Clinical Research Quality Regulatory Coordinator
Clinical research coordinator job in Liberty, MO
BVL Clinical Research is a dedicated clinical research site located in Liberty, Missouri, specializing in gastroenterology and hepatology. We are currently conducting multiple clinical trials focused on Crohn's Disease and Ulcerative Colitis.
Position Overview
We're seeking an on-site Clinical Research Quality Regulatory Coordinator to support and oversee regulatory compliance and quality assurance activities across all clinical trials conducted at our site. This position ensures that studies are conducted in alignment with FDA regulations, GCP guidelines, sponsor requirements, and internal SOPs.
This role focuses on regulatory document management, quality oversight, and inspection readiness to support a high standard of clinical trial execution across all studies.
Please Note: This is a fully on-site position. Candidates must be located within commuting distance to Liberty, MO. Relocation assistance is not available.
Key Responsibilities
Regulatory Coordination
Prepare, submit, and track IRB documents (initial submissions, amendments, continuing reviews, safety reports).
Maintain complete and up-to-date regulatory binders and essential trial documents.
Liaise with sponsors, CROs, IRBs, and regulatory authorities regarding document requests and compliance.
Ensure timely filing of ICFs, protocol amendments, and safety updates.
Quality Assurance & Compliance
Support and enhance the site's Quality Management System (QMS).
Conduct periodic internal audits of regulatory files, source documentation, and CRFs.
Track and manage protocol deviations, noncompliance events, and CAPAs.
Maintain inspection readiness across all active trials.
Study Start-Up Support
Coordinate regulatory tasks related to site initiation and study start-up.
Maintain investigator credentials, training logs, and required documentation (e.g., 1572, CVs, licenses).
Training & Oversight
Ensure clinical staff maintain current GCP and protocol-specific training.
Assist with onboarding and ongoing staff education on regulatory processes.
Support sponsor and CRO monitoring visits and audits.
Documentation & Reporting
Maintain version control and audit trails for all clinical and regulatory documents.
Draft and update SOPs, logs (training, delegation, document tracking), and compliance reports.
Provide regular regulatory status reports to site leadership.
Additional Responsibilities
Contribute to protocol development and review for compliance.
Support internal/external audits, inspections, and monitoring visits.
Collaborate with PIs and study teams to ensure efficient trial execution.
Comply with all policies, standards, mandatory training, and requirements of BVL Clinical Research.
Qualifications
Education
Bachelor's degree in Life Sciences, Healthcare, or a related field (required).
Advanced training or certification in regulatory affairs or clinical quality (preferred).
Experience
2+ years in a clinical research environment, preferably at a private site or research clinic.
Experience with IRB submissions, regulatory binders, and clinical research SOPs.
Skills & Knowledge
Working knowledge of FDA regulations, ICH-GCP, HIPAA, and 21 CFR Part 11.
Proficiency in Microsoft Office and electronic regulatory systems.
Excellent organizational, communication, and multitasking abilities.
Preferred Certifications
ACRP or SOCRA certification (CCRP, CCRC, or equivalent).
GCP or Clinical Research Quality training/certification.
Why Join BVL Research?
At BVL, you'll be part of a passionate and collaborative team dedicated to advancing clinical care for patients with serious gastrointestinal conditions. We combine the integrity of research with the compassion of patient-centered care.
As a growing private site, we offer:
Hands-on experience with cutting-edge clinical trials in gastroenterology and hepatology.
Opportunities for professional growth in regulatory affairs, quality assurance, and clinical operations.
A supportive environment where your ideas and contributions truly matter.
The chance to be part of meaningful research that directly impacts patient outcomes.
Join us in driving innovation, maintaining the highest standards in clinical research, and making a real difference in patients' lives.
Learn more at BVLResearch.com.
Clinical Research Associate
Clinical research coordinator job in Lenexa, KS
Clinical Research Associate - Central/East Coast ICON plc is a world-leading healthcare intelligence and clinical research 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 Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate II 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 2 years of experience as a Clinical Research Associate.
+ 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
Clinical Study Manager
Clinical research coordinator job in Lenexa, KS
Clinical Study Manager - Lenexa, KS (Onsite) ICON plc is a world-leading healthcare intelligence and clinical research 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.
At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.
Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.
Overview:
With oversight from the manager of study management or director of operations, the study manager will be responsible for the overall direction, coordination, implementation and execution of the project ensuring consistency with company strategy, commitments and goals.
With oversight from the manager of study management or director of operations, will provide study management leadership to cross functional teams by integrating, facilitating, coordinating and managing all activities related to the initiation, planning, execution and closeout of assigned projects.
With oversight from the manager of study management or director of operations, will be responsible for managing projects to ensure integration, coordination and consistency of processes throughout the project life cycle.
A minimum of two years clinical research experience in leading and directing clinical trials with bachelor's degree or local equivalent
Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON 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.
