Clinical Research Associate, Sponsor Dedicated
Clinical research coordinator job in Overland Park, KS
, you must reside in the same country where the job is located. Whether you're beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You'll have training and development to plan and progress your career in the direction you choose. And you won't do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards.
Award winning and innovative, we'll give you access to cutting-edge in-house technology, allowing you to work on global projects but with a regional / home state travel remit, so no need for national travel in certain countries. You'll be building a smart and flexible career with no limits.
**While projects vary, your typical responsibilities might include:**
+ Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
+ Supporting the development of a subject recruitment plan
+ Establishing regular lines of communication plus administering protocol and related study training to assigned sites
+ Evaluating the quality and integrity of site practices - escalating quality issues as appropriate
+ Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements.
You should have:
+ A Bachelor's degree in a health care or other scientific discipline or educational equivalent
+ Successful completion of a CRA Trainee Program or at least three months of on-site monitoring experience. 2 years of clinical research coordinator experience strongly preferred.
+ Alternatively, you should have an equivalent combination of education, training and experience
If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team.
\#CRASDAJD
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $64,000.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Senior Clinical Research Coordinator - Cell Therapy
Clinical research coordinator job in Kansas City, KS
Department:Comprehensive Integrated Research Operations (CIRO)
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AdministrationPosition Title:Senior Clinical Research Coordinator - Cell TherapyJob Family Group: Professional Staff Summary:This position is responsible for working collaboratively with multidisciplinary teams, research and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The Clinical Research Coordinator Senior will manage clinical research studies by coordinating and overseeing a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Participate in periodic quality assurance audits of protocols. Assist with study budgets and contracts and assist with grant applications.:
Position Summary:
The Senior Clinical Research Coordinator (Sr. CRC) plays a key-role in complex clinical trials focused on cellular therapies, including CAR-T and other investigational treatments. As part of a centralized research team supporting multiple departments and medical specialties, the Sr. CRC collaborates with multidisciplinary teams to coordinate all aspects of clinical research with a high degree of autonomy. Responsibilities include serving as the primary liaison with sponsors and investigators, leading participant recruitment and coordination, ensuring regulatory compliance, managing data and quality audits, and supporting the development of study budgets, contracts, and grant applications.
Job Duties:
Cell Therapy Clinical Trial Management
Independently manage all operational aspects of multiple clinical trials from initiation through close-out.
Collaborate on developing and implementing centralized support for cell therapy and early-phase trials.
Coordinate and track essential regulatory and study documentation to ensure audit and monitoring readiness.
Create and maintain study binders, source documentation templates, and other regulatory-compliant materials.
Participate in site selection, initiation, monitoring, and close-out visits with sponsors and research partners.
Facilitate protocol feasibility assessments and coordinate site qualification documentation.
Serve as primary liaison among sponsors, research partners, and internal departments.
Support feasibility by gathering and analyzing data on patient populations and operational needs.
Develop and update standard operating procedures, guidelines, and source documents.
Participant Coordination & Oversight
Conduct prescreening, recruitment, informed consent, and enrollment in collaboration with investigators.
Educate and evaluate potential participants for trial eligibility under investigator direction.
Ensure adherence to protocol during study visits, including specimen collection, investigational product accountability, and accurate data recording.
Perform study procedures within regulatory and institutional scope of practice.
Provide ongoing participant support to ensure retention and address questions or concerns.
Identify, document, and report adverse events, protocol deviations, and unexpected issues to the principal investigator.
Assist principal investigators in timely regulatory reporting of adverse events and deviations.
Regulatory Affairs, Data Management & Quality Assurance
Prepare and assist with regulatory submissions, amendments, and continuing reviews.
Maintain up-to-date and audit-ready regulatory binders and documentation systems.
Conduct regular self-audits and internal quality reviews to ensure protocol and procedure compliance.
Lead internal audits and support external monitoring visits, audits, and regulatory inspections.
Ensure accurate and timely data entry and reconciliation between source documents and study databases.
Maintain source documentation and prepare case report forms for clinical trial reporting.
Administrative & Financial Oversight
Collaborate with investigators to provide input for study budgets and contract development.
Manage clinical trial contract documentation and budget tracking.
Oversee study supply inventory and coordinate procurement as needed.
Submit reimbursement requests for study-related expenses, including participant stipends and equipment.
Maintain accurate financial records to support timely payments and billing compliance.
Respond to financial inquiries and assist with invoice reconciliation and reporting.
Leadership & Mentorship
Provide direction and oversight to other research staff.
Assist with onboarding and training of new team members.
Participate in process improvement initiatives and contribute to the development and refinement of standard operating procedures.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.
Required Qualifications
Education:
Associate's degree and six (6) years of relevant experience
OR
Equivalent combination of post-secondary education and work experience totaling at least eight (8) years
Education may be substituted for experience on a year for year basis.
