Clinical Research Coordinator
Clinical Research Coordinator Job In Kansas City, MO
PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship.
Kelly Science & Clinical is seeking a Clinical Research Analyst for a temporary position (with potential to extend/covert) at a leading client in Kansas City, MO. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Pay Rate:
$30-38.00/Hour (commensurate with experience)
Overview:
A Clinical Research Analyst plays a critical role in the identification of qualified clinical study participants and in the collection of data required to support the development of new diagnostic and screening solutions and other medical treatments and therapies. This position requires attention to detail, a commitment to ethical research practices, and a strong ability to work in a collaborative, interdisciplinary environment.
Schedule:
Friday - Monday, 1st/Day: Standard Hours
Responsibilities:
Study Planning:
• Collaborate with research teams to design and develop processes to meet the requirements of research protocols.
• Assist in selection of study participants, data collection methods, and study timelines.
Data Collection & Management:
• Oversee data collection for clinical studies, ensuring accuracy and regulatory compliance.
• Maintain and organize study-related documents and records.
• Review potential participants' clinical records to ensure study qualification.
• Ensure proper data entry within operational platforms (e.g., Electronic Data Capture System, Customer Relationship Management System).
Data Analysis:
• Utilize statistical and data analysis tools to process and analyze clinical data.
• Extract meaningful insights and trends to support research objectives.
Regulatory Compliance:
• Ensure all research activities adhere to ethical and regulatory guidelines (e.g., Good Clinical Practice, Institutional Review Board protocols).
• Stay updated on and strictly follow data privacy regulations (e.g., HIPAA, GDPR) and ensure compliance.
Reporting:
• Prepare comprehensive reports and summaries of research findings.
• Contribute to scientific publications and presentations.
Collaboration:
• Work with cross-functional teams to facilitate smooth execution of clinical studies.
Quality Control:
• Implement quality control measures to guarantee data accuracy and integrity.
• Identify discrepancies and address issues promptly.
Literature Review:
• Stay updated on current research trends and developments in clinical research.
Technology Utilization:
• Proficiently use data management software and statistical analysis tools.
Communication:
• Effectively communicate research progress, challenges, and findings to stakeholders.
Data Privacy & Security:
• Implement and maintain data privacy and security protocols.
• Conduct regular risk assessments and participate in security audits.
• Ensure proper data encryption and access controls are in place.
• Report any potential data breaches or security incidents immediately.
Qualifications:
• Bachelor's degree in a relevant field (e.g., Life Sciences, Statistics, Public Health).
• Strong analytical and data management skills.
• Excellent communication and collaboration skills.
• Detail-oriented with a focus on data accuracy and quality.
• Familiarity with ethical and regulatory guidelines in clinical research.
• Understanding of data privacy laws and information security best practices.
• Experience with clinical trial management systems and statistical software (e.g., SAS, R, SPSS).
• Certification in Good Clinical Practice (GCP) preferred.
Physical Requirements
• Ability to sit for extended periods and use a computer for long hours.
• May require occasional travel to research sites or conferences.
Dialysis Clinical Coordinator (RN)
Clinical Research Coordinator Job In Kansas City, MO
$7500 SIGN ON BONUS! Dialysis Clinic, Inc. is recruiting top talent interested in supporting our nonprofit mission to prioritize individualized care for patients facing chronic kidney disease. Our mission states “the care of the patient is our reason for existence,” and our dedicated team embodies our sole purpose during every patient interaction. We seek motivated, compassionate individuals to provide top-notch patient care and offer paid training, competitive pay, outstanding benefits, Sundays off and a strong culture. Join DCI today to build relationships and gain fulfillment serving individuals in our comfortable clinical setting with a lower caregiver-to-patient ratio than other providers.
The Clinical Coordinator (RN) is responsible for the clinical management of the hospital dialysis program and the supervision of all nursing personnel in order to ensure every patient receives the safest care with the highest quality optimal outcomes. This position will be part of our Hospital Services program at Research Medical Center.
Schedule: Full-time, four 10-hour days, shifts start at 6:00am; Sundays off; no overnight shifts
Benefits:
Comprehensive medical, dental and vision benefits
Life and long-term care insurance provided at no additional expense to employee
Paid time off (PTO) including holidays
Extended Sick Bank (ESB) in addition to PTO - paid time for doctor appointments, sickness or medical leave
Retirement plans with $.50 of each contributed dollar matched for eligible employees, up to 8 percent
Education reimbursement
Employee assistance program
Wellness program
Among others
Responsibilities:
What You Can Expect:
Perform duties as a Dialysis Hospital Services Nurse.
Supervise and monitor direct patient care provided by PCTs, LPNs, and RNs including but not limited to initiating, monitoring and terminating dialysis treatments as well as physical assessment of patients.
Monitor overall performance and clinical outcomes for the facility in collaboration with the Medical Director and Clinic Administrator.
In collaboration with the Clinic Administrator, review of patient flow sheets is completed at end of day as well as spot checks during the day; verifying documentation accuracy for decreased blood flow rates, other prescription changes, early discontinuation, and fluctuations in blood pressure with notification to charge nurse.
Audit flowsheets to ensure transcription and implementation of Physician's orders is completed.
Participate in QAPI and supports outcome management through appropriate action plans.
Collaborate with the Clinic Administrator for patient care staffing, matching patient needs with staff capabilities and experiences to maximize staffing resources.
Collaborate with the Clinic Administrator on the scheduling of patients to ensure all patients are treated in a timely manner.
Assist in the teaching and training of new staff members as directed by the Nurse Educator - i.e., machines, Ros, procedures etc.
Act as the Subject Matter Expert and assist nurse educator with training for staff in all clinical systems.
Ensure vascular access management for the patients is documented as needed.
