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  • Clinical Trial Specialist (Remote)

    Tandym Group

    Remote coordinator and research assistant job

    A leading organization is currently seeking a skilled Clinical Trial Specialist for a Remote contract opportunity. This role is pivotal in ensuring the successful execution of clinical trials from start-up through closeout. Responsibilities: Actively involved in the performance of study feasibility assessments Develop and review study documents (e.g., site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (e.g., site specific informed consent forms) Manage the collection, review and approval of regulatory documents from clinical sites Coordinate investigational product release activities across clinical sites Manage and track study specific payments Create study-specific site budgets Initiate, maintain and reconcile the Trial Master File Assist in the preparation of Investigator and Study Coordinator Meetings Set-up and maintain tracking systems (e.g., CTMS), tools and report study metrics to support the clinical trial programs Coordinate communication of tracking information within the study team and to the clinical sites Develop and review Standard Operating Procedures Perform other duties, as needed Qualifications: Bachelor's Degree Previous experience in Clinical Trial Coordination and/or Site Management Understanding of Study Phases and general knowledge of how they apply to Clinical Development Working knowledge of ICH Good Clinical Practice guidelines Experience using computer applications including spreadsheets, email, word-processing software and web-based systems
    $75k-125k yearly est. 1d ago
  • Research Administrator (Remote) - Infectious Diseases

    Washington University In St. Louis 4.2company rating

    Remote coordinator and research assistant job

    Scheduled Hours40Plays a vital role in the sponsor project life cycle, ensuring that research proposals adhere to sponsor guidelines and are successfully submitted. Manages a portfolio of faculty post award and payroll sourcing activities with minimal supervision/oversight for a research-intensive department. This position may oversee a complex portfolio of Global Health grants and contracts, working closely with the PIs and Operational Program Manager.Job Description Primary Duties & Responsibilities: Proposal/Grant Management Serves as responsible for the oversight and day-to-day management of research administration. Manages budgeting, analysis, justifications for proposals; gathers information for protocols and non-technical proposal components as needed. Acts as liaison between the Chair, Faculty, and Department Administrators (DAs). Stays current on federal and university developments regarding research administration and complex regulations. Compiles and ensures accurate regulatory compliance of necessary data collected from various sources. Works with Principal Investigator to compile and submit the entire grant according to established agency/university guidelines. Prepares and reviews all agency forms for submission. Enters grant budgeting documents on line, as needed. Obtains PI and institutional signatures for proposal submissions. Initiates subaward setup through SUBS system (new process/system). Uploads pre-award documents and hands it off to Post-award to enter fund number. Coordinates with the Post-award unit and OSRS to ensure timely implementation of contracts and subcontracts by examining and supplying the necessary requirements in the SUBS system. Serves as responsible for the oversight and day-to-day management of research administration. Implements and maintains procedures to ensure efficient work flow; responsible for the proper training of staff. Award Management Manages reviews of more complex notice of award (NOA), including sponsor award documents, to SPA and PI, noting any special terms and conditions as well as committed effort. Tracks and maintains online database of grants submitted, awarded, rejected, etc. Monitors and works with PI to submit annual agency reports (e.g., Research Performance Progress Reports/RPPRs). Teams with the Post-Award unit on revised budgets. Oversees and coordinates the proper transfer of PI grants and contracts into WashU. Research Compliance Coordinates the necessary support with internal and external requests for complex grant-related information (i.e. current biosketches, trainee information, and human/animal protocol approvals, other support). Research Reporting Provides analysis of online database of grants submitted, awarded, rejected, etc. metrics and funding trends. Grant Closeout Serves as responsible for closure of complex sponsored projects accounts. Submits final progress report and invention statement (if applicable) to the appropriate agency. Follows up with PI and facilitates submission of delinquent final technical, outcomes, patent, and property reports. Post Award Manages and monitors complex sponsored projects budgets and ensures appropriate and timely expenditures and reconciliation of funds. Identifies and assigns payroll to appropriate sources and enter directly into Workday, with PI approval. Documents and confirms with PI all salary sourcing for project personnel, including research faculty, postdocs, staff and students. Notifies DA and/or initiates payroll accounting adjustments when cost transfers are needed to reflect retroactive changes. Approves purchasing documents and provides guidance to purchasing staff on appropriate expenditures according to specific grant policies. Manages subawards, including, receiving the subaward invoice, reviewing and forwarding to PI for approval. Checks for accuracy and provides complex troubleshooting error resolutions/solutions for fund profile setups and financial reports. Creates, addresses, and processes correspondence of moderate complexity with granting agencies (i.e. inquiries, carry forward requests, change in effort requests, prior approvals, no cost extensions, equipment purchase, and budget reallocation requests). Serves as internal liaison and grant content representative with SPA to ensure that all funds are set up in a timely manner; prepares any necessary project advances, no-cost extensions, and ensures that funds are carried forward as appropriate. Ensures that human and animal study protocols are associated with the applicable proposal or award. Obtains documentation on participation of foreign nationals on research projects. Coordinates the necessary support with internal and external requests for grant-related information (i.e. audit inquiries, effort distribution, trainee information, and human/animal protocol approvals,). Stays in communication with the leadership on pre- and post-award activities to ensure the highest level of customer service to faculty. Tracks and maintains online database of grants submitted, awarded, rejected, etc. Prepares monthly financial reports on complex research accounts and distribute/discuss with PIs and senior leadership. Assists DA in reconciling funds and monitoring spending levels, overdrafts, and cost sharing commitments. Processes budget adjustments on expense categories as needed. Obtains signatures and forwards grant/contract financial status reports to PI and senior leadership. Works with PIs to provide fund management and make any necessary budgetary changes. Oversees and coordinates the proper transfer of PI grants and contracts from Wash U to new institutions or new departments. May prepare and submit invoices according to final executed contract, track receipt of checks from sponsor and ensure they are deposited in correct fund. Research Center Grants Manages Cores and Subcores, program income, bridge/seed and institutional funds. Provides monthly financial reports to the Program Director and Core/Subcore Directors. Serves as financial resource for the entire Center. Performs data gathering, analysis and report on Center major equipment inventories, maintenance and replacement, along with annual financial and strategic planning. Designs and implements reporting database for Cores/Subcores to track services for billing purposes. Performs data gathering, analysis and reports for the Cores/Subcores and forecasts anticipated annual expenses and program income. Prepares, sends, and monitors invoices for services performed by the Cores. In addition, reconciles the service funds each month. Assists in the preparation of all financial and summary information, including investigators, grants, publications and Core use, for the Director/Associate Director meetings, annual progress report and renewal. Performs role as liaison for Program Director in communicating policies and procedures to Center Investigators, Core/Subcore Directors, Administrators and Staff in daily operations directly related to the research associated with the Center. Distributes, monitors, tracks and reports on performance survey results provided by Center Investigators who have utilized the Centers' Core/Subcore services. Serves as responsible for coordinating all Center lectures, scientific forums, workshops, as well as advertising via e-mails/flyers/posters, etc. Participates in all Center-related meetings and symposiums. Other Functions Assists senior leadership with special projects as requested. Manages two to four grant specialists. Assists with the training of current and new staff ensuring their portfolio management is compliant with all policies and procedures. Performs other duties as assigned. Working Conditions: Job Location/Working Conditions Normal office environment. Physical Effort Typically standing or walking. Repetitive wrist, hand or finger movement (PC Typing). 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: Bachelor's degree or combination of education and/or experience may substitute for minimum education. Certifications/Professional Licenses: No specific certification/professional license is required for this position. Work Experience: Relevant Experience (4 Years), Grants Administration (2 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position.More About This JobPreferred Qualifications Knowledge of S2S and SUBS system Knowledge of agency guidelines. Preferred Qualifications Education: Master's 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: Adobe Acrobat, Analytical Thinking, Computerized Accounting, Computer Literacy, Deadline Management, Grant Administration, IBM Cognos Analytics, Interpersonal Communication, Learning New Technologies, Maintaining Composure, Microsoft Excel, Microsoft Word, Oral Communications, Supervisory Management, Workday Software, Written CommunicationGradeG13Salary Range$65,900.00 - $112,700.00 / AnnuallyThe 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 ScreeningAll 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 StatementWashington 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.
    $65.9k-112.7k yearly Auto-Apply 9d ago
  • Research Study Coordinator (Data Editor, Health Disparities & Public Policy))