Certifications (one or more of the following):
Certified Clinical Research Coordinator (CCRC)
Certified Clinical Research Professional (CCRP)
Work Experience:
Experience coordinating clinical trials
Experience with FDA, GCP, HIPAA, and IRB regulations and guidelines
Experience with study budgets, contracts, and grant submissions
Experience coordinating monitoring visits, audits, and inspections
Experience with early phase and/or complex therapeutic trials (e.g., inpatient, oncology, or cell therapy)
Preferred Qualifications
Education:
Bachelor's degree in health sciences, biological sciences, nursing, or related field
Work Experience:
Experience with cellular therapy clinical trials, including CAR-T or investigational biologics
Experience working within a centralized research model or multi-departmental trial coordination
Experience supporting clinical trials involving high-risk investigational products
Skills
Organization
Attention to Detail
Project Management
Data Analysis
Communication
Interpersonal Skills
Leadership
Computer Skills
Required Documents
Resume/CV
Cover Letter
Comprehensive Benefits Package:
Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. **************************************************
Employee Type: RegularTime Type: Full time Rate Type: Salary
Compensation Statement:
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Pay Range:$65,000.00 - $99,000.00
Minimum
$65,000.00
Midpoint
$82,000.00
Maximum
$99,000.00
Auto-ApplyClinical Research Associate - East/Central
Clinical research coordinator job in Lenexa, KS
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 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 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
Clinical Research Associate 1
Clinical research coordinator job in Minneapolis, KS
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision, PTO and 401K
Clinical Trials Coordinator
Clinical research coordinator job in Hutchinson, KS
A Clinical Research Coordinator (CRC) is responsible for reviewing, processing, and managing clinical research data and documents, both regulatory and patient records. The CRC performs a variety of clinical procedures, and assists with daily workload planning; ie; collect, record, report, and interpret data on patients enrolled in and/or seeking enrollment in clinical studies according to the protocol, SOPs, and GCPs.
RESPONSIBILITIES
* Provide clinical research support to investigators to prepare for and execute assigned research studies, including: Collect, record, and maintain research subject study data according to study protocols and SOPs, preserving quality control for content, accuracy, and completeness. Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research. Recruit and screen participants for clinical trials and maintain subject screening logs. Assist in the initial and ongoing consent process; orient research subjects to the study, including the purpose of the study, procedures, and research process. Maintain source documentation based on protocol requirements. Schedule and execute study visits and perform study procedures. Handle lab testing and analysis, including preparation of specimen collection tubes, shipment, and lab logistics. Monitor subject safety and report adverse events/reactions to the Principal Investigator and/or appropriate medical personnel. Correspond with research subjects and troubleshoot study-related questions or issues. Participate in "huddles" to confirm daily study tasks are assigned to team members and are executed to the expected standards.
* Assist with study data quality checking and query resolution.
* Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation, and cardiac telemetry monitoring, if needed.
* Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards.
* Provide training to new investigator site staff members on study-specific topics and requirements. Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.
* Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies.
* Assist research site with coverage planning related to staffing and scheduling for research studies.
* Monitor subject safety and report adverse reactions to appropriate medical personnel.
* Maintain confidentiality of data and PHI as required.
* Collaborate with provider offices to carry out research in the most efficient workflow possible.
* Maintains stock of supplies needed to carry out each study per protocol.
* Performs other duties and projects as assigned.
Sr. Clinical Research Associate - Oncology - Southeast Region - FSP
Clinical research coordinator job in Topeka, KS
The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
**Monitoring Responsibilities and Study Conduct:**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk:**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Skills:**
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
+ Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Ability to travel 60-80%
+ Valid driver's license and passport required
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
\#LI-LO1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Clinical Research Coordinator
Clinical research coordinator job in Wichita, KS
The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study.
To consistently embody AMR Clinical's Core Values:
United We Achieve
Celebrate Diverse Perspectives
Do the Right Thing
Adapt and Persevere
The Clinical Research Coordinator reports to the Site Manager/Team Lead.
Classification: Non-Exempt
Primary Responsibilities:
Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures.
Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols.
Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution.
Establish understanding of SOP's and implement the SOP's
Gain understanding of the pharmaceutical drug per clinical trial.
Develop detailed knowledge of protocol and procedures per clinical research study.
Communicate effectively with study sponsors, CROs, monitors/CRA's, IRBs, laboratories, and clinical personnel within the research industry.
Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study.
Establish and maintain patient rapport.
Clinical data collection (vital signs, EKG recording, weight, height, etc.)
Obtain medical records and review as required.
Phlebotomy
Specimen collection, processing, and storage
Transporting clinical specimens to the laboratory.
Educate subjects on diaries and oversees compliance with diary completion.
Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.)
