Clinical research associate jobs in Olathe, KS - 152 jobs
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Clinical Research Associate
Senior Clinical Research Associate
Clinical Coordinator
Clinical Research Coordinator
Clinical Research Assistant
Study Coordinator
Clinical Trial Coordinator
Research Nurse
Clinical Research Associate, Sponsor Dedicated
Iqvia 4.7
Clinical research associate job in Kansas City, KS
, you must reside in the same country where the job is located. Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Requires at least 2 years of year of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinicalresearch regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinicalresearch 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 $71,900.00 - $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 clinicalresearch 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
$71.9k-189k yearly 18d ago
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Lead Clinical Research Associate
Oracle 4.6
Clinical research associate job in Topeka, KS
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us!
As a global leader we're looking for a Senior **Lead ClinicalResearchAssociate (CRA)** to drive success as part of our Non-interventional Study team.
Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinicalresearch, and driving groundbreaking projects on a global scale!
**What you will do**
**As a Senior Lead ClinicalResearchAssociate at Oracle, you will:**
+ **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors.
+ **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters.
+ **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents.
+ **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans.
+ **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of ClinicalResearchAssociates, develop project-specific training materials, and ensure delivery of high-quality site management.
+ **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports.
+ **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement.
+ **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required.
**Required Experience**
+ **Education** : Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinicalresearch experience.
+ **Clinicalresearch expertise** : At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies.
+ **Communication skills** : Outstanding spoken and written proficiency in English (C1 level minimum).Additional languages are considered a strong asset.
+ **Technical proficiency** : Comfort with MS Office, EDC, CTMS exprience and willingness to learn and handle various technical systems and tools.
+ **Personal qualities** : Exceptional organizational and problem-solving skills, strong cross-culturalteamwork, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment.
+ **Financial management:** Experience reviewing site contracts, budget and invoices.
+ **Attention to detail** : Ability to work independently with careful, precise, and thorough execution of complex tasks.
**Responsibilities**
**What you will do**
**As a Senior Lead ClinicalResearchAssociate at Oracle, you will:**
+ **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors.
+ **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters.
+ **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents.
+ **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans.
+ **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of ClinicalResearchAssociates, develop project-specific training materials, and ensure delivery of high-quality site management.
+ **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports.
+ **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement.
+ **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required.
Disclaimer:
**Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.**
**Range and benefit information provided in this posting are specific to the stated locations only**
US: Hiring Range in USD from: $70,600 to $141,200 per annum. May be eligible for bonus and equity.
Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business.
Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following:
1. Medical, dental, and vision insurance, including expert medical opinion
2. Short term disability and long term disability
3. Life insurance and AD&D
4. Supplemental life insurance (Employee/Spouse/Child)
5. Health care and dependent care Flexible Spending Accounts
6. Pre-tax commuter and parking benefits
7. 401(k) Savings and Investment Plan with company match
8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
9. 11 paid holidays
10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
11. Paid parental leave
12. Adoption assistance
13. Employee Stock Purchase Plan
14. Financial planning and group legal
15. Voluntary benefits including auto, homeowner and pet insurance
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Career Level - IC3
**About Us**
As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
$70.6k-141.2k yearly 15d ago
Animal Health Clinical Research Associate
Argenta
Clinical research associate job in Shawnee, KS
At Argenta, we're more than a company - we're a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it.
Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions and services cover every stage of the process, from molecule to market.
We're in a unique position. We are the world's only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated to animal health.
Our uniqueness means:
We are ambitious, growing and building a ‘one team' culture, guided by our values.
We are team players;
We are doers;
We are customer-centric;
We are innovators.
We value diversity, as a global company, we get the richness of working with different people in different places whether it be location, stages of their career, their development, their role. We believe that when everyone works together and puts their best “paw” forward we will make the lives of the animals we care for, better.
With bases in New Zealand, the US, the UK and Europe, our 900+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let's Make It Happen, Together.
TEAM PLAYERS who want to DO great work and find INNOVATIVE ways to make animals lives better through our CUSTOMER CENTRIC efforts should apply.
Our US Clinical team is looking for experienced, motivated, driven individuals who thrive in their ability to multitask and work as a team!
Our ClinicalResearchAssociates add value through the following responsibilities:
Coordinates and conducts GCP and study protocol training at study sites and assures training is documented
Builds rapport with study site staff to assure compliance with the protocol, applicable regulatory and guidance documents, SOPs, and all study activities
Assists in reviewing the study records and all study notebooks to ensure contents are current and complete
Assists in providing tracking and Quality Control (QC) of data as required and assists with responses to QA audits
Evaluates Investigators and assists with selection of appropriate sites to conduct clinical studies
Collaborates with the study Project Manager to assure study sites selected meet the needs of the study protocol
Monitors assigned study sites through review of electronic data capture (EDC) systems, faxed, emailed, and paper documentation.
Serves as the liaison between Argenta US Clinical and study site personnel
Facilitates clarifications, corrections, and data query resolution with study sites or data management personnel
Tracks adverse events (AE's) encountered in clinical studies and ensures all serious AEs and non-serious AEs are documented and communicated appropriately to the Project Manager and Sponsor
Learns to assist with facilitates clarifications, corrections, and data query resolution with study sites or data management personnel
Builds relationships with key individuals and contributors in the organization and beyond
Job Requirements include:
Minimum of 5 years' experience in an animal health research role, Monitor and ClinicalResearchAssociate positions preferred
Experience in Good Clinical Practice (GCP) data management, quality control, and/or quality assurance preferred
Collaborative working style. Lead and motivate people through influence across all levels and functions of the organization
Ability to look for creative solutions to resolve complex issues
Strong technical writing ability
Results oriented and driven
Strong communication and listening skills
Well organized and analytically driven
Willingness to travel, expected to travel nationally 40 to 60%
Argenta has strongly embedded company values which is key to who we are and how we deliver. We offer an opportunity to work for a successful and rapidly expanding global business where your input will be valued. At Argenta we are a hard-working group who really enjoy the people we work with each day. That is why we support our people through strong culture, great benefits, and opportunity for growth.
This role is subject to a DEA background check as well as a pre-employment drug screen and/or physical.
