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Clinical research associate jobs in Minnesota - 105 jobs

  • Assoc Clinical Research Specialist

    Artech LLC 3.4company rating

    Clinical research associate job in Minneapolis, MN

    Job Title: Associate Clinical Research Specialist Duration: 24 Months Pay Rate: $35 - $38/hr on W2 The Associate Clinical Research Specialist (Clinical Safety) supports the management of clinical study safety data and potential complaint reporting to ensure compliance with regulatory and internal requirements. This role partners with cross-functional teams to manage adverse event reporting, device deficiencies, and safety documentation throughout the clinical study lifecycle. Must-Have Skills: Science, nursing, or medical background Experience with clinical databases (e.g., RAVE, Veeva Vault) Strong written and verbal communication skills Ability to review and assess clinical safety data (AEs/SAEs) Knowledge of clinical research regulations and compliance Key Responsibilities: Review and assess Adverse Events (AEs), Serious Adverse Events (SAEs), and device deficiencies Identify potential complaints and unreported safety events from CRFs Collaborate with Regulatory Affairs and complaint teams for timely safety reporting Communicate with clinical sites and monitors for follow-up information Support safety documentation, reports, and audits Experience & Education: Bachelor's degree required 0-5 years of clinical research or safety experience 40 hours/week
    $35-38 hourly 2d ago
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  • Clinical Research Associate - NAMSA Future Openings USA

    Namsa 4.2company rating

    Clinical research associate job in Minneapolis, MN

    NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: * Act with integrity in everything we do. * Provide best-in-class customer experiences. * Develop superior talent and deliver expertise. * Respond with agility and provide timely results. * Embrace collaboration, diverse perspectives and ideas. Job Description: * Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. * Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. * May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. * Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. * Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. * Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. * Performs study-related training. * Manages the development and maintenance of study documents, processes and systems as assigned. * Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. * Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. * Attends internal and external meetings as required. * Provides all job-related progress reports and visit documentation as required. * May support safety activities such as narrative writing, managing the CEC/DSMB, etc. * OUS: Prepares and coordinates submissions to regulatory authorities. * May perform other activities as assigned. Qualifications & Technical Competencies: * Fluency in English and local language, if different, required. * Higher education degree or equivalent education, training, and experience. * Preferred 2 years clinical trial experience. * Preferred monitoring experience. * Able to work independently once trained. * Good verbal and written communication skills. * Strong organizational skills. * Basic computer proficiency. * Understanding of clinical research processes and regulations. * Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: * Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. * The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. * Extensive use of a computer keyboard. Pay Range Minimum: $54,400.00 Pay Range Target: $80,100.00 Pay Frequency: Annual Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: * May operate equipment * Records data timely and accurately * May analyze and interpret data * Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
    $54.4k-80.1k yearly Auto-Apply 58d ago
  • Clinical Study and Biospecimen Coordinator

    Vyriad

    Clinical research associate job in Rochester, MN

    Salary range: $52,000-$67,000 Full-time. Exempt, salaried. The Clinical Study and Biospecimen Coordinator (CSC) plays a key role in supporting the operational execution of Vyriad's Phase 1/2 clinical trials and will be responsible for managing biospecimens used for exploratory and translational research. This position is critical in coordinating supply of test kits and receipt of clinical samples, ensuring high-quality sample collection, processing, shipping, tracking, and documentation across a network of clinical sites and research laboratories. The candidate will maintain sample inventory, receive data reports and be responsible for data entry and analysis. The CSC will collaborate closely with Clinical Operations, Translational Science, external vendors, and clinical sites to maintain compliance, ensure protocol adherence, and facilitate timely generation of high-quality data. Supervisory Responsibilities None Duties and Responsibilities Clinical Study Coordination * Assist in day-to-day oversight of multiple ongoing Phase 1/2 trials, supporting study start-up, conduct, and close-out activities * Maintain and update study trackers, timelines, enrollment metrics, and essential documentation * Support preparation, review, and approval of study materials (e.g., site training slides, study manuals, sample handling guides, visit worksheets) * Coordinate and document study team meetings, vendor meetings, and cross-functional check-ins * Monitor site performance metrics and assist with issue identification, follow-up, and escalation * Work with CROs, central labs, and vendors to ensure deliverables are met according to the study plan * Support data review activities such as data listings checks, lab reports reconciliation, and query management Biospecimen & Exploratory Testing Management * Serve as the primary operational contact for test kits, biospecimen collection, processing, and logistics across clinical sites * Ensure all sample-related procedures follow protocol requirements, sample manuals, IATA regulations, and GCP guidelines * Track and log daily/weekly sample collections, deviations, processing results, and shipments using internal LIMS system and eCRF * Coordinate shipment logistics including temperature-controlled handling, courier pickup scheduling, and documentation * Receives correlative research data reports and ensures data entry and analysis * Work closely with patient management and operations teams at clinical sites to align sample workflows with central lab biomarker analysis needs * Maintain complete, accurate sample chain-of-custody records and promptly address discrepancies * Support biorepository activities such as inventory reviews, sample labeling audits, and sample reconciliations * Assist in onboarding and training clinical sites on biospecimen handling procedures, including updates to sample manuals and shipping instructions Additional duties as assigned. Education and Experience * Bachelor's degree in Life Sciences or related field; Masters degree a plus but not required * 2+ years of experience in clinical research or clinical operations, ideally within a biotech or early-phase trial environment * Prior hands-on experience with biomarker operations (eg. biospecimen handling, central lab coordination, translational research workflows, etc.) strongly preferred * Familiarity with oncology Phase 1/2 study designs, PK/PD sampling and data evaluation desirable Required skills and/or qualifications * Working knowledge of GCP/ICH guidelines, clinical trial conduct, and regulatory documentation * Strong understanding of specimen types (e.g., whole blood, serum, plasma, PBMCs, tumor tissue) and proper collection/processing requirements * Highly organized with the ability to manage multiple tasks simultaneously across studies * Strong communication and interpersonal skills for effective collaboration with internal central lab staff, clinical operations team members, vendors, and site staff * Detail oriented with excellent documentation, tracking, and problem-solving abilities * Ability to adapt quickly and work effectively in a fast-paced, dynamic environment. * Strong problem-solving skills with the ability to navigate ambiguous situations and make sound decisions. * Proficiency with EDC systems, LIMS/sample-tracking tools, and Microsoft Office tools Physical Requirements * Prolonged periods of sitting at a desk and working on a computer. * Must be able to lift up to 15 pounds at times. Benefits * Group Healthcare Plan, including company paid dental and vision. * Short- and long-term disability, life and AD&G insurance. * Simple IRA with employer match * Educational assistance program * Holiday and PTO
    $52k-67k yearly 60d+ ago
  • Clinical Research Coordinator I