Responsible for completing patient phone call visits in accordance to the standard protocol period.
Ensure documentation follows ALCOA standards and is completed in a timely manner.
Ensure all necessary documents are completed, signed and dated.
Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required.
Manage study inventory and order supplies as needed.
Prepare and assist study monitors during onsite visits.
Maintain familiarity with all ongoing clinical research studies.
Travel to Investigator meetings as needed.
Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties
Position may require occasional weekend and/or overtime hours.
Other duties as assigned
Desired Skills and Qualifications:
1 year of experience in clinical research.
Completion of formal medical training, educational program, or healthcare experience
Strong medical terminology
Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.).
Ability to work independently and lead study-related tasks.
Ability to multi-task in a high-paced evolving environment.
Exceptional listening, written, and verbal communication skills as well.
Demonstrate proficiency in office equipment and software programs.
Excellent organizational and task management skills.
Ability to be ambulatory most of the workday.
Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.
AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.
** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.
Auto-ApplySpecialist, Clinical Business Operations, Oncology
Clinical research coordinator job in Topeka, KS
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
**Job Duties and Responsibilities**
+ Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA).
+ Assist with the entry of Contractual Agreements into an electronic document repository.
+ Ensure all outsourcing decisions are properly documented, compliant, and audit-ready.
+ Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate.
+ Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements.
+ Perform other duties as requested.
**Key Core Competencies**
+ Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities
+ Ability to proactively identify and act on opportunities for operational efficiencies
+ Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude
+ Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution
+ Excellent written and oral communication skills
**Education and Experience**
+ BA/BS preferred with at least 2 years experience, or 5 years equivalent experience
+ Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles.
The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at **********************************************
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
Field Based HSS Clinical Coordinator - Sedgwick, Harvey, Butler Counties or Surrounding Areas
Clinical research coordinator job in Burrton, KS
At UnitedHealthcare, we're simplifying the health care experience, creating healthier communities and removing barriers to quality care. The work you do here impacts the lives of millions of people for the better. Come build the health care system of tomorrow, making it more responsive, affordable and equitable. Ready to make a difference? Join us to start **Caring. Connecting. Growing together.**
The **Long-Term Services and Supports (LTSS) Care Coordinator** is responsible for establishing a set of person-centered goal-oriented, culturally relevant, and logical steps to ensure that a person receiving LTSS receives services in a supportive, effective, efficient, timely and cost-effective manner. Care coordination includes case management, disease management, discharge planning, transition planning, and addressing social determinants of health and integration into the community.
This position is a Field-Based position with a Home-Based office. Expected travelling 2-3 days per week within 30-60-mile radius.
If you reside within **Sedgwick, Harvey, Butler Counties or the surrounding counties** , you will enjoy the flexibility to telecommute* as you take on some tough challenges.
**Primary Responsibilities:**
+ Assess, plan, and implement care strategies that are individualized by the individual and directed toward the most appropriate, least restrictive level of care
+ Identify and initiate referrals for social service programs, including financial, psychosocial, community and state supportive services
+ Manage the person-centered service/support plan throughout the continuum of care
+ Communicate with all stakeholders the required health - related information to ensure quality coordinated care and services are provided expeditiously to all persons
+ Advocate for persons and families as needed to ensure the persons needs and choices are fully represented and supported by the health care team
+ Conduct home visits in coordination with person and care team, which may include a community service coordinator
+ Conduct in-person visits which may include nursing homes, assisted living, hospital or home
+ Serve as a resource for community care coordinator, if applicable
**What are the reasons to consider working for UnitedHealth Group? Put it all together - competitive base pay, a full and comprehensive benefit program, performance rewards, and a management team who demonstrates their commitment to your success. Some of our offerings include:**
+ Paid Time Off which you start to accrue with your first pay period plus 8 Paid Holidays
+ Medical Plan options along with participation in a Health Spending Account or a Health Saving account
+ Dental, Vision, Life& AD&D Insurance along with Short-term disability and Long-Term Disability coverage
+ 401(k) Savings Plan, Employee Stock Purchase Plan
+ Education Reimbursement
+ Employee Discounts
+ Employee Assistance Program
+ Employee Referral Bonus Program
+ Voluntary Benefits (pet insurance, legal insurance, LTC Insurance, etc.)
+ More information can be downloaded at: *************************
You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear directions on what it takes to succeed in your role as well as provide development for other roles you may be interested in.