Qualifications:
Successful Candidates Bring:
Excellent communication skills
Demonstrated clinical excellence
Desire to collaborate with care teams
Ability to problem solve
Education/Training:
Maintain a current MO license as a registered nurse
Completion from an accredited Registered Nursing Program
2 years' experience in an acute/hospital dialysis setting
Experience in critical care nursing is preferred
Experience in a supervisory role is preferred
DCI provides comprehensive hands-on training in order to equip our nurses for success
DCI is committed to building a diverse and inclusive organization. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status.
DCI's Differentiator:
Since opening the first clinic 50 years ago in Nashville, Tenn., our Dialysis Clinic, Inc. family has grown to be the nation's largest nonprofit dialysis provider with more than 270 locations in 30 states, serving nearly 14,000 patients each day. DCI invests in our care teams and funds research to further kidney care and treatment options. DCI prioritizes a holistic approach and offers hemodialysis, home dialysis and peritoneal dialysis treatment options. We empower patients to live meaningful and productive lives while also delivering high quality kidney care, saving lives and reducing hospitalizations. Learn more about DCI and see if we're hiring in a clinic near you! ***************
DCI is a federal contractor and an Equal Opportunity/Affirmative Action Employer-Veterans/Individuals with Disabilities. If you are having difficulty using the online application system or would like to request other accommodations or application methods, please contact Doug Patterson at Accommodations@dciinc.org or ************. Once a request has been made, DCI will initiate a discussion with you about your needs and whether an accommodation can be provided. DCI is committed to providing such accommodations where possible.
For more information about equal opportunity please see:
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Security Roles and Responsibilities can be reviewed at: *************************************
Study Start-Up Clinical Research Associate, Sponsor Dedicated
Clinical Research Coordinator Job 16 miles from Kansas City
IQVIA is seeking Study Start-Up Clinical Research Associates to join our Sponsor Dedicated teams. Ideal candidates will have experience in Study Start-Up and at least 8 months of on-site monitoring experience. Candidates can be located anywhere in the United States. This role does require travel up to 70-80%.
Job Overview
The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV trials in the country in accordance with monitoring procedures and processes following ICH/GCP, local regulations and SOPs.
Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).
Supports country SSU strategy in close collaboration with the SSO Study Start-Up Team Lead, the SSO Study Start-Up Manager, and the SSO Feasibility Manager as well as the SSO Site Partnership Manager
Collaborates with the SSO Study Start-Up Manager, the SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments
Accountable for timely start-up activities from country allocation until site greenlight at assigned sites
Conducts site selection visits, verifies site eligibility for a specific study
Acts as the main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation
Ensures that milestones (KPIs) and time schedule for study start-up are met as planned
Facilitates the preparation and collection of site and country level documents
Collects submission-related site-specific documents for all relevant site personnel within agreed timelines (e.g., FD, CV, GCP certificates, DSL, etc.)
Supports the SSU Manager with preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
Supports the SSO Study Start-Up Manager and assigned sites with vendor set-up activities
Prepares and finalizes site specific documents for submission
Negotiates investigator payments, as needed
Supports preparation of financial contracts between Sponsor and investigational sites and investigators, as needed
Updates all systems until site Green Light on an ongoing basis
Supports preparation of audits and inspections, as applicable
Supports reduction of formal site-specific IRB/IEC deficiencies
Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readiness
Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health
Authority and SOP requirements Implements innovative and efficient processes which are aligned with the sponsor strategy
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $87,200.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Clinical Research Associate- West Coast
Clinical Research Coordinator Job 13 miles from Kansas City
As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing:** **Study Planning** - Contribute to the identification of new sites for clinical trials; analyse capability and support CRMA and CSM in making recommendation for trial inclusion.
- Assume ambassadorial role to facilitate communication between sites to increase value proposition to investigators.
- Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
- Negotiate investigator remuneration; prepare financial contracts between investigational sites and investigators. Ensure adherence to payment schedule.
**Study Execution**
- Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
- Identify problems at sites; resolve issues and escalate as appropriate.
- Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
- Complete preparation and generation of visit monitoring reports as per relevant SOP
- Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
- If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues
**Study Close-out**
- Implement site close-out activities and generate site close-out report.
- Provide feedback on site performance for future trial site feasibility/selection
**General**
- Improve skills by timely completion performance of assigned global and local training.
**You are:**
+ Minimum 18 months prior monitoring experience with global trials.In-depth knowledge of FDA regulations and ICH/GCP guidelines
+ Bachelors of Science
+ Excellent interpersonal and communication skills (verbal & written), including proficiency in medical terminology and computer systems
+ Ability to work effectively with investigators and other research personnel, maintaining a professional demeanor
+ Ability to independently resolve site or study related issues
+ Self motivated; detail oriented; team player; flexible
+ Ability to prioritize workload to meet project timelines, while managing multiple protocols across therapeutic areas
+ Excellent organizational and time management skills
+ Function effectively with high degree of personal accountability
+ CCRA or SoCRA certified
_Pay Range ($73,864.00 - $92,330.00 USD)_
_Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level._
Thank you!
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs
+ Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
+ Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ************************************
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
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Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Senior Clinical Research Coordinator - Cancer Center
Clinical Research Coordinator Job In Kansas City, MO
Department: SOM KC Cancer Center Clinical Trials * ---- Administration Senior Clinical Research Coordinator - Cancer Center Job Family Group: Professional Staff The Senior Clinical Research Coordinator works collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The Senior Clinical Research Coordinator will manage assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Participates in periodic quality assurance audits of protocols. Supports the development of study budgets, contracts, and grant applications. Provides task direction, as needed, for junior level clinical research coordinators.
This position will be 100% onsite due to the fact this is a patient facing role.
The University of Kansas Cancer Center is the region's only National Cancer Institute-designated comprehensive cancer center. We strive to provide the most advanced comprehensive care possible. In addition to standard care and treatments, we perform studies to help find better ways of preventing, diagnosing and treating various types of cancer.