Argenta is an equal opportunity employer
To find out more about Argenta, click here: *********************
$49k-79k yearly est. 44d ago
Clinical Research Associate
Icon Clinical Research
Clinical research associate job in Lenexa, KS
ClinicalResearchAssociate - Northeast or Midwest ICON plc is a world-leading healthcare intelligence and clinicalresearch organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a ClinicalResearchAssociate to join our diverse and dynamic team. As a ClinicalResearchAssociate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
**What you will be doing**
+ Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
+ Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
+ Collaborating with investigators and site staff to facilitate smooth study conduct.
+ Performing data review and resolution of queries to maintain high-quality clinical data.
+ Contributing to the preparation and review of study documentation, including protocols and clinical study reports
**Your profile**
+ Bachelor's degree in a scientific or healthcare-related field.
+ Minimum of 12 months onsite monitoring experience as a ClinicalResearchAssociate; level (CRA I, CRA II, or Senior CRA) determined by total years of experience. In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
+ Strong organizational and communication skills, with attention to detail.
+ Ability to work independently and collaboratively in a fast-paced environment.
+ Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
**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 maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Visit our careers site (************************************* to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here (******************************************************
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.
Are you a current ICON Employee? Please click here (****************************************************** to apply
$49k-79k yearly est. 23d ago
Clinical Research Associate/Senior Clinical Research Associate- FSP
Parexel 4.5
Clinical research associate job in Topeka, KS
**Parexel FSP is looking for a CRA/Sr CRA in the MidWest and West region of the United States!** **Oncology Experience required.** **Job Purpose:** The ClinicalResearchAssociate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
**Key Accountabilities** :
**Site Management Responsibilities**
+ Contributes to the selection of potential investigators.
+ In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
+ Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
+ Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
+ Actively participates in Local Study Team (LST) meetings.
+ Contributes to National Investigators meetings, as applicable.
+ Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
+ Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
+ Updates CTMS and other systems with data from study sites as per required timelines.
+ Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
+ Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits.
+ Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
+ Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
+ Ensures data query resolution in a timely manner.
+ Works with data management to ensure robust quality of the collected study data.
+ Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
+ Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
+ Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
+ Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
+ Assists site in maintaining inspection ready ISF.
+ Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
+ Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
+ Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
+ Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
+ Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.
**Compliance with Sponsor Standards**
+ Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
+ Ensures compliance with local, national, and regional legislation, as applicable.
+ Completes timesheets accurately as required.
**Compliance with Parexel Standards**
+ Complies with required training curriculum.
+ Completes timesheets accurately as required.
+ Submits expense reports as required.
+ Updates CV as required.
+ Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
**Skills (Essential):**
+ Excellent attention to detail.
+ Good written and verbal communication skills.
+ Good collaboration and interpersonal skills.
+ Good negotiation skills.
+ Proficient in written and spoken English language required.
+ Fluency in local language(s) required.
**Skills (Desirable):**
+ Ability to work in an environment of remote collaborators.
+ Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
+ Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
+ Good analytical and problem-solving skills.
+ Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
+ Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
+ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
**Knowledge and Experience (Essential)** **:**
+ Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
+ Good knowledge of relevant local regulations.
+ Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
+ Basic understanding of the drug development process.
+ Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
**Knowledge and Experience (Desired):**
+ Familiar with risk-based monitoring approach including remote monitoring.
+ Good cultural awareness.
**Education:**
+ Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
**Other:**
+ Ability to travel nationally/internationally as Required
+ Valid driving license per country requirements, as applicable.
\#LI-SS1
\#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.
$74k-100k yearly est. 7d ago
Clinical Trial Enrollment Coordinator
Icon Plc 4.8
Clinical research associate job in Lenexa, KS
Clinical Trial Enrollment Coordinator - Onsite - Lenexa, KS - ICON ICON plc is a world-leading healthcare intelligence and clinicalresearch organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
ICON plc is a world-leading healthcare intelligence and clinicalresearch organisation. From molecule to medicine, we advance clinicalresearch providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Overview:
Supports the recruitment and enrollment of qualified volunteers for clinical drug trials through the review and analysis of relevant data and protocol requirements.
Primary Responsibilities:
* Maintains the feasibility of a study from a recruitment point of view during the proposal phase and communicates findings as appropriate.
* Collaborates with recruitment team to identify qualified volunteers to participate in a specific study.
* Supports the project team by consolidating training materials for the recruiting and screening departments.
* Provides updates to the project team on recruitment and screening activities and assists in maintaining accurate screening and enrollment logs.
* Reviews the recruitment and screening outcome throughout the study to ensure that full groups are dosed according to the timelines.
Additional Responsibilities:
* Assists with the creation and review of recruitment and screening documents prior to submission to the sponsor and relevant boards and committees for approval.
* Partners with specialists to review protocol inclusion and exclusion to optimize recruitment.
* Collaborates and supports recruitment feasibility on current and future studies.
* Monitors risks to subject recruitment and assists with developing contingency plans.
* Assists with the analysis of recruitment effectiveness.
* Interacts with study participants during the recruitment and screening process.
To be successful in the role, you will have:
* Good knowledge of clinical drug trials
* Good knowledge of medical terminology
* Good knowledge of work instructions, standard operating procedures and internal and external regulations
* Good written and oral communication skills
* Demonstrated ability to read and interpret study protocols
* Ability to handle confidential information
Requirements:
* High school diploma or international equivalent
* 2 years of relevant experience
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.
#LI-TR1
#LI-Onsite
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 maximize savings and plan with confidence for the years ahead.
* Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here
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.
Are you a current ICON Employee? Please click here to apply
$40k-54k yearly est. 9d ago
Clinical Study Coordinator-JCCT
Johnson County Clintrials
Clinical research associate job in Lenexa, KS
Study Coordinator
Department: Study Management
Purpose:
The Study Coordinator is responsible for the coordination and administration of clinical studies under the direction of the Director of Study Management, and the Medical Director/Principal Investigator.
Position Summary:
This position will develop, implement and coordinate research and administrative procedures for the successful management of clinical studies. The Study Coordinator will perform diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. This position will report directly to the Clinical Study Team Manager.
Key Responsibilities (Essential Functions):
Maintain required records of study activity including study logs, case report forms, and/or regulatory forms
Schedule volunteers for appointments, procedures and inpatient stays as required by study protocols
Assess eligibility of potential volunteers through methods such as subject interviews, reviews of medical records, and discussions with Investigators and ResearchAssociates
Communicate with the Laboratory and/or Investigators regarding Lab procedures and/or findings
Educate study volunteers on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements.