**Required Qualifications:**
+ Bachelor's Degree in Social Work, Rehabilitation, Nursing, Psychology, Special Education, Gerontology or related human services area
+ 2+ years of experience working within the community health setting in a healthcare role
+ 1+ years of experience working with persons with long-term care needs
+ 1+ years of experience working with persons receiving services on one of the homes and community-based waivers in KS
+ 1+ years of experience working with MS Word, Excel and Outlook
+ Ability to travel in assigned regions to visit Medicaid members in their homes and / or other settings, including community centers, hospitals, or providers' offices
+ Access to reliable transportation & valid US driver's license
**Preferred Qualifications:**
+ Licensed Social Worker or clinical degree
+ Registered Nurse
+ Background in managing populations with complex medical or behavioral needs
+ Experience with electronic charting
+ Experience with arranging community resources
*All Telecommuters will be required to adhere to UnitedHealth Group's Telecommuter Policy.
Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you'll find a far-reaching choice of benefits and incentives. The hourly pay for this role will range from $28.27 to $50.48 per hour based on full-time employment. We comply with all minimum wage laws as applicable.
_At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location, and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups, and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission._
_UnitedHealth Group is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations._
_UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment._
\#RPO #RED
MDS / Clinical Reimbursement Coordinator
Clinical research coordinator job in Pratt, KS
Lincoln Care and Rehab in Wichita, KS is looking to hire a full-time MDS/Clinical Reimbursement Coordinator to join our team. Are you looking for a career with a health care company that will value you? Do you want to be part of a dynamic and caring clinical team? If so, please read on!
This nursing position earns a competitive salary of $80,000 - $84,000 per year. We also provide comprehensive benefits, including medical, dental, vision, short- and long-term disability, a flexible spending account (FSA), a 401(k) plan, paid time off (PTO), life insurance, continuing education unit (CEU) reimbursement, and daily pay options. If this sounds like the right opportunity in health care for you, apply today!
As an MDS/Clinical Reimbursement Coordinator, The MDS Coordinator is responsible for the timely and accurate completion of the Federal and State assessment tools but may also be called upon to perform duties of an RN, if needed. This position requires an understanding of the MDS rules and regulations as described in the MDS User's Manual, including item coding, RAPS, CAA's, Care Planning, electronic submission, scheduling, PPS including knowledge of MDS submission process, final validation reports, and an understanding of Medicare rules and regulations including coverage, benefit periods, certification, 30 Day rule. you will intake all processed forms, including but not limited to, order sheets, doctor notes, pharmacy recommendations, order summaries and lab results and scanning them into electronic form to upload each document into the applicable resident's electronic medical record.
WORK SCHEDULE
This full-time health care position works typically Monday-Friday but is subject to facility needs.
QUALIFICATIONS FOR A LICENSED PRACTICAL NURSE (LPN)
Current RN licensure with the KS Board of Nursing
Current CPR certification
1-2 years of experience as an MDS Coordinator
Good organization skills
Experience with 3.0, PPS, and Case Mix
Ability to pass license check, background check and drug screen
Ability to maintain confidentiality and comply with all HIPPA regulations
Desire to work with the elderly
ARE YOU READY TO JOIN OUR TEAM?
If you feel that you would be right for this rehabilitation nursing job, please fill out our initial 3-minute, mobile-friendly application. We look forward to meeting you!
************************************************
Residential Clinical Coordinator
Clinical research coordinator job in Wichita, KS
Full-time Description
Residential Coordinator
FLSA CLASSIFICATION: Exempt-Administrative
REPORTS TO: Senior Director of Housing and Facilities
POSITIONS SUPERVISED: Residential Team Leaders, Residential Behavioral Health Specialists
POSITION OVERVIEW: The Residential Clinical Coordinator is responsible for assisting in hiring, training, scheduling, and supervision of Residential Behavioral Health Specialist (RBHS) staff and Residential Team Leaders, handling employee and consumer complaints/concerns, monitoring consumer general circumstances as it involves housing, and assuring general safety and cleanliness. The Residential Clinical Coordinator will monitor the attendance of Residential employees. The Residential Clinical Coordinator will document and communicate client occupancy and status, support social events, and participate in staff meetings and training. The Residential Clinical Coordinator will assist in monitoring the productivity of Residential staff and timeliness of completed documentation. The Residential Clinical Coordinator will make sure Residential Care is compliant with KDADS, Comcare and other licensing requirements, as well as provide clinical oversight to all residential programs.
ESSENTIAL POSITION RESPONSIBILITIES:
Responsible for scheduling residential shifts and proper staffing levels at each location. Ensuring licensing requirements and departmental budget guidelines are met. Provides back up as needed for Residential staff.
Provides supervision to Residential staff, ensures staff are supported and trained in accordance with policies. Handles questions and concerns and follows up on any issues related to residents in the program or personnel issues. Facilitates monthly team meetings and 1:1's with all employees.
Provides direction and support to Residential staff in matters related to staffing the program, licensing standards, utilization of residential facilities and services, scheduling special activities, and other concerns which impact quality care and agency collaboration.
Assists in securing timely and appropriate documentation and billing of services, within 24 hours of service delivery. Ensures services provided by Residential Care staff are medically necessary and submitted as required per contract guidelines.
Responsible for monitoring direct care staff billing, ensuring team members meet productivity requirements. Provide assistance and support to ensure employees maximize their performance and productivity. Ensures timely and appropriate documentation and billing of services to ensure MHA, COMCARE and MCO guidelines are followed.
Handles personnel matters effectively and consistently with existing policies, including interviewing, hiring, counseling, terminating, and helping complete annual evaluations for direct care staff. Provides appropriate documentation as necessary.
Creates, updates and provides orientation and training to new Residential staff, ensures completeness of competency-based training and adherence to applicable standards.
Provides on-site problem solving and crisis support with direct care staff to ensure safety of staff and residents and continuity of care.
Works with Residential Management team and other departments as needed to ensure program vacancies are filled and that the tenants' units are in readiness for move-in. Ensure that linens, supplies, and food are immediately available when applicable; and that unit mate is adequately prepared for and introduced to a new tenant.
Meets with COMCARE representatives at minimum monthly to review tenant issues and needs in crisis home program.
Responsible for completing all clinical intakes for the department, working with the property management team to ensure vacancies are filled promptly.
Serves as QMHP for the department and assists the agency in ensuring the implementation and monitoring of treatment plans in cooperation with the clients' treatment team ensuring resident satisfaction. Supports and oversees all clinical services of the department through reviews of treatment plans, strengths assessments, clinical intakes and reviews as necessary to ensure quality of client care and coordination of services.
Files reports with the Senior Director of Housing and Facilities, other Departments, COMCARE, KDADS and other parties as directed.
Meets with the Senior Director of Housing and Facilities on a regular basis and participates with other staff to ensure successful delivery of services and agency-wide collaboration, this extends to COMCARE and other contractors or affiliates.
Approves times sheets and ensures correct programs are charged for staff time. Approves time off requests, mileage reports, and expense reports in accordance with MHA policy. Monitors program expenditures and reviews program budget monthly with Clinical Director of Residential Programs and Senior Director of Housing and Facilities.
OTHER POSITION REQUIREMENTS:
Maintains acceptable overall attendance record, to include department staff meetings, agency meetings, and training as required. Ensures appropriate notification to supervisor for absences and ensures that work is covered. Flexibility in work schedule when needed.
Exhibits appropriate level of technical knowledge for the position.
Produces quantity of work necessary to meet job requirements.
Works well with a team, keeps others informed of information needed. Treats others with respect, maintaining a spirit of cooperation.
Maintain professional verbal and written interactions with peers, participants, supervisors and other staff, which also includes effective listening skills. Use diplomacy and tact in dealing with difficult situations or people. Provide strong customer service skills, so that residents will have the best experience possible while in the residential setting, increasing their chances of success while in the program and successfully transition into the community.
Demonstrates the ability and willingness to handle new assignments, changes in procedures and business requirements. Identifies what needs to be done and takes appropriate action.
Completes assigned work, meets deadlines without reminders/follow-up from supervisor or others.
Performs work conscientiously with a high degree of accuracy.
Collaboration with partnering agencies and CIT Teams for mobile response and stabilization services.
Meets goals and objectives as mutually agreed upon during last performance review (if applicable).
POSITION REQUIREMENTS: The Residential Coordinator is expected to have a bachelor's degree in human services or equivalent experience, as well as experience working with adults who have a severe and persistent mental illness. Preferred areas of experience include supervision of staff, program management and a commitment to consumer advocacy and quality care. Must demonstrate effective communication and documentation skills. The ability to maintain a flexible work schedule to include some evening and weekend hours and availability for emergency and/or on-call services are essential. A valid Kansas driver's license and access to personal vehicle required.
PHYSICAL REQUIREMENTS:
* Sitting for extended periods of time
* Extensive data entry
* Driving (for purposes of community mobility)
* Lifting/carrying up to thirty (30) pounds
* Bending/stooping
All the above duties and responsibilities are considered essential job functions subject to reasonable accommodation. All job requirements listed indicate the minimum level of knowledge, skills and/or ability deemed necessary to perform the job proficiently. This job description is not to be construed as a detailed statement of duties, responsibilities, or requirements. Employees may be required to perform any other job-related instructions as requested by their supervisors, subject to reasonable accommodation.
EEO race, color, religion, sex, parental status, national origin, age, disability, genetic information, political affiliation, military service, or other non-merit based factors.
Hospice Clinical Coordinator
Clinical research coordinator job in Lawrence, KS
At Elara Caring, we have a unique opportunity to play a huge role in the growth of an entire home care industry. Here, each employee has the chance to make a real difference by carrying out our mission every day. Join our elite team of healthcare professionals, providing the Right Care, at the Right Time, in the Right Place.
:
Clinical Coordinator
At Elara Caring, we care where you are and believe the best place for your care is where you live. We know there's no place like home, and that's why our teams continue to provide high-quality care to more than 60,000 patients each day in their preferred home setting. Wherever our patients call home and wherever they are on their health journey, we care. Each team member has a part to play in this mission. This means you have countless ways to make a difference as Clinical Coordinator. Being a part of something this great, starts by carrying out our mission every day through your true calling: developing an amazing team of compassionate and dedicated healthcare providers.
To continue to be an industry pioneer delivering unparalleled care, we need a Clinical Coordinator with commitment and compassion. Are you one of them? If so, apply today!
Why Join the Elara Caring mission?
* Work in a collaborative environment.
* Be rewarded with a unique opportunity to make a difference
* Competitive compensation package
* Tuition reimbursement for full-time staff and continuing education opportunities for all employees at no cost
* Opportunities for advancement
* Comprehensive insurance plans for medical, dental, and vision benefits
* 401(K) with employer match
* Paid time off, paid holidays, family, and pet bereavement
* Pet insurance
As Clinical Coordinator, you'll contribute to our success in the following ways:
* Builds teams to offer the highest quality of life to our patients.
* Maintains organized, effective, and efficient systems and communication to ensure the continuity of quality patient care is delivered.
* Evaluates agency operations, maintains a variety of tracking systems, and identifies ways to enhance workflow and productivity.
* Assists staff in maintaining current and accurate medical records and utilization review.
* Assists clinical supervisor with non-clinical phone inquiries.
* Notifies supervisor of any problems requiring administrative attention and intervention.
* Processes and distributes in and out daily mail for the department, collects and maintains inventory, and cleans equipment.
* Implements all available actions to prevent avoidable hospitalization and ER visits.
* Attends training, education, seminars, or other means of learning.
* Treats patients and caregivers in the highest and most effective manner.
* Provides positive, supportive communication to physicians, patients, families, visitors, and other agency personnel.
* Promotes Elara Caring's philosophy, mission statement and administrative policies to ensure quality of care.
* Maintains patient and staff privacy and confidentiality pursuant to HIPAA Privacy Final Rule.
* Performs other duties/projects as assigned.
What is Required?
* 1+ year experience in a hospice or home health care setting
* Proficiency with Medical Terminology
* Experience working with clinical management team
* Proficiency with office equipment including computer, fax, copy machines
* Experience with Medicare and Medicaid guidelines are preferred
You will report to the Clinical Manager.
This is not a comprehensive list of all job responsibilities; a full will be provided.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
We value the unique skills of veterans and military spouses. We encourage applications from military veterans and their families.
Elara Caring provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to sex (including pregnancy, childbirth or related medical conditions), race, color, age (40 and older), national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity, gender reassignment, protected veteran status, or any other basis prohibited under applicable federal, state or local law.
Elara Caring participates in E-Verify and we will provide the Federal Government with your Form I-9 information to confirm that you are authorized to work in the United States. Employers like Elara Caring can only use E-Verify once you have accepted the job offer and completed the Form I-9.
At Elara Caring, pay and compensation are determined by a variety of factors, including education, job-related knowledge, skills, training, and experience. Our compensation structure reflects the cost of labor across different U.S. geographic markets, and may vary based on location.
This is not a comprehensive list of all job responsibilities and requirements; upon request, a job description can be provided.
If you are an individual with a disability and are unable or limited in your ability to use or access our career site as a result of your disability, you may request reasonable accommodations by reaching out to ********************.
Auto-ApplyHospice Clinical Coordinator
Clinical research coordinator job in Topeka, KS
At Elara Caring, we have a unique opportunity to play a huge role in the growth of an entire home care industry. Here, each employee has the chance to make a real difference by carrying out our mission every day. Join our elite team of healthcare professionals, providing the Right Care, at the Right Time, in the Right Place.
:
Clinical Coordinator
At Elara Caring, we care where you are and believe the best place for your care is where you live. We know there's no place like home, and that's why our teams continue to provide high-quality care to more than 60,000 patients each day in their preferred home setting. Wherever our patients call home and wherever they are on their health journey, we care. Each team member has a part to play in this mission. This means you have countless ways to make a difference as Clinical Coordinator. Being a part of something this great, starts by carrying out our mission every day through your true calling: developing an amazing team of compassionate and dedicated healthcare providers.
To continue to be an industry pioneer delivering unparalleled care, we need a Clinical Coordinator with commitment and compassion. Are you one of them? If so, apply today!
Why Join the Elara Caring mission?
Work in a collaborative environment.
Be rewarded with a unique opportunity to make a difference
Competitive compensation package
Tuition reimbursement for full-time staff and continuing education opportunities for all employees at no cost
Opportunities for advancement
Comprehensive insurance plans for medical, dental, and vision benefits
401(K) with employer match
Paid time off, paid holidays, family, and pet bereavement
Pet insurance
As Clinical Coordinator, you'll contribute to our success in the following ways:
Builds teams to offer the highest quality of life to our patients.