:
Job Duties:
* Under the direction of the principal investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials.
* Assist clinical staff with maintaining source documents and submit case report forms (CRFs) as required for clinical trials.
* Responsible for lead worker duties including mentoring, training and assisting junior staff with onboarding and learning the clinical research coordinator position.
* Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
* Assist clinical staff with study procedures, as outlined in the protocol and within state and KUMC scope of practice.
* As requested, facilitate monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
* Prepare and maintain clinical trial contract documents and study budget reports.
* Perform study procedures, as outlined in the protocol and within state and institutional scope of practice.
* Assist clinical staff with sample collection, processing, handling, and shipping as outlined in the protocol and within KUMC policy.
* Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies and study participants.
* Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
* Attend continuing education, research and training seminars as requested by manager.
* Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR.
* Coordinate closely with the Research Institute and Human Research Protection Program and have a significant working knowledge of KUMC policies and procedures.
* Review and assist with editing of new protocols. Assesses feasibility of research protocol including appropriate patient population, budget and specific needs for the study.
* Assist Principal Investigators with internal and external funding application submissions.
* This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.
Required Qualifications
Education:
* Bachelor's degree OR an equivalent combination of relevant post-secondary education and work experience that equals at least 4 years.
Certification:
* Research certification such as Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP).
Work Experience: 4 years clinical research experience that includes the following:
* Experience with regulations governing clinical research (CFR, GCP, HIPAA).
* Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
* Experience with study budgets, contracts, and grant applications.
* Excellent communication as evidenced by application materials.
* Experience using computer MSO Suite: Outlook, Windows, Excel and Word.
Preferred Qualifications
Education:
* Master's degree in relevant field.
Skills:
* Communication skills including, written, verbal, and presentation.
* Organizational skills.
* Organization and time management skills.
Required Documents:
* Resume/CV AND Cover Letter
Comprehensive Benefits Package:
Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. **************************************************
Employee Type:
Regular
Time Type:
Full time
Rate Type:
Salary
Compensation Statement:
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Pay Range:
$65,000.00 - $99,000.00
Minimum
$65,000.00
Midpoint
$82,000.00
Maximum
$99,000.00
Senior Clinical Research Coordinator - Internal Medicine (Pulmonary)
Clinical Research Coordinator Job In Kansas City, KS
Department:SOM KC Internal Medicine - Pulmonary, Critical Care, and Sleep Medicine
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Pulmonary and Critical Care MedicinePosition Title:Senior Clinical Research Coordinator - Internal Medicine (Pulmonary) Job Family Group: Professional Staff Summary:The Senior Clinical Research Coordinator will manage assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Participates in periodic quality assurance audits of protocols. Supports the development of study budgets, contracts, and grant applications. Provides task direction, as needed, for junior-level clinical research coordinators.
*** This role is required to be on campus due to the nature of the work***
Compensation to commensurate with experience.Job Description:
Required Qualifications:
Education/Certifications:
Associate's degree or an equivalent combination of relevant post-secondary education and work experience that equals at least 2 years
At least one of the following certifications:
Certified Clinical Research Coordinator(CCRC)
Certified Clinical Research Professional(CCRP)
Work Experience:
4 years related work experience
Advanced understanding of regulations governing clinical research (CFR, GCP, HIPAA).
Experience with study budgets, contracts and grant applications.
Advanced understanding of statutes and guidelines relevant to regulatory affairs in clinical research as evidenced by application materials
Preferred Qualifications
Education:
Master's degree in relevant field.
Skill:
Business and financial acumen to assist in developing study budgets, contracts, and grant applications.
Ability to fully contribute to multidisciplinary teams including physicians, and administrative staff.
Ability to effectively manage competing priorities and deadlines.
Job Duties
Under the direction of the principal investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials.
Assist clinical staff with maintaining source documents and submit case report forms (CRFs) as required for clinical trials.
Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
Assist clinical staff with study procedures, as outlined in the protocol and within state and KUMC scope of practice.
As requested, facilitate monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
Prepare and maintain clinical trial contract documents and study budget reports.
Perform study procedures, as outlined in the protocol and within state and institutional scope of practice.
Assist clinical staff with phlebotomy and sample collection, processing, handling, and shipping as outlined in the protocol and within KUMC policy.
Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies and study participants.
Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
Attend continuing education, research and training seminars as requested by manager.
Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR.
Coordinate closely with the Research Institute and Human Research Protection Program and have a significant working knowledge of KUMC policies and procedures.
Reviews and assists with editing of new protocols. Assesses feasibility of research protocol including appropriate patient population, budget and specific needs for the study.
Assist Principal Investigators with internal and external funding application submissions
Assure that all professional nursing care provided is conducted in accordance with all KUMC and other regulatory requirements and is in accordance with the scope of practice for the nursing license held
Other relevant duties as requested by the supervisor.
Required Documents
Resume
Cover letter showing how you meet the required and preferred qualifications.
3 professional references
Comprehensive Benefits Package:
Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. **************************************************
Employee Type: RegularTime Type: Full time Rate Type: Salary
Compensation Statement:
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Pay Range:$65,000.00 - $99,000.00
Minimum
$65,000.00
Midpoint
$82,000.00
Maximum
$99,000.00
Clinical Research Site Manager (Kansas City, MO)*
Clinical Research Coordinator Job In Kansas City, MO
The Company Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available.
Mission, Vision, Values
o Mission: Improving Lives by Providing Advanced Therapeutic Options
o Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research.
o Values:
o Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions.
o Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues.
o Solution Orientation: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions.
o Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards.
Profound Ethos
o Physicians are the Vanguard
o All Decisions Improve Patient Care
o Never Compromise Quality
Role & Responsibilities:
-Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
-Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
-Responsible for immediate supervision and performance of the assigned site including conducting performance reviews as well as coaching, counseling, and implementing disciplinary action if needed.