    Northwestern University 4.6company rating

    Remote coordinator and research assistant job

    Department: MED-Psych & Behavioral Science Salary/Grade: NEX/11 . The Health Disparities & Public Policy program investigates health disparities in traditionally underserved populations. For the past 30 years, we have been conducting the Northwestern Juvenile Project, a longitudinal study of the health needs and outcomes of 1,829 youth involved with the justice system (now median age 44). The Research Study Coordinator will: review and process incoming structured interview data for coherence, missing information, coding errors, and logical inconsistencies; code open-ended questions; work collaboratively with other staff members to request clarifications and provide feedback; and maintain codebooks and manuals that document the status of edits and revisions. This position will work standard business hours Monday through Friday, with 3 days in-office on our Streeterville (Chicago) campus office required, and the option to work remotely 2 days per week. The Research Study Coordinator will complete all activities by strictly following all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), and Code of Federal Regulations (CFR). Specific Responsibilities: Technical * Collects, compiles, tabulates & processes responses. * Gathers information. * Extracts & analyzes data from medical charts. Administration * Collects, records, reviews & summarizes research data. * Prepares reports for investigators and sponsors on recruitment status and other pertinent study data. Completes documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols Miscellaneous Performs other duties as assigned. Minimum Qualifications: (Education, experience, and any other certifications or clearances) * Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 2 years' research study or other relevant experience required; OR * Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience. * Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years. Minimum Competencies: (Skills, knowledge, and abilities.) * Keen attention to detail * Excellent organizational skills and habits * Strong troubleshooting and problem-solving skills * Intermediate proficiency with Microsoft Word and Excel * Strong interpersonal skills (listening, asking questions, providing feedback) * Ability to work independently and efficiently Preferred Qualifications: (Education and experience) * Experience working with empirical research studies * Experience with research involving structured interview data and data processes * Experience with human subjects research Preferred Competencies: (Skills, knowledge, and abilities) * Experience with REDCap or other survey software * Sound decision making based on available documentation Target hiring range for this position will be between $19.89 - 27.97 per hour. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Benefits: At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more. Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more. Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process. #LI-JP1
    $19.9-28 hourly 14d ago
  • Clinical Research Coordinator, Sr - Floater

    U.S. Renal Care, Inc. 4.7company rating

    Remote coordinator and research assistant job

    The Senior Clinical Research Coordinator (SCRC) is responsible for the facilitation and coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The SCRC will work collaboratively with the principal investigator (PI), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The SCRC will assist the PI in protecting the rights, safety and welfare of all study participants. Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned. Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation. Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46). Maintain and update each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information. Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312). Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product(IP), IP side effects and safety, communication with study staff and research rights. Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times. Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI. Engage and collaborate with the USRC clinical team. Provide study specific training, oversee trial implementation, and ensure compliance with the study protocol by our clinical partners. Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner. Coordinate long-term storage of research records in accordance with contractual requirements. Timely preparation for, accommodation of and attendance during site initiation, monitoring visits, audit visits or regulatory authority inspections. Maintains records of all reports as well as the site's response. Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports. Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution. Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial. Adheres to the USRC Research quality assurance program guidelines. Travel to Investigator Meetings or similar research related meetings is required. Travel may be required between dialysis facilities or nephrology practices within the community. Maintains a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications. May provide training and oversight of Clinical Research Coordinators and/or Research Assistants. Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization. Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures. Participate in staff meetings as required. Regular and reliable attendance is required for the job.
    $47k-76k yearly est. 1d ago
  • Respiratory Care Research Coordinator (Intermittent)