Maintains organized, effective, and efficient systems and communication to ensure the continuity of quality patient care is delivered.
Evaluates agency operations, maintains a variety of tracking systems, and identifies ways to enhance workflow and productivity.
Assists staff in maintaining current and accurate medical records and utilization review.
Assists clinical supervisor with non-clinical phone inquiries.
Notifies supervisor of any problems requiring administrative attention and intervention.
Processes and distributes in and out daily mail for the department, collects and maintains inventory, and cleans equipment.
Implements all available actions to prevent avoidable hospitalization and ER visits.
Attends training, education, seminars, or other means of learning.
Treats patients and caregivers in the highest and most effective manner.
Provides positive, supportive communication to physicians, patients, families, visitors, and other agency personnel.
Promotes Elara Caring's philosophy, mission statement and administrative policies to ensure quality of care.
Maintains patient and staff privacy and confidentiality pursuant to HIPAA Privacy Final Rule.
Performs other duties/projects as assigned.
What is Required?
1+ year experience in a hospice or home health care setting
Proficiency with Medical Terminology
Experience working with clinical management team
Proficiency with office equipment including computer, fax, copy machines
Experience with Medicare and Medicaid guidelines are preferred
You will report to the Clinical Manager.
This is not a comprehensive list of all job
responsibilities
; a full
will be provided.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
We value the unique skills of veterans and military spouses. We encourage applications from military veterans and their families.
Elara Caring provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to sex (including pregnancy, childbirth or related medical conditions), race, color, age (40 and older), national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity, gender reassignment, protected veteran status, or any other basis prohibited under applicable federal, state or local law.
Elara Caring participates in E-Verify and we will provide the Federal Government with your Form I-9 information to confirm that you are authorized to work in the United States. Employers like Elara Caring can only use E-Verify once you have accepted the job offer and completed the Form I-9.
At Elara Caring, pay and compensation are determined by a variety of factors, including education, job-related knowledge, skills, training, and experience. Our compensation structure reflects the cost of labor across different U.S. geographic markets, and may vary based on location.
This is not a comprehensive list of all job responsibilities and requirements; upon request, a job description can be provided.
If you are an individual with a disability and are unable or limited in your ability to use or access our career site as a result of your disability, you may request reasonable accommodations by reaching out to ********************.
Auto-ApplyAmbulatory Clinic Healthcare Associate (PRN) - Cancer Center; Westwood Campus
Clinical research coordinator job in Westwood, KS
Position TitleAmbulatory Clinic Healthcare Associate (PRN) - Cancer Center; Westwood CampusWestwood Medical Pavilion - West / Career Interest:The Ambulatory Clinic Healthcare Associate is responsible for assuring efficient flow of patients through the health care setting by facilitating examination and treatment of patients in a culturally sensitive manner with exceptional customer service; contributes to patient care by preparing patient for visit, performing limited procedures, scheduling diagnostic test or consults, maintaining patient records, organizing clinic/exam rooms, maintaining supply/equipment inventory, and/or assisting physicians, other medical staff, nurses, other interdisciplinary team members and support staff.
Responsibilities and Essential Job Functions
Accurately schedules radiology tests; obtains films and reports; prepares laboratory specimens according to policy.
Assists physicians and/or nurses with special procedures and examinations as defined on competency checklist.
Collaborates with members of the health care team in coordinating and implementing plans for patient care; may record elements of the patient history for clinical staff review.
Ensures data collected for completed procedures is recorded on appropriate forms and in medical records
Maintains medical records; ensures all required documentation is available in the medical record; distributes reports and correspondence; files, photocopies and processes forms related to medical charts.
Maintains orderliness and cleanliness of examination rooms; stocks assigned areas and ensures par levels of supplies are maintained; checks and completes required logs and equipment such as refrigerator logs, eyewash logs, emergency/crash carts, suction and other required checks.
Performs clerical duties such as greeting patients; registration; scheduling; pre-certification of tests, procedures and medications; processing insurance forms; preparing financial records; answering phones; and entering ambulatory care charges.
Performs simple procedures as directed by the nurse or physician and as defined on the competency checklist.
Performs vital signs, height, weight, and screening procedures and documents in medical record.
Must be able to perform the professional, clinical and or technical competencies of the assigned unit or department.
These statements are intended to describe the essential functions of the job and are not intended to be an exhaustive list of all responsibilities. Skills and duties may vary dependent upon your department or unit. Other duties may be assigned as required.
Required Education and Experience
High School Graduate or GED equivalent.