-Responsible for ensuring appropriate training of all staff to ensure compliance and inspection readiness.
-Work closely with Operations and Business Development leadership on feasibility and study placement.
-Accountable for enrollment planning and success at sites across all studies; understand revenue expectations.
-Coordinate as primary CRC on at least one trial of medium to high complexity and serve as a back-up CRC for other study procedures and trials when needed. This includes completing all relevant training in a continued timely manner.
-Share best practices with other Profound site locations with the goal of raising the overall level of operational competencies at Profound.
-Work closely with the Quality Assurance team to ensure quality at the site; create processes and CAPAs to improve trends as needed.
-Identify and build relationships with outside medical practices, pharmacies, and other healthcare professionals/organizations to aid in the patient recruitment process.
-Act as a site liaison and champion by communicating effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
-Ensure weekly, monthly, and quarterly assigned goals are met for the respective sites.
-In addition to trial specific responsibilities, support in building and implementing a scalable operations infrastructure at new, regional Profound Research sites as needed.
-Other duties as assigned by leadership.
Requirements & Skills:
-Associate degree or BS / BA in Life Sciences or related discipline.
-8+ years prior experience as a clinical research coordinator
-3-5 years of direct line management responsibilities
-Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification preferred.
-Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens.
-Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done.
-Excellent attention to detail, organization, and communication with varied stakeholders.
-Able to travel regionally and to professional meetings as required.
Physical Requirements
· Prolonged periods of sitting at a desk and working on a computer, standing and walking.
· Must be able to lift 25 pounds at times.
· Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
· Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
· Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound.
· The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
Senior Clinical Research Associate
Clinical Research Coordinator Job In Kansas City, MO
Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest's headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.
Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that's us…that's Everest.
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Research Associates for coverage on the East Region. The incumbents may be required to travel to other locations across the USA to support monitoring activities as necessary.
Key Accountabilities:
Interact with personnel from study Sponsors, investigational sites, vendors, and Everest functional groups to enable quality and on-time execution of clinical trials in compliance with ICH-GCP and relevant local regulations.
Identify potential sites for participation in clinical trials.
Perform protocol/site feasibility and Pre-Study Visits to recommend qualified sites.
Participate in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions, and assist sites with study-related questions as needed.
Provide feedback to study manuals, Case Report Form completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as needed.
Perform Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan.
Submit quality and on-time Monitoring Visit Reports and follow-up letters to the Clinical Operations Lead or designee for review and approval via Clinical Trial Management System (CTMS).
Complete monitoring visit reports and follow-up letters, including summaries of the significant findings, deviations, deficiencies, and recommended actions to ensure site compliance.
Assist with oversight visits and monitoring visit report review/approval of CRA I/II, evaluating their performance and providing feedback to their supervisor, if requested.
Review ISFs to ensure essential documents are current and submitted to the TMF throughout the trial for reconciliation purposes. Ensure sites have submitted relevant documents to their Institutional Review Board/Ethics Committee as needed. The CRA is responsible for ensuring that the TMF is maintained in an inspection-ready state.
Establish regular lines of communication and administer ongoing protocol/study-related training to assigned sites.
Assist with site management tasks and ensure continuous data flow (i.e., on-time site data entry, query resolution, and source document verification). Assess the clinical research site's patient recruitment/retention success and offer suggestions for improvement.
Ensure proper handling, accountability, and reconciliation of all investigational products, medical devices, and clinical trial supplies.
Prepare sites for inspections/audits conducted either by regulatory authorities, Sponsors, or Contract Research Organizations.
Submit accurate and on-time expense reports.
Assist with preparation of materials for Requests for Proposals and bid defenses.
Assist the Clinical Operations team with additional related tasks as needed.
Plan and carry out professional development.
Complete timesheets as requested and on-time.
Qualifications and Experience:
Bachelor's degree in a Life Science or related field of study.
Minimum of 4 years' of relevant and/or monitoring experience.
Thorough knowledge of ICH-GCP guidelines and applicable regulations.
Thorough comprehension of medical terminology.
Excellent organization and communication skills (both verbal and written).
Ability to travel a maximum of 70% of working hours to locations nationwide. Less travel hours may apply for projects with remote/virtual visits.
Must maintain a valid driver's license and be able to drive to monitor sites.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at ****************
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
#LI-Remote
#LI-MG1
Senior Clinical Research Associate
Clinical Research Coordinator Job In Kansas City, MO
Senior Clinical Research Associate - Regional Type: Full time This is an excellent opportunity to check off all of the above! You are working for a sponsor, in a therapeutically aligned model conducting remote and onsite monitoring of regional sites in a risk-based monitoring model.
Responsibilities:
+ Responsible for providing site management and support to external trial staff (Principal Investigators and Study Coordinators) from trial initiation to closeout.
+ Ensure collection of high-quality data, timely adverse event reporting, subject protection, and compliance to the protocol.
+ Manage recruitment and retention strategies at the site level, analyzing enrollment and randomization projections against actual recruitment numbers to ensure targets are met.
+ Collaborates regularly with Local Trial Manager (LTM) and Line of Business Manager, communicating site progress and escalating critical issues that could impact trial milestones.
+ Trains and supports external trial staff regarding requirements for CRF and IVRS data entry, AE/SAE/MESI reporting, ethics reporting, protocol deviation identification, drug accountability and temperature monitoring, query resolution, essential document collection and ITF filing.
+ Identifies objectives for scheduled monitoring visits; ensures planned visit objectives are achieved to meet protocol and SOP timelines.
+ Prepares and completes monitoring visit reports and follow up letters within the timeline established by the applicable SOPs and guidelines.