    Brigham and Women's Hospital 4.6company rating

    Clinical research associate job in Lexington, MN

    Site: The General Hospital Corporation 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. The Lurie Center for Autism, a Mass General Brigham program based in Lexington, is a multidisciplinary program designed to evaluate and treat children, adolescents and adults with autism spectrum disorder (ASD) and other neurodevelopmental disorders. The Center is seeking a Research Coordinator I to implement a portfolio of clinical research trials and projects related to ASD. The Clinical Research Coordinator I will work under the supervision of the Senior Clinical Research Program Manager, with direction by the Principal Investigators on specific protocols, and will participate in tasks related to all phases of the clinical research including the development, initiation, monitoring, completion, and reporting phases. All activities will be conducted in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP) Guidelines. Job Summary Summary Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Candidates who are in the process of completing their bachelor's degree have a grace period of six months from their hire date (up to 1 year if starting per diem) to provide degree equivalency verification. Does this position require Patient Care? No Essential Functions * Reviews proposals for compliance with sponsor and organizational guidelines; verify all sponsor requirements are met. * Recruiting patients for clinical trials, conducts phone interviews. * Verifies the accuracy of study forms and updates them per protocol. * Prepares data for analysis and data entry. * Documents patient visits and procedures. * Assists with regulatory binders and QA/QC Procedures. * Assists with interviewing study subjects. * Assists with study regulator submissions. Qualifications Education Bachelor's Degree Science required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Some relevant research project work 0-1 year preferred Knowledge, Skills and Abilities - Careful attention to detail and good organizational skills. - Ability to follow directions. - Good interpersonal and communication skills. - Computer literacy. - Working knowledge of clinical research protocols. - Ability to demonstrate respect and professionalism for subjects' rights and individual needs. Additional Job Details (if applicable) Remote Type Onsite Work Location 1 Maguire Road 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: 1200 The General Hospital Corporation 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 9d ago
  • Clinical Research Coordinator - Comprehensive Cancer Center

    Mayo Clinic Health System 4.8company rating

    Clinical research associate job in Rochester, MN

    Why Mayo Clinic Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans - to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. Benefits Highlights * Medical: Multiple plan options. * Dental: Delta Dental or reimbursement account for flexible coverage. * Vision: Affordable plan with national network. * Pre-Tax Savings: HSA and FSAs for eligible expenses. * Retirement: Competitive retirement package to secure your future. Responsibilities Don't miss this chance to join a world-class team and make a difference in the lives of millions of patients. Apply today and become part of the Mayo Clinic Experience. As a Clinical Research Coordinator, you will: * Independently coordinate complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. * Collaborate with research team to assess feasibility and management of research protocols. * Ensure implementation of research protocols after IRB approval and provide information as appropriate for progress reports. * Screen, enroll, and recruit research participants. * Coordinate schedules and monitor research activities and subject participation. * Identify, review, and report adverse events, protocol deviations, and other unanticipated problems appropriately. * Manage, monitor, and report research data to maintain quality and compliance. * Provide education/training for others within the department. * Perform administrative and regulatory duties related to the study as appropriate. * Perform Protocol Development and Maintenance Activities Responsibilities, which may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements. * Accurately apply investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements. * Participate in other protocol development activities and execute other assignments as warranted and assigned. * Some travel may be required. This position may have the option of working hybrid after some time, requiring the candidate to be within reasonable driving distance of the Rochester, MN campus. Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension. During the selection process you will participate in an OnDemand (pre-recorded) interview that you can complete at your convenience. During the OnDemand interview, a question will appear on your screen, and you will have time to consider each question before responding. You will have the opportunity to re-record your answer to each question - Mayo Clinic will only see the final recording. The complete interview will be reviewed by a Mayo Clinic staff member and you will be notified of next steps. Qualifications * HS Diploma with at least 5 years of clinical research coordination/related experience OR * Associate's degree/college Diploma/Certificate Program with at least 3 years of experience OR * Associate's in Clinical Research from an accredited academic institution without experience OR * Bachelor's with at least 1 year of experience or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience. * Experience should be in the clinical setting or related experience. Additional Qualifications * Graduate or diploma from a study coordinator training program is preferred. * One year of clinical research experience is preferred. * Medical terminology course is preferred. Exemption Status Nonexempt Compensation Detail $27.44 - $41.16 / hour Benefits Eligible Yes Schedule Full Time Hours/Pay Period 80 Schedule Details Day shift; Monday - Friday Weekend Schedule N/A International Assignment No Site Description Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is. Equal Opportunity All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status or disability status. Learn more about the 'EOE is the Law'. Mayo Clinic participates in E-Verify and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization. Recruiter Chad Musolf
    $27.4-41.2 hourly 38d ago
  • Clinical Research Coordinator - Comprehensive Cancer Center

    Mayo Healthcare 4.0company rating

    Clinical research associate job in Rochester, MN

    Don't miss this chance to join a world-class team and make a difference in the lives of millions of patients. Apply today and become part of the Mayo Clinic Experience. As a Clinical Research Coordinator, you will: Independently coordinate complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. Collaborate with research team to assess feasibility and management of research protocols. Ensure implementation of research protocols after IRB approval and provide information as appropriate for progress reports. Screen, enroll, and recruit research participants. Coordinate schedules and monitor research activities and subject participation. Identify, review, and report adverse events, protocol deviations, and other unanticipated problems appropriately. Manage, monitor, and report research data to maintain quality and compliance. Provide education/training for others within the department. Perform administrative and regulatory duties related to the study as appropriate. Perform Protocol Development and Maintenance Activities Responsibilities, which may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements. Accurately apply investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements. Participate in other protocol development activities and execute other assignments as warranted and assigned. *Some travel may be required. **This position may have the option of working hybrid after some time, requiring the candidate to be within reasonable driving distance of the Rochester, MN campus.** **Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension.** **During the selection process you will participate in an OnDemand (pre-recorded) interview that you can complete at your convenience. During the OnDemand interview, a question will appear on your screen, and you will have time to consider each question before responding. You will have the opportunity to re-record your answer to each question - Mayo Clinic will only see the final recording. The complete interview will be reviewed by a Mayo Clinic staff member and you will be notified of next steps. ** HS Diploma with at least 5 years of clinical research coordination/related experience OR Associate's degree/college Diploma/Certificate Program with at least 3 years of experience OR Associate's in Clinical Research from an accredited academic institution without experience OR Bachelor's with at least 1 year of experience or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience. Experience should be in the clinical setting or related experience. Additional Qualifications Graduate or diploma from a study coordinator training program is preferred. One year of clinical research experience is preferred. Medical terminology course is preferred.
    $43k-61k yearly est. Auto-Apply 38d ago
  • Clinical Research Assistant