Responsible for assuring training and documentation is completed for protocol amendments, ICFs, updated guidelines, etc.
Communicate with Nursing staff on an ongoing basis regarding study updates, amendments/ changes.
Communicate with Investigators on an ongoing basis regarding study progress, safety issues and other important information.
Maintain contact with sponsors/CROs and respond in a timely manner as well as schedule/ coordinate site visits.
Professional communication and collaborative work ethic with CRAs at Site visits.
Order and track supplies or devices necessary for study completion.
Prepare study-related source documentation according to protocol and system guidelines and work with QA department collaboratively to make appropriate changes.
Record adverse events and discuss with Investigators regarding the reporting of events to oversight agencies.
Track enrollment status of volunteers and documentation in Clinical Conductor system.
Perform specific protocol procedures such as interviewing volunteers, taking vital signs, and performing electrocardiograms, etc.
Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies or specially designated review groups
Adherent to safety and privacy regulations
Other duties as assigned
Education and Work Experience:
High school diploma or GED is required; Bachelor's degree in Science is preferred
3 to 5 years of experience in a clinicalresearch setting or related work environment is preferred
Basic understanding of regulations governing clinicalresearch (CFR, GCP, HIPAA)
Solid understanding of statutes and guidelines relevant to regulatory affairs in clinicalresearch
Familiarity with or ability to learn clinical trial management system software
Skills and Competencies:
Excellent communication, interpersonal, analytical and problem-solving skills Microsoft Office Suite proficiency
Writing and verbal communication skills
Strong study documentation skills in compliance with ALCOA+
Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc.
Ability to work effectively with a team
Ability to manage small projects personally and work independently
Ability to prioritize and manage multiple projects simultaneously
Memory to retain information and know where to research answers
Time management skills
Organizational skills
Detail oriented with the ability to perform at a high level of accuracy
Demonstrates strong critical thinking, problem solving skills
Self-motivated
Must be results oriented, multi-tasking, quick learner
Respond to the urgent needs of the team and show a strong track record of meeting deadline
Physical Requirements:
Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel
Ability to lift and/or move up to 20 pounds
Why JCCT?
JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in our company getting recognized as one of the best clinicalresearch sites in the United States.
We are actively growing through acquisition and organic growth and need high performing individuals to help support our continued success. Our clients come from all over the world to place a study at our research sites. We are proud of what we have accomplished and invite you to explore career opportunities with us. JCCT makes a promise to support, accept and respect you as an individual, in our family focused environment.
Our vision is to make a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our impact is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors.
If you are looking for a positive work environment and the opportunity for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today!
EEO
JCCT provides equal employment opportunities (EEO) to all employees and applicants. We value diversity at our company, and it is our policy to recruit, hire, and promote qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Salary Description $28-$36 /Hour
$28-36 hourly 60d+ ago
Clinical Research Coordinator - Internal Medicine (Pulmonary, Critical Care and Sleep Medicine)
University of Kansas Medical Center 3.8
Clinical research associate 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:ClinicalResearch Coordinator - Internal Medicine (Pulmonary, Critical Care and Sleep Medicine) Job Family Group: Professional Staff Summary:The ClinicalResearch Coordinator (CRC) in the Division of Pulmonary, Critical Care, and Sleep Medicine is responsible for coordinating and managing clinicalresearch studies in accordance with regulatory requirements and institutional policies. This role involves the planning, implementation, and oversight of research protocols, ensuring compliance with FDA regulations, GCP guidelines, IRB approvals, and HIPAA requirements. The CRC will collaborate with investigators, sponsors, and participants to facilitate all aspects of study conduct, including subject recruitment, informed consent, data collection, and reporting.:
Job Duties
Study Coordination & Management:
Coordinate multiple clinicalresearch studies, including investigator-initiated and industry-sponsored trials.
Develop and maintain study-specific documents, including regulatory binders, case report forms, and data collection tools.
Ensure research protocols are conducted in accordance with IRB, FDA, NIH, and institutional regulations.
Monitor study progress, ensuring adherence to timelines and compliance with protocols.
Patient Recruitment & Enrollment:
Identify and screen eligible participants for clinical studies based on protocol inclusion/exclusion criteria.
Obtain informed consent and educate participants about study procedures, risks, and benefits.
Schedule study visits, follow-ups, and coordinate necessary clinical assessments.
Data Collection & Regulatory Compliance:
Collect and enter accurate research data into electronic data capture (EDC) systems.
Maintain compliance with Good Clinical Practice (GCP) and institutional policies.
Prepare and submit regulatory documents to IRB and sponsor organizations.
Assist in audits, monitoring visits, and responses to queries from regulatory agencies.
Clinical & Laboratory Responsibilities:
Coordinate sample collection, processing, and shipping according to study requirements.
Assist with study-related procedures such as pulmonary function tests, sleep studies, and vital sign monitoring under supervision.
Ensure investigational products (drugs, devices) are handled per protocol and regulatory requirements.
Collaboration & Communication:
Act as a liaison between study sponsors, investigators, patients, and healthcare providers.
Participate in research team meetings, sponsor calls, and professional development sessions.
Provide education and training to new research personnel and clinical staff as needed.
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.
Work Environment:
Evening hours may occasionally be required.
Position is primarily based on-site.
Required Qualifications
Work Experience:
4 years of experience in health sciences, nursing, biology, or related field. Education may be substituted for experience on a year for year basis.
2 years of clinicalresearch experience.
Experience with clinicalresearch regulations (FDA, GCP, IRB, HIPAA).
Preferred Qualifications
Certifications: Phlebotomy certification.
Work Experience:
4 years of clinicalresearch experience.
Experience in pulmonary, critical care, or sleep medicine research.
Experience with REDCap, Epic, or similar data management systems.
Skills
Organization.
Problem-solving.
Communication.
Computer skills.
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:$60,800.00 - $91,200.00
Minimum
$60,800.00
Midpoint
$76,000.00
Maximum
$91,200.00
$60.8k-91.2k yearly Auto-Apply 60d+ ago
Clinical Research Coordinator
Saint Luke's Health System 4.3
Clinical research associate job in Kansas City, MO
Saint Luke's Hospital in Kansas City, MO is seeking a Research Coordinator to join our research team to assist with providing and coordinating care for patients active in various research studies. As a ClinicalResearch Coordinator in this position, you will prepare the site for conduct of the study identify potential study participants, conduct informed consent, assist with scheduling labs and appointments, gather and record study related data, and provide patient education for various research studies.