Requirements:
+ Educational requirement: BA/BS
+ Years of experience: 3+ years of CRA (monitoring experience)
+ Industry experience: 5+ years of clinical research industry experience
+ Diabetes experience is a nice to have
+ Remote Monitoring Experience
+ Risk Based Monitoring
Working Conditions:
+ Works from a home office environment at least one day a week.
+ Works at hospitals, medical clinics three to four times a week.
+ May be required to drive, fly, or take train to location to perform duties of the job.
+ Up to 70% travel required.
Benefits:
System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
Ref: #568-Clinical
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Clinical Research Coordinator
Clinical Research Coordinator Job In Kansas City, MO
Supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Works under the direction of the clinical Principal Investigator PI. Works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
**Job Requirements**
Applicable Experience:
Less than 1 year
Bachelor's Degree
**Job Details**
Full Time
Day (United States of America)
**_The best place to get care. The best place to give care_** **. Saint Luke's 12,000 employees strive toward that vision every day. Our employees are proud to work for the only faith-based, nonprofit, locally owned health system in Kansas City. Joining Saint Luke's means joining a team of exceptional professionals who strive for excellence in patient care. Do the best work of your career within a highly diverse and inclusive workspace where all voices matter.**
**Join the Kansas City region's premiere provider of health services. Equal Opportunity Employer.**
Clinical Research Coordinator
Clinical Research Coordinator Job In Kansas City, MO
Supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Works under the direction of the clinical Principal Investigator PI. Works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
Job Requirements
Applicable Experience:
Less than 1 year
Bachelor's Degree
Job Details
Full Time
Day (United States of America)
The best place to get care. The best place to give care. Saint Luke's 12,000 employees strive toward that vision every day. Our employees are proud to work for the only faith-based, nonprofit, locally owned health system in Kansas City. Joining Saint Luke's means joining a team of exceptional professionals who strive for excellence in patient care. Do the best work of your career within a highly diverse and inclusive workspace where all voices matter.
Join the Kansas City region's premiere provider of health services. Equal Opportunity Employer.
Clincal Research Coordinator II (Contract)
Clinical Research Coordinator Job In Kansas City, MO
JOB DESCRIPTION: CLINICAL RESEARCH COORDINATOR II
POSITION DESCRIPTION: The Clinical Research Coordinator II (CRC) reports to the Regional Research Manager and is responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs. The CRC collects and records clinical research data, assists in patient assessments, scheduling, maintain study files, study supplies and study medication accountability.
RESPONSIBILITIES:
Responsible for up to 10 studies and expected to perform 20-40 visits a month.
Knowledge of all active protocols and disease indications within the company, and providing information about these protocols to staff and patients.
Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.
The CRC is responsible for meeting recruitment goals for each study. The methodology of recruitment will include, but is not limited to daily chart review, hosting recruitment breakfasts, advertising when funds are available, referrals from rheumatologists and other AARA staff and may include attending health fairs and community outreach.
Keeping the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators, and ensuring status of each patient is accurate.
Responsible for chain of custody and accurate accountability of investigation product and devices.
Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:
Informed Consent
Obtaining patient medical history and medication lists
Phlebotomy and basic laboratory tests
Processing & shipping labs for central and local labs
Patient education and training
ECG
Administer questionnaires and assessments
Vital signs
Collect information for adverse event reporting
Assist with joint counts and other efficacy assessments
Data Entry and Query Resolution
Study drug administration, including injections
Tracking study supply inventory and reordering when necessary
Schedule patient visits in appropriate electronic systems
Documenting all patient visits and communications in progress notes
Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed.
Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program.
Ensures uniform implementation of protocols by completing required training documentation in a consistent, accurate and timely manner.
Assists in regulatory functions, including but not limited to preparing appropriate Institutional Review Board (IRB) forms, processing updated informed consents, protocols, correspondence, and regulatory filing in an accurate and timely manner.
Responsible for administrative duties including filing documents related to subjects participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc.
Serves as a liaison to all physicians, AARA employees, and third party vendors.
Participates in monitoring visits from sponsor provided appointees, ensures monitors are able to meet/speak with PI and ensures all concerns are addressed in a timely manner.
Ensure the delegation logs are correct and only delegated site staff are performing duties as listed on the delegation log for any given study.
Ensures that primary referring physicians receive timely progress notes on the patient's diagnosis and treatment.
May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.
Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards.
Provides all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.
Maintaining office supply inventory while keeping an organized office space.
Travel as necessary for Investigator Meetings and other AARR sites.
Requirements
Qualifications:
Bachelor's Degree
1 year experience as a clinical research coordinator
Individual must have or be working towards obtaining Clinical Research Coordinator Certification (CRCC).
Must have in-depth knowledge of medical procedures and clinical terminology
CPR certified
Possess strong organizational skills
Ability to develop and maintain strong professional relationships with all providers and research subjects
Maintains confidentiality of patient and study information
Excellent working knowledge of ICH-GCP Guidelines and all Federal regulations
Understands and supports specific State regulations governing clinical research
Excellent verbal and written communication skills
Ability to lift 20 pounds
Willing and able to travel for Investigator Meeting and training
Clinical Trials Coordinator
Clinical Research Coordinator Job 10 miles from Kansas City
Job Details Leawood-Granada - Leawood, KS Full Time $59,000.00 - $62,000.00 Salary/year Description
)
Under general supervision of a physician in an outpatient clinical setting, provides assistance to principal
investigator to complete clinical trial visits. Ensures that trial subjects are scheduled appropriately and all
protocol-specified tasks are performed in a timely manner.
