.) as required to maintain a safe and healthy clinical research environment. Additional safety training may be required to work in clinical research. Position requires ability to focus in a busy cubicle environment with multiple distractions. Position requires successful completion of BLS certification.
Due to the increased focused writing and focused attention on creation of sensitive study start-up regulatory materials this position is permitted to work remotely 1 day per week to complete this portion of the role.
The other aspects of this role are patient facing on-site role. All obligations to clinical schedules and security of paper PHI and clinical trials regulations must be maintained at all times - this severely restricting the ability to conduct work remotely.#LI-CC1
All are welcome
Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at ************ or *************.
Auto-Apply