Shift Details: Monday - Friday
This is a wonderful opportunity to work with nationally recognized providers and leaders in Cancer research and treatment options.
Responsibilities:
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.
We are seeking an experienced Research Coordinator. This team is innovative and is working with cutting edge technologies and procedures while evolving medicine in oncology care. We are seeking an organized, flexible, adaptable coordinator that can manage various tasks, projects, and deadlines simultaneously.
Bachelor's degree is required
Why Saint Luke's?
We believe in creating a collaborative environment, while looking for innovative ways to improve. We offer competitive salaries and benefits packages to all eligible employees:
Medical health plans
Tuition reimbursement
Leave of Absence, PTO, Extended Sick Leave, and various Welfare plans
Retirement contributions
Employee Assistance Program
#LI-CM1
Job Requirements
Applicable Experience:
Less than 1 year Bachelor's DegreeJob DetailsFull TimeDay (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.
$46k-57k yearly est. Auto-Apply 3d ago
Clinical Research Coordinator/DHS II - Kansas City 1.14.26
N-Power Medicine
Clinical research associate job in Kansas City, KS
About N-Power Medicine N-Power Medicine aims to establish a new paradigm in drug development by reinventing the ‘how' and transforming clinical trials through better integration with clinical practice, ensuring broader participation by physicians and patients. We are building an exceptional multi-disciplinary team with diverse expertise spanning healthcare, engineering, technology and regulatory, and with people who share our core value of Empowering Community through generosity, curiosity and humility. We are working with urgency to bring better therapies to patients faster.
Position Summary
You will be a part of the rapidly changing clinical oncology environment with the opportunity to impact the future of clinicalresearch and improve patients' lives while growing professionally at a dynamic, fast-growing, start-up organization. As the Digital Health Specialist II (internal title), you will work at a clinical site in Kansas City, KS.
The ideal candidate has clinical oncology research experience or research experience in a healthcare setting. You are confident in your understanding of clinical workflow, patient data systems and clinicalresearch in an oncology setting. We are looking for individuals who are motivated and ambitious professionals who desire to positively influence and innovate upon the quality of care for patients diagnosed with cancer.
Roles and Responsibilities
Serve as the Company's trusted face to the clinical practice, providing clinical support while advancing research data collection.
Interface directly with the healthcare providers and patients.
Perform peer review of clinical documentation for data quality and completeness.
Partner with Senior DHS to address any clinic or team issues and concerns.
Obtain informed consent for N-Power Medicine's clinical trials.
Assist and participate in the site clinical trial initiation and clinical trial(s) activities as assigned.
Ensure adherence to study protocols, data completeness and patient consent.
Assist in patient recruitment strategies where appropriate.
Foster collaborative relationships by effectively communicating with clinical site staff, internal stakeholders, and the N-Power Medicine team by attending site specific meetings.
Build and maintain relationships at the clinical site, becoming part of the functional team of practitioners.
Ensure quality and integrity of data capture, compliance and confidentiality with N-Power Medicine's and site's policies, standard operating procedures (SOPs), and Good Clinical Practice (GCP).
Respond to queries regarding missing, aberrant, or potential outlier data and data verification- escalate to the health care provider as necessary for resolution.
Provide proactive input and user experiences for our software.
Additional duties and responsibilities as required.
Generous, curious and humble.
Qualifications
3+ years of experience in oncology clinicalresearch and/or oncology ambulatory care preferred
Bachelor's degree, focused in health science or related field preferred
Certified ClinicalResearch Coordinator, Associate or Professional (CCRC, CCRA or CCRP) preferred
Knowledge of clinical trials, study-specific operating procedures and patient consent forms
Strong desire to drive a paradigm change in clinicalresearch conduct and improve patients' lives
Compassionate focused patient care
Supports and encourages other team members, contributing to a positive team environment
Self-starter, able to work independently, prioritize actively, seek input, and problem solve in complex and fast-evolving environments
Results oriented focused on delivering the goals set-forth
Attention to detail and strong organizational skills
Excellent oral/written communication and interpersonal skills
Critical thinking and proven problem-solving skills
Work hours are dependent on local Network Partner Clinics (typically M-F, 8-5pm)
Please note that state-specific background checks and screenings may be required for this role. Employment is contingent upon successfully passing all applicable screenings.Travel Requirements
Daily travel between sites may be required
More About UsWe are a mission driven, well -funded, rapidly growing company, eager to attract passionate professionals offering a highly attractive compensation package with a balanced and flexible work environment, competitive industry benefits as well as a 401K plan and other great company “perks.”
We are an Equal Opportunity Employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Covid-19 Policy - The Company is committed to providing and maintaining a safe workplace, and to safeguard the health and well-being of our employees, families, visitors, and the community. While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary. We currently do not have mandatory COVID-19 vaccination requirements for our employees and contractors, as the COVID-19 public health emergency has ended. However, there are certain N-Power Medicine employees and contractors who, based on their role, will be required to continue to follow our 2021 COVID-19 vaccination and other requirements as mandated by N-Power Medicine's partners they serve. We reserve the right to modify or amend our corporate policy at any time.
Applicants must be currently authorized to work in the U.S. on a full-time basis. The Company will not sponsor applicants for work visas.
If you find this opportunity compelling, we encourage you to apply today! We promptly review all applications. Highly qualified candidates will be directly contacted by a team member.
$46k-67k yearly est. Auto-Apply 17d ago
Clinical Research Coordinator
Saint Luke's Physician Group 4.3
Clinical research associate job in Kansas City, MO
Saint Luke's Hospital in Kansas City, MO is seeking a Research Coordinator to join our research team to assist with providing and coordinating care for patients active in various research studies. As a ClinicalResearch Coordinator in this position, you will prepare the site for conduct of the study identify potential study participants, conduct informed consent, assist with scheduling labs and appointments, gather and record study related data, and provide patient education for various research studies.
Shift Details: Monday - Friday
This is a wonderful opportunity to work with nationally recognized providers and leaders in Cancer research and treatment options.
Responsibilities:
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.
We are seeking an experienced Research Coordinator. This team is innovative and is working with cutting edge technologies and procedures while evolving medicine in oncology care. We are seeking an organized, flexible, adaptable coordinator that can manage various tasks, projects, and deadlines simultaneously.