SECTION 2: Duties and Responsibilities (Responsibilities necessary to accomplish job functions)
Maintain all aspects of study protocol during recruitment, screening, enrollment, and follow-up visits
Conduct and coordinate patient visits including patient demography, vitals, EKG, phlebotomy, photography, administering investigational drug, assisting PI and sub-investigators with physical exam, and scheduling appropriate follow-up visits
Educate patients on study-specific protocol requirements, procedures, side effects and risks of trials and investigative medications
Communicate frequently with contract research organizations, IRB, Sponsors, Central Lab Facilities, and other outside vendors to manage the day to day needs for current and prospective trials
Maintain all source documents and investigational drug accountability records
Enter source data into EDC within one calendar day of subject visit
Continually review EDC for accuracy and completion, and resolve queries as they arise
Assists with direct patient care procedures including biopsies, surgeries, cosmetic procedures and related tasks; records patient medical history and exam notes in EMR. Selects appropriate billing and diagnosis codes based on procedures performed
Process prescriptions and prior authorizations as directed by physician. Address patient and/or pharmacy questions concerning medication. Enroll patients in patient education/assistance programs
Scans correspondence into EMR
Stocks and organizes medical supplies in exam rooms as needed. Notify appropriate personnel when supplies are needed
Practices safety, environmental, and/or infection control methods
Performs miscellaneous job-related duties as assigned
Process blood and urine samples in accordance with IATA and OSHA standards
Working knowledge, at minimum, of all applicable protocols. Some team members may be assigned as the primary coordinator for a specific protocol, and should therefore have in-depth knowledge of that protocol.
Qualifications
SECTION 3: Experience Requirements
4 years / Bachelor's Degree, or:
Medical assistant or equivalent clinical training; at least 1 year of experience that is directly related to the duties and responsibilities specified.
SECTION 4: Knowledge, Skills and Abilities Requirements
Meticulously detail oriented, professional attitude, reliable
Organizational skills to support accurate record-keeping
Ability to follow verbal & written instructions
Interpersonal skills to work as a team with patients and outside parties
Able to communicate effectively in English, both verbally and in writing, with proper grammar and spelling skills to avoid mistakes or misinterpretations
Mathematical and analytical ability for basic to intermediate problem solving
Basic to intermediate computer operation
Proficiency with Microsoft Excel, Word, and Outlook
Specialty knowledge of systems relating to job function
Knowledge of state and federal regulations such as ICH GCP, IATA; general understanding of HIPAA guidelines
SECTION 5: Supervisory Responsibilities:
This position has no supervisory responsibilities.
Benefits:
Medical, Dental, & Vision
401k
PTO & Paid Holidays
Company Paid Life Insurance
Employee Perks Program
Clinical Associate
Clinical Research Coordinator Job In Kansas City, KS
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.
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
In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
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.
* Acts as a clinical interface between the medical community and the business.
* Demonstrates ability to build and sustain credible business relationships with customers and shares product expertise accordingly.
* Provides engineering, sales, education and clinical support in response to field inquiries on as-needed basis. Demonstrates a thorough command of all EP products, related product and technical knowledge, trends and players.
* Develops, leads and/or facilitates trainings and other programs on EP products to healthcare professionals.
* Provides insight, guidance, and feedback to management on market feedback and components of next generation of products.
* Provides regional EP procedural case coverage.
* Provides additional back-up support to EP Sales Representatives in the following areas:
* Sales support;
* Regional training seminars;
* Clinical studies/data collection;
* Trouble Shooting; and,
* New product in-service training to physicians, nurses and sales representatives.
* Continuously develops engineering, sales and technical skills relative to the overall Arrhythmia Management strategy, including learning opportunities via Sr. Sales personnel and management.
* Assists Training and Education departments with advanced educational seminars, and the preparation of educational materials.
* Assists Sales with advanced product demonstrations to visiting physicians and sales personnel.
* Remains current on developments in field(s) of expertise, regulatory requirements, and a good working knowledge of company and competitor products, markets, and objectives as well as industry trends.
* Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
* Performs related functions and responsibilities, on occasion, as assigned.
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.
Field-Based HSS Clinical Coordinator - Shawnee, Douglas, Leavenworth Counties, KS
Clinical Research Coordinator Job 36 miles from Kansas City
At UnitedHealthcare, we're simplifying the health care experience, creating healthier communities and removing barriers to quality care. The work you do here impacts the lives of millions of people for the better. Come build the health care system of tomorrow, making it more responsive, affordable and equitable. Ready to make a difference? Join us to start **Caring. Connecting. Growing together.**
The **Long-Term Services and Supports (LTSS) Care Coordinator** is responsible for establishing a set of person-centered goal-oriented, culturally relevant, and logical steps to ensure that a person receiving LTSS receives services in a supportive, effective, efficient, timely and cost-effective manner. Care coordination includes case management, disease management, discharge planning, transition planning, and addressing social determinants of health and integration into community.
This position is a Field-Based position with a Home-Based office. Expected travelling 2-3 days per week within 30-60-mile radius.
If you reside within **Shawnee, Douglas, or Leavenworth Counties or the surrounding area** , you will enjoy the flexibility to telecommute* as you take on some tough challenges.
**Primary Responsibilities:**
+ Assess, plan, and implement care strategies that are individualized by the individual and directed toward the most appropriate, least restrictive level of care
+ Identify and initiate referrals for social service programs, including financial, psychosocial, community and state supportive services
+ Manage the person-centered service/support plan throughout the continuum of care
+ Communicate with all stakeholders the required health - related information to ensure quality coordinated care and services are provided expeditiously to all persons
+ Advocate for persons and families as needed to ensure the persons needs and choices are fully represented and supported by the health care team
+ Conduct home visits in coordination with person and care team, which may include a community service coordinator
+ Conduct in-person visits which may include nursing homes, assisted living, hospital or home
+ Serve as a resource for community care coordinator, if applicable
You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.