    Actalent

    Clinical research associate job in Maple Grove, MN

    Join a dynamic team as a Clinical Research Assistant, where you will provide essential administrative support to clinical study activities, ensuring compliance with GCP and FDA regulations. This role is a fantastic opportunity to get involved in clinical research pivotal trials, working closely with experienced professionals. Responsibilities * Provide administrative assistance to the clinical team in support of all clinical study activities. * Support clinical trials in collaboration with other team members, including site qualification, initiation, site management, and data management. * Ensure compliance with GCP and FDA regulations for clinical trials. * Contribute to the formatting and management of clinical documents using Grand Avenue Software (GAS) for final approvals. * Assemble and distribute study-related documents, including regulatory binders, case report form binders, and study manuals to sites. * Create and maintain study trackers, dashboards, and reports. * Support clinical study payments, where applicable. * Participate in study-specific meetings and manage minutes and documentation. * Manage electronic and paper study site and master files, ensuring audit readiness. * Provide travel and logistical support to physician proctors and the clinical team as needed. * Support the planning and conduct of investigator/study meetings. * Ensure proper handling, accountability, and reconciliation of all Investigational Products (IP). * Assist with updates on clinicaltrials.gov. * Develop and maintain successful working relationships and manage deliverables with cross-functional team members. Essential Skills * Excellent organizational skills. * Strong interpersonal, written, and verbal communication skills. * Ability to effectively build and maintain positive relationships with physicians, peers, and colleagues across all organizational levels. * Capability to multitask effectively while maintaining high-quality output. * Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook. Additional Skills & Qualifications * Knowledge of Good Clinical Practice (GCP) and FDA regulations. * Experience with SharePoint. * Background in biology or a related science field with a science degree. * 1 year of undergraduate research or clinical research experience. Work Environment This role is based 100% onsite in Maple Grove, providing an excellent opportunity to work directly with senior clinical research professionals in a collaborative setting. Job Type & Location This is a Contract to Hire position based out of Maple Grove, MN. Pay and Benefits The pay range for this position is $30.00 - $31.25/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Maple Grove,MN. Application Deadline This position is anticipated to close on Jan 20, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
    $30-31.3 hourly 7d ago
  • Research Coordinator - Clinical

    Twin Cities Spine 3.8company rating

    Clinical research associate job in Minneapolis, MN

    *Candidates must be a Minnesota resident. Job Status: Full-time (Monday - Friday) We are seeking a motivated and talented Clinical Research Coordinator to join our busy, fast paced specialty office at Twin Cities Spine Center (TC Spine). Come be a part in our patient's lives and work for an organization that has consistently been named one of the area's Top Workplaces. The Research Coordinator is a critical role responsible for managing the activities of ongoing research projects and studies that support Twin Cities Spine Center's (TC Spine) research and fellowship programs. Working closely with the Research Director and staff, Surgeon Investigators, and Fellows, this role assists with the development of research studies and is responsible for managing multiple research projects. The Research Coordinator duties include study material preparation, data management, regulatory document preparation, and project coordination in accordance with established protocols, federal and state regulations, and Institutional Review Board (IRB) requirements. The Research Coordinator also plays a key role in scholarly activity by co-authoring abstracts and manuscripts for submission to conferences and peer-reviewed medical journals. In addition, this role manages research and quality data that supports organizational Quality Assurance and continuous improvement initiatives. Job Responsibilities: Co-author and submit abstracts and manuscripts to conferences and peer-reviewed medical journals Develop and write research protocols, informed consent forms, grants, and other study related documents Prepare and submit Institutional Review Board (IRB) documentation (initial approvals, continuing reviews, adverse event reports, and study closure reports) Maintain regulatory binders, source documentation and appropriate forms per protocol Perform data abstraction for research studies Ensure the accuracy, completeness, and integrity of data Maintain research database including validity and consistency assessments Learn and implement new technology and software for research (e.g., Outcomes Based Electronic Research Database - OBERD) Plan project timelines, milestones and deliverables, then implement and track project progress Communicate project status to the Research Director, surgeon investigators and Fellows (study advances or delays with approvals, data collection, patient enrollment, etc.) Maintain regular communication with study participants and address any concerns Ensure research studies are conducted ethically and in compliance with Federal and state laws Respect and protect confidentiality of subjects (HIPAA) Screen and enroll study participants (obtain and document Informed Consent) Develop and implement strategies for participant recruitment and retention Attend weekly Monday conferences in-person Work with the other Research Coordinators, the Research Director, surgeon investigators, and Fellows to ensure projects are completed Job Requirements: Master of Science or Arts Degree or higher, required Requires a minimum of 5 years' experience in clinical research Proficient with healthcare software (Epic, NextGen) for research purposes Proficient with IRB processes and compliance rules pertaining to research, confidentiality, and HIPAA Working knowledge of US Food and Drug Administration (FDA) and state laws and regulations pertaining to clinical trials Advanced knowledge of Microsoft Office Suite Ability to adapt to different working styles and effectively communicate with staff and providers using excellent interpersonal and verbal/written communication skills Ability to pay attention to the smallest details involved in taking service to the next level to deliver high-quality customer service to external/internal customers and communicate with knowledge and compassion Ability to effectively manage and prioritize multiple tasks, frequent interruptions, and details with accuracy Ability to resolve basic service recovery issues and understand when to escalate to the next level Ability to work with people of all ages, ethnicities, and backgrounds Benefits: Medical, Dental, and Vision Insurance Group Life and AD&D coverage Company Paid Short and Long Term Disability coverage Flexible Spending and Health Saving Account options 401(k) plan through salary deferrals PTO and Paid Holidays The above description is intended to provide a general outline of some of the basic job requirements and responsibilities and is not all inclusive. Job responsibilities, required skills, and working conditions are also subject to change from time to time. Twin Cities Spine Center is an Equal Employment Opportunity Employer, and provides reasonable accommodation to qualified disabled individuals in accordance with applicable federal and state law.
    $41k-58k yearly est. Auto-Apply 8d ago
  • Clinical Research Coordinator - Contract