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
Clinical Study Coordinator-JCCT
Clinical research coordinator 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 Research Associates
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 clinical research setting or related work environment is preferred
Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research
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 clinical research 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
Senior Clinical Research Associate
Clinical research coordinator job in Kansas City, MO
Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest's headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.
Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that's us…that's Everest.
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Research Associates for coverage on the East Region. The incumbents may be required to travel to other locations across the USA to support monitoring activities as necessary.
Key Accountabilities:
Interact with personnel from study Sponsors, investigational sites, vendors, and Everest functional groups to enable quality and on-time execution of clinical trials in compliance with ICH-GCP and relevant local regulations.
Identify potential sites for participation in clinical trials.
Perform protocol/site feasibility and Pre-Study Visits to recommend qualified sites.
Participate in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions, and assist sites with study-related questions as needed.
Provide feedback to study manuals, Case Report Form completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as needed.
Perform Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan.
Submit quality and on-time Monitoring Visit Reports and follow-up letters to the Clinical Operations Lead or designee for review and approval via Clinical Trial Management System (CTMS).
Complete monitoring visit reports and follow-up letters, including summaries of the significant findings, deviations, deficiencies, and recommended actions to ensure site compliance.
Assist with oversight visits and monitoring visit report review/approval of CRA I/II, evaluating their performance and providing feedback to their supervisor, if requested.
Review ISFs to ensure essential documents are current and submitted to the TMF throughout the trial for reconciliation purposes. Ensure sites have submitted relevant documents to their Institutional Review Board/Ethics Committee as needed. The CRA is responsible for ensuring that the TMF is maintained in an inspection-ready state.
Establish regular lines of communication and administer ongoing protocol/study-related training to assigned sites.
Assist with site management tasks and ensure continuous data flow (i.e., on-time site data entry, query resolution, and source document verification). Assess the clinical research site's patient recruitment/retention success and offer suggestions for improvement.
Ensure proper handling, accountability, and reconciliation of all investigational products, medical devices, and clinical trial supplies.
Prepare sites for inspections/audits conducted either by regulatory authorities, Sponsors, or Contract Research Organizations.
Submit accurate and on-time expense reports.
Assist with preparation of materials for Requests for Proposals and bid defenses.
Assist the Clinical Operations team with additional related tasks as needed.
Plan and carry out professional development.
Complete timesheets as requested and on-time.
Qualifications and Experience:
Bachelor's degree in a Life Science or related field of study.
Minimum of 4 years' of relevant and/or monitoring experience.
Thorough knowledge of ICH-GCP guidelines and applicable regulations.
Thorough comprehension of medical terminology.
Excellent organization and communication skills (both verbal and written).
Ability to travel a maximum of 70% of working hours to locations nationwide. Less travel hours may apply for projects with remote/virtual visits.
Must maintain a valid driver's license and be able to drive to monitor sites.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at ****************
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
#LI-Remote
#LI-MG1
Clinical Research Coordinator II/III
Clinical research coordinator job in Kansas City, MO
Full-time Description
JOB DESCRIPTION: CLINICAL RESEARCH COORDINATOR II/III
POSITION DESCRIPTION: The Clinical Research Coordinator (CRC) reports to the Director of Research and is responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs. The CRC collects and records clinical research data, assists in patient assessments, scheduling, maintain study files, study supplies and study medication accountability.
RESPONSIBILITIES:
Knowledge of all active protocols and disease indications within the company, and providing information about these protocols to staff and patients.
Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.
The CRC is responsible for meeting recruitment goals for each study. The methodology of recruitment will include, but is not limited to daily chart review, hosting recruitment breakfasts, advertising when funds are available, referrals from rheumatologists and other AARA staff and may include attending health fairs and community outreach.
Keeping the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators, and ensuring status of each patient is accurate.
Responsible for chain of custody and accurate accountability of investigation product and devices.
Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:
Informed Consent
Obtaining patient medical history and medication lists
Phlebotomy and basic laboratory tests
Processing & shipping labs for central and local labs
Patient education and training
ECG
Administer questionnaires and assessments
Vital signs
Collect information for adverse event reporting
Assist with joint counts and other efficacy assessments
Data Entry and Query Resolution
Study drug administration, including injections
Tracking study supply inventory and reordering when necessary
Schedule patient visits in appropriate electronic systems
Documenting all patient visits and communications in progress notes
Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed.
Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program.
Ensures uniform implementation of protocols by completing required training documentation in a consistent, accurate and timely manner.
Assists in regulatory functions, including but not limited to preparing appropriate Institutional Review Board (IRB) forms, processing updated informed consents, protocols, correspondence, and regulatory filing in an accurate and timely manner.
Responsible for administrative duties including filing documents related to subjects participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc.
Serves as a liaison to all physicians, AARA employees, and third party vendors.
Participates in monitoring visits from sponsor provided appointees, ensures monitors are able to meet/speak with PI and ensures all concerns are addressed in a timely manner.
Ensure the delegation logs are correct and only delegated site staff are performing duties as listed on the delegation log for any given study.
Ensures that primary referring physicians receive timely progress notes on the patient's diagnosis and treatment.
May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.
Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards.
Provides all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.
Maintaining office supply inventory while keeping an organized office space.
Travel as necessary for Investigator Meetings and other AARR sites.
Requirements
Qualifications:
Bachelor's Degree or equivalent
1 year experience as a clinical research coordinator
Must have in-depth knowledge of clinical research, medical procedures and clinical terminology
Excellent organization & communication skills
Ability to lift 20 pounds
Willing and able to travel for Investigator Meetings and other research sites
Salary:
$65,000-$80,000 annual salary (plus additional bonuses available)
Salary Description 65,000-80,000
Clinical Research Associate/SR CRA, Field Trials
Clinical research coordinator job in Saint Joseph, MO
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Clinical Research Associate (CRA) conducts in-house and external monitoring to verify that reported data collected in Clinical Lab Studies and Field Trials are accurate, complete, and verifiable from source documents and to ensure that the studies are conducted in compliance with the current approved protocol, GCP/ VICH requirements, FDA/CVM Regulations, and BI SOPs. The incumbent is responsible for ensuring quality of study protocols, raw data, and reports to support registrations and other claims related to veterinary products. The CRA performs these duties for on-site and off-site (national and global) clinical studies and trials for all animal species.
Duties for this role include interaction with CROs/Investigators, monitoring of study status, quality control and integrity of data, management of study data and performing procedures in compliance to GxP and relevant regulatory guidelines. The CRA also circulates documents for approval, drafts study documents and reports, assists with study in-life phase, designs and implements study related processes, and is responsible for the closure of studies including preparation of archiving.
**Duties & Responsibilities**
+ Makes certain that all documents related to in-house, CRO, and field studies are accurate as to drug dosages, drug accountability, numerical calculations, concurrent medications, clinical signs when compared to clinic records, adverse events, clinical observations, and analytical results.
+ Documents to be audited include, but not limited to, study notebooks, study reports, protocols, study checklists, and analytical data.
+ Identification of qualified CROs/FT Investigators.
+ Conduct Investigation Site Visits to evaluate qualifications of the site, Investigator, and research staff.
+ Conduct pre-study and ongoing monitoring visits in compliance with Guidelines for all study/trial sites.
+ Monitors the progress of in-house studies, field studies, and contract laboratory clinical studies, providing status reports in progression of the animal or report writing phases of the study.
+ Verifies both individual subject and overall drug accountability.
+ Identifies problems with enrollment and mitigations to resolve the issues.
+ Collaborates with the Clinical Scientist and Study/Trial team in protocol development, CRF design, writing amendments, creating site-training materials, final study report, training materials, etc.
+ Assists Scientists in planning and implementation of investigator meetings and/or webinars.
+ Monitors Adverse Event (AE) reporting and request primary and follow-up information.
+ Provides information to pharmacovigilance and RA according to the study protocol and SOPs.
+ Ensures availability of all final study documentation for audits/inspections (internal compliance or CVM).
+ Prepares protocols, data, reports, and other documents for submission to regulatory agencies.
+ Collaborates closely with Regulatory Affairs to align on document organization.
Responsible for:
+ Appropriate quality of study protocols, raw data and reports.
+ All study/trial data are accurate, complete and verifiable from source documents (e.g., as subject research records, medical charts etc.) and regulatory documents.
+ Protocol adherence and study documentation is completely and properly maintained in accordance with Sponsor protocol, BIVI SOPs, GCP/GLP/ VICH requirements and FDA regulations.
+ Deviations are identified and reported to the appropriate Study personnel.
+ Quality control audits of data entry and statistical reports.
**Requirements**
+ Good verbal and written communication skills (correspondence, protocols, reports, etc.)
+ Good interpersonal skills.
+ Collaborative team player.
+ Possesses a customer service orientation, delivering results and executing in a fast and focused manner.
+ Solid organizational skills with a quality orientation.
+ Strives for business process excellence.
+ Effective time management.
+ High degree of attention to detail.
+ Ability to find errors or inconsistencies others may miss.
+ Exhibits integrity and trust.
+ Willingness to travel up to 60% of time.
+ English: Fluent (read, write and speak).
CRA:
+ Bachelor's degree (prefer relevant disciplines such as biology, animal science, nutrition, etc.) with one (1) year of experience focusing on clinical studies or two-plus (2+) years' experience in Human Pharma or Animal Health Research areas.
SR CRA:
+ Bachelor's degree (prefer relevant disciplines such as biology, animal science, nutrition, etc.); MS preferred.
+ Minimum of 3-5 years' experience as a CRA/Monitor or similar role
**Eligibility Requirements** :
+ Must be legally authorized to work in the United States without restriction.
+ Must be willing to take a drug test and post-offer physical (if required).
+ Must be 18 years of age or older.
**GI_US925**
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Senior Clinical Research Associate
Clinical research coordinator job in Overland Park, KS
Your New Company! At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.
We are better together and together We Are Altasciences.
About The Role
The Senior Clinical Research Associate (Senior CRA) reports directly to a member of the Clinical Monitoring Management team, as defined in the current organizational chart. The SCRA performs monitoring activities for clinical research projects according to the Clinical Monitoring Plans (CMPs) to assess the studies progress at assigned investigator sites (either on-site or remotely) and to ensure projects are conducted, recorded, and reported in accordance with the Protocol, Altasciences and Sponsor (when applicable) standard operating procedures (SOPs), ICH-GCP and applicable local and federal regulatory requirements. The Senior CRA coordinates the monitoring activities at the site level and is the main contact person for any questions (internal/external) related to the monitoring activities.
Preferred candidate will reside in or near Dallas, TX or Atlanta, GA due to these locations being the travel hub for this role.
What You'll Do Here
Create Clinical Monitoring Plans (CMPs) and prepare required Site Initiation Visits documents (e.g., Power Point presentations).
Perform site qualification, initiation, interim, and close-out visits (either on-site or remotely) accordingly to the CMPs.
Document activities via confirmation letters, visit reports, follow-up letters, and any other study-specific documents as per the CMP
Assess the sites processes.
Perform Source Documentation Verification (SDV) of source documents.
Perform dosing observations and/or assist to Investigational Products (IPs) dispensation.
Verify clinical data entered in the Case Report Forms (CRFs) and/or electronic CRFs (eCRFs).
Apply query resolution techniques and provide guidance to site staff as necessary, driving queries resolution within agreed timelines.
Review the Investigator Site Files (ISFs).
Review IPs inventory, reconciliation, and storage conditions.
Review and track Serious Adverse Events (SAEs).
Review study Protocols, Informed Consent Forms (ICFs) and any other study-specific documents.
Responsible for leading complex projects and involving multiple resources.
Interprets data to recommend plans and tactics.
Provides advice, guidance and answers to management on sensitive strategic matters pertaining to the entire organization.
Train study site personnel on the Protocol, study-specific documents, and applicable regulatory requirements in collaboration with assigned project team members.
Ensure monitoring SOPs and templates are up-to-date and update them as required.
At the site level: Assist with planning/scheduling, assigning, tracking, and overseeing the monitoring activities, including the internal reports revision.
Assists in managing and helping create clinical trial tracking metrics and reporting.
Mentoring, training for Clinical Research Associates.
Review and approve monitoring documents.
What You'll Need to Succeed
Bachelor's or equivalent health related (e.g., Medical, Scientific, Nursing) degree preferred.
Minimum of 5 years of clinically-related experience, of which a period of 2 years is preferable in clinical research monitoring or equivalent experience.
Knowledge of clinical research industry, terminology and practices.
Knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
Strong verbal and written communication skills.
Familiarity with EDC systems; ability to learn required systems quickly and to train others, especially site staff.
Ability to meet deadlines, multitasks, and prioritize based on study needs.
Ability to make sound decisions based on available information.
Ability to establish and maintain a good working relationship with site personnel/ colleagues.
Ability to work both in a team and independently.
Ability to facilitate team meetings and teleconferences.
Ability to present at internal study team meeting(s).
Proficient with Microsoft Office Word, Excel and Power Point.
Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
Ability to travel.
What We Offer
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
Altasciences' Benefits Package Includes:
Health/Dental/Vision Insurance Plans
401(k)/RRSP with Employer Match
Paid Vacation and Holidays
Paid Sick and Bereavement Leave
Employee Assistance & Telehealth Programs
Altasciences' Incentive Programs Include:
Training & Development Programs
Employee Referral Bonus Program
Annual Performance Review
#LI-TN1
MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH
Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!
Auto-ApplyClinical Research Coordinator
Clinical research coordinator job in Kansas City, MO
Alcanza is a growing multi-site, multi-phase clinical research 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.
The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.
Key Responsibilities
Essential Job Duties: In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies. Responsibilities may include but are not limited to:
* 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;
* Filing SAE/Deviation reports to Sponsor and IRB as needed;
* Documenting and reporting adverse events;
* Reporting non-compliance to appropriate staff in timely manner;
* Maintaining positive and effective communication with clients and team members;
* Always practicing ALCOAC principles with all documentation;
* May assist with study recruitment, patient enrollment, and tracking as needed;
* Maintaining confidentiality of patients, customers and company information, and;
* Performing all other duties as requested or assigned.
* 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;
* May set up, train and maintain all technology needed for studies.
Skills, Knowledge and Expertise
Minimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical 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. 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.
Travel Per Diem Mobile Research Nurse
Clinical research coordinator job in Kansas City, MO
Science 37's Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials. Science 37's extraordinary work environment allows continuous collaboration between clinicians, clinical researchers, patient recruitment specialists, data managers and technology developers. The Nursing Solutions Group is involved throughout the trial life cycle, from protocol development and feasibility analysis to clinical trial implementation and closeout.
The Per Diem Mobile Research Nurse is a Registered Nurse who will work per diem and has experience across multiple therapeutic areas with the ability to work independently and integrate well with the Nursing Solutions Group. With interest/expertise in Science 37's decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. The Mobile Research Nurse ensures the professional delivery of patient care in compliance with all federal and state regulations, Good Clinical Practice, and Standard Operating Procedures.
*This is a travel role that requires on-site visits to participants homes.
Duties for this position include but are not limited to:
Participate and provide research nurse services to qualified study participants at home
Apply clinical research and nursing practices to develop solutions to complex problems
Collaborate with Lead and Per Diem Mobile Research Nurses on solutioning, education, and resource support
Participate in activities that will further the operational development of Science 37 nursing service delivery
Develop relationships with study team members and serve as the subject matter expert (SME) on all nursing processes
Other duties as assigned as the needs of Science 37 evolve and change
This position has the following qualifications:
BSN degree preferred
Full Covid Vaccination strongly preferred. Science 37 follows CDC guidelines for vaccination recommendations and such guidelines are subject to change.
Active RN licensure in home state as well as eligibility for Compact Licensure required
Minimum 2+ years clinical/research experience preferred
Basic Life Support (BLS) Certification
Maintain a positive reflection of the company by representation in participant's homes or in clinic settings
Travel and availability qualifications are as follows:
1-2 days minimum a week dedicated to support Science 37's study visits
Weekday/night availability required
Must be willing to travel to a participants homes
Active Driver's License
Science 37 is looking for people with the following skills and competencies:
BSN degree preferred
Active RN licensure in home state as well as eligibility for Compact Licensure required
Minimum 2+ years clinical/research experience preferred
Basic Life Support (BLS) Certification
Active Driver's License
Weekday/night availability required
Maintain a positive reflection of the company by representation in participant's homes or in clinic settings
Up to 100% travel, as needed, for study participant visits, project team meetings, and other professional meetings/conferences as needed
Occasional Travel to NYC may be required for visits
Ability to obtain nursing license in multiple states based on study needs
Physical ability to perform nursing tasks and lift equipment up to 15 kg in weight
Access to a reliable vehicle to perform study participant visits and transport equipment
Ability to drive to local and/or remote locations to perform study participant visits
Ability to use technology effectively and appropriately for study participant assessments and documentation including but not limited to study participant care equipment, laptop computers, communication devices and tablets
Ability to communicate in English (both verbal and written)
There is minimal supervision for this position, with individuals reporting to the Manager, Nursing Solutions Group.
Compensation varies based on location and work being performed. The starting pay range for a candidate selected for this position is generally within the range of $50-55 per hour. Employees may be eligible for additional discretionary bonuses and commissions. The successful candidate's actual pay will also be based on qualifications and experience, so the actual starting pay may be above or below this range.
Science 37 is an equal opportunity employer.
We are committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to age, race, ethnicity (including but not limited to hair texture and protected hairstyles), ancestry, color, sex, national origin, sexual orientation, gender, gender identity, gender expression, transgender status, religious creed, physical or mental disability (including actual or perceived disability), medical condition (including HIV/AIDS), pregnancy, perceived pregnancy and pregnancy related conditions, genetic information, marital status, political affiliation or activities, status as a victim of domestic violence, assault, or stalking, veteran status or participation in the uniformed military services of the United States, including the National Guard, or any other basis prohibited by applicable law.
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.
Submit your resume to apply!
To learn about Science 37's privacy practices including compliance with applicable privacy laws, please click here
Auto-ApplyClinical Research Coordinator - Emergency Medicine Administration
Clinical research coordinator job in Kansas City, MO
If you are a current University Health or University Health Physicians employee and wish to be considered, you must apply via the internal career site. Please log into my WORKDAY to search for positions and apply. Clinical Research Coordinator - Emergency Medicine Administration
101 Truman Medical Center
Job Location
University Health Truman Medical Center
Kansas City, Missouri
Department
Admin ER UHTMC
Position Type
Full time
Work Schedule
7:00AM - 5:00PM
Hours Per Week
40
Job Description
Be Part of Breakthroughs That Change Lives
Are you ready to play a key role in advancing medicine and improving patient care through clinical research?
As a Clinical Research Coordinator I, you'll help bring innovative treatments from the lab to real people - coordinating and managing research studies that make a real difference.
Working closely with our investigators, sponsors, and study participants, you'll ensure every detail - from patient enrollment to regulatory documentation - meets the highest standards of ethics, accuracy, and care.
What You'll Do
* Coordinate every phase of clinical studies - from start-up and recruitment to completion - ensuring all activities follow Good Clinical Practice (GCP) and institutional policies.
* Serve as a key liaison among investigators, sponsors, IRB, and study participants.
* Manage research documentation, including regulatory files, informed consents, and case report forms.
* Partner with investigators to prepare and submit protocols and amendments to the IRB.
* Support the financial and administrative aspects of each study, working with leadership to ensure appropriate funding and compliance.
* Maintain subject confidentiality and safety in accordance with HIPAA and research regulations.
* Collaborate across departments to successfully launch new studies and support recruitment efforts.
* Stay up to date on research ethics, regulatory changes, and institutional requirements.
What You Bring
Minimum Qualifications:
* Bachelor's degree in an allied health or related field
* Strong organization and time management skills with the ability to manage multiple projects
* Excellent written and verbal communication skills
* Attention to detail and ability to work independently
* Proficiency with computer systems and documentation tools
Preferred Qualifications:
* One year of clinical research experience
* Clinical Research Coordinator Certification (ACRP or SoCRA)
* Working knowledge of GCP, FDA, and DHHS regulations, ICH Guidelines, and HIPAA
You'll Thrive Here If You…
* Love being part of a mission-driven team advancing healthcare innovation
* Are naturally organized and thrive in a fast-paced, regulated environment
* Take pride in accuracy, integrity, and collaboration
* Want to make an impact on patients' lives while growing your research career
Auto-ApplyResearch Nurse Coord I
Clinical research coordinator 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 clinical research under the supervison of a CRC II, Sr. CRC, and or Clinical Research 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 all are 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.
Auto-ApplyClinical Coordinator, Acute Rehabilitation
Clinical research coordinator job in Saint Joseph, MO
Facility Name: Mosaic Life Care St Joseph Medical Center ARU
Clinical Coordinator Occupational Therapist or Physical Therapist
Shift: Full Time Days
Schedule: 8-hour shifts, rotating weekend required
Your experience matters
Lifepoint Rehabilitation is part of Lifepoint Health, a diversified healthcare delivery network with facilities coast to coast. We are driven by a profound commitment to prioritize your well-being so you can provide exceptional care to others. As a Clinical Coordinator joining our team, you're embracing a vital mission dedicated to making communities healthier
.
Join us on this meaningful journey where your skills, compassion and dedication will make a remarkable difference in the lives of those we serve.
More about our team: Mosaic Life Care provides Inpatient Rehabilitation/Post-Acute Care in St. Joseph, MO. Therapy plays a very important role in recovery from a life-altering injury or illness. We offer a hospital-based physical rehabilitation program for the treatment of those who have experienced a debilitating injury or illness. Our Unit is a very fast-paced yet fun environment with endless opportunities to learn and grow!
What we're looking for: We are looking for a dynamic Clinical Coordinator who is passionate about helping others and is a team player!
What you will do in this role:
A Clinical Coordinator assists with the daily coordination of personnel and resources within the scope of assignment. Acts as the liaison between the nursing departments and all the ancillary departments to promote continuity of care, optimal patient outcomes, patient satisfaction, cost efficiency and compliance.
Discharge planning is the process of transitioning a patient from one level of care to the next. Ideally, discharge plans are individualized instructions provided to the patient as they move from the hospital to home or instructions provided to subsequent healthcare providers. Discharge planner reports off to the Social Work team and staff.
Required Skills
Requires critical thinking skills, decisive judgment and the ability to work with minimal supervision. Must be able to work in a stressful environment and take appropriate action.
Essential Functions
Coordinates staff scheduling, educational/development activities and performance evaluations.
Collaborates with physicians, nursing, pharmacy and other healthcare team members/departments to determine, coordinate, and provide medical nutrition therapy.
Identifies and resolves issues affecting the delivery of clinical services.
During tour of duty, maintains constant communication between all nursing areas and the registration area in order to facilitate a smooth through put of patients.
Provides basic direct patient care as needed.
Insertion of PICC lines when ordered by the physician.
Accesses Hickman catheters and port-a-cath lines when needed.
Responds to all in hospital emergencies to guide and assure appropriate outcomes.
Treats patients and their families with respect and dignity
During tour of duty, rounds on all post surgical or procedural patients.
Provides ‘just in time' education for staff during tour of duty.
Assists physicians with procedures.
Reports all incidents or unusual events to their Director or appropriate supervisor.
Provides moderate sedation when required. Knowledgeable of policy and procedure.
Understands and practices within the scope of practice as an RN.
Abides by and promotes the behavioral performance standards as set by the facility.
Qualifications:
Masters degree for OT Doctorate for PT
Must be license in the state of MO
BLS Required
ACLS Required
Why join us:
We believe that investing in our employees is the first step to providing excellent patient care. In addition to your base compensation, this position also offers
· Comprehensive Benefits: Multiple levels of medical, dental and vision coverage for full-time and part-time employees.
· Financial Protection & PTO: Life, accident, critical illness, hospital indemnity insurance, short- and long-term disability, paid family leave and paid time off.
· Financial & Career Growth: Higher education and certification tuition assistance, loan assistance and 401(k) retirement package and company match.
· Employee Well-being: Mental, physical, and financial wellness programs (free gym memberships, virtual care appointments, mental health services and discount programs).
· Professional Development: Ongoing learning and career advancement opportunities.
EEOC Statement
Mosaic Life Care St Joseph Medical Center is an Equal Opportunity Employer. Mosaic Life Care St Joseph Medical Center is committed to Equal Employment Opportunity for all applicants and employees and complies with all applicable laws prohibiting discrimination and harassment in employment.
Auto-ApplyClinical Research Coordinator
Clinical research coordinator job in Liberty, MO
BVL Clinical Research is a premier clinical research site specializing in gastroenterology and inflammatory bowel disease (IBD) studies. Our team partners with leading physicians, sponsors, and patients to advance innovative treatments that improve lives.
We're seeking a Clinical Research Coordinator (CRC) to join our on-site team in Liberty, Missouri. This position is ideal for candidates with a background in healthcare or research who want to play a hands-on role in the development of new medical therapies.
Position Overview
As a Clinical Research Coordinator, you'll work under the direction of the Principal Investigator (PI) to coordinate and manage all aspects of clinical trial operations. You'll collaborate with patients, physicians, sponsors, and research staff to ensure studies are conducted with accuracy, safety, and full regulatory compliance.
This position blends hands-on patient care with the opportunity to help advance innovative new treatments.
RN license is preferred but not required. We also welcome candidates with relevant clinical, laboratory, or research coordination experience who do not hold an RN license. Experience with Phase 2-4 clinical trials is a strong plus.
Key Responsibilities
Explain study protocols, procedures, and treatments to patients and families
Conduct the informed consent process in collaboration with investigators
Prepare and process laboratory specimens; ship frozen samples per study protocol
Manage study documentation, including case report forms and regulatory files
Monitor, document, and report adverse events to the IRB and sponsors
Ensure compliance with all study protocols and regulatory standards
Coordinate subject screening, enrollment, and follow-up visits
Assist with feasibility assessments and pre-study/site initiation visits
Maintain study data integrity and implement quality control procedures
Collaborate with PIs, sponsors, and monitors to support study execution
Participate in audits, investigator meetings, and training sessions
Support preparation of study reports and internal communications
Perform other assigned duties and comply with all BVL Research policies and standards
Education:
Bachelor's degree in a health-related field (Nursing, Life Sciences, or equivalent)
Preferred Experience:
2+ years of experience in clinical research coordination, nursing, or healthcare
Familiarity with Phase 2, 3, or 4 clinical studies
Knowledge of FDA, GCP, and clinical trial regulatory requirements
Strong attention to detail, organizational, and communication skills
Proficiency in Microsoft Office/Google Workspace
Active RN license (preferred but not required)
Why Join BVL?
At BVL Clinical Research, you'll find meaningful work that helps bring new treatments to patients in need. You'll collaborate directly with physicians and research experts in a supportive, team-oriented environment while developing specialized skills in clinical research.
If you're a healthcare professional or aspiring research coordinator eager to make a real impact in advancing medical treatments, we'd love to hear from you. Apply today to join our team, and help shape the future of clinical research.
To learn more about who we are and the work we do, visit our website at *******************
Clinical Research Associate - Midwest
Clinical research coordinator job in Lenexa, KS
As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing:** + 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
+ Bachelor's degree in a scientific or healthcare-related field highly preferred.
+ Minimum of 2 years of experience as a Clinical Research Associate (on site monitoring experience required)
+ 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.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs
+ Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
+ Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ************************************
At ICON, 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, colour, 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.
*****************************************************
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.
Clinical Study Team Manager
Clinical research coordinator job in Lenexa, KS
Full-time Description
Clinical Study Team Manager
Department: Study Management
The Clinical Study Team Manager is responsible for assuring the study team is accountable for performing assigned responsibilities in compliance with project plans, federal regulations, GCP and good medical practice. This position reports directly to the Director of Clinical Operations.
Position Responsibilities
Reviews study compliance against protocol, SOPs, regulations and ICH/GCP guidelines
Acts as a primary liaison with CRO/sponsors; establishes quality guidelines to ensure clinical study vendors are adhering to the agreed upon timelines
Ensures timely responses to clinical site staff and all regulatory agencies
Develop strong, collaborative working relationships with CROs, sponsors, investigators, and other essential staff members
Assembles and coordinates clinical trial study teams of study coordinators and other personnel needed to support the execution of the clinical study
Oversees overall study progress, data collection, and cleaning activities for all study trials
Interacts and coordinates with sponsor on study specifics
Prepares study reports and provides ongoing updates for leadership team/meetings
Develops best practices and SOPs
Provides clinical leadership to CROs and sponsors
Effectively leads and manages a team of direct reports
Oversees leadership of the Study Management team while ensuring site training/communications are occurring
Interviews and onboards new hires for the Study Management team
Conducts continuing performance management and annual reviews of the Study Management team
Participates in and assists Director of Clinical Operations with preinitiation and other study related meetings
Ensures staff work is “inspection ready” at all times
Requirements
Experience and Skills:
Customer service
Microsoft Office proficiency
Working knowledge of Clinical Conductor CTMS
Understanding of research principles, protocols, and basic finance
Excellent communication and interpersonal skills in person, email and telephone etiquette
Ability to work effectively with a team
Ability to manage small projects personally and work independently
Memory to retain information and know where to research answers
Time management skills
Close attention to detail and strong organizational skills to deliver high quality work within project timelines
Demonstrates strong analytical, problem-solving skill
Self-motivated
Must be results oriented, multi-tasking and a quick learner
Education and Experience:
Minimum 5-6 years of experience in clinical research
Strong knowledge of relevant regulations ICH/GCP and FDA guidelines
Effective site management and organizational skills/ability to meet key study milestones
Bachelor's degree preferred
Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands and wrists
Ability to lift and/or move up to 25 pounds.
Salary Description $85,000-$95,000 Annually
Clinical Research Coordinator II/III
Clinical research coordinator job in Kansas City, MO
Description:
JOB DESCRIPTION: CLINICAL RESEARCH COORDINATOR II/III
POSITION DESCRIPTION: The Clinical Research Coordinator (CRC) reports to the Director of Research and is responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs. The CRC collects and records clinical research data, assists in patient assessments, scheduling, maintain study files, study supplies and study medication accountability.
RESPONSIBILITIES:
Knowledge of all active protocols and disease indications within the company, and providing information about these protocols to staff and patients.
Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.
The CRC is responsible for meeting recruitment goals for each study. The methodology of recruitment will include, but is not limited to daily chart review, hosting recruitment breakfasts, advertising when funds are available, referrals from rheumatologists and other AARA staff and may include attending health fairs and community outreach.
Keeping the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators, and ensuring status of each patient is accurate.
Responsible for chain of custody and accurate accountability of investigation product and devices.
Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:
Informed Consent
Obtaining patient medical history and medication lists
Phlebotomy and basic laboratory tests
Processing & shipping labs for central and local labs
Patient education and training
ECG
Administer questionnaires and assessments
Vital signs
Collect information for adverse event reporting
Assist with joint counts and other efficacy assessments
Data Entry and Query Resolution
Study drug administration, including injections
Tracking study supply inventory and reordering when necessary
Schedule patient visits in appropriate electronic systems
Documenting all patient visits and communications in progress notes
Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed.
Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program.
Ensures uniform implementation of protocols by completing required training documentation in a consistent, accurate and timely manner.
Assists in regulatory functions, including but not limited to preparing appropriate Institutional Review Board (IRB) forms, processing updated informed consents, protocols, correspondence, and regulatory filing in an accurate and timely manner.
Responsible for administrative duties including filing documents related to subjects participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc.
Serves as a liaison to all physicians, AARA employees, and third party vendors.
Participates in monitoring visits from sponsor provided appointees, ensures monitors are able to meet/speak with PI and ensures all concerns are addressed in a timely manner.
Ensure the delegation logs are correct and only delegated site staff are performing duties as listed on the delegation log for any given study.
Ensures that primary referring physicians receive timely progress notes on the patient's diagnosis and treatment.
May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.
Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards.
Provides all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.
Maintaining office supply inventory while keeping an organized office space.
Travel as necessary for Investigator Meetings and other AARR sites.
Requirements:
Qualifications:
Bachelor's Degree or equivalent
1 year experience as a clinical research coordinator
Must have in-depth knowledge of clinical research, medical procedures and clinical terminology
Excellent organization & communication skills
Ability to lift 20 pounds
Willing and able to travel for Investigator Meetings and other research sites
Salary:
$65,000-$80,000 annual salary (plus additional bonuses available)
Clinical Research Coordinator
Clinical research coordinator job in Kansas City, MO
Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research 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.
The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.
Key ResponsibilitiesEssential Job Duties: In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies. Responsibilities may include but are not limited to:
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;
Filing SAE/Deviation reports to Sponsor and IRB as needed;
Documenting and reporting adverse events;
Reporting non-compliance to appropriate staff in timely manner;
Maintaining positive and effective communication with clients and team members;
Always practicing ALCOAC principles with all documentation;
May assist with study recruitment, patient enrollment, and tracking as needed;
Maintaining confidentiality of patients, customers and company information, and;
Performing all other duties as requested or assigned.
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;
May set up, train and maintain all technology needed for studies.
Skills, Knowledge and ExpertiseMinimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical 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. 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.
Research Nurse Coord I
Clinical research coordinator 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 clinical research under the supervison of a CRC II, Sr. CRC, and or Clinical Research 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.
Remote Work/Work from Home
This is an intermittent remote position, which means that the person hired will work with his or her manager to determine a schedule that includes both at home and on-site hours at a Children's Mercy location. The incumbent must live in the Kansas City metro area.
#LI-Hybrid
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.
Auto-ApplyClinical Research Coordinator
Clinical research coordinator job in Kansas City, MO
Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research 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 Clinical Research 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 Clinical Research 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 clinical research 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 clinical research 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.