**Required Qualifications:**
+ Bachelor's degree in social work, Rehabilitation, Nursing, Psychology, Special Education, Gerontology, or related human services area
+ 2+ years of experience working within the community health setting in a healthcare role
+ 1+ years of experience working with persons with long-term care needs
+ 1+ years of experience working with persons receiving services on one of the homes and community-based waivers in KS
+ 1+ years of experience working with MS Word, Excel and Outlook
+ Ability to travel in assigned region to visit Medicaid members in their homes and / or other settings, including community centers, hospitals, or providers' offices
+ Access to reliable transportation and a valid US driver's license
**Preferred Qualifications:**
+ Licensed Social Worker or clinical degree
+ Registered Nurse
+ Background in managing populations with complex medical or behavioral needs
+ Experience with electronic charting
+ Experience with arranging community resources
*All Telecommuters will be required to adhere to UnitedHealth Group's Telecommuter Policy.
The salary range for this role is $28.61 to $56.06 per hour based on full-time employment. Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. UnitedHealth Group complies with all minimum wage laws as applicable. In addition to your salary, UnitedHealth Group offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with UnitedHealth Group, you'll find a far-reaching choice of benefits and incentives.
_At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location, and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups, and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission._
_Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity / Affirmative Action employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law._
_UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment._
\#RPO #RED
Clinical Associate (PRN)
Clinical Research Coordinator Job 4 miles from Kansas City
SUMMARY: Under the direction of the Director of Nursing, RN, LPN, will assist in the care of patients by performing basic nursing care and support tasks on assigned units. EXPERIENCE: Hospital experience preferred OTHER: Basic computer skills. Enrollment in a nursing program with completion of fundamentals course.
LICENSE/CERT: Required: BLS (Basic Life Support) from AHA (American Heart Association)
EDUCATION: Required: High School or Equivalent
DME Clinic Coordinator
Clinical Research Coordinator Job In Kansas City, MO
**This position requires a highly organized individual that carries strong knowledge in Clinic practices and procedures
with a background in DME Direct Patient care to include Medical insurance Verifications and all that entails **
What we do: Select Ortho is a rapidly growing national company that provides expertise, convenience, and reliability in the delivery and fitting of orthoses and durable medical equipment to orthopedic practices and their patients. Select Ortho leverages resources, technology, and expertise to increase net collection rates, improve compliance, and streamline supply chain in managing the DME Service Line™.
The high value we place on our employees is reflected in our competitive pay and exceptional benefits package, which includes Medical insurance (company pays 75% of the premium), Dental and Vision (company pays 100% of the premium), free life insurance, generous paid vacation time, paid sick time, paid company holidays, and more!
What we stand for: Our goal is to achieve nothing less than ecstatic customers. We do that by operating in a healthy culture of excellence and hiring employees who are happy to go the extra mile to achieve that vision. Working with purposeful energy and accountability comes naturally. Credibility always matters and small details are huge!
Are you ready to make a difference in the world? If so, read on!
What we need: A highly motivated, energetic, and customer service-focused individual that we can train to provide exceptional quality of care to patients in our partner clinics.
Position Summary:
The DME Coordinator is a trained member of the physicians' team, working with all health care professionals in delivering patient care.â¯The DME Coordinator is responsible for all matters related to and concerning DME within the clinic. Including, but not limited to, fitting, refitting, custom measurement, patient education, prior authorization, collection of co-ins/deductible, and patient satisfaction.
Essential Functions:
Provide fitting, patient education on application, use, care, and expected outcome for products as indicated by the physician instructions and manufacturer recommendations.
Educate patients on insurance plans and provisions, financial responsibility, and collection of patient portion.
Ensure all necessary documentation and authorization is obtained as it relates to payer requirements.
Track, maintain, and order inventory for one or multiple locations.
Actively promote and foster excellent relations inter-departmentally and with external case managers, payers, suppliers, physician clinical staff and surgery personnel.
Ensure compliance is maintained by documenting custom measurements, ABN's, MAE's and LMN's as needed.
Ability to work with a team of DMEPOS Coordinators and Billing Specialists.
Other duties, as assigned.
Required Education:
High School Degree or Equivalent (unless located in a state that requires licensing)
Professional health care certification or experience preferred but not required
Preferred Education:
Athletic Trainer
Certified Orthotic Fitter
Certified Orthotist
Medical Assistant
Minimum Requirements:
Aptitude for learning quickly
Working knowledge of word processing, spreadsheets, and databases
Moderate alpha and numeric data entry skills
The ability to work quickly and accurately, and pay attention to detail
Excellent skills in verbal and written communication and patient care
Judgment, decision-making, and time management skills
Ability to organize multiple projects and assignments at once
Must pass drug and alcohol screening
Knowledge, Skills, Abilities, and Experience:
DME or orthoses related medical experience
Knowledge of Anatomy, Physiology, Medical terminology, Insurance Claims, and Insurance Benefits
Biomechanics
Experience fitting DME devices
Knowledge of medical billing/collection practices
Basic medical coding and third-party operating procedures and practices
Ability to establish and maintain effective working relationships with physicians, patients, employees and the public
Work Environment - The job operates in an active clinical environment. This role requires regular movement to various locations within the clinic. This role routinely uses standard office equipment such as computers, phones, photocopiers and fax machines.
Physical Demands - The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is required to communicate effectively in a high traffic environment. This position is active and requires the ability to move from a sitting to standing position regularly, standing for long periods of time each day, movement, bending, kneeling and stooping. The employee must frequently lift or move items weighing 20 pounds or more, in addition to sometimes lifting items weighing 5 pounds or more. The employee is also required to perform high functioning dexterity tasks.
~ Select Ortho is an equal opportunity employer that places high value on diversity and inclusion in people, ideas and our collaborative culture.~
Study Start-Up Clinical Research Associate, Sponsor Dedicated
Clinical Research Coordinator Job 16 miles from Kansas City
IQVIA is seeking Study Start-Up Clinical Research Associates to join our Sponsor Dedicated teams. Ideal candidates will have experience in Study Start-Up and at least 8 months of on-site monitoring experience. Candidates can be located anywhere in the United States. This role does require travel up to 70-80%.