    Talencio

    Clinical research associate job in Minneapolis, MN

    The Clinical Research Coordinator (CRC) assists with the planning, development, and execution of high-quality clinical activities. This role is ideal for someone with an interest in learning and developing skills in clinical research, research methodology, regulations, and applicable guidelines including FDA regulations, international regulatory standards, Good Clinical Practice (GCP), ISO compliance, and company SOPs. The CRC role supports the broader clinical operations team by coordinating study activities and maintaining documentation standards. The CRC must demonstrate strong organizational skills, attention to detail, and the ability to produce high-quality work under tight timelines. The CRC collaborates with the internal team, contract research organizations (CROs), study personnel, and other vendors throughout the execution of clinical trials. This is an entry-level position perfect for someone eager to build a strong foundation in clinical research. Principal Responsibilities: Support clinical trials in collaboration with other clinical team members pertaining to site qualification, initiation, site management, data management and other ongoing tasks to support clinical trials Perform study related activities in compliance with GCP and FDA regulations for clinical trials Contribute to the formatting of study documents and manage the upload and tracking of clinical documents into the Quality Management System (QMS) Ensure ordering of clinical study supplies when needed Assemble and distribute study related documents including regulatory binders, case report form binders, study manuals, retention initiatives, and other study related tools to sites Creation and maintenance of study trackers, dashboards, and reports Support clinical study payments, where applicable Participate in study-specific meetings, record meeting minutes including issues and actions items; and file minutes accordingly Manage and track the electronic (and/or paper) study site and master files, ensuring audit readiness Create and distribute study specific newsletters to the clinical sites Provide travel and logistical support to physician proctors and clinical team as needed Support the planning and conduct of investigator/study meetings Ensure proper handling, accountability, and reconciliation of all Investigational Product (IP) Assist with clinicaltrials.gov updates Complete Central IRB submissions Complete submission to the QMS Organize and manage the Clinical Site email inbox Facilitate licensing agreements with respective vendors Facilitate document translations with respective vendors Develop and maintain successful working relationships, manage deliverables, and provide feedback to cross functional team members. Qualifications, Education & Experience: Must Have: Excellent organizational skills Excellent interpersonal, written, and verbal communication skills Effectively build and maintain positive relationships with physicians, peers, and colleagues across all organizational levels Ability to multitask effectively while maintaining high quality outputs Nice to Have: Proven experience working within an FDA IDE pre-market clinical studies, post-market studies or registries Strong knowledge and understanding of prostate anatomy Working Conditions: Occasionally exerting up to 20lbs and lifting to 50lbs Significant work pace and pressure due to deadlines of a start-up organization Operate a computer, and other office equipment, proficient in Microsoft Office software Travel may be required (up to 5%,); to assist with the logistics of Investigator and Research Coordinator meetings Position based in Maple Grove, MN
    $40k-58k yearly est. 5d ago
  • Clinical Research Coordinator I

    Center for Veterans Research and Education

    Clinical research associate job in Minneapolis, MN

    Job Description The Center for Veterans Research and Education (CVRE), whose mission is to help support innovative research and education initiatives that improve the health and well-being of Veterans, is seeking a Clinical Research Coordinator I Position Description: The Clinical Research Coordinator is responsible for the day-to-day operations of multiple clinical research studies. This position will actively enroll patients at the Minneapolis VA Medical Center. Responsibilities: Major duties and responsibilities may include, but are not limited to the following: Maintain close communication with local and network study leadership and staff. Manage the study start-up process, including finalization of Informed Consent Forms and preparation of study start-up materials. Collaborate with the central Institutional Review Board overseeing VA sites, and the local Research and Development Committee (RDC), to ensure that regulatory requirements at the local site are identified, communicated, and observed. Oversee enrollment and study activities with the Site Investigator. Recruit participants, collect data in accordance with established study procedures, follow up with participants in a timely manner. Dispense and track investigational study drug per protocol and in keeping with safe medication handling practices. Conduct phlebotomy and urine sample collection per study protocol. Coordinate home visits between contract Home Health Service and study participants. Monitor subjects' progress, including documentation and reporting of adverse events. Ensure staff and subject compliance with protocol guidelines and requirements of regulatory agencies. Implement protocols to ensure data is collected in a scientifically valid manner. Serve as primary liaison with Site Investigator, staff, internal/external resources and sponsor regarding patient care issues and progress of the study. Maintain local budgets for the study; regularly report progress on all aspects of the project to the Site Investigator. Prepare documentation to support billing for this study's sub-award, in cooperation with CVRE staff. Track expected and annual payments from the sponsor, in cooperation with CVRE staff. Perform administrative functions including meetings, setting up and participating in conference calls, maintaining written correspondence, and transcribing memoranda. Ensure that study activities are completed in an ethical, culturally responsive, scientifically rigorous, and timely manner in accordance with principles of Good Clinical Practice and Federal Policies for the Protection of Human Subjects. Responsible for alerting the Site Investigator of data collection/protocol breeches, inconsistencies, or other problems that may arise within the study, as well as suggesting methods of correction. Maintain data and study files in accordance with study protocols Other duties as assigned Applicants must include a cover letter Minimum Qualifications: Education: Bachelor's Degree required (Master's preferred) Experience: 1-3 years of Research Assistant experience, or equivalent education/experience 0-2 years of Coordinator experience required for CRC I Preferred working knowledge of the study Licensure/Registration/Certification: None Knowledge, Skills, and Abilities: Demonstrated ability to work effectively both independently and as part of a team. Ability to evaluate the quality of data collected and progress toward overall program objectives Experience in coordinating multiple tasks and project elements with differing timelines and completion deadlines. Excellent oral and written communication skills. Exceptional attention to detail and organizational skills. Proficiency in Microsoft Office products including Outlook, Word, PowerPoint and Excel. Knowledge of Good Clinical Practices, human subjects' protections, and federal regulations relating to clinical research Conditions of Employment: Subject to a criminal and educational background check. Designated and/or random drug testing may be required. Regular and predictable attendance is required. Typical hours fall within standard business hours, work may be required during hours beyond standard business hours, including weekends. Must be a US citizen Physical Requirements: The employee must be able to navigate the medical center, use a keyboard, and life up to 25 lbs. Reasonable accommodation may be considered in determining an applicant's ability to perform the duties/functions of the position.
    $40k-58k yearly est. 7d ago
  • Clinical Research Coordinator

    Invitrogen Holdings

    Clinical research associate job in Richfield, MN

    Join us as a Clinical Research Coordinator - And play a key role in overseeing clinical site activities and ensuring high standards of patient care and data integrity. What You'll Do: • Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines. • Provide medical care to patients, always ensuring patient safety comes first. • Schedule subject visits within protocol windows, ensuring scheduling capacity is maximized. • Perform all defined study activities (i.e., informed consent, screening, and protocol procedures which include but are not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.). • Record all patient information and results from tests as per protocol on required forms. • Where required, may complete IP accountability logs and associated information. • Reports suspected non-compliance with relevant site staff. • Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study. • Promotes the company and builds a positive relationship with patients to ensure retention. • Attend site initiation meetings and all other relevant meetings to receive training on protocol. • May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results. • Logs/complete information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe. • Gather and maintain source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded. • Adhere to company COP/SCOP. • May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility. Education and Experience: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • BLS certificate required. • Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 2+ years'). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.) • Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving • Demonstrated ability to exercise discretion and sound judgement • Good decision-making, negotiation and influencing skills • Good communication skills and English fluency will be an advantage • Good organizational skills • Good proficiency in basic computer applications • Good interpersonal skills to work in a team environment Working Conditions and Environment: • Work is performed in an office/ laboratory and/or a clinical environment. • Exposure to biological fluids with potential exposure to infectious organisms. • Exposure to electrical office equipment. • Personal protective equipment is required such as protective eyewear, garments and gloves. • Occasional travel may be domestic or international. Physical Requirements: • Ability to work in an upright and /or stationary position for 6-8 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. • Frequent mobility required. • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. • Ability to access and use a variety of computer software developed both in-house and off-the-shelf. • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. • Frequently interacts with others to obtain or relate information to diverse groups. • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. • Regular and consistent attendance. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience - and where your contributions truly make a difference. Apply today to help us deliver tomorrow's breakthrough. Compensation and Benefits The hourly pay range estimated for this position based in Minnesota is $26.00-$30.00. 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: *****************************************************
    $40k-58k yearly est. Auto-Apply 7d ago
  • Study Coordinator

    Howard University 4.4company rating

    Clinical research associate job in Washington, MN

    The Talent Acquisition department hires qualified candidates to fill positions which contribute to the overall strategic success of Howard University. Hiring staff "for fit" makes significant contributions to Howard University's overall mission. At Howard University, we prioritize well-being and professional growth. Here is what we offer: * Health & Wellness: Comprehensive medical, dental, and vision insurance, plus mental health support * Work-Life Balance: PTO, paid holidays, flexible work arrangements * Financial Wellness: Competitive salary, 403(b) with company match * Professional Development: Ongoing training, tuition reimbursement, and career advancement paths * Additional Perks: Wellness programs, commuter benefits, and a vibrant company culture Join Howard University and thrive with us! *************************************** JOB PURPOSE: To coordinate study participants in the Clinical Trials Unit. Execute tasks as required by the study protocols. SUPERVISORY AUTHORITY: Involves no responsibility or authority for the direction of others. NATURE AND SCOPE: Interacts with physicians, immediate staff members, research participants, and the general public. PRINCIPAL ACCOUNTABILITIES: * Maintain familiarity with the protocol. Evaluate study candidates for eligibility into the study. * Meet with the patient's caretaker to review the details of study enrollment. * Assure that informed consent has been obtained from the patient's legal guardian and consent from the patient when applicable prior to the initiation of research-related activities. * Schedule tests and appointments for patients within appropriate timeframes. * Send the prescriptions for study medication to the research pharmacist, including the height, weight or body surface area. * Identifying abnormal laboratory results and obtain repeat evaluations are required by the protocol. * Complete case report forms accurately and thoroughly and enter data electronically. * Maintain source documentation in shadow files for each study participant. * Respond to date inquiries in a timely manner. * Complete Serious Adverse Even Reports within the proper timeframes. * Report to the Project Director and the Principal Investigator regarding assignments and duties. * Perform other duties as instructed by the Principal Investigator and Project Director. CORE COMPETENCIES: * Knowledge of clinical trials protocols. * Knowledge of management regulations of Howard University. * Knowledge of the educational and research goals of grant. * Knowledge of federal and Howard University grant policies, administration and regulation. * Excellent skill in the operation of desktop computer and software applications to include e-mail and * calendar functionality, word processing, spreadsheet applications and presentation software. * Competence in both oral and written English to communicate in a clear and concise manner. * Ability to establish and maintain effective and harmonious work relations with faculty, staff, students and customers. * MINIMUM REQUIREMENTS: Minimum of a Bachelor of Science degree. Course study concentration in a health-related field is desirable. Compliance Salary Range Disclosure $50,000-$60,000
    $50k-60k yearly Auto-Apply 60d+ ago
  • Clinical Trials Research Assistant

    Vitreoretinal Surgery PLLC

    Clinical research associate job in Minneapolis, MN

    Job Description Apply Here: ******************************************************************************** We are seeking multiple outgoing, patient focused individuals to work as Clinical Trials Research Assistant at our Retina Consultants of Minnesota Edina, MN clinic.Responsibilities for an Clinical Trials Research Assistant include: Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines. Prepare visit-specific documentation and charts for Clinical Research Coordinator Observe Coordinator in patient care and management Assist Coordinator in monitoring subject flow and assist in subject care and management Observe, assist, collect and record all necessary data for follow up (e.g. adverse events, concomitant medications, etc.) study visits (Phase 2 & 3; NO Gene Therapy) Transcribe subject study information from source documents to the Electronic Case Report Forms Administer all mandatory questionnaires to study subjects Set up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per study protocol Promptly request all necessary medical records for Serious Adverse Event Reporting Process and ship laboratory biological samples for analysis Perform intraocular pressure checks after injections Perform trial frame refraction and ETDRS visual acuity testing (For ISTs only, at selected sites) Inform subjects and obtain written re-consents in regard to ICF's Required Skills, Abilities and Attributes: Applicants MUST be personally motivated to provide excellent patient care! 1+ years of clinical trials research assistant experience in a retina or general ophthalmology environment preferred Knowledge of medical terminology Be an excellent team player who works cooperatively and respectfully with all doctors, supervisors and co-workers Displays a desire to perpetually “Learn and Grow” Efficient and highly accurate user of applicable information technology and health care management systems High School Degree or GED We offer excellent compensation and benefits, to include: Paid Holidays - 7 days per year Personal Time Off (PTO) - 16 days per year Health Insurance Health Reimbursement Account Health Savings Account Dental Insurance (free single coverage) Flexible Spending Accounts Basic and Supplemental Term Life Insurance (free single coverage) Long Term Disability (free single coverage) Long Term Care (free single coverage) Short-Term Disability Vision Annual $250 uniform (scrubs and shoes) reimbursement About Retina Consultants of Minnesota (RCM):RCM has 9 Minnesota locations - St. Louis Park, Edina, Edina Specialty, Woodbury, Blaine, Duluth, Maplewood, Anoka and Mankato.Everything we do…. every decision we make…takes our Guiding Principles into consideration. Our guiding principles are: We exist to serve our patients. We will provide the best available medical skills, technology, and service. We will be their advocates. We will care for our patients as if they were members of our family. We will treat our patients with respect, dignity, and kindness. We are proud of our dedicated staff. We will strive to provide a rewarding career with opportunity for personal and professional growth. We will promote teamwork. We will provide a respectful and safe working environment. We are humbled that other doctors entrust their patients to our care. We will be available when we are needed. We will promptly communicate the results of patient evaluation and treatment. We will respect the referring doctors' relationships with their patients. We recognize that we have a responsibility to our community. We will strive to be desire to perpetually “Learn and Grow” Efficient and highly accurate user of applicable information technology and health care management systems A good corporate citizen. We will function ethically. We will be prudent in our stewardship of healthcare resources. Medical advances are critical to our patients. We will remain at the forefront in the search for new knowledge and treatments of retinal disease. We will participate in clinical research. We will share our knowledge with our patients and referring doctors, and with our retinal colleagues around the world.
    $32k-46k yearly est. 12d ago
  • Clinical Research Associate - NAMSA Future Openings USA

    Namsa 4.2company rating

    Clinical research associate job in Saint Paul, MN

    NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: * Act with integrity in everything we do. * Provide best-in-class customer experiences. * Develop superior talent and deliver expertise. * Respond with agility and provide timely results. * Embrace collaboration, diverse perspectives and ideas. Job Description: * Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. * Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. * May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. * Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. * Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. * Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. * Performs study-related training. * Manages the development and maintenance of study documents, processes and systems as assigned. * Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. * Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. * Attends internal and external meetings as required. * Provides all job-related progress reports and visit documentation as required. * May support safety activities such as narrative writing, managing the CEC/DSMB, etc. * OUS: Prepares and coordinates submissions to regulatory authorities. * May perform other activities as assigned. Qualifications & Technical Competencies: * Fluency in English and local language, if different, required. * Higher education degree or equivalent education, training, and experience. * Preferred 2 years clinical trial experience. * Preferred monitoring experience. * Able to work independently once trained. * Good verbal and written communication skills. * Strong organizational skills. * Basic computer proficiency. * Understanding of clinical research processes and regulations. * Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: * Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. * The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. * Extensive use of a computer keyboard. Pay Range Minimum: $54,400.00 Pay Range Target: $80,100.00 Pay Frequency: Annual Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: * May operate equipment * Records data timely and accurately * May analyze and interpret data * Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
    $54.4k-80.1k yearly Auto-Apply 58d ago
  • Clinical Research Coordinator - Comprehensive Cancer Center

    Mayo Clinic 4.8company rating

    Clinical research associate job in Rochester, MN

    **Why Mayo Clinic** Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans (************************************** - to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. **Benefits Highlights** + Medical: Multiple plan options. + Dental: Delta Dental or reimbursement account for flexible coverage. + Vision: Affordable plan with national network. + Pre-Tax Savings: HSA and FSAs for eligible expenses. + Retirement: Competitive retirement package to secure your future. **Responsibilities** Don't miss this chance to join a world-class team and make a difference in the lives of millions of patients. Apply today and become part of the Mayo Clinic Experience. As a Clinical Research Coordinator, you will: + Independently coordinate complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. + Collaborate with research team to assess feasibility and management of research protocols. + Ensure implementation of research protocols after IRB approval and provide information as appropriate for progress reports. + Screen, enroll, and recruit research participants. + Coordinate schedules and monitor research activities and subject participation. + Identify, review, and report adverse events, protocol deviations, and other unanticipated problems appropriately. + Manage, monitor, and report research data to maintain quality and compliance. + Provide education/training for others within the department. + Perform administrative and regulatory duties related to the study as appropriate. + Perform Protocol Development and Maintenance Activities Responsibilities, which may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements. + Accurately apply investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements. + Participate in other protocol development activities and execute other assignments as warranted and assigned. *Some travel may be required. ****This position may have the option of working hybrid after some time, requiring the candidate to be within reasonable driving distance of the Rochester, MN campus.**** ****Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension.**** **During the selection process you will participate in an OnDemand (pre-recorded) interview that you can complete at your convenience. During the OnDemand interview, a question will appear on your screen, and you will have time to consider each question before responding. You will have the opportunity to re-record your answer to each question - Mayo Clinic will only see the final recording. The complete interview will be reviewed by a Mayo Clinic staff member and you will be notified of next steps. ** **Qualifications** + HS Diploma with at least 5 years of clinical research coordination/related experience OR + Associate's degree/college Diploma/Certificate Program with at least 3 years of experience OR + Associate's in Clinical Research from an accredited academic institution without experience OR + Bachelor's with at least 1 year of experience or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience. + Experience should be in the clinical setting or related experience. **Additional Qualifications** + Graduate or diploma from a study coordinator training program is preferred. + One year of clinical research experience is preferred. + Medical terminology course is preferred. **Exemption Status** Nonexempt **Compensation Detail** $27.44 - $41.16 / hour **Benefits Eligible** Yes **Schedule** Full Time **Hours/Pay Period** 80 **Schedule Details** Day shift; Monday - Friday **Weekend Schedule** N/A **International Assignment** No **Site Description** Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is. (***************************************** **Equal Opportunity** All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status or disability status. Learn more about the "EOE is the Law" (**************************** . Mayo Clinic participates in E-Verify (******************************************************************************************** and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization. **Recruiter** Chad Musolf **Equal opportunity** As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.
    $27.4-41.2 hourly 36d ago
  • Associate Clinical Research Coordinator - Comprehensive Cancer Center

    Mayo Healthcare 4.0company rating

    Clinical research associate job in Rochester, MN

    This is a hybrid position and will require the candidate to be within reasonable driving distance of the Rochester, MN campus. Coordinates non-therapeutic (i.e. minimal risk, survey, chart review) clinical research protocols with direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. May assist in complex (i.e. interventional, therapeutic, greater than minimal risk) studies with direction but does not have overall responsibility for these studies. Screens, enrolls, and recruits research participants. Coordinates schedules and monitors research activities and subject participation. Recognizes adverse events, protocol deviations, and other unanticipated problems and reports appropriately. Collects, abstracts, and enters research data. Performs administrative and regulatory duties related to the study as assigned. Some travel may be required. Protocol Development and Maintenance Activities Responsibilities may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; Institutional Review Board (IRB) submission; and communication with study sites and/or federal agencies regarding study status changes. Participates in other protocol development activities and executes other assignments as warranted and assigned. *Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension. *During the selection process you may participate in an OnDemand (pre-recorded) interview that you can complete at your convenience. During the OnDemand interview, a question will appear on your screen, and you will have time to consider each question before responding. You will have the opportunity to re-record your answer to each question - Mayo Clinic will only see the final recording. The complete interview will be reviewed by a Mayo Clinic staff member and you will be notified of next steps. HS Diploma with at least 3 years of experience OR Associate's degree/college Diploma/Certificate Program with at least 1 year of experience OR Associate's in Clinical Research from an accredited academic institution without experience OR Bachelor's degree. Experience should be in the clinical setting or related experience. Additional Qualifications Graduate or diploma from a study coordinator training program is preferred. One year of clinical research experience is preferred. Medical terminology course is preferred.
    $43k-61k yearly est. Auto-Apply 2d ago
  • Clinical Research Assistant

    Actalent

    Clinical research associate job in Maple Grove, MN

    Join a dynamic team as a Clinical Research Assistant, where you will provide essential administrative support to clinical study activities, ensuring compliance with GCP and FDA regulations. This role is a fantastic opportunity to get involved in clinical research pivotal trials, working closely with experienced professionals. Responsibilities + Provide administrative assistance to the clinical team in support of all clinical study activities. + Support clinical trials in collaboration with other team members, including site qualification, initiation, site management, and data management. + Ensure compliance with GCP and FDA regulations for clinical trials. + Contribute to the formatting and management of clinical documents using Grand Avenue Software (GAS) for final approvals. + Assemble and distribute study-related documents, including regulatory binders, case report form binders, and study manuals to sites. + Create and maintain study trackers, dashboards, and reports. + Support clinical study payments, where applicable. + Participate in study-specific meetings and manage minutes and documentation. + Manage electronic and paper study site and master files, ensuring audit readiness. + Provide travel and logistical support to physician proctors and the clinical team as needed. + Support the planning and conduct of investigator/study meetings. + Ensure proper handling, accountability, and reconciliation of all Investigational Products (IP). + Assist with updates on clinicaltrials.gov. + Develop and maintain successful working relationships and manage deliverables with cross-functional team members. Essential Skills + Excellent organizational skills. + Strong interpersonal, written, and verbal communication skills. + Ability to effectively build and maintain positive relationships with physicians, peers, and colleagues across all organizational levels. + Capability to multitask effectively while maintaining high-quality output. + Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook. Additional Skills & Qualifications + Knowledge of Good Clinical Practice (GCP) and FDA regulations. + Experience with SharePoint. + Background in biology or a related science field with a science degree. + 1 year of undergraduate research or clinical research experience. Work Environment This role is based 100% onsite in Maple Grove, providing an excellent opportunity to work directly with senior clinical research professionals in a collaborative setting. Job Type & Location This is a Contract to Hire position based out of Maple Grove, MN. Pay and Benefits The pay range for this position is $30.00 - $31.25/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Maple Grove,MN. Application Deadline This position is anticipated to close on Jan 20, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
    $30-31.3 hourly 7d ago
  • Clinical Research Assistant II

    Center for Veterans Research and Education

    Clinical research associate job in Minneapolis, MN

    Job Description Job Title: Clinical Research Assistant II (CRA II) Job Code: CRAII, Full Time, Benefit Eligible, Non-Exempt Lead Worker: Diana Burgess Admin Supervisor: Lee Cross Project: Reaching Rural Veterans: Applying Mind-Body Skills for Pain using a Whole Health Telehealth Intervention (RAMP) Summary: The Center for Veterans Research and Education (CVRE), whose mission is to help support innovative research and education initiatives that improve the health and well-being of Veterans, is seeking a Clinical Research Assistant II. Position Description: The Clinical Research Assistant II is responsible for assisting the Principal Investigator with the conduct of preparatory work, recruitment of and follow-up with study participants for the RAMP study. This will involve 9 facilitated group sessions including education and training in different tools and strategies. Responsibilities: Major duties and responsibilities include, but are not limited to the following: Preparing and emailing/mailing recruitment and randomization materials Preparing research participant and advisor payment materials Logging returned assessments Making follow-up phone calls to Veterans Answering Veteran questions via email and phone Conducting health assessments and research questionnaires by telephone Responding to identified suicide risk by following the safety procedures and informing the study Principal Investigators and Project Director Assisting in data collection/cleaning Maintaining data and study files in accordance with project protocols Scheduling study related meetings and keeping minutes documenting decisions Alerting the Principal Investigators and Project Director of data collection/protocol breeches, inconsistencies, or other problems that may arise within the study, as well as suggesting methods of correction Assisting in the preparation of manuscripts and presentation of the data. Activities may include helping to create posters for professional presentations; creating tables and charts; editing scholarly manuscripts; and assisting with formatting and uploading files, etc. Other duties as assigned Applicant must include a cover letter Minimum Qualifications: Education: Bachelor's (BA/BS) or above from an accredited college or university in public health, sociology, psychology, or related allied health field Experience: 1-3 years of experience required for CRA II or a post-graduate degree. Licensure/Registration/Certification: None Preferred Qualifications: Minimum 1 year of Clinical Research Assistant experience dealing with data collection and data storage, human subject studies, and institutional review board processes preferred. Knowledge, Skills, and Abilities: Basic experience with trouble-shooting devices and software settings. Experience in coordinating multiple task and project elements with differing timelines and completion deadlines. Demonstrated ability to work effectively both independently and as part of a team. Excellent oral and written communication skills. Exceptional attention to detail and organizational skills. Proficiency in Microsoft Office products including Outlook, Word, PowerPoint, and Excel. Knowledge of Good Clinical Practices, human subjects' protection, and federal regulations related to clinical research. Conditions of Employment: Subject to a criminal and educational background check. Designated and/or random drug testing may be required. Regular and predictable attendance is required. Typical hours fall within standard business hours, work may be required during hours beyond standard business hours, including weekends. Must be a US citizen Physical Requirements: The employee must be able to navigate the medical center, use a keyboard, and lift 25 lbs. Reasonable accommodation may be considered in determining an applicant's ability to perform the duties/functions of the position. Equal Employment Opportunity: Center for Veterans Research and Education does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy), gender identity or status as transgender, national origin, caste, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor protected by federal, state or local law.
    $32k-46k yearly est. 7d ago
  • Associate Study Coordinator

    Namsa 4.2company rating

    Clinical research associate job in Minneapolis, MN

    NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: • Knows and understands the Animal Welfare Requirements and serves as a support to the Study Directors and/Principal Investigator, when applicable. • Assists Study Directors on select projects under the direction and review of the Study Director team. • Assists in collection, documentation and analysis of pre-clinical data. • Assists in the coordination of study tasks from pre-study initiation to study completion. • Performs accurate and timely record keeping consistent with the maintenance of facility SOPs. Utilizes computer systems to enter and reference data as needed. • Assists in study planning and design of studies, under the direction and review of the study director team, to meet desired project endpoints, including coordinating pre-study meetings and data review. • Responsible for study planning activities, assists with generating study protocols when directed, coordinates and monitors activities in support of study conduct. • Communicates effectively with Sponsors, Study Directors, Principal Investigators and Testing Facility Management on the progress of all studies. • Assists with data collection, database entry and generating/tabulating data. • Distributes study related documents, i.e. copies of study data sheets • Creates documentation per SOP to assist with test/control article accountability. • May ship specimens, documents, CDs, DVDs etc. per SOP, maintaining accurate chain of custody documentation. • Assists with generating technical reports as directed and assist in identifying issues and recommend solutions. • Maintains client inventory and is required to be familiar with internal and competitor products. • Types correspondence and various types of documentation in proper format and proofreads/distributes as assigned. • Completes special department projects and duties (i.e., data collection, report creation, information maintenance, contacting personnel for routine updates, etc.) as required to support daily business operations. • Other duties as assigned. Qualifications & Technical Competencies: • One year experience in an administrative position desirable, preferably with an emphasis in a laboratory setting. • Working knowledge of word processing and spreadsheet software. • Requires a minimum of an Associate degree, preferably in a scientific discipline. Working Conditions: • While performing the duties of this job, the Associate is regularly exposed to general office conditions, and will be required to regularly work on personal computers and keyboards. The Associate is frequently exposed to a variety of livestock, domestic and laboratory animals and to fluoroscopy and faxitron x-ray imaging. The Associate is occasionally exposed to sharp objects, radioactive isotopes, gasses such as CO2 and isoflurane, toxic or caustic chemicals, and a Bio-Safety-Level 2 (BSL2) environment. On rare occasions, the Associate may be exposed to zoonotic diseases and blood borne pathogens. • The noise level in the work environment is usually moderate. • While performing the duties of this job, the Associate is regularly required to sit, stand, walk, use hands and fingers, reach with hands and arms, talk and hear, use computer keyboard, and view computer monitors. The Associate must occasionally lift and/or move up to 50 pounds. • Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination. Pay Range Minimum: $17.79 Pay Range Target: $26.00 Pay Frequency: Hourly Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
    $17.8-26 hourly Auto-Apply 21d ago
  • Associate Clinical Research Coordinator - Comprehensive Cancer Center

    Mayo Clinic 4.8company rating

    Clinical research associate job in Rochester, MN

    This is a hybrid position and will require the candidate to be within reasonable driving distance of the Rochester, MN campus. Coordinates non-therapeutic (i.e. minimal risk, survey, chart review) clinical research protocols with direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. May assist in complex (i.e. interventional, therapeutic, greater than minimal risk) studies with direction but does not have overall responsibility for these studies. Screens, enrolls, and recruits research participants. Coordinates schedules and monitors research activities and subject participation. Recognizes adverse events, protocol deviations, and other unanticipated problems and reports appropriately. Collects, abstracts, and enters research data. Performs administrative and regulatory duties related to the study as assigned. Some travel may be required. Protocol Development and Maintenance Activities Responsibilities may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; Institutional Review Board (IRB) submission; and communication with study sites and/or federal agencies regarding study status changes. Participates in other protocol development activities and executes other assignments as warranted and assigned. *Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension. *During the selection process you may participate in an OnDemand (pre-recorded) interview that you can complete at your convenience. During the OnDemand interview, a question will appear on your screen, and you will have time to consider each question before responding. You will have the opportunity to re-record your answer to each question - Mayo Clinic will only see the final recording. The complete interview will be reviewed by a Mayo Clinic staff member and you will be notified of next steps. HS Diploma with at least 3 years of experience OR Associate's degree/college Diploma/Certificate Program with at least 1 year of experience OR Associate's in Clinical Research from an accredited academic institution without experience OR Bachelor's degree. Experience should be in the clinical setting or related experience. Additional Qualifications Graduate or diploma from a study coordinator training program is preferred. One year of clinical research experience is preferred. Medical terminology course is preferred.
    $38k-51k yearly est. Auto-Apply 2d ago

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