    University of Washington 4.4company rating

    Remote coordinator and research assistant job

    **School of Nursing has an outstanding opportunity for a Respiratory Care Research Coordinator (Intermittent) (Respiratory Care Lead (NE H NI CNU)** The Spirometry 360 research team provides methodological spirometry expertise to clinical and study teams, including virtual spirometry coaching, overreading and grading, and training to facilitate optimal spirometry implementation. The Spirometry 360 Respiratory Care Research Coordinator will assist with the development and implementation of research protocols while ensuring research projects are conducted in compliance with federal regulations, institutional/departmental guidelines, and other regulatory standards. The research team primarily supports studies on pediatric and adult asthma and other respiratory conditions. An ideal candidate is an independent worker who is comfortable working in a team setting. This position is fully remote and requires the ability to manage multiple, and often changing, priorities and timelines, and frequent communication with the project team regarding the status of assigned tasks and any issues that may arise. **Key Responsibilities:** + Regulatory and research protocol adherence. + Development of process and workflows. + General research support. **Regulatory and Research Protocol Adherence (45%):** + Conduct research activities in accordance with applicable institutional/departmental guidelines, federal regulations, and principles. + Overread spirometry tests and record grades into research data portals in accordance with national standards (e.g., American Thoracic Society) and study protocols. + Provide virtual spirometry coaching to study participants as outlined in study protocol. + Report any protocol deviations or concerns to program director to ensure research quality. **Development of Processes and Workflows (40%):** + Contribute to the development of workflows and protocols for data collection, including synchronous spirometry coaching, overreading, logistics, and data reporting. + Assist with creating and performing quality assessment and improvement methods. + Ensure consistent updates are communicated between team and research partners. **General research support (15%):** + Provide instructions on home spirometry maneuvers to practitioners, coordinators, participants and caregivers. + Attend Spirometry 360 team meetings, meetings with research collaborators and external vendors, as appropriate. + Other duties as assigned. **Minimum Requirements:** + Completion of a respiratory care program approved by the State of Washington Department of Health AND eighteen months of experience as a Respiratory Care Practitioner. _Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration._ **Legal Requirement** + Licensed as a Respiratory Care Practitioner (Registered Respiratory Therapist - RRT) by the State of Washington. Additional Requirements: + Two years of experience coaching and reading spirometry maneuvers. + Human Subjects Protection training (e.g., CITI) and Good Clinical Practice (ICH-GCP) certification, current at time of hire or completed prior to start. Training must be maintained per sponsor/IRB requirements. **Desired** **Qualifications:** + NBRC Registered Respiratory Therapist (RRT) credential or active state Respiratory Care Practitioner (RCP) license. + Experience working within clinical setting. + Pediatric spirometry experience. + Research experience. + Strong organizational skills and attention to detail. + Strong verbal and written communication skills with the ability to manage relationships and interact with a wide range of researchers, clinicians, and research participants. + Proficiency in Microsoft Office software. + Proficiency with audio/visual conference software, e.g. Zoom. **Conditions of Employment** + Typical hours occur between 9am and 6pm + The schedule may require occasional prearranged hours outside of business hours due to the nature of global spirometry testing. + Local travel, within Western Washington State, may be required 1-2 times annually. + This is a permanent position, albeit on an intermittent basis, as work becomes available. **Compensation, Benefits and Position Details** **Pay Range Minimum:** $40.98 hourly **Pay Range Maximum:** $58.60 hourly **Other Compensation:** - **Benefits:** For information about benefits for this position, visit **************************************************************************************** **Shift:** First Shift (United States of America) **Temporary or Regular?** This is a temporary position **FTE (Full-Time Equivalent):** 0.00% **Union/Bargaining Unit:** Not Applicable **About the UW** Working at the University of Washington provides a unique opportunity to change lives - on our campuses, in our state and around the world. UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty. **Our Commitment** The University of Washington is committed to fostering an inclusive, respectful and welcoming community for all. As an equal opportunity employer, the University considers applicants for employment without regard to race, color, creed, religion, national origin, citizenship, sex, pregnancy, age, marital status, sexual orientation, gender identity or expression, genetic information, disability, or veteran status consistent with UW Executive Order No. 81 (*********************************************************************************************************************** . To request disability accommodation in the application process, contact the Disability Services Office at ************ or ********** . Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law (********************************************************* . University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.
    $40k-55k yearly est. 5d ago
  • Clinical Research Regulatory Coordinator I

    Massachusetts Eye and Ear Infirmary 4.4company rating

    Remote coordinator and research assistant job

    Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary General Summary/Overview Statement: The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact. Principal Duties and Responsibilities: The following regulatory duties will be performed under general supervision by the Clinical Research Manager: · Maintain and organize study specific regulatory binders · Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB · Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study · Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required · Submit Data and Safety Monitoring Reports · Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process · Collect, complete, and submit essential regulatory documents to various regulatory entities · Participate in monitoring visits and file all monitoring visit correspondence · Ensure appropriate documentation of delegation and training for all study staff members · Maintain screening and enrollment logs Skills/Abilities/Competencies Required · Careful attention to detail · Good organizational skills · Ability to follow directions · Good communication skills · Computer literacy · Working knowledge of clinical research protocols Qualifications Education: Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials: n/a Experience: Knowledge, Skills and Abilities: - Careful attention to detail. - Good organizational skills. - Ability to follow directions. - Computer literacy. - Working knowledge of clinical research protocols. Additional Job Details (if applicable) Working Conditions: · Duties will be performed remotely Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $19.8-28.4 hourly Auto-Apply 21d ago
  • Research Administrator, Post Award

