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Clinical research associate jobs in Manhattan, KS - 79 jobs

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  • Clinical Research Associate, Sponsor Dedicated

    Iqvia 4.7company rating

    Clinical research associate 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
    $64k-189k yearly 60d+ ago
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  • Animal Health Clinical Research Associate

    Argenta

    Clinical research associate job in Shawnee, KS

    At Argenta, we're more than a company - we're a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it. Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions and services cover every stage of the process, from molecule to market. We're in a unique position. We are the world's only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated to animal health. Our uniqueness means: We are ambitious, growing and building a ‘one team' culture, guided by our values. We are team players; We are doers; We are customer-centric; We are innovators. We value diversity, as a global company, we get the richness of working with different people in different places whether it be location, stages of their career, their development, their role. We believe that when everyone works together and puts their best “paw” forward we will make the lives of the animals we care for, better. With bases in New Zealand, the US, the UK and Europe, our 900+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let's Make It Happen, Together. TEAM PLAYERS who want to DO great work and find INNOVATIVE ways to make animals lives better through our CUSTOMER CENTRIC efforts should apply. Our US Clinical team is looking for experienced, motivated, driven individuals who thrive in their ability to multitask and work as a team! Our Clinical Research Associates add value through the following responsibilities: Coordinates and conducts GCP and study protocol training at study sites and assures training is documented Builds rapport with study site staff to assure compliance with the protocol, applicable regulatory and guidance documents, SOPs, and all study activities Assists in reviewing the study records and all study notebooks to ensure contents are current and complete Assists in providing tracking and Quality Control (QC) of data as required and assists with responses to QA audits Evaluates Investigators and assists with selection of appropriate sites to conduct clinical studies Collaborates with the study Project Manager to assure study sites selected meet the needs of the study protocol Monitors assigned study sites through review of electronic data capture (EDC) systems, faxed, emailed, and paper documentation. Serves as the liaison between Argenta US Clinical and study site personnel Facilitates clarifications, corrections, and data query resolution with study sites or data management personnel Tracks adverse events (AE's) encountered in clinical studies and ensures all serious AEs and non-serious AEs are documented and communicated appropriately to the Project Manager and Sponsor Learns to assist with facilitates clarifications, corrections, and data query resolution with study sites or data management personnel Builds relationships with key individuals and contributors in the organization and beyond Job Requirements include: Minimum of 5 years' experience in an animal health research role, Monitor and Clinical Research Associate positions preferred Experience in Good Clinical Practice (GCP) data management, quality control, and/or quality assurance preferred Collaborative working style. Lead and motivate people through influence across all levels and functions of the organization Ability to look for creative solutions to resolve complex issues Strong technical writing ability Results oriented and driven Strong communication and listening skills Well organized and analytically driven Willingness to travel, expected to travel nationally 40 to 60% Argenta has strongly embedded company values which is key to who we are and how we deliver. We offer an opportunity to work for a successful and rapidly expanding global business where your input will be valued. At Argenta we are a hard-working group who really enjoy the people we work with each day. That is why we support our people through strong culture, great benefits, and opportunity for growth. This role is subject to a DEA background check as well as a pre-employment drug screen and/or physical. Argenta is an equal opportunity employer To find out more about Argenta, click here: *********************
    $49k-79k yearly est. 13d ago
  • Clinical Research Associate

    Icon Clinical Research

    Clinical research associate 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 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 highly preferred. + 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
    $49k-79k yearly est. 19d ago
  • Manager, Clinical Research Monitoring

    Edwards Lifesciences 4.6company rating

    Clinical research associate job in Topeka, KS

    Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Innovation starts from the heart. Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what's currently possible, and create solutions for patients many years into the future. If you're an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career. We'll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology. **How you will make an impact:** + Managing and leading a small team within assigned function including team budget responsibilities and managing outside contractors/vendors. Developing team members to increase business acumen and functional skills. + Providing input on strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), acting as a Core Team lead, assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determining if clinical trial/study subject documentation is within parameters of study hypothesis, as well as monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. + Leading in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Acting as a mentor to new or junior level employees. + Overseeing clinical trial conduct including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence. + Participating and contributing to the development of clinical protocols, informed consent forms, and case report forms. + Participating in development and validation of case report forms. + Reviewing and approving monitoring visit reports. + Resolving complex trial/study data and regulatory documentation discrepancies escalated by junior level employees. + Reviewing and completing checklist on informed consent forms (ICF). + Providing direction and guidance to execute project deliverables in collaboration with project managers. + Identifying and evaluating clinical process improvement opportunities. **What you'll need (Required):** + Bachelor's Degree in related field with previous field monitoring experience, quality assurance/control and regulatory compliance required or equivalent work experience based on Edwards criteria. + Ability to travel up to 75% domestically and internationally. **What else we look for (Preferred):** + 8+ years of related experience in cardiology trials + Master's Degree in related field + Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification) + Strong understanding of ISO 14155, FDA, and international regulatory requirements + Ability to lead and mentor field monitors + Strong understanding of risk-based monitoring, strategies and tools to ensure compliance and data integrity + Ability to resolve conflicts and provide clear guidance + Proficiency in trial management systems (e.g. RAVE, CTMS, Veeva, & monitoring dashboard) + Proven successful project management leadership skills + Proven expertise in MS Office Suite, including Word, Excel, and Adobe + Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives + Excellent problem-solving, organizational, analytical and critical thinking skills + Extensive understanding of clinical studies procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline + Extensive understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise + Demonstrated skill set to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations + Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization + Ability to work and excel within a fast paced, dynamic, and constantly changing work environment Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $123,000 to $174,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $123k-174k yearly 13d ago
  • Senior Clinical Research Associate - West Coast - Oncology - FSP

    Parexel 4.5company rating

    Clinical research associate job in Topeka, KS

    The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desirable):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as required. + Valid driving license per country requirements, as applicable \#LI-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.
    $74k-100k yearly est. 29d ago
  • Research and Policy Consultant

    Dpraorporated

    Clinical research associate job in Manhattan, KS

    Helping our clients achieve their goals starts with attracting and obtaining top talent. We look for highly innovative and bright individuals; give them the tools they need, then give them the freedom to do what they do best. We empower our employees to make the best of their opportunities in a rewarding and challenging environment. We have a passion for excellence! Our employees thrive on making a difference and generating results for our clients in a flexible environment that offers support and camaraderie. No matter where you are located throughout the globe, DPRA offers vast learning opportunities and a flexible work style to help our staff manage responsibilities and add balance to their lives. Along with a flexible workplace, DPRA offers a Total Rewards program that provides its employees with not only a competitive salary, but also covers a wide variety of benefits and programs. If you are looking for a challenging position in an innovative company, then this is the position for you. Currently, DPRA is searching for a Research and Policy Consultant in our Manhattan, Kansas office location. This full-time position will provide support for environmental regulatory and statutory reviews, legal research and writing, regulatory impact assessments, and records reconciliation and management. Qualifications and Knowledge: Bachelor's degree or higher in English, Comparative Literature, Journalism, Law, or a related field emphasizing writing and critical reading. 3-5 years of professional experience in a related field. Exceptional attention to detail, with a proven ability to identify and correct subtle errors or inconsistencies. Excellent writing, editing, and proofreading skills, with the ability to adapt writing style and tone to a specific audience. Strong critical and analytical thinking, logical reasoning, time management, and the ability to work both independently and as part of a team. High degree of organizational skill and the ability to manage multiple projects simultaneously. Familiarity with legal or regulatory documents a plus. Knowledge of or experience with the Resource Conservation and Recovery Act (RCRA) statute and related regulations a plus. DPRA is an EOE - Females/Minorities/Protected Veterans/Individuals with Disabilities
    $55k-78k yearly est. Auto-Apply 44d ago
  • Clinical Research Associate 1

    Allen Spolden

    Clinical research associate 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
    $50k-80k yearly est. 60d+ ago
  • Trial Master File (TMF) Specialist Oncology

    Sumitomo Pharma 4.6company rating

    Clinical research associate 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. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. 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_
    $72.5k-90.6k yearly 57d ago
  • Clinical Study Manager

    Icon Plc 4.8company rating

    Clinical research associate job in Lenexa, KS

    Clinical Study Manager - Lenexa, KS (Onsite) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives. Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That's our vision. We're driven by it. And we need talented people who share it. If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry. Overview: With oversight from the manager of study management or director of operations, the study manager will be responsible for the overall direction, coordination, implementation and execution of the project ensuring consistency with company strategy, commitments and goals. With oversight from the manager of study management or director of operations, will provide study management leadership to cross functional teams by integrating, facilitating, coordinating and managing all activities related to the initiation, planning, execution and closeout of assigned projects. With oversight from the manager of study management or director of operations, will be responsible for managing projects to ensure integration, coordination and consistency of processes throughout the project life cycle. A minimum of two years clinical research experience in leading and directing clinical trials with bachelor's degree or local equivalent Benefits of Working in ICON: Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply
    $51k-76k yearly est. 27d ago
  • Clinical Study Coordinator-JCCT

    Johnson County Clintrials

    Clinical research associate job in Lenexa, KS

    Study Coordinator Department: Study Management Purpose: The Study Coordinator is responsible for the coordination and administration of clinical studies under the direction of the Director of Study Management, and the Medical Director/Principal Investigator. Position Summary: This position will develop, implement and coordinate research and administrative procedures for the successful management of clinical studies. The Study Coordinator will perform diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. This position will report directly to the Clinical Study Team Manager. Key Responsibilities (Essential Functions): Maintain required records of study activity including study logs, case report forms, and/or regulatory forms Schedule volunteers for appointments, procedures and inpatient stays as required by study protocols Assess eligibility of potential volunteers through methods such as subject interviews, reviews of medical records, and discussions with Investigators and 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
    $28-36 hourly 60d+ ago
  • Clinical Trials Coordinator

    Hutchinson Clinic 4.3company rating

    Clinical research associate 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.
    $44k-63k yearly est. 21d ago
  • Clinical Research Assistant - Internal Medicine (Medical Oncology)

    University of Kansas Medical Center 3.8company rating

    Clinical research associate job in Kansas City, KS

    Department:SOM KC Internal Medicine - Medical Oncology ----- Medicine Clinical OncologyPosition Title:Clinical Research Assistant - Internal Medicine (Medical Oncology) Job Family Group: Professional Staff Summary:The Clinical Research Assistant in the Department of Internal Medicine, Division of Medical Oncology will work with the Melanoma program. This position will be responsible for obtaining informed consent from patients, research data collection and entry, maintenance of web-based research data base and regulatory paperwork for research studies.: Job Duties Recruit, evaluate, and educate patients regarding clinical trials following established procedures and protocols. Conduct Informed Consent Interviews with participants and when required, participant's family. Document trial related activities as directed and ensure study data is reported in a timely and accurate manner. Coordinate study participant visit activities including scheduling procedures, communicating with subjects, and completing necessary basic study procedures. Maintain trial regulatory documentation files including correspondence with sponsor, KUMC IRB, and subjects. Provide reports to the Principal Investigator and Project Manager, as required. Maintain web-based research data base. Assist in writing of clinical trial protocols/informed consents. Transport study samples from one location to another. Edit and format manuscripts, grants, and PowerPoint presentations. 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: Work Experience: Two (2) years related work experience. Education may be substituted for experience on a year for year basis. Preferred Qualifications: Education: Bachelor's degree in relevant field. Certifications: Certified Clinical Research Coordinator (CCRC) or certification eligible. Certified Clinical Research Professional (CCRP) or certification eligible. Skills Attention to detail Interpersonal skills Communication Computer skills 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: Hourly 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:$22.66 - $32.85 Minimum $22.66 Midpoint $27.75 Maximum $32.85
    $22.7-32.9 hourly Auto-Apply 17d ago
  • Hospice Clinical Coordinator

    Elara Caring

    Clinical research associate job in Topeka, KS

    At Elara Caring, we have a unique opportunity to play a huge role in the growth of an entire home care industry. Here, each employee has the chance to make a real difference by carrying out our mission every day. Join our elite team of healthcare professionals, providing the Right Care, at the Right Time, in the Right Place. : Clinical Coordinator At Elara Caring, we care where you are and believe the best place for your care is where you live. We know there's no place like home, and that's why our teams continue to provide high-quality care to more than 60,000 patients each day in their preferred home setting. Wherever our patients call home and wherever they are on their health journey, we care. Each team member has a part to play in this mission. This means you have countless ways to make a difference as Clinical Coordinator. Being a part of something this great, starts by carrying out our mission every day through your true calling: developing an amazing team of compassionate and dedicated healthcare providers. To continue to be an industry pioneer delivering unparalleled care, we need a Clinical Coordinator with commitment and compassion. Are you one of them? If so, apply today! Why Join the Elara Caring mission? Work in a collaborative environment. Be rewarded with a unique opportunity to make a difference Competitive compensation package Tuition reimbursement for full-time staff and continuing education opportunities for all employees at no cost Opportunities for advancement Comprehensive insurance plans for medical, dental, and vision benefits 401(K) with employer match Paid time off, paid holidays, family, and pet bereavement Pet insurance As Clinical Coordinator, you'll contribute to our success in the following ways: Builds teams to offer the highest quality of life to our patients. Maintains organized, effective, and efficient systems and communication to ensure the continuity of quality patient care is delivered. Evaluates agency operations, maintains a variety of tracking systems, and identifies ways to enhance workflow and productivity. Assists staff in maintaining current and accurate medical records and utilization review. Assists clinical supervisor with non-clinical phone inquiries. Notifies supervisor of any problems requiring administrative attention and intervention. Processes and distributes in and out daily mail for the department, collects and maintains inventory, and cleans equipment. Implements all available actions to prevent avoidable hospitalization and ER visits. Attends training, education, seminars, or other means of learning. Treats patients and caregivers in the highest and most effective manner. Provides positive, supportive communication to physicians, patients, families, visitors, and other agency personnel. Promotes Elara Caring's philosophy, mission statement and administrative policies to ensure quality of care. Maintains patient and staff privacy and confidentiality pursuant to HIPAA Privacy Final Rule. Performs other duties/projects as assigned. What is Required? 1+ year experience in a hospice or home health care setting Proficiency with Medical Terminology Experience working with clinical management team Proficiency with office equipment including computer, fax, copy machines Experience with Medicare and Medicaid guidelines are preferred You will report to the Clinical Manager. This is not a comprehensive list of all job responsibilities ; a full will be provided. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. We value the unique skills of veterans and military spouses. We encourage applications from military veterans and their families. Elara Caring provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to sex (including pregnancy, childbirth or related medical conditions), race, color, age (40 and older), national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity, gender reassignment, protected veteran status, or any other basis prohibited under applicable federal, state or local law. Elara Caring participates in E-Verify and we will provide the Federal Government with your Form I-9 information to confirm that you are authorized to work in the United States. Employers like Elara Caring can only use E-Verify once you have accepted the job offer and completed the Form I-9. At Elara Caring, pay and compensation are determined by a variety of factors, including education, job-related knowledge, skills, training, and experience. Our compensation structure reflects the cost of labor across different U.S. geographic markets, and may vary based on location. This is not a comprehensive list of all job responsibilities and requirements; upon request, a job description can be provided. If you are an individual with a disability and are unable or limited in your ability to use or access our career site as a result of your disability, you may request reasonable accommodations by reaching out to ********************.
    $50k-71k yearly est. Auto-Apply 23d ago
  • Hospice Clinical Coordinator

    Elara Holdings 4.0company rating

    Clinical research associate job in Topeka, KS

    At Elara Caring, we have a unique opportunity to play a huge role in the growth of an entire home care industry. Here, each employee has the chance to make a real difference by carrying out our mission every day. Join our elite team of healthcare professionals, providing the Right Care, at the Right Time, in the Right Place. : Clinical Coordinator At Elara Caring, we care where you are and believe the best place for your care is where you live. We know there's no place like home, and that's why our teams continue to provide high-quality care to more than 60,000 patients each day in their preferred home setting. Wherever our patients call home and wherever they are on their health journey, we care. Each team member has a part to play in this mission. This means you have countless ways to make a difference as Clinical Coordinator. Being a part of something this great, starts by carrying out our mission every day through your true calling: developing an amazing team of compassionate and dedicated healthcare providers. To continue to be an industry pioneer delivering unparalleled care, we need a Clinical Coordinator with commitment and compassion. Are you one of them? If so, apply today! Why Join the Elara Caring mission? Work in a collaborative environment. Be rewarded with a unique opportunity to make a difference Competitive compensation package Tuition reimbursement for full-time staff and continuing education opportunities for all employees at no cost Opportunities for advancement Comprehensive insurance plans for medical, dental, and vision benefits 401(K) with employer match Paid time off, paid holidays, family, and pet bereavement Pet insurance As Clinical Coordinator, you'll contribute to our success in the following ways: Builds teams to offer the highest quality of life to our patients. Maintains organized, effective, and efficient systems and communication to ensure the continuity of quality patient care is delivered. Evaluates agency operations, maintains a variety of tracking systems, and identifies ways to enhance workflow and productivity. Assists staff in maintaining current and accurate medical records and utilization review. Assists clinical supervisor with non-clinical phone inquiries. Notifies supervisor of any problems requiring administrative attention and intervention. Processes and distributes in and out daily mail for the department, collects and maintains inventory, and cleans equipment. Implements all available actions to prevent avoidable hospitalization and ER visits. Attends training, education, seminars, or other means of learning. Treats patients and caregivers in the highest and most effective manner. Provides positive, supportive communication to physicians, patients, families, visitors, and other agency personnel. Promotes Elara Caring's philosophy, mission statement and administrative policies to ensure quality of care. Maintains patient and staff privacy and confidentiality pursuant to HIPAA Privacy Final Rule. Performs other duties/projects as assigned. What is Required? 1+ year experience in a hospice or home health care setting Proficiency with Medical Terminology Experience working with clinical management team Proficiency with office equipment including computer, fax, copy machines Experience with Medicare and Medicaid guidelines are preferred You will report to the Clinical Manager. This is not a comprehensive list of all job responsibilities ; a full will be provided. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. We value the unique skills of veterans and military spouses. We encourage applications from military veterans and their families. Elara Caring provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to sex (including pregnancy, childbirth or related medical conditions), race, color, age (40 and older), national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity, gender reassignment, protected veteran status, or any other basis prohibited under applicable federal, state or local law. Elara Caring participates in E-Verify and we will provide the Federal Government with your Form I-9 information to confirm that you are authorized to work in the United States. Employers like Elara Caring can only use E-Verify once you have accepted the job offer and completed the Form I-9. At Elara Caring, pay and compensation are determined by a variety of factors, including education, job-related knowledge, skills, training, and experience. Our compensation structure reflects the cost of labor across different U.S. geographic markets, and may vary based on location. This is not a comprehensive list of all job responsibilities and requirements; upon request, a job description can be provided. If you are an individual with a disability and are unable or limited in your ability to use or access our career site as a result of your disability, you may request reasonable accommodations by reaching out to ********************.
    $52k-70k yearly est. Auto-Apply 24d ago
  • Clinical or Tenure Assistant/Associate/Full - Beef Production Medicine

    Beef Production Medicine

    Clinical research associate job in Kansas

    About This Role The successful candidate will join an active teaching and research team consisting of several faculty members with an emphasis on beef cattle medicine and management. The ideal candidate will develop a successful beef cattle research program focusing on cattle health, well-being, and production. The successful candidate will be expected to provide teaching related to beef and cattle health management. Teaching activities will include didactic lectures, small group discussions, and laboratories for instruction of veterinary and CVM graduate students. Delivery of continuing education for practicing veterinarians and serving as a content expert for producers are expectations for the position. Worksite Description This position is On-site. All employees must reside in the United States when they begin working to comply with state law. K-State is unable to provide remote or hybrid work opportunities for residents of the state of Idaho. What You'll Need to Succeed Minimum Qualifications: Clinical/Assistant Professor: DVM or Equivalent Degree Clinical/Associate Professor: DVM and demonstrate excellence in clinical service, Patient care and clinical instruction Clinical/Full Professor: DVM or Equivalent Degree and demonstrates sustained excellence in clinical service and dedication to continued professional development The degree requirement is necessary for accreditation purposes and to ensure candidates possess the specialized knowledge, skills, and abilities that can only be attained through a formal educational program at this level. Preferred Qualifications: Relevant advanced training, advanced academic degree, specialty status in a relevant discipline, and/or 5 years of experience in a food animal practice setting. Practice background and clinical experience in beef cattle production medicine Sponsorship eligibility: Candidates must be legally authorized to work in the U.S. on an ongoing basis without sponsorship. Application Window Applications close on: February 13, 2026 Anticipated Hiring Pay Range $90,000-$100,000 per year
    $90k-100k yearly 10d ago
  • Clinical Research Associate - Sponsor Dedicated

    Iqvia Holdings Inc. 4.7company rating

    Clinical research associate job in Overland Park, KS

    Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions: * Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice. * Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. * Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. * Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. * Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. * Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. * Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. * Collaborate and liaise with study team members for project execution support as appropriate. * If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. * If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications: * Bachelor's Degree Degree in scientific discipline or health care preferred. Req * Requires at least 1.5 years of year of on-site monitoring experience. Req * Equivalent combination of education, training and experience may be accepted in lieu of degree. Req * Good 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 $57,500.00 - $226,800.00. 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.
    $77k-102k yearly est. 23d ago
  • Lead Clinical Research Associate

    Icon Clinical Research

    Clinical research associate job in Lenexa, KS

    Lead 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 Lead Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Lead CRA at ICON, you will play a pivotal role in overseeing and managing clinical trial sites, ensuring that studies are conducted in accordance with regulatory requirements, study protocols, and company standards. You will be a key contributor to the success of clinical trials by driving site performance, providing mentorship to CRAs, and ensuring the highest levels of data quality and patient safety. **What You Will Be Doing:** + Leading site management activities, including site selection, initiation, monitoring, and close-out visits, to ensure compliance with study protocols and regulatory guidelines. + Serving as the primary point of contact for clinical sites, addressing site queries, and resolving issues to maintain site engagement and performance. + Ensuring the integrity of clinical data by conducting thorough source data verification, reviewing site records, and monitoring for protocol deviations. + Mentoring and providing guidance to CRAs, contributing to their professional development and supporting the consistent application of best practices across studies. + Collaborating with cross-functional teams, including clinical project managers, data managers, and biostatisticians, to ensure the successful execution of clinical trials. **Your Profile:** + Bachelor's degree in life sciences, nursing, pharmacy, or a related field. Advanced degree preferred. + Extensive experience as a Clinical Research Associate within the pharmaceutical, biotech, or CRO industry, with a proven track record of managing complex clinical trials. + In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes. + Strong leadership and mentoring skills, with the ability to manage and motivate CRAs and site staff effectively. + Excellent communication, organizational, and problem-solving skills, with a proactive approach to managing site performance and resolving issues. **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply
    $49k-79k yearly est. 19d ago
  • Clinical Study Coordinator-JCCT

    Johnson County Clintrials

    Clinical research associate 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:
    $35k-51k yearly est. 11d ago
  • Clinical Research Assistant - ONC Radiation Oncology

    University of Kansas Medical Center 3.8company rating

    Clinical research associate job in Kansas City, KS

    Department:SOM KC Radiation Oncology ----- Radiation OncologyPosition Title:Clinical Research Assistant - ONC Radiation OncologyJob Family Group: Professional Staff Summary:The Clinical Research Assistant assists in entry level clinical research activities. Under general supervision, the Clinical Research Assistant works with multidisciplinary teams including patients/study participants, families, physicians, administrative staff, and sponsor and CRO representatives to assist in coordination of all aspects of clinical research. This encompasses study recruitment, pre-screening for eligibility, data entry, maintenance of regulatory files, study visit scheduling, and collection data within scope of role. The University of Kansas Cancer Center is the region's only National Cancer Institute-designated comprehensive cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research. Radiation Oncology department is recognized nationally as a leader in cancer research, care and education. We are an integral part of The University of Kansas Cancer Center, the only National Cancer Institute (NCI)-comprehensive designated Cancer Center in the state of Kansas and the Kansas City metro area. Our world-class physician faculty provide compassionate and state-of-the-art care for KU Cancer Center patients. We are leading the way with research and clinical trials that aim to improve cancer treatments, increase cure rates, decrease treatment-related side effects and improve quality of life.: Key Roles and Responsibilities: Work with the Research Manager to assist with research coordination which includes data collection forms, and entering data for various departmental research. Review necessary research documents, such as protocols, data collection forms, Institutional Review Board (IRB) documentation, abstracts, presentations, and manuscripts preparation. Assist in the administration of clinical research trials by ensuring completion of numerous research activities, including participant enrollment and data collection and chart review. Maintain complete and accurate research documentation, including electronic medical records, participant files, case report forms, databases, and study binders follow standard operating procedures (SOPs) for department and research. Allow for schedule flexibility that may include collecting data, consenting participants, or performing study duties. Participate in activities related to specimen collection, specimen handling, processing and shipping. Provide written and verbal reports to the Principal Investigator and Clinical Research Coordinator, as required. Recruit, evaluate, and educate patients regarding clinical trials following established procedures and protocols. Conducts Informed Consent Interviews with participants and where required, participant families Document trial related activities as directed and ensure study data is reported in a timely and accurate manner. Coordinate study participant visit activities including scheduling procedures, communicating with subjects, and completing necessary basic study 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 Work Experience: 4 year of experience with research or within the healthcare field. Education may be substituted for experience on a year for year basis. Experience using Microsoft Office Suite Preferred Qualifications Education: Bachelor's degree in a related field. Work Experience: Data management experience with Microsoft Excel, REDCap, CRIS, Access, or other electronic data capture systems. Experience with electronic medical records and working knowledge of medical terminology. Skills: Organizational skills Written and oral communication skills 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: Hourly 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:$22.66 - $32.85 Minimum $22.66 Midpoint $27.75 Maximum $32.85
    $22.7-32.9 hourly Auto-Apply 7d ago
  • Hospice Clinical Coordinator

    Elara Caring

    Clinical research associate job in Lawrence, KS

    At Elara Caring, we have a unique opportunity to play a huge role in the growth of an entire home care industry. Here, each employee has the chance to make a real difference by carrying out our mission every day. Join our elite team of healthcare professionals, providing the Right Care, at the Right Time, in the Right Place. : Clinical Coordinator At Elara Caring, we care where you are and believe the best place for your care is where you live. We know there's no place like home, and that's why our teams continue to provide high-quality care to more than 60,000 patients each day in their preferred home setting. Wherever our patients call home and wherever they are on their health journey, we care. Each team member has a part to play in this mission. This means you have countless ways to make a difference as Clinical Coordinator. Being a part of something this great, starts by carrying out our mission every day through your true calling: developing an amazing team of compassionate and dedicated healthcare providers. To continue to be an industry pioneer delivering unparalleled care, we need a Clinical Coordinator with commitment and compassion. Are you one of them? If so, apply today! Why Join the Elara Caring mission? * Work in a collaborative environment. * Be rewarded with a unique opportunity to make a difference * Competitive compensation package * Tuition reimbursement for full-time staff and continuing education opportunities for all employees at no cost * Opportunities for advancement * Comprehensive insurance plans for medical, dental, and vision benefits * 401(K) with employer match * Paid time off, paid holidays, family, and pet bereavement * Pet insurance As Clinical Coordinator, you'll contribute to our success in the following ways: * Builds teams to offer the highest quality of life to our patients. * Maintains organized, effective, and efficient systems and communication to ensure the continuity of quality patient care is delivered. * Evaluates agency operations, maintains a variety of tracking systems, and identifies ways to enhance workflow and productivity. * Assists staff in maintaining current and accurate medical records and utilization review. * Assists clinical supervisor with non-clinical phone inquiries. * Notifies supervisor of any problems requiring administrative attention and intervention. * Processes and distributes in and out daily mail for the department, collects and maintains inventory, and cleans equipment. * Implements all available actions to prevent avoidable hospitalization and ER visits. * Attends training, education, seminars, or other means of learning. * Treats patients and caregivers in the highest and most effective manner. * Provides positive, supportive communication to physicians, patients, families, visitors, and other agency personnel. * Promotes Elara Caring's philosophy, mission statement and administrative policies to ensure quality of care. * Maintains patient and staff privacy and confidentiality pursuant to HIPAA Privacy Final Rule. * Performs other duties/projects as assigned. What is Required? * 1+ year experience in a hospice or home health care setting * Proficiency with Medical Terminology * Experience working with clinical management team * Proficiency with office equipment including computer, fax, copy machines * Experience with Medicare and Medicaid guidelines are preferred You will report to the Clinical Manager. This is not a comprehensive list of all job responsibilities; a full will be provided. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. We value the unique skills of veterans and military spouses. We encourage applications from military veterans and their families. Elara Caring provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to sex (including pregnancy, childbirth or related medical conditions), race, color, age (40 and older), national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity, gender reassignment, protected veteran status, or any other basis prohibited under applicable federal, state or local law. Elara Caring participates in E-Verify and we will provide the Federal Government with your Form I-9 information to confirm that you are authorized to work in the United States. Employers like Elara Caring can only use E-Verify once you have accepted the job offer and completed the Form I-9. At Elara Caring, pay and compensation are determined by a variety of factors, including education, job-related knowledge, skills, training, and experience. Our compensation structure reflects the cost of labor across different U.S. geographic markets, and may vary based on location. This is not a comprehensive list of all job responsibilities and requirements; upon request, a job description can be provided. If you are an individual with a disability and are unable or limited in your ability to use or access our career site as a result of your disability, you may request reasonable accommodations by reaching out to ********************.
    $50k-71k yearly est. Auto-Apply 22d ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Manhattan, KS?

The average clinical research associate in Manhattan, KS earns between $40,000 and $98,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Manhattan, KS

$63,000
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