Bachelor's degree is required
Why Saint Luke's?
We believe in creating a collaborative environment, while looking for innovative ways to improve. We offer competitive salaries and benefits packages to all eligible employees:
Medical health plans
Tuition reimbursement
Leave of Absence, PTO, Extended Sick Leave, and various Welfare plans
Retirement contributions
Employee Assistance Program
#LI-CM1
Job Requirements
Applicable Experience:
Less than 1 year Bachelor's DegreeJob DetailsFull TimeDay (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.
$39k-57k yearly est. Auto-Apply 25d ago
Clinical Research Coordinator
Alcanza Clinical Research
Clinical research associate job in Kansas City, MO
Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinicalresearch company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.
We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow, the ClinicalResearch Coordinator under the direction of the Site Manager/Director and the Principal/Sub Investigators conducts the following according to the study protocol, company processes & procedures, and in compliance with FDA, GCP, and ICH regulations and guidelines. The ClinicalResearch Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations, and SOPs.
Key ResponsibilitiesIn collaboration with other members of the clinicalresearch site team works to ensure the execution of assigned studies. Responsibilities may include but are not limited to:
Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines:
Screening of patients for study enrollment;
Patient consents;
Patient follow-up visits;
Documenting in source clinic charts;
Entering data in EDC and answers queries;
Obtaining vital signs and ECGs;
May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;
Requesting and tracking medical record requests;
Updating and maintaining logs, chart filings;
Maintaining & ordering study specific supplies;
Scheduling subjects for study visits and conducts appointment reminders;
Building/updating source as needed;
Conducting monitoring visits and resolves issues as needed in a timely manner;
Ensuring study related reports and patient results are reviewed by investigator in a timely manner;
o Filing SAE/Deviation reports to Sponsor and IRB as needed;o Documenting and reporting adverse events;o Reporting non-compliance to appropriate staff in timely manner;o Maintaining positive and effective communication with clients and team
members;o Always practicing ALCOAC principles with all documentation;
Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;
Prepare and attend site initiation visits (SIV's) and Investigator Meetings (IMs), as needed;
Handles all IRB functions for assigned studies independently, and/or with assigned regulatory team member, as needed;
Assist with training of new research assistants and coordinators;
Assist with scheduling and planning for visit capacity for assigned studies;
May set up, train and maintain all technology needed for studies;
May assist with study recruitment, patient enrollment, and tracking as needed;
May handle more complex study assignments and volumes;
May participate in community outreach / education events;
Maintaining confidentiality of patients, customers and company information, and;
Performing all other duties as requested or assigned.
Skills, Knowledge and ExpertiseMinimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential AND 2+ years of clinicalresearch coordination experience, OR an equivalent combination of education and experience, is required. Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred. CCRC or CCRP credential and BLS certification preferred. Bi-lingual (English / Spanish) proficiency is a plus.
Required Skills:
Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm);
Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc
Strong organizational skills and attention to detail.
Well-developed written and verbal communication skills.
Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
Must be professional, respectful of others, self-motivated, and have a strong work ethic.
Must possess a high degree of integrity and dependability.
Ability to work under minimal supervision, identify problems and implement solutions.
Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
Benefits
Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
$38k-56k yearly est. 22d ago
Clinical Coordinator - Lenexa, KS
Medbridge Healthcare
Clinical research associate job in Lenexa, KS
🩺 Clinical Coordinator
📍 On-Site | Lenexa, KS
Sleep Safe Drivers, Inc.
Sleep Safe Drivers is growing, and we are looking for a Clinical Coordinator to join our on-site team in Lenexa, KS. This role is ideal for a licensed clinical professional who enjoys blending hands-on clinical work with patient support, coordination, and problem solving in a fast-paced environment.
If you are passionate about sleep health, patient outcomes, and being part of a collaborative clinical team, we want to hear from you.
✨ What You'll Do
As a Clinical Coordinator, you will play a key role in supporting sleep therapy patients and ensuring smooth clinical operations.
Clinical Support
Manage the full Home Sleep Testing workflow
Handle high-volume inbound clinical support calls
Provide clinical guidance and troubleshooting for sleep therapy patients
Monitor patient compliance and treatment effectiveness
Assist patients with compliance reports and related questions
Set up and manage compliance monitoring services
Troubleshoot equipment, data transmission, and interface issues
Customer & Operational Support
Serve as a primary point of contact for patients and healthcare providers
Process referrals accurately and efficiently
Collect, index, and upload medical records in compliance with HIPAA
Coordinate with internal teams regarding equipment, supplies, and services
Team & Performance
Maintain high performance and quality standards
Collaborate with the Clinical Director/Manager on training and process improvements
Participate in team-building and continuous improvement initiatives
✅ What We're Looking For
Licensed clinical professional, including:
Respiratory Therapist (RRT or CRT)
Sleep Technologist (RPSGT)
Registered Nurse (RN)
Active, unrestricted Kansas license
Strong clinical knowledge with excellent communication skills
Comfortable managing multiple priorities in a fast-paced setting
Customer-focused mindset with strong attention to detail
💼 Why Join Sleep Safe Drivers?
Stable, growing healthcare organization
Meaningful clinical work with real patient impact
Collaborative, supportive team environment
Opportunity to contribute to operational growth and innovation
📌 This is a full-time, on-site position in Lenexa, KS.
Apply today to join a team dedicated to improving sleep health and patient outcomes.
STATEMENT OF POLICY
MedBridge is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, or status as an individual with a disability.
AFFIRMATIVE ACTION PLAN (AAP)
The Affirmative Action Plans for Minorities and Women, Individuals with Disabilities, and Protected Veterans are available for inspection by appointment with Human Resources during regular business hours.
REASONABLE ACCOMMODATION
Individuals with disabilities who need accommodation may contact Brenda Underwood, HR Director, at ************** or TTY 711 (Relay).
EMPLOYMENT ELIGIBILITY
This employer participates in E-Verify. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States.