Job Overview
The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV trials in the country in accordance with monitoring procedures and processes following ICH/GCP, local regulations and SOPs.
Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).
Supports country SSU strategy in close collaboration with the SSO Study Start-Up Team Lead, the SSO Study Start-Up Manager, and the SSO Feasibility Manager as well as the SSO Site Partnership Manager
Collaborates with the SSO Study Start-Up Manager, the SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments
Accountable for timely start-up activities from country allocation until site greenlight at assigned sites
Conducts site selection visits, verifies site eligibility for a specific study
Acts as the main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation
Ensures that milestones (KPIs) and time schedule for study start-up are met as planned
Facilitates the preparation and collection of site and country level documents
Collects submission-related site-specific documents for all relevant site personnel within agreed timelines (e.g., FD, CV, GCP certificates, DSL, etc.)
Supports the SSU Manager with preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
Supports the SSO Study Start-Up Manager and assigned sites with vendor set-up activities
Prepares and finalizes site specific documents for submission
Negotiates investigator payments, as needed
Supports preparation of financial contracts between Sponsor and investigational sites and investigators, as needed
Updates all systems until site Green Light on an ongoing basis
Supports preparation of audits and inspections, as applicable
Supports reduction of formal site-specific IRB/IEC deficiencies
Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readiness
Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health
Authority and SOP requirements Implements innovative and efficient processes which are aligned with the sponsor strategy
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $87,200.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Senior Clinical Research Coordinator - Cancer Center
Clinical Research Coordinator Job In Kansas City, KS
Department:SOM KC Cancer Center Clinical Trials
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AdministrationPosition Title:Senior Clinical Research Coordinator - Cancer CenterJob Family Group: Professional Staff Summary:The Senior Clinical Research Coordinator works collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The Senior Clinical Research Coordinator will manage assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Participates in periodic quality assurance audits of protocols. Supports the development of study budgets, contracts, and grant applications. Provides task direction, as needed, for junior level clinical research coordinators.
This position will be 100% onsite due to the fact this is a patient facing role.
The University of Kansas Cancer Center is the region's only National Cancer Institute-designated comprehensive cancer center. We strive to provide the most advanced comprehensive care possible. In addition to standard care and treatments, we perform studies to help find better ways of preventing, diagnosing and treating various types of cancer.:
Job Duties:
Under the direction of the principal investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials.
Assist clinical staff with maintaining source documents and submit case report forms (CRFs) as required for clinical trials.
Responsible for lead worker duties including mentoring, training and assisting junior staff with onboarding and learning the clinical research coordinator position.
Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
Assist clinical staff with study procedures, as outlined in the protocol and within state and KUMC scope of practice.
As requested, facilitate monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
Prepare and maintain clinical trial contract documents and study budget reports.
Perform study procedures, as outlined in the protocol and within state and institutional scope of practice.
Assist clinical staff with sample collection, processing, handling, and shipping as outlined in the protocol and within KUMC policy.
Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies and study participants.
Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
Attend continuing education, research and training seminars as requested by manager.
Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR.
Coordinate closely with the Research Institute and Human Research Protection Program and have a significant working knowledge of KUMC policies and procedures.
Review and assist with editing of new protocols. Assesses feasibility of research protocol including appropriate patient population, budget and specific needs for the study.
Assist Principal Investigators with internal and external funding application submissions.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.
Required Qualifications
Education:
Bachelor's degree OR an equivalent combination of relevant post-secondary education and work experience that equals at least 4 years.
Certification:
Research certification such as Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP).
Work Experience: 4 years clinical research experience that includes the following:
Experience with regulations governing clinical research (CFR, GCP, HIPAA).
Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
Experience with study budgets, contracts, and grant applications.
Excellent communication as evidenced by application materials.
Experience using computer MSO Suite: Outlook, Windows, Excel and Word.
Preferred Qualifications
Education:
Master's degree in relevant field.
Skills:
Communication skills including, written, verbal, and presentation.
Organizational skills.
Organization and time management skills.
Required Documents:
Resume/CV AND Cover Letter
Comprehensive Benefits Package:
Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. **************************************************
Employee Type: RegularTime Type: Full time Rate Type: Salary
Compensation Statement:
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Pay Range:$65,000.00 - $99,000.00
Minimum
$65,000.00
Midpoint
$82,000.00
Maximum
$99,000.00
Clinical Research Associate - Oncology - Northern California
Clinical Research Coordinator Job 13 miles from Kansas City
As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What will you be doing?** + Works on multiple trials within Oncology + Quality of life focus wtih Regional Travel
+ Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes - Mentors/coaches junior flex team
+ Acts as Lead SM-training other SMs on study
+ Develops site start up documents for studies including SIV agenda
+ Provides SM "voice" when reviewing study documents (e.g. Monitoring Guidelines)
+ Represents LTMs or SMs on SMTs/meetings
+ Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial
+ Supports country budget development and/or contract negotiation in liaison with CCS colleagues
+ Assists with ASV
+ Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
Interfaces - Primary/Other:
+ Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.
+ Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.)
**What do you need to have?**
+ Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
+ Must be located in Northern California near a major airport
+ Have a minimum of 2 -3 years' experience in monitoring pharmaceutical industry clinical trials
+ Have a minimum of 1-3 years' experience monitoring Oncology trials
+ Knowledge of several therapeutic areas
+ Analytical/risk-based monitoring experience is an asset
+ Ability to actively drive patient recruitment strategies at assigned sites
+ Ability to partner closely with investigator and site staff to meet all of our study timelines
+ Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
+ Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
+ Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
+ Need to travel up to 50%
+ To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
_Pay Range ($_ _91,336.00_ _USD - $_ _114,170.00_ _USD)_
_Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level._
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs
+ Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
+ Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ************************************
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
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Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.