    George Mason University 4.0company rating

    Coordinator and research assistant job in Fairfax, VA

    Department: College of Science Classification: Financial Svcs Specialist 1 Job Category: Classified Staff Job Type: Full-Time Work Schedule: Full-time (1.0 FTE, 40 hrs/wk) Workplace Type: Hybrid Eligible Pay Band: 04 Salary: Salary commensurate with education and experience Criminal Background Check: Yes About the Department: The function of the Research Administration team, in the Office of the Dean, within the College of Science (COS), is to support faculty in proposal submission, financial management and compliance of their research grants and contracts in an efficient manner and with a customer-service focus. George Mason University College of Science (Mason Science) is committed to advancing inclusive excellence and fostering an environment free from discrimination, harassment, and retaliation throughout our STEM community. At Mason Science, our values include cultivating an organizational culture that promotes belonging, respect, and civility. We believe that varied opinions, cultures, and perspectives are what provides vibrancy, innovation, and growth to an academic community. By prioritizing cultural responsiveness in academics, teaching, research, and global engagement, we strive to attract faculty and staff who exemplify the Mason Science mission and vision. About the Position: The Post Award Research Administrator is responsible for managing post-award activities in support of an assigned portfolio of grants and contracts within one or more units (i.e., school, department, division, institute, or center) using knowledge of grant and contract management rules and regulations, technical expertise, and analytical skills. Post-award activities include regular review, reconciliation, and projection of award finances, preparing adjustments and corrections to award budgets, preparing financial reports, and at the end of the award, ensuring all financial requirements have been met and closing out the award. The Post Award Research Administrator interacts regularly with and provides high quality customer service to faculty members conducting sponsored research. This position ensures adherence to quality standards and all policies and award regulations. This position is expected to function with minimal oversight or supervision, be highly engaged with investigators, and collaborative with the Office of Sponsored Programs (OSP). This position is expected to demonstrate understanding, adoption, and adherence to Standard Operating Procedures (SOPs) and training. Responsibilities: Reviews and reconciles award expenditures, budgets, and makes adjustments as necessary; Projects and forecasts future award expenditures; Reviews all expenditures to ensure they are allowable, allocable, and reasonable; Manages budget, reporting and compliance timelines through the lifecycle of the grant or contract; Communicates and meets with PIs on a regular basis regarding budget and expense adjustments and revisions; Completes financial reports to be sent to sponsor, as required by the award terms and conditions; Monitors compliance with agency and University regulations regarding reporting; Completes invoices for sponsor (for certain award types only); Assists PIs with non-financial report submissions, as necessary; Coordinates and submits requests for no cost extensions, carryover, budgeting requests, changes in scope, and other changes to the award; Ensures all requests are done in compliance with sponsor guidelines and University policies, and coordinates with pre-award counterparts as needed; Facilitates the approval of invoices to pay subcontractors, as needed; Reviews effort reports and manages quarterly effort certification process for assigned units; Applies federal and University rules to management of effort allocation appropriately for individuals compensated whole or in part from federal awards; Assists in transferring awards out of the university; Prepares funded projects for closeout for all funded projects consistent with University processes and timelines, and follows and adheres to defined business practices related to post-award functions; Works with Senior Post Award Research Administrators; Follows and adheres to processes and activities related to post-award functions; Performs post-award activities including assisting faculty/Pl in the financial, regulatory, and reporting of grant and contract awards; Develops related knowledge and skills; Upon award acceptance, defines account establishment parameters, including billing and reporting requirements, budget, and cost sharing obligations; Sets-up awards in financial system; Distributes award information to PIs, co-PIs, and relevant staff; and Coordinates with relevant individuals to adjust payroll for all budgeted positions (including relative cost sharing positions). Required Qualifications: High school diploma or equivalent; Some experience related to grants and contracts management (generally 0-2 years); An appropriate combination of relevant education and/or work experience may be considered; Knowledge of federal rules, regulations, and University policies and procedures relating to research grant and/or contract activity; Knowledge of University processes, systems, and offices related to and/or involved in grant and contract submission and management; Knowledge of financial processes and controls including the reconciliation process; Knowledge of principles and processes for providing customer service; Skill in mathematics, financial management, and/or accounting, with the ability to analyze data and formulate conclusions; Excellent oral and written communication with fundamental, professional interpersonal skills, including skill in creating high quality written documents; Skill in the use of computers with solid working knowledge of MS Office Suite (Word, Excel, PowerPoint); Demonstrated ability to learn complex electronic systems and changing technologies related to grants and contracts management; Ability to proactively resolve problems and issues in a timely manner; Understanding of and ability to apply costing rules and regulations to federally funded projects; Understand and apply federal and University rules to management of effort allocation for individuals compensated whole or in part from federal awards; Ability to manage and prioritize multiple projects/tasks simultaneously; Work well under pressure and meet deadlines; Work independently with minimal supervision managing a large volume of complex awards; Ability to effectively manage research budgets, interpret allowable costs, and other specific financial issues; Ability to work collaboratively with other levels of post-award specialists to solve problems, answer questions, and give guidance on post-award activities and other grants management topics on a daily basis; interact and communicate with senior leadership and communicate effectively with colleagues and peers; Work collaboratively with colleagues to solve questions and challenges in their daily work; and Performs other related duties as assigned. Preferred Qualifications: Bachelor's degree in related field; Experience in Sponsored Programs Administration or related field preferred; and Knowledge of the Banner Financial system, or demonstrated ability to learn complex electronic systems. Instructions to Applicants: For full consideration, applicants must apply for the Research Administrator, Post Award at ********************** Complete and submit the online application to include three professional references with contact information, and provide a cover letter and resumes for review. Posting Open Date: July 29, 2025 For Full Consideration, Apply by: August 12, 2025 Open Until Filled:
    $49k-61k yearly est. 60d+ ago
  • Senior Clinical Research Coordinator

    Topography Health

    Coordinator and research assistant job in Washington, DC

    Job DescriptionOVERVIEWThis role will coordinate research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and include the opportunity to help spearhead on-site efforts for Topography's partner healthcare groups. This role will be evaluated on provider success, patient experience, protocol management and adherence, and data quality. This role will require a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers. You will need to be able to thrive with multiple balls in the air, and where independent problem solving is a daily need. You will need to lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country. KEY RESPONSIBILITIES Act as senior study coordinator to execute trials conducted within physician practices, including but not limited to: a. Visit preparation activities b. Visit follow-up activities c. Supply and inventory management d. Third party vendor management Conduct patient recruitment and enrollment of eligible patients. Lead patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. 4. Independently administer the informed consent process with care and quality 5. Ensure protocol adherence and high data integrity Provide high quality source data capture and documentation Support study start-up and planning, including PSVs and SIVs Support IRB submission and correspondence Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process IP management, dispensation and accountability Adverse Event management, tracking, and follow-up Data entry to CRF/EDC and query resolution in a timely manner Support study close-out, including COVs Protocol deviation tracking, reporting, and reconciliation Train and mentor junior research staff Using and helping improve Topography's proprietary tool set Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation Conduct Quality Control activities including routine QC checks during and following study visits Any other duties assigned by manager MINIMUM QUALIFICATIONS Bachelor's degree or equivalent combination of training and experience Ability to be on site 5 days a week in Chevy Chase, MD5+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role 5+ years of experience independently coordinating studies, from study startup to close out5+ years demonstrated track record of delivering clean data and a high-quality patient experience Expert knowledge of FDA regulations and ICH/GCP guidelines Strong communication skills, teamwork, cooperation, self-awareness, and flexibility We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
    $59k-92k yearly est. 1d ago
  • Research Coordinator

    The Geneva Foundation 4.4company rating

    Coordinator and research assistant job in Bethesda, MD

    The Research Coordinator provides assistance to the Principal Investigator and Study Team coordinating research activities that may include recruiting research participants, data collection and management and other research activities as assigned. The Research Coordinator will assist with report generation and project close-out support. This is a part time (20 hours per week) position that will be required to work on site at the Uniformed Services University in Bethesda, MD. A government background check will be administered. Salary Range $22.00 - $28.00. Salaries are determined based on several factors including external market data, internal equity, and the candidate's related knowledge, skills, and abilities for the position. Qualifications Bachelor's degree or equivalent work experience required 2-4 years' experience in clinical research preferred 2-4 years' non-profit, research, or healthcare experience desired Demonstrate competence in oral and written communication Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software Knowledge of CFR, GCP and ICH guidelines Visa sponsorship not available US Citizenship required Responsibilities Participant recruitment, consent forms Promote safety and confidentiality of research participants at all times Adhere to Occupational Safety and Health Administration (OSHA), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and infection control procedures Plan and coordinate the initiation of research study protocol, and the implementation of operating policies and procedures Plan, implement and maintain data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data Recruit, instruct and coordinate research subjects and/or volunteers, as appropriate to specific study objectives and work scope Coordinate the day-to-day activities of technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives Organize and facilitate meetings, conferences, and other events associated with research activities; may perform and/or coordinate outreach activities, as appropriate to research objectives Document all correspondence and communication pertinent to the research Interact and communicate effectively with Principal Investigator, other site personnel, research participants, The Geneva Foundation, and the funding organization
    $22-28 hourly Auto-Apply 60d+ ago
  • Clinical Research Systems Coordinator - (Clinical Conductor experience required)

    Alcanza Clinical Research

    Remote coordinator and research assistant job

    Department Clinical Systems Employment Type Full Time Location Alcanza Corporate Workplace type Fully remote Reporting To Tina White 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.
    $39k-57k yearly est. 7d ago
  • Research Support Administrator 1

    OPS Consulting

    Coordinator and research assistant job in College Park, MD

    OPS Consulting is seeking an experienced Research Support Administrator Level 1 to work in the following locations: Baltimore, MD College Park, MD Required Experience: The Research Support Administrator will provide administrative and security support to the project. The Research Support Administrator will also coordinate with visitors, travel, meetings, and special handling of VIP guests. Additional responsibilities will include: Answer telephones, greet and log-in visitors, and distribute mail. Procure supplies for research lab. Management of the time accounting system. Preform record management. Plan and Schedule activities for facility maintenance and improvements. Coordination of schedules, meetings and facility tours; arrange for travel and management of travel expense tracking system. Qualifications: A minimum of five (5) years of experience providing administrative support is required. Knowledge and proficiency in the use of computer application software such as MS Word, Excel, and PowerPoint is required. Security Clearance: A current government clearance, background investigation, and polygraph are required. We are an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other protected class. The Swift Group and Subsidiaries are an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class. Pay Range: $49,996.80 - $290,004.00 Pay ranges are a general guideline and not intended as a guaranteed and/or implied final compensation or salary for this job opening. Determination of official compensation or salary relies on several different factors including, but not limited to: level of position, complexity of job responsibilities, geographic location, work experience, education, certifications, Federal Government contract labor categories, and contract wage rates. At The Swift Group and Subsidiaries, you will receive comprehensive benefits including but not limited to: healthcare, wellness, financial, retirement, education, and time off benefits.
    $50k-66k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Coordinator III - RN

    Invitrogen Holdings

    Remote coordinator and research assistant job

    Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Discover Impactful Work: We are seeking a Clinical Research Coordinator III (Registered Nurse) to support our government customer on-site in Silver Spring, Maryland . This is a per diem, non benefited position. Availability needed (6:00 am - 10: 00 am). Relocation assistance is NOT provided for this role. Must be a U.S. citizen. Must be able to pass a comprehensive background check, which includes a drug screening and a physical. Required to be a Registered Nurse licensed to practice in the state of Maryland. A day in the Life: Organizes and prioritizes all activities associated with conducting phase 1, 2, and 3 clinical and operational research studies within a military clinic setting. Reviews and understands research protocols, ensuring applicable regulations and guidelines are followed. Organizes research information for clinical projects Selects and observes subjects and assists with data analysis and reporting. Oversees experiment scheduling and collection of data. Participates in source document and study document design, writing SSP, materials planning, visit schedule creation, etc. Enters required data routinely on CRFs and audit records for accuracy, resolve discrepancies, and correct as necessary. Maintains study/test article or investigational product accountability and administration. Monitors study data collection procedures to ensure uniformly high levels of compliance with GCP, GLP, FDA and other government- or locally required guidance. Relies on experience and judgment to plan and accomplish goals. Works under general supervision and performs a variety of tasks. Keys to Success: Required Education Required to be a Registered Nurse licensed to practice in the state of Maryland, who is skilled and qualified in nursing procedures to include, but not limited to the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314. Basic Life Support (BLS -CPR/AED) certification. Required Experience and Skills: Five (5) years of experience in clinical research coordination, with expertise in FDA-regulated trials. Experience utilizing clinical trial management systems and databases (e.g., REDcap and Inform). Must be able to work both independently and in a team setting following a brief period of specific technical training. Must have excellent communication, organization, and prioritization skills. Ability to establish and maintain effective working relationships with coworkers, managers and customers. Maintenance of Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). Desired Experience and Skills Advanced Cardiac Life Support (ACLS) certification encouraged. Certification in clinical research (e.g., CCRP or CCRA) is preferred. Commission for Case Manager Certification (CCMC) certification preferred. Compensation and Benefits The salary pay range estimated for this position CRA (Level II) based in Maryland is $38.46-$44.23. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************
    $44k-62k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Coordinator I

    St. Charles Health System 4.6company rating

    Remote coordinator and research assistant job

    This position may be filled at the coordinator level 1 or level 2, based on experience/qualifications and requires the incumbent to reside in Central Oregon: Level 1 Pay range: $25.18 - $37.77 per hour. Level 2 Pay range: $27.20 - $40.79 per hour. St. Charles Health System is a leading healthcare provider in Central Oregon, offering a comprehensive range of services to meet the needs of our community. We are committed to providing high-quality, compassionate care to all patients, regardless of their ability to pay. Our values of compassion, excellence, integrity, teamwork, and stewardship guide our work and shape our culture. What We Offer: Competitive Salary Comprehensive benefits including Medical, Dental, Vision for you and your immediate family 403b with up to 6% match on Retirement Contributions Generous Earned Time Off Growth Opportunities within Healthcare ST. CHARLES HEALTH SYSTEM JOB DESCRIPTION TITLE: Clinical Research Coordinator I REPORTS TO POSITION: Research Manager DEPARTMENT: Research DATE LAST REVIEWED: November 15, 2024 OUR VISION: Creating America's healthiest community, together OUR MISSION: In the spirit of love and compassion, better health, better care, better value OUR VALUES: Accountability, Caring and Teamwork DEPARTMENTAL SUMMARY: St. Charles Research Department conducts clinical trials for promising new treatments and therapies in a wide variety of medical fields, including cancer treatment and prevention, cardiovascular disease and supportive care. POSITION OVERVIEW: The Clinical Research Coordinator I is responsible for conducting clinical trials in compliance with FDA regulation, ICH Guidelines and applicable industry standards. The Clinical Research Coordinator 1 will oversee up to ten clinical trials as the main research coordinator. This position does not directly manage other caregivers, however may be asked to review and provide feedback on the work of other caregivers. ESSENTIAL FUNCTIONS AND DUTIES: Maintains surveillance system to identify potential subjects for study eligibility, prescreen patients, and assists physicians in determining eligibility. Obtains informed consent according to GCP and ICH guidelines. Performs study procedures and assessments following protocol specific guidelines. Assures research is conducted in an ethical and safe manner according to FDA, ICH and St. Charles Health System guidelines. Adheres to St. Charles Health System's compliance plan. Attends IRB meetings as requested by the IRB. Supports the processing of study alerts, protocol revisions, amendments, accrual suspension notices, informed consent modifications, product information and advertisement, and related memoranda. Supports the modification of template informed consent forms for local application in compliance with federal guidelines for patients in lay language at appropriate reading level Prepares for and participates in required sponsor and regulatory audits. Attend Investigator meetings as required to assure seamless study start-up. Assists with subject education and informed consent process, including tissue and genetics consent when indicated. Surveys for re-consent and obtains from eligible subjects. Educates patients regarding protocol diagnostic tests and assists with appointments. Process tissue/blood specimens and prepare it for shipment. Manages treatment and follow-up schedules to assure protocol compliance. Attends subject clinic visits and interacts with subjects and staff as appropriate to assist in protocol adherence. Track study drug usage per protocol and oversee study drug supply. Maintains subject research records including long-term follow up and reporting. Participates in institutional research activities (committee meetings, Tumor Boards, Grand Rounds, other conferences, etc.) that are relevant to the Position. Keeps current with new developments in research methodologies. Participates in quality assurance program for St. Charles Health System and affiliated research partners. Supports the vision, mission and values of the organization in all respects. Supports Value Improvement Practice (VIP- Lean) principles of continuous improvement with energy and enthusiasm, functioning as a champion of change. Provides and maintains a safe environment for caregivers, patients and guests. Conducts all activities with the highest standards of professionalism and confidentiality. Complies with all applicable laws, regulations, policies and procedures, supporting the organization's corporate integrity efforts by acting in an ethical and appropriate manner, reporting known or suspected violation of applicable rules, and cooperating fully with all organizational investigations and proceedings. Delivers customer service and/or patient care in a manner that promotes goodwill, is timely, efficient and accurate May perform additional duties of similar complexity within the organization, as required or assigned. EDUCATION: Required: Bachelor of Science degree, or combination of college level education and Research experience to perform the full scope of position duties. Preferred: Bachelor of Science degree in related field. LICENSURE/CERTIFICATION/REGISTRATION Required: Association of Clinical Research Professional (ACRP) or Society of Clinical research Associates (SOCRA) certification or must obtain within 2 years of full time employment. Current American Heart Association (AHA) Basic Life Support for Healthcare Provider certification. Preferred: N/A EXPERIENCE: Required: None Required. Preferred: Experience as a Clinical Research Coordinator. Experience dealing with multidisciplinary teams. Basic Clinical task knowledge. ADDITIONAL POSITION INFORMATION: N/A Schedule Weekly Hours: 40 Caregiver Type: Regular Shift: First Shift (United States of America) Is Exempt Position? No Job Family: COORDINATOR CLERICAL Scheduled Days of the Week: Monday-Friday Shift Start & End Time: Variable
    $25.2-37.8 hourly Auto-Apply 13d ago
  • Clinical Research Regulatory Coordinator I

    Brigham and Women's Hospital 4.6company rating

    Remote coordinator and research assistant job

    Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary General Summary/Overview Statement: The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact. Principal Duties and Responsibilities: The following regulatory duties will be performed under general supervision by the Clinical Research Manager: * Maintain and organize study specific regulatory binders * Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB * Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study * Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required * Submit Data and Safety Monitoring Reports * Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process * Collect, complete, and submit essential regulatory documents to various regulatory entities * Participate in monitoring visits and file all monitoring visit correspondence * Ensure appropriate documentation of delegation and training for all study staff members * Maintain screening and enrollment logs Skills/Abilities/Competencies Required * Careful attention to detail * Good organizational skills * Ability to follow directions * Good communication skills * Computer literacy * Working knowledge of clinical research protocols Qualifications Education: Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials: n/a Experience: Knowledge, Skills and Abilities: * Careful attention to detail. * Good organizational skills. * Ability to follow directions. * Computer literacy. * Working knowledge of clinical research protocols. Additional Job Details (if applicable) Working Conditions: * Duties will be performed remotely Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $19.8-28.4 hourly Auto-Apply 21d ago
  • Neonatal Intensive Care Clinical Research Coordinator

    Uwmsn University of Wisconsin Madison

    Remote coordinator and research assistant job

    Current Employees: If you are currently employed at any of the Universities of Wisconsin, log in to Workday to apply through the internal application process. Want to join a fun, hard-working, collaborative team? Come join the Clinical Research team within the Department of Pediatrics at UW-Madison! The Clinical Research team supports clinical research across multiple divisions in the Department of Pediatrics. Working within the Neonatal Intensive Care Unit at both American Family Children's Hospital and UnityPoint-Meriter, this position is a unique opportunity to contribute to research aimed at prevention, detection, and treatment of disease in critically ill infants. This position will assist with coordinating a variety of clinical research studies by performing various tasks and activities. These tasks include, but are not limited to, recruitment, screening, and enrolling study participants and families, as well as ensuring study participants and families follow the research study protocol. Our team of clinical research coordinators and research nurses apply expertise, knowledge, and skills to a broad range of clinical studies, navigate resources, identify issues requiring escalation, and contribute to the development of new team and unit processes, procedures, and tools. The Clinical Research Coordinator will work in collaboration with pediatric faculty, nurses and staff to coordinate clinical research studies for the Department of Pediatrics, ranging from industry partnered to investigator initiated clinical trials. This position is full or part time, 90-100% Some work may need to be performed outside of standard business hours. However, most work is expected to occur during standard business hours. This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location. This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years. Applicants for this position will be considered for the following titles: Clinical Research Coordinator I, Clinical Research Coordinator II. The title is determined by the experience and qualifications of the finalist. The responsibilities in this job posting are for the Clinical Research Coordinator I title. A Clinical Research Coordinator II will perform tasks more independently, collect more complex information, perform quality checks, identify resource needs, develop clinical research documents, contribute to the development of protocols, and may assist with training of staff. Key Job Responsibilities: Serves as an initial point of contact for clinical research participants and clinical staff, providing information regarding research procedures, expectations, and informational inquiries. Ensures participants follow the research protocol and alerts Principal Investigator of issues Schedules logistics, determines workflows, and secures resources for a defined clinical research trial(s) Identifies work unit resources needs and manages supply and equipment inventory levels Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols Recruits, screens, selects, determines eligibility and enrolls trial participants, collects information, and answers questions under supervision of a medically licensed professional. May perform basic medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy Department: School of Medicine and Public Health, Department of Pediatrics, Administration - Clinical Research The Department of Pediatrics at the University of Wisconsin School of Medicine and Public Health is a vibrant academic department comprising more than 200 faculty in 16 subspecialty divisions. The department promotes and enhances the health of children through outstanding clinical care, exemplary education of pediatric trainees, performance of cutting-edge research, and vigorous advocacy. To learn more about the department's work and accomplishments, please visit: ********************************* Compensation: The starting salary for a Clinical Research Coordinator I is $41,244. The starting salary for a Clinical Research Coordinator II is $44,543. Salary is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. For more information, refer to the campus benefits webpage. SMPH Faculty /Academic Staff Benefits Flyer 2026 Effective July 1, 2024, the U.S. Department of Labor Fair Labor Standards Act (FLSA) requires that positions earning less than $43,888 annually be considered non-exempt under FLSA provisions for overtime. Based on these rules, if the person selected for this recruitment will earn less than the new salary threshold at July 1, 2024 ($43,888 annually), they will be an academic staff non-exempt employee, will be paid hourly and will receive overtime compensation for any hours worked over 40 in a workweek. Preferred Qualifications: Minimum 2 years of experience working in a clinical research role Experience working with the pediatric population Experience working in a healthcare setting Experience working with research data collection and/or sample processing Experience utilizing a variety of platforms including Health Link or other electronic medical record, Microsoft Office Suite, REDCap, OnCore, and Google Drive Clinical Research Certification Experience with quality checks, and/or study monitoring (for Clinical Research Coordinator II) Additional knowledge, skills, and abilities include effective oral and written communication skills, ability to manage multiple projects at the same time, excellent attention to detail and organization skills, excellent time management and prioritization, ability to independently and creatively problem solve Education: Bachelor's Degree preferred How to Apply: For the best experience completing your application, we recommend using Chrome or Firefox as your web browser. To apply for this position, select either “I am a current employee” or “I am not a current employee” under Apply Now. You will then be prompted to upload your application materials. Important: The application has only one attachment field. Upload all required documents in that field, either as a single combined file or as multiple files in the same upload area. Upload required documents: Cover Letter Resume Your cover letter should address how your training and experience align with the qualifications listed above. Application reviewers will rely on these written materials to determine which applicants move forward in the process. References will be requested from final candidates. All applicants will be notified once the search concludes and a candidate is selected. University sponsorship is not available for this position, including transfers of sponsorship and TN visas. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. If you are selected for this position you must provide proof of work authorization and eligibility to work. The department will not be able to support a request for a J-1 waiver. If you choose to pursue a waiver and apply for our position, neither the UW nor UWMF will reimburse you for your legal or waiver fees. Contact Information: Hope Jende, *******************, ************ Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information. Institutional Statement on Diversity: Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. The University of Wisconsin-Madison is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgrounds and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, visit the Human Resources Workplace Poster website. To request a disability or pregnancy-related accommodation for any step in the hiring process (e.g., application, interview, pre-employment testing, etc.), please contact the Divisional Disability Representative (DDR) in the division you are applying to. Please make your request as soon as possible to help the university respond most effectively to you. Employment may require a criminal background check. It may also require your references to answer questions regarding misconduct, including sexual violence and sexual harassment. The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7). The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.
    $41.2k-44.5k yearly Auto-Apply 8d ago
  • Clinical Research Assistant

    Care Access 4.3company rating

    Coordinator and research assistant job in Arlington, VA

    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 Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. How You'll Make An Impact * Ability to understand and follow institutional SOPs * Participate in recruitment and pre-screening events (may be at another location) * Assist with preparation of outreach materials * Identify potential participants by reviewing medical records, study charts and subject database * Assist with recruitment of new participants by conducting phone screenings * Request medical records of potential and current research participants * Schedule visits with participants, contact with reminders * Obtain informed consent per Care Access Research SOP, under the direction of the CRC * Complete visit procedures as required by protocol, under the direction of the CRC * Collect, process and ship specimens as directed by protocol, under the direction of the CRC * Record data legibly and enter in real time on paper or e-source documents * Request study participant payments * Update all applicable internal trackers and online recruitment systems * Assist with query resolution * Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc. * Assist with maintaining all site logs * Assist with inventory and ordering equipment and supplies * 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/participants, sponsor representatives, Investigators and Care Access Research personnel and management. * Communicate clearly verbally and in writing. * Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required * Ability and willingness to work independently with minimal supervision * Ability to learn to work in a fast-paced environment * Excellent communication skills and a high degree of professionalism with all types of people * Excellent organizational skills with strong attention to detail * A working knowledge of medical and research terminology * A working knowledge of federal regulations, Good Clinical Practices (GCP) * Critical thinker and problem solver * Friendly, outgoing personality with the ability to maintain a positive attitude under pressure * Contribute to team and site goals * Proficiency in Microsoft Office Suite * High level of self-motivation and energy * An optimistic, "can do" attitude Certifications/Licenses, Education, and Experience: * A minimum of 1-year recent working experience as a Medical Assistant, EMT, LPN, Clinical Research Assistant or Phlebotomist. * Phlebotomy Experience and Proficiency Required * Some Clinical Research experience preferred * 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. Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal ( * Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $19.00-$33.00 USD per hour. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off. 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: ********************************
    $19-33 hourly 28d ago
  • Clinical Research Coordinator

    Cenexel 4.3company rating

    Coordinator and research assistant job in Gaithersburg, MD

    About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Compensation: $26-30/h. Essential Responsibilities and Duties: Assists Director with coordinating all aspects of patient involvement from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Documents adverse events, protocol deviations, and other unanticipated problems appropriately. Reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: High school graduate or equivalent; Bachelor's Degree, preferred. 1-2 years of coordinating experience, high volume of clinical trials, preferably with psych/CNS trials Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
    $26-30 hourly 60d+ ago
  • Clinical Research Assistant

    Velocity Clinical Research

    Coordinator and research assistant job in Rockville, MD

    Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity. Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program. Summary: The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities. Responsibilities Duties/Responsibilities: Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial Enter source data into the sponsor's and/or vendor's data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed Prepare source document charts, copy and/or file medical records and study related documents as required. Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems. Other duties as assigned Qualifications Education/Experience: High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry Required Licenses/Certifications: Phlebotomy if applicable and required by state law Intramuscular dose administration and preparation if applicable and required by state law Required Skills: Demonstrated knowledge of medical terminology Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone. Understanding of verbal, written, and organizational skills Demonstrated ability to work as a team player Demonstrated ability to read, write, and speak English Demonstrated ability to multi-task Demonstrated ability to follow written guidelines Demonstrated ability to be flexible/adapt as daily schedule may change rapidly Required Physical Abilities: Sit or stand for long periods of time Communicate in person and by a telephone Limited walking required Limited to lifting up to 30 pounds NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management. Compensation Approximate range $20.00-24.00/hour. The base pay offered will be determined based on relevant factors such as experience, education, and geographic location.
    $20-24 hourly Auto-Apply 60d+ ago
  • Clinical Research Coordinator

    Uva Health

    Coordinator and research assistant job in Manassas, VA

    Clinical Research Coordinator, UVA Health Affiliate Research Program This is a new position that will support the Affiliate Research Program within the Health Systems Strategy Office. This position is responsible for coordinating and overseeing clinical research activities across affiliated partners. The incumbent will facilitate study start-up, regulatory and compliance oversight, and support infrastructure development and on-site patient visits at affiliate locations to enable participation in clinical research studies. Candidate must have the ability to travel regularly to UVA Community Health hospitals, including Culpeper, Haymarket, and Prince William Medical Centers and Riverside Health Systems (Newport News). The final title and level (CRC level 3 or CRC level 4,) will be determined based on the qualifications of the selected candidate. JOB SUMMARY Clinical Research Coordinator- 4, Non-Licensed (CRC-4, NL), plan, organize, lead, and perform comprehensive and advanced level clinical research duties for multiple and/or complex clinical trials. A CRC 4 has the ability to directly impact the overall efficiency, productivity and success of each clinical trial they coordinate. The CRC in this role is able to work independently and has the authority to interact with internal or external stakeholders involved in a clinical trial or modify clinical trial workflow or processes within their respective Department or Division to meet the needs of a given study. A CRC in this role may manage or support a research team of CRCs. Manage multiple Principal Investigator relationships with internal and external research stakeholders. Provide guidance and assistance to Principle Investigators for grant submissions, budget management and research compliance oversight to ensure full compliance with local, state and federal policies and procedures. Serve as the primary liaison with the Sponsor for assigned studies. Assist Principal Investigator in developing clinical trial protocols and submit the required documentation to the Institutional Review Board, the University, federal regulators n industry or government sponsor. Coordinate and manage all aspects of clinical trial conduct for multiple ongoing clinical trials of any level of complexity. Prepare and submit all types of clinical research documentation to the IRB of record (central or local) for review and approval. Participate in planning and analysis of research portfolios, in conjunction with department management and Principal Investigators. Oversee the financial management of multiple clinical research projects, including budget development, billing reconciliation, and quarterly review of all Principal Investigator accounts. Manage a team of Clinical Research Coordinators and/or laboratory or research support staff, with responsibilities that include hiring, scheduling, workload management, compensation, rewards, professional development, and performance management. Coordinate clinical research education, training and/or orientation for new Faculty, Fellows, Residents or medical students. Develop administrative and financial recommendations for department management and Principal Investigators for research portfolio review. Compile data and documents during internal and external audits and is ultimately responsible for quality of submissions. Participate in at least 1 research-related working group at the institutional level, or lead a process improvement initiative at a department or division level. Conduct research data analysis and literature searches. Co-author scientific papers, publications or presentations Analysis: Analyzes processes and creates deliverables to provide information and recommendations for improvements. Breaks down problems and issues into sub-components and assesses the costs, benefits, and risks of various options. Is able to select and recommend the best solution based on a thorough examination of all considerations. Is able to explain and justify actions in a systematic and logical fashion. Communication: Shares and receives information using clear oral, written, and interpersonal communication skills. Demonstrates effective written and oral communication skills. Actively listens, provides constructive feedback, and demonstrates respect for differing views. Tailors communications to diverse audiences. Quality Improvement: Demonstrates involvement in the unit's annual and/or periodic assessment efforts, including efforts to improve the quality services. Understands the value of innovation and quality improvement. Improves processes and practices by identifying inefficiencies and redundancies. Demonstrates efficiency and quality in one's own work. Customer Service: Builds relationships and maintains strategic partnerships with key internal and external stakeholders. Understands the importance of quality service. Is able to adjust and adapt service delivery to diverse customer needs and sensitivities. Frequently suggests and implements changes to improve the quality of service. Financial Management: Manages tasks and resources within the department to achieve quality and meet budget requirements. Ensures that financial and material resources are used effectively and efficiently. Leverages resources to maximize utility and return on investment (ROI). Implements measures to minimize theft, damage, or equipment breakdown. The incumbent may be asked to perform additional duties as assigned. QUALIFICATIONS Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications. Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master's or other advanced degree may substitute for one year of clinical research experience. Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire. Additional Skills/Requirements Preferred: PHYSICAL DEMANDS Physical Demand Code: Work Function/Activity: OTHER May require the use of safety equipment, such as HEPA mask, for infection prevention: Yes On call responsibilities as directed: Yes Ability to travel between campus buildings, remote facilities, and out of town as needed: Yes
    $44k-65k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Assistant

    Cnhs 3.9company rating

    Coordinator and research assistant job in Washington, DC

    Clinical Research Assistant - (250002RZ) Description The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies. Qualifications Minimum EducationBA/BS degree in a science, technical, health-related field or another applicablediscipline. (Required) Minimum Work Experience0 years Experience working in a medical or scientific research setting (Preferred) Functional AccountabilitiesResponsible Conduct of Research Consistently demonstrates adherence to the standards for the responsible conduct of research. Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator. Stays informed of and adheres to institutional policies and federal regulations (e. g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information. Uses research funds and resources appropriately. Maintains confidentiality of data as required. Meets all annual job-related training and compliance requirements. Research Administration Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility. Accurately creates, completes, maintains and organizes study documents. Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives. Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned. Attends study meetings, which could include overnight travel, as requested by principal investigator. Works well with other members of the research team and seeks and provides input when appropriate. Participant Enrollment Adheres to the IRB-approved recruitment plan. Identifies participants that meet eligibility requirements under the supervision of a senior research team member. Screens subjects for eligibility per the protocol and institutional policies. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest. Engages participants/LARs in the informed consent process according to institutional policies. Follows procedures for documenting participant incentive distribution. Study Management Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member. Conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction. Completes accurate IRB submissions within institutional timeframes. Records participant visits in the appropriate tracking system. Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner. Data Collection Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete). Ensures that queries are resolved within sponsor and institutional timelines. Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation. Ensures secure storage of study documents and assists in maintaining regulatory documents per sponsor and institutional requirements. Anticipate and responds to customer needs; follows up until needs are met Teamwork/CommunicationDemonstrate collaborative and respectful behavior Partner with all team members to achieve goals Receptive to others' ideas and opinions Performance Improvement/Problem-solving Contribute to a positive work environment Demonstrate flexibility and willingness to change Identify opportunities to improve clinical and administrative processes Make appropriate decisions, using sound judgment Cost Management/Financial ResponsibilityUse resources efficiently Search for less costly ways of doing things SafetySpeak up when team members appear to exhibit unsafe behavior or performance Continuously validate and verify information needed for decision making or documentation Stop in the face of uncertainty and takes time to resolve the situation Demonstrate accurate, clear and timely verbal and written communication Actively promote safety for patients, families, visitors and co-workers Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance Primary Location: District of Columbia-WashingtonWork Locations: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010Job: ResearchOrganization: Ctr Clinical & Community RsrchPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: 8:30a-5pJob Posting: Nov 10, 2025, 4:06:21 PMFull-Time Salary Range: 42702. 4 - 71156. 8
    $43k-52k yearly est. Auto-Apply 1d ago

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