Licensed clinical professional, including:
Respiratory Therapist (RRT or CRT)
Sleep Technologist (RPSGT)
Registered Nurse (RN)
Active, unrestricted Kansas license
Strong clinical knowledge with excellent communication skills
Comfortable managing multiple priorities in a fast-paced setting
Customer-focused mindset with strong attention to detail
$50k-71k yearly est. 16d ago
Hospice Clinical Coordinator
Elara Caring
Clinical research associate job in Lawrence, KS
At Elara Caring, we have a unique opportunity to play a huge role in the growth of an entire home care industry. Here, each employee has the chance to make a real difference by carrying out our mission every day. Join our elite team of healthcare professionals, providing the Right Care, at the Right Time, in the Right Place.
:
Clinical Coordinator
At Elara Caring, we care where you are and believe the best place for your care is where you live. We know there's no place like home, and that's why our teams continue to provide high-quality care to more than 60,000 patients each day in their preferred home setting. Wherever our patients call home and wherever they are on their health journey, we care. Each team member has a part to play in this mission. This means you have countless ways to make a difference as Clinical Coordinator. Being a part of something this great, starts by carrying out our mission every day through your true calling: developing an amazing team of compassionate and dedicated healthcare providers.
To continue to be an industry pioneer delivering unparalleled care, we need a Clinical Coordinator with commitment and compassion. Are you one of them? If so, apply today!
Why Join the Elara Caring mission?
* Work in a collaborative environment.
* Be rewarded with a unique opportunity to make a difference
* Competitive compensation package
* Tuition reimbursement for full-time staff and continuing education opportunities for all employees at no cost
* Opportunities for advancement
* Comprehensive insurance plans for medical, dental, and vision benefits
* 401(K) with employer match
* Paid time off, paid holidays, family, and pet bereavement
* Pet insurance
As Clinical Coordinator, you'll contribute to our success in the following ways:
* Builds teams to offer the highest quality of life to our patients.
* Maintains organized, effective, and efficient systems and communication to ensure the continuity of quality patient care is delivered.
* Evaluates agency operations, maintains a variety of tracking systems, and identifies ways to enhance workflow and productivity.
* Assists staff in maintaining current and accurate medical records and utilization review.
* Assists clinical supervisor with non-clinical phone inquiries.
* Notifies supervisor of any problems requiring administrative attention and intervention.
* Processes and distributes in and out daily mail for the department, collects and maintains inventory, and cleans equipment.
* Implements all available actions to prevent avoidable hospitalization and ER visits.
* Attends training, education, seminars, or other means of learning.
* Treats patients and caregivers in the highest and most effective manner.
* Provides positive, supportive communication to physicians, patients, families, visitors, and other agency personnel.
* Promotes Elara Caring's philosophy, mission statement and administrative policies to ensure quality of care.
* Maintains patient and staff privacy and confidentiality pursuant to HIPAA Privacy Final Rule.
* Performs other duties/projects as assigned.
What is Required?
* 1+ year experience in a hospice or home health care setting
* Proficiency with Medical Terminology
* Experience working with clinical management team
* Proficiency with office equipment including computer, fax, copy machines
* Experience with Medicare and Medicaid guidelines are preferred
You will report to the Clinical Manager.
This is not a comprehensive list of all job responsibilities; a full will be provided.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
We value the unique skills of veterans and military spouses. We encourage applications from military veterans and their families.
Elara Caring provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to sex (including pregnancy, childbirth or related medical conditions), race, color, age (40 and older), national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity, gender reassignment, protected veteran status, or any other basis prohibited under applicable federal, state or local law.
Elara Caring participates in E-Verify and we will provide the Federal Government with your Form I-9 information to confirm that you are authorized to work in the United States. Employers like Elara Caring can only use E-Verify once you have accepted the job offer and completed the Form I-9.
At Elara Caring, pay and compensation are determined by a variety of factors, including education, job-related knowledge, skills, training, and experience. Our compensation structure reflects the cost of labor across different U.S. geographic markets, and may vary based on location.
This is not a comprehensive list of all job responsibilities and requirements; upon request, a job description can be provided.
If you are an individual with a disability and are unable or limited in your ability to use or access our career site as a result of your disability, you may request reasonable accommodations by reaching out to ********************.
$50k-71k yearly est. Auto-Apply 53d ago
Research Nurse Coord I
Children's Mercy KC
Clinical research associate job in Kansas City, MO
Thanks for your interest in Children's Mercy!
Do you envision finding a meaningful role with an inclusive and compassionate team? At Children's Mercy, we believe in making a difference in the lives of all children and shining a light of hope to the patients and families we serve. Our employees make the difference, which is why we have been recognized by U.S. News & World Report as a top pediatric hospital, for eleven consecutive years.
Children's Mercy is in the heart of Kansas City - a metro abounding in cultural experiences, vibrant communities and thriving businesses. This is where our patients and families live, work and play. This is a community that has embraced our hospital and we strive to say thanks by giving back. As a leader in children's health, we engage in meaningful programs and partnerships throughout the region so that we can improve the lives of children beyond the walls of our hospital.
Overview
Uses professional nursing knowledge and judgement when conducting nursing research activities. Assist and perform a variety of research, data and other research related duties in order to support the conduct of clinicalresearch under the supervison of a CRC II, Sr. CRC, and or ClinicalResearch Manager. Participates in the day to day operations related to the collection, compliation, and documentation of research data.
At Children's Mercy, we are committed to ensuring that everyone feels welcomed within our walls. A successful candidate for this position will join us as we strive to create a workplace that reflects the community we serve, as well as our core values of kindness, curiosity, inclusion, team and integrity.
Additionally, it's important to us that we remain transparent with all potential job candidates. Because we value the safety of the patients and families we serve, as well as the Children's Mercy staff, we want to let you know that the seasonal influenza vaccine is a condition of employment for all employees in our organization. New employees must be willing to be vaccinated if found non-immune to measles, mumps, rubella (MMR) and chicken pox (varicella) and/or without evidence of tetanus, diphtheria, acellular pertussis (Tdap) vaccination since 2005. If you are selected for this position, you will be asked to supply your immunization records as proof of vaccination. If you and have any concerns about receiving these vaccines, medical and/or religious exemptions can be further discussed with Human Resources.
Responsibilities
Research Operations
Regulatory Support
Data Capture Management
Staff Training/Research Education
Financials/Fiscal Management
Qualifications
Bachelor's Degree BSN and 1-2 years experience nursing experience in a hospital, clinic, or similar health care setting required. or
Associate's Degree ASN; Must obtain bachelor's degree in nursing (BSN) within 5 years of hire. and 3-5 years experience nursing experience in a hospital, clinic, or similar health care setting required.