Enrolled in an accredited school of nursing having completed fundamentals OR
Bachelors Degree in a Health Care or Science related field OR
3 years of inpatient/rehab/LTC experience under the direction of a RN.
Preferred Education and Experience
Previous medical office experience.
Required Licensure and Certification
CPR/ AED/ BLS - Other BLS
Time Type:Part time Job Requisition ID:R-47830
We are an equal employment opportunity employer without regard to a person's race, color, religion, sex (including pregnancy, gender identity and sexual orientation), national origin, ancestry, age (40 or older), disability, veteran status or genetic information.
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Auto-ApplyClinical Research Associate 2, Sponsor Dedicated, IQVIA
Clinical research coordinator job in Overland Park, KS
IQVIA is hiring Clinical Research Associates (CRA) at the 1 and 2 level. Ideal candidates will have 1-2 years of onsite monitoring experience with expertise in Cardiovascular/Renal/Metabolic, Oncology, and/or Neurology. Candidates can be located anywhere in the US.
Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Some organizations require completion of CRA training program or prior monitoring experience.
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $71,900.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Auto-ApplyClinical Research Associate
Clinical research coordinator job in Lenexa, KS
Clinical Research Associate - Ophthalmology 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 (CRA) to join our diverse and dynamic team. As a CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.
**What You Will Be Doing:**
+ Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
+ Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
+ Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
+ Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
+ Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
**Your Profile:**
+ Advanced degree in a relevant field such as life sciences, nursing, or medicine highly preferred.
+ Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
+ Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
+ Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
+ Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex 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 Research Coordinator -Cancer Center (Overland Park Community Site)
Clinical research coordinator job in Overland Park, KS
Department:SOM KC Cancer Center Clinical Trials
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Clinical Trials Clinical OperationsPosition Title:Clinical Research Coordinator -Cancer Center (Overland Park Community Site) Job Family Group: Professional Staff Summary::
The Clinical Research Coordinator works collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. This position manages assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Monitors participants' progress including documenting and reporting adverse events. Participates in periodic quality assurance audits of protocols.
The Overland Park Community site is located at: 12200 W. 110th St., Overland Park, KS 66210.
The University of Kansas Cancer Center is the only National Cancer Institute designated Comprehensive Cancer Center in the region, 1 of only 57 in the nation to receive this distinction. Patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.
Job Responsibilities
Under the direction of the principal investigator, recruit and educate potential patients for and evaluate potential patient eligibility for clinical trials.
Maintain source documents and submit case report forms (CRFs) as required for clinical trials.
Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
Perform study procedures, as outlined in the protocol and within state and institutional scope of practice.
Assist clinical staff with phlebotomy and sample collection, processing, handling, and shipping as outlined in the protocol and within institutional/KUMC policy.
Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies and study participants.
Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR.
Work closely with the Research Institute and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.
Attend continuing education, research and training seminars as requested by manager.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.
Work Environment: This position will be 100% onsite due to the fact this is a patient facing role.
Required Qualifications
Work Experience:
4 years of relevant work experience. Education may be substituted for experience on a year for year basis.
Experience with regulations governing clinical research (CFR, GCP, HIPAA).
Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
Experience study budgets, contracts, and grant applications.
Preferred Qualifications
Education: Bachelor's degree.
Certifications/Licenses:
Certified Clinical Research Coordinator (CCRC)
Certified Clinical Research Professional (CCRP)
Skills
Communication.
Organization.
Multi-tasking.
Required Documents
Resume
Cover Letter
Comprehensive Benefits Package:
Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. **************************************************
Employee Type: RegularTime Type: Full time Rate Type: Salary
Compensation Statement:
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Pay Range:$58,656.00 - $86,000.00
Minimum
$58,656.00
Midpoint
$72,328.00
Maximum
$86,000.00
Auto-ApplySenior Clinical Research Associate/Clinical Research Associate II - Oncology - US - FSP
Clinical research coordinator job in Topeka, KS
**Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.
**Key Accountabilities:**
**Oversight of Monitoring Responsibilities and Study Conduct**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and
+ recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Collaboration**
+ Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM)
+ Partners with SCP and Country Study Operations Manager (SOM)
+ When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist)
+ May act as a Mentor for Clinical Research Associates
**Skills:**
+ Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
+ Preferred therapeutic experience in Oncology
+ Global clinical trial experience preferred
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Travel (60-80%) within area is required
+ Valid driver's license and passport required
**Knowledge and Experience:**
+ Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
+ Demonstrated knowledge of global and local regulatory requirements
+ Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
+ Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
+ Demonstrated ability to support sponsor regulatory interactions/inspections
+ Demonstrated knowledge of the processes around protocol design and feasibility assessment
+ Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
+ Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial
+ Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation
+ Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required
\#LI-CF1
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Clinical Study Coordinator-JCCT
Clinical research coordinator job in Lenexa, KS
Job DescriptionDescription:
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.
Requirements: