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Clinical research associate jobs in Columbia, MO

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  • Clinical Coordinator-Cath Lab

    Mercy 4.5company rating

    Clinical research associate job in Joplin, MO

    Find your calling at Mercy!The Clinical Coordinator is responsible for professional cardiac care for patients and their families by direction, supervision and example. Provides direction to Registered Nurses, Radiology Technologist, students and non-professional nursing personnel in providing direct patient care. Responsible for clinical operation of the Cath Lab on a shift by shift basis ensuring that all regulatory requirements and standards are being fulfilled. Participates in the education and development of Cardiology personnel and performance evaluation as well as other administrative duties as designated by the Director of CV Services. Must have strong interpersonal skills, the ability to manage multiple priorities, be dedicated to the provision of quality patient care and use sound judgment in decision making. Performs duties and responsibilities in a manner consistent with our mission, values, and Mercy Service Standards.Position Details: Education: Graduate of an accredited school of nursing. ADN required, BSN preferred (RN) or graduation from an AMA approved school of Radiologic Technology, either college-affiliated or hospital-trained (Cath Lab Tech). Licensure: Registered Nurse in the applicable state of practice or compact state with a license in good standing or ARRT and a Rad Tech License in the applicable state of practice. Experience: 3-5 years cath lab experience is preferred. Certification/Registration: CPR, ACLS, RCIS Other skills & knowledge (skills, knowledge, abilities): Ability to read and communicate effectively in English. Additional languages preferred. Basic computer knowledge. Organizing and coordinating skills. Knowledge of accreditation and certification requirements and standards. Strong interpersonal skills and the ability to effectively work with a wide range of individuals and constituencies in a diverse community. Advanced assessment skills. Why Mercy? From day one, Mercy offers outstanding benefits - including medical, dental, and vision coverage, paid time off, tuition support, and matched retirement plans for team members working 32+ hours per pay period. Join a caring, collaborative team where your voice matters. At Mercy, you'll help shape the future of healthcare through innovation, technology, and compassion. As we grow, you'll grow with us.
    $27k-35k yearly est. 3d ago
  • Clinical Coordinator-Cath Lab

    Mercy Health 4.4company rating

    Clinical research associate job in Joplin, MO

    Find your calling at Mercy!The Clinical Coordinator is responsible for professional cardiac care for patients and their families by direction, supervision and example. Provides direction to Registered Nurses, Radiology Technologist, students and non-professional nursing personnel in providing direct patient care. Responsible for clinical operation of the Cath Lab on a shift by shift basis ensuring that all regulatory requirements and standards are being fulfilled. Participates in the education and development of Cardiology personnel and performance evaluation as well as other administrative duties as designated by the Director of CV Services. Must have strong interpersonal skills, the ability to manage multiple priorities, be dedicated to the provision of quality patient care and use sound judgment in decision making. Performs duties and responsibilities in a manner consistent with our mission, values, and Mercy Service Standards.Position Details: Education: Graduate of an accredited school of nursing. ADN required, BSN preferred (RN) or graduation from an AMA approved school of Radiologic Technology, either college-affiliated or hospital-trained (Cath Lab Tech). Licensure: Registered Nurse in the applicable state of practice or compact state with a license in good standing or ARRT and a Rad Tech License in the applicable state of practice. Experience: 3-5 years cath lab experience is preferred. Certification/Registration: CPR, ACLS, RCIS Other skills & knowledge (skills, knowledge, abilities): Ability to read and communicate effectively in English. Additional languages preferred. Basic computer knowledge. Organizing and coordinating skills. Knowledge of accreditation and certification requirements and standards. Strong interpersonal skills and the ability to effectively work with a wide range of individuals and constituencies in a diverse community. Advanced assessment skills. Why Mercy? From day one, Mercy offers outstanding benefits - including medical, dental, and vision coverage, paid time off, tuition support, and matched retirement plans for team members working 32+ hours per pay period. Join a caring, collaborative team where your voice matters. At Mercy, you'll help shape the future of healthcare through innovation, technology, and compassion. As we grow, you'll grow with us.
    $19k-41k yearly est. 8d ago
  • Clinical Research Quality Regulatory Coordinator

    BVL Clinical Research

    Clinical research associate job in Liberty, MO

    BVL Clinical Research is a dedicated clinical research site located in Liberty, Missouri, specializing in gastroenterology and hepatology. We are currently conducting multiple clinical trials focused on Crohn's Disease and Ulcerative Colitis. Position Overview We're seeking an on-site Clinical Research Quality Regulatory Coordinator to support and oversee regulatory compliance and quality assurance activities across all clinical trials conducted at our site. This position ensures that studies are conducted in alignment with FDA regulations, GCP guidelines, sponsor requirements, and internal SOPs. This role focuses on regulatory document management, quality oversight, and inspection readiness to support a high standard of clinical trial execution across all studies. Please Note: This is a fully on-site position. Candidates must be located within commuting distance to Liberty, MO. Relocation assistance is not available. Key Responsibilities Regulatory Coordination Prepare, submit, and track IRB documents (initial submissions, amendments, continuing reviews, safety reports). Maintain complete and up-to-date regulatory binders and essential trial documents. Liaise with sponsors, CROs, IRBs, and regulatory authorities regarding document requests and compliance. Ensure timely filing of ICFs, protocol amendments, and safety updates. Quality Assurance & Compliance Support and enhance the site's Quality Management System (QMS). Conduct periodic internal audits of regulatory files, source documentation, and CRFs. Track and manage protocol deviations, noncompliance events, and CAPAs. Maintain inspection readiness across all active trials. Study Start-Up Support Coordinate regulatory tasks related to site initiation and study start-up. Maintain investigator credentials, training logs, and required documentation (e.g., 1572, CVs, licenses). Training & Oversight Ensure clinical staff maintain current GCP and protocol-specific training. Assist with onboarding and ongoing staff education on regulatory processes. Support sponsor and CRO monitoring visits and audits. Documentation & Reporting Maintain version control and audit trails for all clinical and regulatory documents. Draft and update SOPs, logs (training, delegation, document tracking), and compliance reports. Provide regular regulatory status reports to site leadership. Additional Responsibilities Contribute to protocol development and review for compliance. Support internal/external audits, inspections, and monitoring visits. Collaborate with PIs and study teams to ensure efficient trial execution. Comply with all policies, standards, mandatory training, and requirements of BVL Clinical Research. Qualifications Education Bachelor's degree in Life Sciences, Healthcare, or a related field (required). Advanced training or certification in regulatory affairs or clinical quality (preferred). Experience 2+ years in a clinical research environment, preferably at a private site or research clinic. Experience with IRB submissions, regulatory binders, and clinical research SOPs. Skills & Knowledge Working knowledge of FDA regulations, ICH-GCP, HIPAA, and 21 CFR Part 11. Proficiency in Microsoft Office and electronic regulatory systems. Excellent organizational, communication, and multitasking abilities. Preferred Certifications ACRP or SOCRA certification (CCRP, CCRC, or equivalent). GCP or Clinical Research Quality training/certification. Why Join BVL Research? At BVL, you'll be part of a passionate and collaborative team dedicated to advancing clinical care for patients with serious gastrointestinal conditions. We combine the integrity of research with the compassion of patient-centered care. As a growing private site, we offer: Hands-on experience with cutting-edge clinical trials in gastroenterology and hepatology. Opportunities for professional growth in regulatory affairs, quality assurance, and clinical operations. A supportive environment where your ideas and contributions truly matter. The chance to be part of meaningful research that directly impacts patient outcomes. Join us in driving innovation, maintaining the highest standards in clinical research, and making a real difference in patients' lives. Learn more at BVLResearch.com.
    $38k-56k yearly est. 1d ago
  • Sr. Clinical Research Associate - FSP

    Parexel 4.5company rating

    Clinical research associate job in Jefferson City, MO

    **CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
    $77k-104k yearly est. 5d ago
  • Clinical Research Associate II

    Allen Spolden

    Clinical research associate job in Memphis, MO

    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 and 401K
    $39k-63k yearly est. 60d+ ago
  • Trial Master File (TMF) Specialist Oncology

    Sumitomo Pharma 4.6company rating

    Clinical research associate job in Jefferson City, MO

    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 39d ago
  • Senior Clinical Research Coordinator- St. Louis, MO

    Iterative Health

    Clinical research associate job in Saint Louis, MO

    Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. In the performance of their respective tasks and duties all employees are expected to conform to the following: Perform quality work within deadlines with or without direct supervision. Interact professionally with other employees, customers and suppliers. • Work effectively as a team contributor on all assignments. Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations. Position purpose The Senior Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Director and Clinical Principal Investigator (PI). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Responsibilities/Duties/Functions/Tasks: Communicate study requirements to all individuals involved in the study. Develop and implement recruitment strategies in accordance with Impact Research and IRB requirements and approvals. Screen subjects for eligibility using protocol specific inclusion and exclusion criteria. Entry of participant information and study visit procedures into the Clinical Trial Management System to ensure billing to appropriate funding source. Maintains adequate inventory of study supplies. When handling investigational drugs/devices, follows the sponsor protocol and/or Impact ResearchPolicy on Investigational Drug/Device Accountability. Complete study documentation and maintenance of study files in accordance with sponsor requirements and Impact Research policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms. Maintains effective and ongoing communication with sponsor, research participants, Director and PI during the course of the study. Manage the day to day activities of the study including problem solving, communication and protocol management. Collects and reports ongoing patient recruitment/ enrollment metrics to Director and PI. Arranges secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer. Protects the rights and welfare of all human research participants involved in research in accordance with Federal regulations Cooperates with Impact Research compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office. Other duties as assigned. Qualifications Education: High school diploma/GED certificate required. Associates degree from an accredited university preferred. Experience: Minimum 4 or more years of clinical research experience. Other Requirements: CRC certification preferred. Performance Requirements: Knowledge of grammar, spelling, and punctuation. Knowledge of purchasing, budgeting, and inventory control. Skill in taking and transcribing dictation and operating office equipment. • Skill in answering the phone and responding to questions. Skill in time management, prioritization, and multitasking. Skill in writing and communicating effectively. Ability to work under pressure, communicate and present information. • Ability to read, interpret, and apply clinic policies and procedures. Ability to identify problems, recommend solutions, organize and analyze information. • Ability to multi-task, establish priorities, and coordinate work activities. • Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and appropriate practice management software. Must be able to lift up to 25 lbs. Must be able to travel and MVR Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc. Work Environment: Position is in a well-lighted medical office environment. Occasional evening and weekend work. Physical Requirements: Must possess the physical and mental abilities to perform tasks such as sitting for 90 percent of the day; manual dexterity to operate office machines including computer and calculator; stooping, bending to handle files and supplies; and mobility to complete errands or deliveries. Stress can be triggered by multiple staff demands and deadlines. At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
    $41k-64k yearly est. Auto-Apply 26d ago
  • Clinical Research Study Assistant II - Neurology

    Washington University In St. Louis 4.2company rating

    Clinical research associate job in Saint Louis, MO

    Scheduled Hours 40 Our clinical research program includes dozens of studies sponsored through the NIH, Department of Defense, National MS Society, and various pharmaceutical companies. Our comprehensive program studies the most relevant and greatest unmet needs. This includes basic lab research, biomarkers, imaging, clinical repositories, clinical trials, and international consortiums. Key research includes causes of MS, diagnosis, prognostication, therapies, imaging, clinical outcomes, and socioeconomic factors. This position focuses on industry-sponsored clinical trials. Dr. Rob Naismith, Professor of Neurology, directs a clinical research team of over 10 research coordinators and a research nurse. MS faculty include Drs. Anne Cross, Rob Naismith, Greg Wu, Salim Chahin, Matt Brier, and Kimystian (Mysti) Harrison, all who are involved in both clinical care and research. The MS clinical staff includes a nurse practitioner, two nurses, a medical assistant, administrative coordinator, and pre-authorization specialist. Job Description Primary Duties & Responsibilities: * Assists clinical research coordinators with management of clinical trials, including: screening, enrolling, preparing informed consent packets, extracting data accurately from source documents and reporting in various data entry systems within protocol specified deadlines, routinely ensuring timely completion of all protocol requirements. * Completes all necessary paperwork/documentation according to study protocol; obtains consent, interviews study subjects and schedules follow-ups as needed. * Performs basic/scripted assessments to confirm eligibility to participate in study; explains and schedules laboratory and diagnostic procedures and/or treatment as required in the study; refers participants to basic resources as necessary. * Collects data from study participants, medical records, interviews, questionnaires, diagnostic tests and other sources; performs basic evaluation and interpretation of collected data and prepares appropriate reports and documentation as necessary; prepares and distributes study packets and information. * Performs other duties as assigned. Working Conditions: Job Location/Working Conditions: * Normal office environment. Physical Effort: * Typically sitting at desk or table. * Repetitive wrist, hand or finger movement. Equipment: * Office equipment. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time. Required Qualifications Education: High school diploma or equivalent high school certification or combination of education and/or experience. Certifications: The list below may include all acceptable certifications and issuers. More than one credential or certification may be required depending on the role. Basic Life Support - American Heart Association, Basic Life Support - American Red Cross Work Experience: Administrative Or Research (2 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position. More About This Job Required Qualifications: * Basic Life Support certification must be obtained within one month of hire date * Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Preferred Qualifications: * Previous experience conducting informed consent discussions with patients participating in clinical trials, ensuring they understood the study's purpose, procedures, risks, and benefits. Preferred Qualifications Education: Associate degree Certifications: No additional certification unless stated elsewhere in the job posting. Work Experience: No additional work experience unless stated elsewhere in the job posting. Skills: Data Collection Methods, Detail-Oriented, Diagnostic Testing, Interpersonal Communication, Oral Communications, Organizing, Screenings, Written Communication Grade C07-H Salary Range $19.21 - $28.85 / Hourly The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget. Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Pre-Employment Screening All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening. Benefits Statement Personal * Up to 22 days of vacation, 10 recognized holidays, and sick time. * Competitive health insurance packages with priority appointments and lower copays/coinsurance. * Take advantage of our free Metro transit U-Pass for eligible employees. * WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%. Wellness * Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more! Family * We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered. * WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us. For policies, detailed benefits, and eligibility, please visit: ****************************** EEO Statement Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information. Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
    $19.2-28.9 hourly Auto-Apply 51d ago
  • Clinical Research Coordinator II

    Care Access 4.3company rating

    Clinical research associate job in Springfield, MO

    Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact * Patient Coordination * Prioritize activities with specific regard to protocol timelines * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. * Maintain effective relationships with study participants and other care Access Research personnel. * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. * Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) * Prescreen study candidates * Obtain informed consent per Care Access Research SOP . * Complete visit procedures in accordance with protocol. * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. * Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. * Documentation * Record data legibly and enter in real time on paper or e-source documents * Accurately record study medication inventory, medication dispensation, and patient compliance. * Resolve data management queries and correct source data within sponsor provided timelines * Assist regulatory personnel with completion and filing of regulatory documents. * Assist in the creation and review of source documents. * Patient Recruitment * Assist with planning and creation of appropriate recruitment materials. * Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. * Actively work with recruitment team in calling and recruiting subjects * Review and assess protocol (including amendments) for clarity, logistical feasibility * Ensure that all training and study requirements are met prior to trial conduct * Communicate clearly verbally and in writing * Attend Investigator meetings as required * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) The Expertise Required * Ability to understand and follow institutional SOPs. * Excellent working knowledge of medical and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP) * Ability to communicate and work effectively with a diverse team of professionals. * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure. * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: * Bachelor's Degree preferred, or equivalent combination of education, training and experience. * A minimum of 3 years prior Clinical Research Coordinator experience required * Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator * Recent phlebotomy experience required * Licenses: * California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health * Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners * Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health * Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together * Location: This is an on-site position with regional commute requirements, located in Springfield, Missouri * Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. * Type of travel required: Regional (within 100 miles) * Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. * Walking - 20% * Standing - 20% * Sitting - 20% * Lifting - 20% * Up to 25lbs * Over 25lbs Overhead * Driving - 20% The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
    $60k-90k yearly 12d ago
  • Clinical Research Coordinator II

    Objectivehealth 3.7company rating

    Clinical research associate job in Creve Coeur, MO

    Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator II. The ideal candidate will possess 3+ years of clinical research coordination experience, and have a strong desire to work directly with patients. Who We Are ObjectiveHealth is a clinical research company that uses proprietary technology to: * Increase patient access to research trials within our communities, * Provide physicians with enhanced care options for current patients, and * Deliver superior clinical research enrollment metrics to Pharma sponsors All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that. Who You Are * A lover of patient interaction and skilled at providing patient care * A team player with a bias for action and an attitude that takes personal responsibility * Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc. * Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc. * Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence * An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others * A strong advocate for Company values, mission, and initiatives * Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies * Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology What Success Looks Like for This Role * Taking ownership of assigned studies and patients * Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction * Showing up on time, every time * Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies * Learning and using the technologies we provide to increase efficiency in your day-to-day activities * Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication What We Offer Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits. Requirements This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.
    $39k-57k yearly est. 10d ago
  • Clinical Research Assistant / Medical Assistant

    Alcanza Clinical Research

    Clinical research associate job in Kansas City, MO

    Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site. Key Responsibilities Essential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to: * Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol: * Assists with the basic screening of patients for study enrollment; * Assists with patient follow-up visits; * Documents in source clinic charts; * Enters data in EDC and answers queries; * Obtains vital signs and ECGs; * May perform blood draws; * Perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; * Request and track medical record requests; * Enters data in EDC and answers queries; * Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and * Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed; * Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner. * Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed; * Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and * Perform all other duties as requested or assigned. Skills, Knowledge and Expertise Minimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus. Required Skills: * Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm). * Must possess strong organizational skills and attention to detail. * Well-developed written and verbal communication skills. * Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers. * Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities. * Must be professional, respectful of others, self-motivated, and have a strong work ethic. * Must possess a high degree of integrity and dependability. * Ability to work under minimal supervision, identify problems and implement solutions. * Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines. Benefits * Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. * Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
    $30k-43k yearly est. 22d ago
  • Clinical Research Coordinator

    BVL Clinical Research

    Clinical research associate job in Liberty, MO

    BVL Clinical Research is a premier clinical research site specializing in gastroenterology and inflammatory bowel disease (IBD) studies. Our team partners with leading physicians, sponsors, and patients to advance innovative treatments that improve lives. We're seeking a Clinical Research Coordinator (CRC) to join our on-site team in Liberty, Missouri. This position is ideal for candidates with a background in healthcare or research who want to play a hands-on role in the development of new medical therapies. Position Overview As a Clinical Research Coordinator, you'll work under the direction of the Principal Investigator (PI) to coordinate and manage all aspects of clinical trial operations. You'll collaborate with patients, physicians, sponsors, and research staff to ensure studies are conducted with accuracy, safety, and full regulatory compliance. This position blends hands-on patient care with the opportunity to help advance innovative new treatments. RN license is preferred but not required. We also welcome candidates with relevant clinical, laboratory, or research coordination experience who do not hold an RN license. Experience with Phase 2-4 clinical trials is a strong plus. Key Responsibilities Explain study protocols, procedures, and treatments to patients and families Conduct the informed consent process in collaboration with investigators Prepare and process laboratory specimens; ship frozen samples per study protocol Manage study documentation, including case report forms and regulatory files Monitor, document, and report adverse events to the IRB and sponsors Ensure compliance with all study protocols and regulatory standards Coordinate subject screening, enrollment, and follow-up visits Assist with feasibility assessments and pre-study/site initiation visits Maintain study data integrity and implement quality control procedures Collaborate with PIs, sponsors, and monitors to support study execution Participate in audits, investigator meetings, and training sessions Support preparation of study reports and internal communications Perform other assigned duties and comply with all BVL Research policies and standards Education: Bachelor's degree in a health-related field (Nursing, Life Sciences, or equivalent) Preferred Experience: 2+ years of experience in clinical research coordination, nursing, or healthcare Familiarity with Phase 2, 3, or 4 clinical studies Knowledge of FDA, GCP, and clinical trial regulatory requirements Strong attention to detail, organizational, and communication skills Proficiency in Microsoft Office/Google Workspace Active RN license (preferred but not required) Why Join BVL? At BVL Clinical Research, you'll find meaningful work that helps bring new treatments to patients in need. You'll collaborate directly with physicians and research experts in a supportive, team-oriented environment while developing specialized skills in clinical research. If you're a healthcare professional or aspiring research coordinator eager to make a real impact in advancing medical treatments, we'd love to hear from you. Apply today to join our team, and help shape the future of clinical research. To learn more about who we are and the work we do, visit our website at *******************
    $38k-56k yearly est. 1d ago
  • Sr. Clinical Research Associate - Oncology - Southeast Region - FSP

    Parexel 4.5company rating

    Clinical research associate job in Jefferson City, MO

    The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk:** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
    $77k-104k yearly est. 4d ago
  • Specialist, Clinical Business Operations, Oncology

    Sumitomo Pharma 4.6company rating

    Clinical research associate job in Jefferson City, MO

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $72.5k-90.6k yearly 39d ago
  • Clinical Research Study Assistant II - Obstetrics and Gynecology

    Washington University In St. Louis 4.2company rating

    Clinical research associate job in Saint Louis, MO

    Scheduled Hours 40 Under direction, participates in clinical research study activities; screens, obtains consent, and enrolls participants in study; performs a variety of duties involved in the collection, documentation, and reporting of clinical research data. This research assistant will conduct study visits including patient interviews, clinician interviews, MRIs tests and other study related procedures under the guidance of clinical research coordinators and supervisors. This job will be a mix of patient focused job responsibilities and clinical data collection. An ideal candidate may have clinical research experience, specifically with vulnerable patient populations. Job Description Primary Duties & Responsibilities: * Participates in the recruitment of study participants as identified in related protocol; visits with study participants to explain study, screens for eligibility and obtains informed consent of participants. * Completes all necessary paperwork/documentation according to study protocol; obtains consent, interviews study subjects and schedules follow-ups as needed. * Performs basic/scripted assessments to confirm eligibility to participate in study; explains and schedules laboratory and diagnostic procedures and/or treatment as required in the study; refers participants to basic resources as necessary. * Collects data from study participants, medical records, interviews, questionnaires, diagnostic tests and other sources; performs basic evaluation and interpretation of collected data and prepares appropriate reports and documentation as necessary; prepares and distributes study packets and information. * Performs other duties as assigned. Working Conditions: Job Location/Working Conditions: * Normal office environment. Physical Effort: * Typically sitting at desk or table. * Repetitive wrist, hand or finger movement. Equipment: * Office equipment. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time. Required Qualifications Education: High school diploma or equivalent high school certification or combination of education and/or experience. Certifications/Professional Licenses: The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certification or professional license may be required depending on the role. Basic Life Support - American Heart Association, Basic Life Support - American Red Cross Work Experience: Administrative Or Research (2 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position. More About This Job Required Qualifications: * Basic Life Support certification must be obtained within one month of hire date. * Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Preferred Qualifications Education: Associate degree Certifications/Professional Licenses: No additional certification/professional licenses unless stated elsewhere in the job posting. Work Experience: No additional work experience unless stated elsewhere in the job posting. Skills: Interpersonal Communication, Oral Communications, Organizing, Written Communication Grade C07-H Salary Range $19.21 - $28.85 / Hourly The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget. Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Pre-Employment Screening All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening. Benefits Statement Personal * Up to 22 days of vacation, 10 recognized holidays, and sick time. * Competitive health insurance packages with priority appointments and lower copays/coinsurance. * Take advantage of our free Metro transit U-Pass for eligible employees. * WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%. Wellness * Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more! Family * We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered. * WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us. For policies, detailed benefits, and eligibility, please visit: ****************************** EEO Statement Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information. Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
    $19.2-28.9 hourly Auto-Apply 6d ago
  • Clinical Research Coordinator II

    Care Access 4.3company rating

    Clinical research associate job in Springfield, MO

    Job Description Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact Patient Coordination Prioritize activities with specific regard to protocol timelines Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. Maintain effective relationships with study participants and other care Access Research personnel. Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) Prescreen study candidates Obtain informed consent per Care Access Research SOP . Complete visit procedures in accordance with protocol. Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. Documentation Record data legibly and enter in real time on paper or e-source documents Accurately record study medication inventory, medication dispensation, and patient compliance. Resolve data management queries and correct source data within sponsor provided timelines Assist regulatory personnel with completion and filing of regulatory documents. Assist in the creation and review of source documents. Patient Recruitment Assist with planning and creation of appropriate recruitment materials. Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. Actively work with recruitment team in calling and recruiting subjects Review and assess protocol (including amendments) for clarity, logistical feasibility Ensure that all training and study requirements are met prior to trial conduct Communicate clearly verbally and in writing Attend Investigator meetings as required Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) The Expertise Required Ability to understand and follow institutional SOPs. Excellent working knowledge of medical and research terminology Excellent working knowledge of federal regulations, good clinical practices (GCP) Ability to communicate and work effectively with a diverse team of professionals. Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. Critical thinker and problem solver Friendly, outgoing personality; maintain a positive attitude under pressure. High level of self-motivation and energy Excellent professional writing and communication skills Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: Bachelor's Degree preferred, or equivalent combination of education, training and experience. A minimum of 3 years prior Clinical Research Coordinator experience required Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator Recent phlebotomy experience required Licenses: California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together Location: This is an on-site position with regional commute requirements, located in Springfield, Missouri Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. Type of travel required: Regional (within 100 miles) Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. Walking - 20% Standing - 20% Sitting - 20% Lifting - 20% Up to 25lbs Over 25lbs Overhead Driving - 20% The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
    $60k-90k yearly 12d ago
  • Clinical Research Assistant / Medical Assistant

    Alcanza Clinical Research

    Clinical research associate job in Kansas City, MO

    Department Operations Employment Type Full Time Location Kansas City Research Institute Workplace type Onsite Reporting To Taleah Brown Key Responsibilities Skills, Knowledge and Expertise Benefits About Alcanza Clinical Research Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all. We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life. Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined. Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.
    $30k-43k yearly est. 21d ago
  • Clinical Research Study Assistant II - Emergency Medicine

    Washington University In St. Louis 4.2company rating

    Clinical research associate job in Saint Louis, MO

    Scheduled Hours 40 Under direction, participates in clinical research study activities; screens, obtains consent, and enrolls participants in study; performs a variety of duties involved in the collection, documentation, and reporting of clinical research data. Job Description Primary Duties & Responsibilities: * Participates in the recruitment of study participants as identified in related protocol; visits with study participants to explain study, screens for eligibility and obtains informed consent of participants. * Completes all necessary paperwork/documentation according to study protocol; obtains consent, interviews study subjects and schedules follow-ups as needed. * Performs basic/scripted assessments to confirm eligibility to participate in study; explains and schedules laboratory and diagnostic procedures and/or treatment as required in the study; refers participants to basic resources as necessary. * Collects data from study participants, medical records, interviews, questionnaires, diagnostic tests and other sources; performs basic evaluation and interpretation of collected data and prepares appropriate reports and documentation as necessary; prepares and distributes study packets and information. * Performs other duties as assigned. Working Conditions: Job Location/Working Conditions: * Normal office environment. Physical Effort: * Typically sitting at desk or table. * Repetitive wrist, hand or finger movement. Equipment: * Office equipment. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time. Required Qualifications Education: High school diploma or equivalent high school certification or combination of education and/or experience. Certifications: The list below may include all acceptable certifications and issuers. More than one credential or certification may be required depending on the role. Basic Life Support - American Heart Association, Basic Life Support - American Red Cross Work Experience: Administrative Or Research (2 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position. More About This Job Required Qualifications: * Basic Life Support certification must be obtained within one month of hire date * Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Preferred Qualifications: * Administrative or research experience in a medical environment. * Effective verbal, written and interpersonal communication skills. * Effective organization skills. Preferred Qualifications Education: Associate degree Certifications: No additional certification beyond what is stated in the Required Qualifications section. Work Experience: No additional work experience beyond what is stated in the Required Qualifications section. Skills: Interpersonal Communication, Oral Communications, Organizing, Written Communication Grade C07-H Salary Range $19.21 - $28.85 / Hourly The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget. Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Pre-Employment Screening All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening. Benefits Statement Personal * Up to 22 days of vacation, 10 recognized holidays, and sick time. * Competitive health insurance packages with priority appointments and lower copays/coinsurance. * Take advantage of our free Metro transit U-Pass for eligible employees. * WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%. Wellness * Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more! Family * We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered. * WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us. For policies, detailed benefits, and eligibility, please visit: ****************************** EEO Statement Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information. Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
    $19.2-28.9 hourly Auto-Apply 51d ago
  • Clinical Research Coordinator II

    Care Access 4.3company rating

    Clinical research associate job in Saint Louis, MO

    Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact * Patient Coordination * Prioritize activities with specific regard to protocol timelines * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. * Maintain effective relationships with study participants and other care Access Research personnel. * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. * Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) * Prescreen study candidates * Obtain informed consent per Care Access Research SOP . * Complete visit procedures in accordance with protocol. * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. * Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. * Documentation * Record data legibly and enter in real time on paper or e-source documents * Accurately record study medication inventory, medication dispensation, and patient compliance. * Resolve data management queries and correct source data within sponsor provided timelines * Assist regulatory personnel with completion and filing of regulatory documents. * Assist in the creation and review of source documents. * Patient Recruitment * Assist with planning and creation of appropriate recruitment materials. * Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. * Actively work with recruitment team in calling and recruiting subjects * Review and assess protocol (including amendments) for clarity, logistical feasibility * Ensure that all training and study requirements are met prior to trial conduct * Communicate clearly verbally and in writing * Attend Investigator meetings as required * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) The Expertise Required * Ability to understand and follow institutional SOPs. * Excellent working knowledge of medical and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP) * Ability to communicate and work effectively with a diverse team of professionals. * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure. * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: * Bachelor's Degree preferred, or equivalent combination of education, training and experience. * A minimum of 3 years prior Clinical Research Coordinator experience required * Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator * Recent phlebotomy experience required * Licenses: * California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health * Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners * Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health * Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together * Location: This is an on-site position with regional commute requirements, located in St. Louis, Missouri * Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. * Type of travel required: Regional (within 100 miles) * Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. * Walking - 20% * Standing - 20% * Sitting - 20% * Lifting - 20% * Up to 25lbs * Over 25lbs Overhead * Driving - 20% The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
    $60k-90k yearly 18d ago
  • Clinical Research Assistant / Medical Assistant

    Alcanza Clinical Research

    Clinical research associate job in Kansas City, MO

    Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site. Key ResponsibilitiesEssential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to: Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol: Assists with the basic screening of patients for study enrollment; Assists with patient follow-up visits; Documents in source clinic charts; Enters data in EDC and answers queries; Obtains vital signs and ECGs; May perform blood draws; Perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Request and track medical record requests; Enters data in EDC and answers queries; Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed; Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner. Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed; Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and Perform all other duties as requested or assigned. Skills, Knowledge and ExpertiseMinimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus. Required Skills: Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm). Must possess strong organizational skills and attention to detail. Well-developed written and verbal communication skills. Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers. Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities. Must be professional, respectful of others, self-motivated, and have a strong work ethic. Must possess a high degree of integrity and dependability. Ability to work under minimal supervision, identify problems and implement solutions. Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines. Benefits Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
    $30k-43k yearly est. 22d ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Columbia, MO?

The average clinical research associate in Columbia, MO earns between $31,000 and $77,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Columbia, MO

$49,000
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