One of the following: Licensed RN - MO, Registered Nurse Multistate License Missouri required upon hire
One of the following: Licensed RN - Kansas, Registered Nurse Multistate License Kansas required upon hire
RN Compact license for all states besides KS and MO
Refer to Nursing and Advanced Practice Provide Licensure and Certification policy for required Life Support Certifications Required Upon Hire
Benefits at Children's Mercy
The benefits plans at Children's Mercy are one of many reasons we are recognized as one of the best places to work in Kansas City. Our plans are designed to meet the changing needs of our employees and their families.
Learn more about Children's Mercy benefits. Starting Pay
Our pay ranges are market competitive. The pay range for this job begins at $29.82/hr, but your offer will be determined based on your education and experience.
EEO Employer/Disabled/Vet
Children's Mercy hires individuals based on their job skills, expertise and ability to maintain professional relationships with fellow employees, patients, parents and visitors. A personal interview, formal education and training, previous work experience, references and a criminal background investigation are all factors used to select the best candidates. The hospital does not discriminate against prospective or current employees based on the race, color, religion, sex, national origin, age, disability, creed, genetic information, sexual orientation, gender identity or expression, ancestry or veteran status. A drug screen will be performed upon hire. Children's Mercy is smoke and tobacco free.
CM is committed to creating a workforce that supports the diverse backgrounds of our patients and families. We know that our greatest strengths come from the people who make up our team, so we hire great people from a wide variety of backgrounds, not just because it's the right thing to do, but because it makes our hospital stronger and our patient care more compassionate.
If you share our values and our enthusiasm for service, you will find a home at CM. In recruiting for our team, we welcome the unique contributions that you can bring, including education, ideas, culture, and beliefs.
$29.8 hourly Auto-Apply 60d+ ago
Hospice Clinical Coordinator
Elara Holdings 4.0
Clinical research associate job in Topeka, KS
At Elara Caring, we have a unique opportunity to play a huge role in the growth of an entire home care industry. Here, each employee has the chance to make a real difference by carrying out our mission every day. Join our elite team of healthcare professionals, providing the Right Care, at the Right Time, in the Right Place.
:
Clinical Coordinator
At Elara Caring, we care where you are and believe the best place for your care is where you live. We know there's no place like home, and that's why our teams continue to provide high-quality care to more than 60,000 patients each day in their preferred home setting. Wherever our patients call home and wherever they are on their health journey, we care. Each team member has a part to play in this mission. This means you have countless ways to make a difference as Clinical Coordinator. Being a part of something this great, starts by carrying out our mission every day through your true calling: developing an amazing team of compassionate and dedicated healthcare providers.
To continue to be an industry pioneer delivering unparalleled care, we need a Clinical Coordinator with commitment and compassion. Are you one of them? If so, apply today!
Why Join the Elara Caring mission?
Work in a collaborative environment.
Be rewarded with a unique opportunity to make a difference
Competitive compensation package
Tuition reimbursement for full-time staff and continuing education opportunities for all employees at no cost
Opportunities for advancement
Comprehensive insurance plans for medical, dental, and vision benefits
401(K) with employer match
Paid time off, paid holidays, family, and pet bereavement
Pet insurance
As Clinical Coordinator, you'll contribute to our success in the following ways:
Builds teams to offer the highest quality of life to our patients.
Maintains organized, effective, and efficient systems and communication to ensure the continuity of quality patient care is delivered.
Evaluates agency operations, maintains a variety of tracking systems, and identifies ways to enhance workflow and productivity.
Assists staff in maintaining current and accurate medical records and utilization review.
Assists clinical supervisor with non-clinical phone inquiries.
Notifies supervisor of any problems requiring administrative attention and intervention.
Processes and distributes in and out daily mail for the department, collects and maintains inventory, and cleans equipment.
Implements all available actions to prevent avoidable hospitalization and ER visits.
Attends training, education, seminars, or other means of learning.
Treats patients and caregivers in the highest and most effective manner.
Provides positive, supportive communication to physicians, patients, families, visitors, and other agency personnel.
Promotes Elara Caring's philosophy, mission statement and administrative policies to ensure quality of care.
Maintains patient and staff privacy and confidentiality pursuant to HIPAA Privacy Final Rule.
Performs other duties/projects as assigned.
What is Required?
1+ year experience in a hospice or home health care setting
Proficiency with Medical Terminology
Experience working with clinical management team
Proficiency with office equipment including computer, fax, copy machines
Experience with Medicare and Medicaid guidelines are preferred
You will report to the Clinical Manager.
This is not a comprehensive list of all job
responsibilities
; a full
will be provided.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
We value the unique skills of veterans and military spouses. We encourage applications from military veterans and their families.
Elara Caring provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to sex (including pregnancy, childbirth or related medical conditions), race, color, age (40 and older), national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity, gender reassignment, protected veteran status, or any other basis prohibited under applicable federal, state or local law.
Elara Caring participates in E-Verify and we will provide the Federal Government with your Form I-9 information to confirm that you are authorized to work in the United States. Employers like Elara Caring can only use E-Verify once you have accepted the job offer and completed the Form I-9.
At Elara Caring, pay and compensation are determined by a variety of factors, including education, job-related knowledge, skills, training, and experience. Our compensation structure reflects the cost of labor across different U.S. geographic markets, and may vary based on location.
This is not a comprehensive list of all job responsibilities and requirements; upon request, a job description can be provided.
If you are an individual with a disability and are unable or limited in your ability to use or access our career site as a result of your disability, you may request reasonable accommodations by reaching out to ********************.
$52k-70k yearly est. Auto-Apply 55d ago
Clinical Clerkship Coordinator
Kansas City University 4.1
Clinical research associate job in Kansas City, KS
Job Type:StaffJob Description:The Clinical Clerkship Coordinator supports the Department of Clinical Education by managing clinical clerkship experiences within an assigned region. This role ensures accurate student record maintenance, provides guidance and support to students and clinical site partners, and helps uphold curriculum goals and learning objectives. The coordinator plays a key role in delivering exceptional service and promoting excellence throughout the department.
Essential Roles and Responsibilities:
Coordinates clinical clerkship experiences for assigned region
Maintains master schedule for third- and fourth-year students
Coordinates the number of students assigned to a clerkship site for each academic year
Provides direction and guidance to second year students in the selection of securing of core clerkships
Ensure accurate and timely establishment and maintenance of student records
Processes required documents for core site clerkships
Coordinates the evaluation process for students, preceptors, and sites within assigned region
Accurately and timely produces reports and ensures achievement of deadlines
Ensure students and clinical site constituents receive adequate and appropriate services
Provides assistance, support, and helps enforce curriculum educational goals and learning objectives
Help ensure compliance with clinical curriculum
Participates in student orientation sessions prior to clerkship experiences
Help provide quality educational experiences for third- and fourth-year students
Represents the University favorably and in accordance with established Core Values and expectations
Perform other duties as assigned or directed to meet the goals and objectives of the organization and department
Qualifications:
High School Diploma or GED required, Associate/Bachelor's Degree preferred.
Two years working in a college environment preferred.
High level of proficiency with Microsoft Office applications and a strong working knowledge of databases.
Equal Opportunity Employer
KCU is committed to promoting an equal employment opportunity workplace. Equal opportunity is and shall be provided for all employees and applicants for employment on the basis of their demonstrated ability and competence without discrimination on the basis of race, color, religion, sex, age, national origin, genetic information (GINA), physical or mental disability, pregnancy, sexual orientation, gender identity, marital status, familial status, ancestry, military and/or veteran status, and/or any other status protected by applicable Federal, state or local law.
Annual Security Report
KCU is committed to providing a safe campus for students, faculty, and staff. Our annual campus security report lists campus crimes and statistics for the campus and public areas around campus for the last three years, in accordance with the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act.
Thank you for your interest in a career at KCU!
$52k-62k yearly est. Auto-Apply 7d ago
Clinical Research Associate - Sponsor Dedicated
Iqvia 4.7
Clinical research associate job in Overland Park, KS
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Some organizations require completion of CRA training program or prior monitoring experience.
- Basic knowledge of, and skill in applying, applicable clinicalresearch regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinicalresearch 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 $71,900.00 - $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 clinicalresearch 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
$71.9k-189k yearly 60d+ ago
Lead Clinical Research Associate
Icon Clinical Research
Clinical research associate job in Lenexa, KS
Lead ClinicalResearchAssociate - Ophthalmology ICON plc is a world-leading healthcare intelligence and clinicalresearch organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Lead ClinicalResearchAssociate (CRA) to join our diverse and dynamic team. As a Lead CRA at ICON, you will play a pivotal role in overseeing and managing clinical trial sites, ensuring that studies are conducted in accordance with regulatory requirements, study protocols, and company standards. You will be a key contributor to the success of clinical trials by driving site performance, providing mentorship to CRAs, and ensuring the highest levels of data quality and patient safety.
**What You Will Be Doing:**
+ Leading site management activities, including site selection, initiation, monitoring, and close-out visits, to ensure compliance with study protocols and regulatory guidelines.
+ Serving as the primary point of contact for clinical sites, addressing site queries, and resolving issues to maintain site engagement and performance.
+ Ensuring the integrity of clinical data by conducting thorough source data verification, reviewing site records, and monitoring for protocol deviations.
+ Mentoring and providing guidance to CRAs, contributing to their professional development and supporting the consistent application of best practices across studies.
+ Collaborating with cross-functional teams, including clinical project managers, data managers, and biostatisticians, to ensure the successful execution of clinical trials.
**Your Profile:**
+ Bachelor's degree in life sciences, nursing, pharmacy, or a related field. Advanced degree preferred.
+ Extensive experience as a ClinicalResearchAssociate within the pharmaceutical, biotech, or CRO industry, with a proven track record of managing complex clinical trials.
+ In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
+ Strong leadership and mentoring skills, with the ability to manage and motivate CRAs and site staff effectively.
+ Excellent communication, organizational, and problem-solving skills, with a proactive approach to managing site performance and resolving issues.
**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 maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Visit our careers site (************************************* to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here (******************************************************
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.
Are you a current ICON Employee? Please click here (****************************************************** to apply
$49k-79k yearly est. 50d ago
Sr. Clinical Research Associate - FSP
Parexel 4.5
Clinical research associate job in Topeka, KS
**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The ClinicalResearchAssociate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
**Key Accountabilities** :
**Site Management Responsibilities**
+ Contributes to the selection of potential investigators.
+ In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
+ Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
+ Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
+ Actively participates in Local Study Team (LST) meetings.
+ Contributes to National Investigators meetings, as applicable.
+ Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
+ Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
+ Updates CTMS and other systems with data from study sites as per required timelines.
+ Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
+ Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits.
+ Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
+ Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
+ Ensures data query resolution in a timely manner.
+ Works with data management to ensure robust quality of the collected study data.
+ Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
+ Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
+ Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
+ Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
+ Assists site in maintaining inspection ready ISF.
+ Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
+ Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
+ Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
+ Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
+ Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.
**Compliance with Sponsor Standards**
+ Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
+ Ensures compliance with local, national, and regional legislation, as applicable.
+ Completes timesheets accurately as required.
**Compliance with Parexel Standards**
+ Complies with required training curriculum.
+ Completes timesheets accurately as required.
+ Submits expense reports as required.
+ Updates CV as required.
+ Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.
**Skills (Essential):**
+ Excellent attention to detail.
+ Good written and verbal communication skills.
+ Good collaboration and interpersonal skills.
+ Good negotiation skills.
+ Proficient in written and spoken English language required.
+ Fluency in local language(s) required.
**Skills (Desirable):**
+ Ability to work in an environment of remote collaborators.
+ Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
+ Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
+ Good analytical and problem-solving skills.
+ Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
+ Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
+ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
**Knowledge and Experience (Essential)** **:**
+ Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
+ Good knowledge of relevant local regulations.
+ Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
+ Basic understanding of the drug development process.
+ Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
**Knowledge and Experience (Desired):**
+ Familiar with risk-based monitoring approach including remote monitoring.
+ Good cultural awareness.
**Education:**
+ Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
**Other:**
+ Ability to travel nationally/internationally as Required
+ Valid driving license per country requirements, as applicable.
LI-LG4
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
How much does a clinical research associate earn in Olathe, KS?
The average clinical research associate in Olathe, KS earns between $40,000 and $98,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.
Average clinical research associate salary in Olathe, KS
$63,000
What are the biggest employers of Clinical Research Associates in Olathe, KS?
The biggest employers of Clinical Research Associates in Olathe, KS are: