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Clinical research associate jobs in Novi, MI - 83 jobs

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  • Clinical Research Associate II

    Allen Spolden

    Clinical research associate job in Oakland, MI

    Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K
    $58k-93k yearly est. 60d+ ago
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  • Clinical Research Associate

    Actalent

    Clinical research associate job in Grosse Pointe Woods, MI

    The Clinical Research Associate will focus primarily on data management for clinical trials and act as a backup for regulatory associates. Initially, the role involves working with Registry studies, including pre-screening, recruiting, consenting, and following up with participants. This will occupy approximately 40% of the time, with the remainder dedicated to data entry, data management, and assisting the Research Nurse during patient visits. Responsibilities + Manage data for clinical trials and serve as a backup for regulatory associates. + Work with Registry studies, including pre-screening, recruiting, consenting, and follow-up activities. + Perform data entry and data management tasks. + Assist the Research Nurse with patient visits. Required Skills & Experience + Minimum of 1 year of clinical research experience + Understanding of clinical trials terminology + Proficiency in EDC systems, with the ability to learn various systems Additional Skills & Qualifications + Experience in oncology is ideal + Willingness to undergo oncology training Job Type & Location This is a Contract to Hire position based out of Grosse Pointe Woods, MI. Pay and Benefits The pay range for this position is $20.00 - $31.00/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 Grosse Pointe Woods,MI. Application Deadline This position is anticipated to close on Jan 22, 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.
    $20-31 hourly 11d ago
  • Clinical Research Study Assistant II - Neurology

    Washington University In St. Louis 4.2company rating

    Clinical research associate job in Taylor, MI

    Scheduled Hours40Under direction, participates in clinical research study activities; screens, obtains consent, and enrolls participants in study; performs a variety of duties involved in the collection, documentation, and reporting of clinical research data.Job Description Primary Duties & Responsibilities: Participates in the recruitment of study participants as identified in related protocol; visits with study participants to explain study, screens for eligibility and obtains informed consent of participants. Completes all necessary paperwork/documentation according to study protocol; obtains consent, interviews study subjects and schedules follow-ups as needed. Performs basic/scripted assessments to confirm eligibility to participate in study; explains and schedules laboratory and diagnostic procedures and/or treatment as required in the study; refers participants to basic resources as necessary. Collects data from study participants, medical records, interviews, questionnaires, diagnostic tests and other sources; performs basic evaluation and interpretation of collected data and prepares appropriate reports and documentation as necessary; prepares and distributes study packets and information. Performs other duties as assigned. Working Conditions: Job Location/Working Conditions: Normal office environment. Physical Effort: Typically sitting at desk or table. Repetitive wrist, hand or finger movement. Equipment: Office equipment. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.Required Qualifications Education: High school diploma or equivalent high school certification or combination of education and/or experience. Certifications: The list below may include all acceptable certifications and issuers. More than one credential or certification may be required depending on the role.Basic Life Support - American Heart Association, Basic Life Support - American Red Cross Work Experience: Administrative Or Research (2 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position.More About This JobRequired Qualifications: Basic Life Support certification must be obtained within one month of hire date Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Preferred Qualifications Education: Associate degree Certifications: No additional certification unless stated elsewhere in the job posting. Work Experience: No additional work experience unless stated elsewhere in the job posting. Skills: Interpersonal Communication, Oral Communications, Organizing, Written CommunicationGradeC07-HSalary Range$19.21 - $28.85 / HourlyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.Pre-Employment ScreeningAll external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.Benefits Statement Personal Up to 22 days of vacation, 10 recognized holidays, and sick time. Competitive health insurance packages with priority appointments and lower copays/coinsurance. Take advantage of our free Metro transit U-Pass for eligible employees. WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%. Wellness Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more! Family We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered. WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us. For policies, detailed benefits, and eligibility, please visit: ****************************** EEO StatementWashington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
    $19.2-28.9 hourly Auto-Apply 60d+ ago
  • Senior Clinical Research Coordinator

    Flourish Research

    Clinical research associate job in Southfield, MI

    Job Description Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Senior Clinical Research Coordinators at our Detroit, MI location! The Senior Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday-Friday, 9 AM - 5 PM; one Saturday each month (9am - 1pm) Location: 20755 Greenfield Rd # 107, Southfield, MI 48075 Compensation: $30 - $36 based on experience + quarterly discretionary performance bonuses Benefits: Health, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES The Clinical Research Coordinator (CRC) obtains study participant informed consent. Executes study protocol procedures in a detailed, organized, and professional manner. Performs human specimen lab draws and processing, and packages specimen shipments. Creates and completes study source documents and adverse event reporting on an e-source system. Maintains study-specific files and supplies. Communicate with the Study Sponsor/CRO regarding study-specific questions. Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits. Additional duties as assigned by management QUALIFICATIONS Bachelor's degree preferred but not required Phlebotomy experience is required; EKG or other patient labs/processes preferred 5+ years of experience as a Clinical Research Coordinator Familiar with e-source reporting via an electronic platform A clear understanding of ICH, FDA, and GCP regulations Impeccable organizational skills and attention to detail Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven High-level critical thinking skills Working knowledge of medical terminology and lab collection/processing/storage procedures Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Powered by JazzHR DPd1apIQ1W
    $30-36 hourly 29d ago
  • Senior Clinical Research Coordinator

    DM Clinical Research

    Clinical research associate job in Detroit, MI

    Department Clinical Operations - Detroit, MI Employment Type Full-Time Minimum Experience Experienced DM Clinical Research, the largest privately-owned research management organization in the Houston area and one of the top 50 in the country, is looking for a Senior Clinical Research Coordinator experienced in coordinating studies for one of our research sites in Detroit, MI. This position works closely with our Clinical Research staff to provide excellent care to patients participating in our clinical trials. Responsibilities: Completing DMCR-required training, including GCP and IATA. Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols. Adhering to their assigned protocols at their respective site(s). Maintain working knowledge of current FDA GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols. Collecting source and submitting source per Sponsor requirements via the Sponsor-specified CRF system. Completing Sponsor-required training prior to study-start, to include, but not limited to: a. Sponsor provided and IRB approved protocol b. All amendments c. Investigator Brochure d. Sponsor-specified EDC and/or IVRS Continued recruitment and screening for their assigned protocols at their respective site(s) at all times as applicable Being prepared for and available at all required company meetings and monitoring visits for their assigned protocols at their respective site(s). Utilizing the most recent version of the Protocol, Informed Consent, and Investigator Brochures at their respective site(s). Compiling and organizing all regulatory and administrative binders for their assigned protocols at their respective site(s) upon initial receipt of and wherever applicable. Creating source documents for their assigned protocols at their respective site(s). Conducting patient visits, and all other protocol-required procedures and documenting these in a timely manner. Reporting all Adverse and Serious Adverse Events to the appropriate authorities per Sponsor, IRB, and ICH Guidelines. Completing data entry and query resolution in a timely manner. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings. Ensuring data quality in all trials being conducted at their respective site(s). Addressing and resolving all issues from that monitor letters for all assigned protocols at their respective site(s) in a timely manner. Striving to meet Sponsor goals for their assigned protocols at their respective site(s). Strive to ensure weekly, monthly, and quarterly assigned goals are met for their respective site(s). Any other matters as assigned by management. Requirements: Have at least three (5) years of experience as a CRC, preferably with practice coordinating industry sponsored trials in a private setting. Foreign Medical Graduate a plus. Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Have ACRP certification, which is a plus. Bilingual in Spanish is a plus.
    $47k-74k yearly est. 60d+ ago
  • Senior Clinical Research Coordinator

    Topography Health

    Clinical research associate job in Ann Arbor, MI

    OVERVIEWThis role will coordinate research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and include the opportunity to help spearhead on-site efforts for Topography's partner healthcare groups. This role will be evaluated on provider success, patient experience, protocol management and adherence, and data quality. This role will require a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers. You will need to be able to thrive with multiple balls in the air, and where independent problem solving is a daily need. You will need to lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country. KEY RESPONSIBILITIES Act as senior study coordinator to execute trials conducted within physician practices, including but not limited to: a. Visit preparation activities b. Visit follow-up activities c. Supply and inventory management d. Third party vendor management Conduct patient recruitment and enrollment of eligible patients. Lead patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. 4. Independently administer the informed consent process with care and quality 5. Ensure protocol adherence and high data integrity Provide high quality source data capture and documentation Support study start-up and planning, including PSVs and SIVs Support IRB submission and correspondence Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process IP management, dispensation and accountability Adverse Event management, tracking, and follow-up Data entry to CRF/EDC and query resolution in a timely manner Support study close-out, including COVs Protocol deviation tracking, reporting, and reconciliation Train and mentor junior research staff Using and helping improve Topography's proprietary tool set Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation Conduct Quality Control activities including routine QC checks during and following study visits Any other duties assigned by manager MINIMUM QUALIFICATIONS Bachelor's degree or equivalent combination of training and experience Ability to be on site 5 days a week in Chevy Chase, MD5+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role 5+ years of experience independently coordinating studies, from study startup to close out5+ years demonstrated track record of delivering clean data and a high-quality patient experience Expert knowledge of FDA regulations and ICH/GCP guidelines Strong communication skills, teamwork, cooperation, self-awareness, and flexibility
    $47k-73k yearly est. Auto-Apply 20d ago
  • Senior Clinical Research Coordinator

    Topography

    Clinical research associate job in Ann Arbor, MI

    This role will coordinate research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and include the opportunity to help spearhead on-site efforts for Topography's partner healthcare groups. This role will be evaluated on provider success, patient experience, protocol management and adherence, and data quality. This role will require a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers. You will need to be able to thrive with multiple balls in the air, and where independent problem solving is a daily need. You will need to lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country. KEY RESPONSIBILITIES Act as senior study coordinator to execute trials conducted within physician practices, including but not limited to: a. Visit preparation activities b. Visit follow-up activities c. Supply and inventory management d. Third party vendor management Conduct patient recruitment and enrollment of eligible patients. Lead patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. 4. Independently administer the informed consent process with care and quality 5. Ensure protocol adherence and high data integrity Provide high quality source data capture and documentation Support study start-up and planning, including PSVs and SIVs Support IRB submission and correspondence Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process IP management, dispensation and accountability Adverse Event management, tracking, and follow-up Data entry to CRF/EDC and query resolution in a timely manner Support study close-out, including COVs Protocol deviation tracking, reporting, and reconciliation Train and mentor junior research staff Using and helping improve Topography's proprietary tool set Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation Conduct Quality Control activities including routine QC checks during and following study visits Any other duties assigned by manager MINIMUM QUALIFICATIONS Bachelor's degree or equivalent combination of training and experience Ability to be on site 5 days a week in Chevy Chase, MD 5+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role 5+ years of experience independently coordinating studies, from study startup to close out 5+ years demonstrated track record of delivering clean data and a high-quality patient experience Expert knowledge of FDA regulations and ICH/GCP guidelines Strong communication skills, teamwork, cooperation, self-awareness, and flexibility We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
    $47k-73k yearly est. 21d ago
  • Clinical Research Coordinator- Cardiology (Detroit, MI)*

    Profound Research

    Clinical research associate job in Detroit, MI

    Profound Research:Profound Research seeks to drive clinical innovation by partnering with community physicians to offer clinical research as a therapeutic option to their patients. Profound enables providers with the right people and tools to launch clinical research operations, often for the first time, to offer new care pathways to patients. Profound Research is looking to grow its energetic team inspired by changing how patients and providers engage in clinical research. Our Mission: Improving Lives by Providing Advanced Therapeutic Options Our Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research Our Values: Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions. Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues. Solution Orientation: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards. Profound Ethos o Physicians are the Vanguard o All Decisions Improve Patient Care o Never Compromise Quality Why this Role Exists The Clinical Research Coordinator will manage all clinical trial activities under supervision in compliance with all applicable laws, regulations, and procedures of study protocol while maintaining company mission, vision and values. Responsibilities-Conduct and manage all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. -Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner. -Mentor and train staff in the conduct of clinical trials, protocol requirements, communication and trial management skills. -Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up. -Ensure good documentation practices are applied by all team members when collecting, maintaining and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms. -Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. -Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products. -Other duties as assigned. Requirements-Bachelor's degree and 2 years relevant experience in the life science industry OR -Associate's degree with 4 years relevant experience in the life science industry OR -High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year -Clinical Research Coordinator experience -Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification within 6 months of being in the role -Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens -Proficient ability to work independently, plan and prioritize with minimal guidance -Excellent attention to detail, organization, and communication with varied stakeholders -Ability to work as a team player with the ability to adapt to changing schedules and assignments Travel RequirementsDaily commute to site(s) Why Join Profound Research? · Flexible PRN scheduling that works with your availability· Exposure to diverse therapeutic areas and cutting-edge treatments· Supportive team environment with comprehensive training· Opportunity to make a direct impact on patient access to innovative therapies· Professional development in the growing field of clinical research
    $43k-64k yearly est. Auto-Apply 41d ago
  • Clinical Research Coordinator

    Revival Research Institute

    Clinical research associate job in Southfield, MI

    Unique opportunity to make an Impact in the healthcare industry Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, and Nebraska North Carolina. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials. As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us. The role of a Clinical Research Coordinator builds upon the foundational responsibilities of an Assistant Clinical Research Coordinator, expanding into more autonomous management of clinical research activities with moderate supervision. This role requires a blend of specific certifications, detailed knowledge of clinical trial processes, regulatory compliance, and practical skills in managing both the operational and administrative aspects of clinical studies. Here's a detailed overview of the responsibilities and skills required for a CRC: Core Responsibilities: Regulatory Document Management: Manage essential regulatory documents, including Institutional Review Board (IRB) submissions and safety reports, ensuring compliance with all regulatory authorities and guidelines (e.g., FDA, DSMB). Data Management: Complete and maintain accurate source documentation and data entry. Address queries and action items promptly to ensure the integrity and timeliness of trial data. Perform E-source data entry and maintain real-time data accuracy, as applicable. Regulatory Submissions and Communications: Submit necessary documents to regulatory authorities and/or review/monitoring boards, including DSMB and independent safety officers, in a timely and compliant manner. Site and Study Visit Facilitation: Facilitate pre-study, site qualification, study initiation, and monitoring visits, as well as study close-out activities. Team Coordination and Communication: Coordinate research/project team meetings, ensuring effective communication and collaboration among team members. Specimen Management: Collect, process, and ship laboratory specimens following study protocols and regulatory requirements. Patient Management: Schedule subject visits and procedures, ensuring participants' compliance with the study schedule. Conduct recruitment, pre-screening, screening, baseline enrollment, and follow-up visits, maintaining a participant-centered approach. Inventory and Records Management: Manage inventory and maintain accountability logs for investigational products, devices, and study-related supplies. Retain records and archive documents after study close out, following regulatory guidelines and best practices. Phlebotomy and Clinical Procedures: Requires Phlebotomy certification, indicating the ability to perform blood draws and other specimen collection as part of the study procedures. Required Skills and Abilities: Effective Writing and Communication: Capable of clear and concise documentation, and excellent interpersonal communication skills for interactions with study participants, team members, and regulatory bodies. Teamwork: Ability to work collaboratively within a research team, contributing positively to team dynamics and supporting team members. Multitasking: Proficiency in managing multiple tasks and priorities efficiently, adapting to changing demands with attention to detail and accuracy. Regulatory Knowledge: In-depth understanding of clinical trial regulations, ethical guidelines, and compliance standards, with the ability to apply these in practical settings. Organizational Skills: Strong organizational and project management skills to oversee study activities, manage documentation, and ensure compliance with study protocols Preferred Qualifications: The preferred qualifications for a Clinical Research Coordinator 1 (CRC 1) typically encompass a blend of educational achievements, practical experience, and specialized skills that equip the individual to effectively manage and coordinate clinical research studies. Here is a detailed outline of these qualifications: Educational Background Bachelor's Degree: A bachelor's degree in life sciences, nursing, public health, or a related field is often the minimum educational requirement. This background provides a foundational understanding of biological principles, research methodologies, and ethical considerations in clinical research. Master's Degree: A master's degree in a relevant field (such as clinical research, biostatistics, epidemiology, or healthcare management) may be preferred or allow candidates to enter the role with less practical experience, given the advanced knowledge and research skills acquired during their studies. Professional Experience For Bachelor's Degree Holders: Typically, 1-2 years of relevant experience in clinical research or a closely related field is preferred. This experience should demonstrate familiarity with clinical trial processes, regulatory compliance, patient interaction, and data management. For Master's Degree Holders: No practical experience is necessary, but any internships, training, or exposure to clinical research during academic studies will be advantageous. Skills Regulatory Knowledge: A thorough understanding of regulatory requirements and guidelines governing clinical research, including Good Clinical Practice (GCP), HIPAA, and IRB processes. Data Management Skills: Proficiency in data management software and systems, with the ability to perform accurate data entry, manage databases, and resolve queries. Communication Skills: Strong verbal and written communication skills are crucial for liaising with research participants, team members, regulatory bodies, and sponsors. Organizational and Multitasking Abilities: The capacity to efficiently manage multiple tasks and priorities, coordinate study activities, and maintain detailed records. Personal Attributes Attention to Detail: Essential for ensuring accurate data collection, regulatory compliance, and adherence to study protocols. Problem-Solving Skills: Ability to identify issues and develop effective solutions in a timely manner. Adaptability: Flexibility to adapt to changing study requirements, protocols, and research environments. Teamwork: Demonstrated ability to work collaboratively within a multidisciplinary team, supporting colleagues and contributing to a positive work environment. Additional Considerations Experience with Specific Populations or Therapeutic Areas: Depending on the focus of the research institution or the clinical trials being conducted, experience with specific patient populations or therapeutic areas may be preferred. Technology Proficiency: Familiarity with electronic health records (EHR), electronic data capture (EDC) systems, and other clinical research technologies. These qualifications ensure that a CRC is well-equipped to handle the complexities of clinical trials, contribute effectively to research objectives, and uphold the highest standards of ethical and scientific integrity. IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!
    $43k-64k yearly est. 60d+ ago
  • Clinical Research Assistant / Medical Assistant

    Alcanza Clinical Research

    Clinical research associate job in Farmington Hills, MI

    Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site. Key ResponsibilitiesEssential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to: Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol: Assists with the basic screening of patients for study enrollment; Assists with patient follow-up visits; Documents in source clinic charts; Enters data in EDC and answers queries; Obtains vital signs and ECGs; May perform blood draws; Perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Request and track medical record requests; Enters data in EDC and answers queries; Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed; Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner. Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed; Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and Perform all other duties as requested or assigned. Skills, Knowledge and ExpertiseMinimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus. Required Skills: Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm). Must possess strong organizational skills and attention to detail. Well-developed written and verbal communication skills. Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers. Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities. Must be professional, respectful of others, self-motivated, and have a strong work ethic. Must possess a high degree of integrity and dependability. Ability to work under minimal supervision, identify problems and implement solutions. Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines. Benefits Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
    $31k-46k yearly est. 9d ago
  • Clinical Research Technician/ Assistant Underfill - Term-Limited

    University of Michigan (The Regents @ Ann Arbor 4.6company rating

    Clinical research associate job in Ann Arbor, MI

    How to Apply A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position. Job Summary The Mary H. Weiser Food Allergy Center is seeking a clinical research technician/assistant for an innovative and large prospective cohort study at the University of Michigan. Join our dynamic interdisciplinary team of experts in Allergy, Immunology, Epidemiology, Obstetrics, and Genetics as we investigate the pathogenesis of food allergy and other allergic conditions. As a clinical research technician/assistant for M-SIBS, a birth cohort examining the development of food allergies, you will play a key role in the study's data collection by helping with study participant recruitment, data and biospecimen collection, scheduling study visits and the family experience. We are looking for a candidate who can autonomously recruit participants, collect biospecimens, perform home visits, and schedule participants. The candidate will help to ensure compliance with pre-established work scope responsibilities with a focus on completion of duties within established periods to meet study objectives while utilizing study protocol standards. This individual will also collaborate with other study coordinators within a large team-based science initiative with the goal of professional growth as the study progresses. This is an exceptional opportunity to leverage your skills and contribute to groundbreaking research. This job is a 100% (40 hours/week) effort. This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Michigan Medicine CRC Career Ladder
    $35k-48k yearly est. 11d ago
  • Clinical Research Assistant

    Insight Hospital & Medical Center

    Clinical research associate job in Flint, MI

    Insight Institute of Neuroscience & Neurosurgery (IINN) aims to advance, challenge, and revolutionize neurosciences and medicine through scientific research and advanced technology, driven by a passion to help others regardless of any obstacles and challenges that may lie ahead. Our integrated team of medical professionals does so through creative, innovative techniques and care principles developed because of our continuous pursuit to improve the field of medicine. Our integrated team works together to find solutions to both common and complex medical concerns to ensure more powerful, reliable results. Having multiple specialties "under one roof" Insight achieves its purpose in providing a comprehensive, collaborative approach to neuromusculoskeletal care and rehabilitation to ensure optimal results. Our singular focus is Patient Care Second to None! Job Summary: We are seeking competent, proactive, self-directed individuals with effective time management skills to assist our clinical research site. The Clinical Research Assistant will support the clinical research team at our Research Dearborn location. They will work under the direction of the Clinical Research Manager. Job Type: * Full time (on-site, in-person) * Monday to Friday, Full-time (8 hours), 8am - 5pm EST * Ability and willingness to commute between our research locations as needed per study tasks * Professional references may be required. Benefits for our Full Time Team Members: * Comprehensive health, dental, and vision insurance coverage * Paid time off, including vacation, holidays, and sick leave * 401K with Matching; offerings vested fully @ 3 months of employment paired with eligibility to contribute * Short & Long Disability, and Life Term insurance, complementary of Full Time Employment * Additional Supplementary coverages offered @ employee's elections: Accident, Critical Illness, Hospital Indemnity, AD&D, etc. Duties and Responsibilities: * Schedule visit appointments after coordination with relevant parties * Coordinate collection, processing and shipping of study specimens * Assemble study kits for study visits * Attend and participate in study meetings, SIVs, monitoring visits and other sponsor and regulatory meetings * Complete Data Entry for studies both in sponsor EDC and CTMS * Ensure all paper sources are filed and securely kept in the binders * Assist and work closely with the Clinical Research Coordinator and Clinical Research manager in executing and monitoring the overall clinical study to ensure compliance with protocol * Report any adverse events according to the study protocol * Identify and assist in pre-screening potential subject leads * Assist in marketing the active trials in the community * Actively meet with investigator and study team to discuss study progress/status * Provides administrative updates on enrollment and queries if any * Other duties as needed per assigned study protocol Qualifications: * Ability to demonstrate authorization to work in the U.S. for any employer * Bachelor's degree or equivalent training required via work experience or education * At least one year of previous job-related experience preferred * Ability to follow oral and written instructions and established policies and procedures * Ability to analyze and interpret data * Ability to finish tasks in a timely manner * Ability to maintain accuracy and consistency * Ability to maintain confidentiality * Ability to work as an effective team member * Knowledge of medical terminology * Ability to function independently and manage their own time and work tasks * Diligent, thorough in their tasks, and show their commitment to their job Insight is an equal opportunity employer and values workplace diversity!
    $32k-46k yearly est. 60d+ ago
  • Clinical Research Associate

    Actalent

    Clinical research associate job in Grosse Pointe Woods, MI

    The Clinical Research Associate will focus primarily on data management for clinical trials and act as a backup for regulatory associates. Initially, the role involves working with Registry studies, including pre-screening, recruiting, consenting, and following up with participants. This will occupy approximately 40% of the time, with the remainder dedicated to data entry, data management, and assisting the Research Nurse during patient visits. Responsibilities * Manage data for clinical trials and serve as a backup for regulatory associates. * Work with Registry studies, including pre-screening, recruiting, consenting, and follow-up activities. * Perform data entry and data management tasks. * Assist the Research Nurse with patient visits. Required Skills & Experience * Minimum of 1 year of clinical research experience * Understanding of clinical trials terminology * Proficiency in EDC systems, with the ability to learn various systems Additional Skills & Qualifications * Experience in oncology is ideal * Willingness to undergo oncology training Job Type & Location This is a Contract to Hire position based out of Grosse Pointe Woods, MI. Pay and Benefits The pay range for this position is $20.00 - $31.00/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 Grosse Pointe Woods,MI. Application Deadline This position is anticipated to close on Jan 22, 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.
    $20-31 hourly 11d ago
  • Senior Clinical Research Coordinator

    Flourish Research

    Clinical research associate job in Southfield, MI

    Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Senior Clinical Research Coordinators at our Detroit, MI location! The Senior Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday-Friday, 9 AM - 5 PM; one Saturday each month (9am - 1pm) Location: 20755 Greenfield Rd # 107, Southfield, MI 48075 Compensation: $30 - $36 based on experience + quarterly discretionary performance bonuses Benefits: Health, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays. RESPONSIBILITIES The Clinical Research Coordinator (CRC) obtains study participant informed consent. Executes study protocol procedures in a detailed, organized, and professional manner. Performs human specimen lab draws and processing, and packages specimen shipments. Creates and completes study source documents and adverse event reporting on an e-source system. Maintains study-specific files and supplies. Communicate with the Study Sponsor/CRO regarding study-specific questions. Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits. Additional duties as assigned by management QUALIFICATIONS Bachelor's degree preferred but not required Phlebotomy experience is required; EKG or other patient labs/processes preferred 5+ years of experience as a Clinical Research Coordinator Familiar with e-source reporting via an electronic platform A clear understanding of ICH, FDA, and GCP regulations Impeccable organizational skills and attention to detail Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven High-level critical thinking skills Working knowledge of medical terminology and lab collection/processing/storage procedures Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
    $30-36 hourly Auto-Apply 28d ago
  • Senior Clinical Research Coordinator

    Topography Health

    Clinical research associate job in Ann Arbor, MI

    Job DescriptionOVERVIEWThis role will coordinate research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and include the opportunity to help spearhead on-site efforts for Topography's partner healthcare groups. This role will be evaluated on provider success, patient experience, protocol management and adherence, and data quality. This role will require a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers. You will need to be able to thrive with multiple balls in the air, and where independent problem solving is a daily need. You will need to lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country. KEY RESPONSIBILITIES Act as senior study coordinator to execute trials conducted within physician practices, including but not limited to: a. Visit preparation activities b. Visit follow-up activities c. Supply and inventory management d. Third party vendor management Conduct patient recruitment and enrollment of eligible patients. Lead patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. 4. Independently administer the informed consent process with care and quality 5. Ensure protocol adherence and high data integrity Provide high quality source data capture and documentation Support study start-up and planning, including PSVs and SIVs Support IRB submission and correspondence Facilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up process IP management, dispensation and accountability Adverse Event management, tracking, and follow-up Data entry to CRF/EDC and query resolution in a timely manner Support study close-out, including COVs Protocol deviation tracking, reporting, and reconciliation Train and mentor junior research staff Using and helping improve Topography's proprietary tool set Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation Conduct Quality Control activities including routine QC checks during and following study visits Any other duties assigned by manager MINIMUM QUALIFICATIONS Bachelor's degree or equivalent combination of training and experience Ability to be on site 5 days a week in Chevy Chase, MD5+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role 5+ years of experience independently coordinating studies, from study startup to close out5+ years demonstrated track record of delivering clean data and a high-quality patient experience Expert knowledge of FDA regulations and ICH/GCP guidelines Strong communication skills, teamwork, cooperation, self-awareness, and flexibility We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
    $47k-73k yearly est. 20d ago
  • Unblinded Clinical Research Coordinator

    DM Clinical Research

    Clinical research associate job in Detroit, MI

    Unblinded Clinical Research Coordinator DM Clinical Research is looking for an Unblinded Clinical Research Coordinator to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinical research trials. Duties & Responsibilities: Compound and dispense prescribed IP. Supervise and maintain records of all medications Ensure compliance with study-specific blinding plans. Provide consultative support regarding the preparation and dosing of drugs. Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction. Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials. Understand and apply all applicable site procedures. Ensure receipt and proper storage of IP and bioretention samples. Manage inventory, ensuring that expired items are removed from the inventory prior to expiration, and purchasing, and delivery processes for the pharmacy. Review protocols and provide input on clinical and pharmacy supply needs. Meet with sponsors, monitors, auditors, and regulatory authorities to review drug accountability and other study-specific information. Temperature reporting. Any other duties/ tasks assigned by the manager, computer proficiency, especially Word, Excel, Outlook, and Google Docs. Knowledge & Experience: Education: High School Diploma or equivalent required Foreign Medical Graduate is a plus Pharmacy Technician Certification a plus Experience: Clinical Experience Credentials: LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant) Knowledge and Skills: Computer proficiency, especially Word, Excel, Outlook, and Google Docs. Excellent communication and customer service skills. Outgoing personality Well-organized with attention to detail. Must be able to multitask. Bilingual (Spanish) preferred but not required
    $43k-64k yearly est. 60d+ ago
  • Clinical Research Coordinator

    Revival Research Institute

    Clinical research associate job in Dearborn Heights, MI

    Unique opportunity to make an Impact in the healthcare industry Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, Nebraska and North Carolina. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials. As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us. The role of a Clinical Research Coordinator builds upon the foundational responsibilities of an Assistant Clinical Research Coordinator, expanding into more autonomous management of clinical research activities with moderate supervision. This role requires a blend of specific certifications, detailed knowledge of clinical trial processes, regulatory compliance, and practical skills in managing both the operational and administrative aspects of clinical studies. Here's a detailed overview of the responsibilities and skills required for a CRC: Core Responsibilities: Regulatory Document Management: Manage essential regulatory documents, including Institutional Review Board (IRB) submissions and safety reports, ensuring compliance with all regulatory authorities and guidelines (e.g., FDA, DSMB). Data Management: Complete and maintain accurate source documentation and data entry. Address queries and action items promptly to ensure the integrity and timeliness of trial data. Perform E-source data entry and maintain real-time data accuracy, as applicable. Regulatory Submissions and Communications: Submit necessary documents to regulatory authorities and/or review/monitoring boards, including DSMB and independent safety officers, in a timely and compliant manner. Site and Study Visit Facilitation: Facilitate pre-study, site qualification, study initiation, and monitoring visits, as well as study close-out activities. Team Coordination and Communication: Coordinate research/project team meetings, ensuring effective communication and collaboration among team members. Specimen Management: Collect, process, and ship laboratory specimens following study protocols and regulatory requirements. Patient Management: Schedule subject visits and procedures, ensuring participants' compliance with the study schedule. Conduct recruitment, pre-screening, screening, baseline enrollment, and follow-up visits, maintaining a participant-centered approach. Inventory and Records Management: Manage inventory and maintain accountability logs for investigational products, devices, and study-related supplies. Retain records and archive documents after study close out, following regulatory guidelines and best practices. Phlebotomy and Clinical Procedures: Requires Phlebotomy certification, indicating the ability to perform blood draws and other specimen collection as part of the study procedures. Required Skills and Abilities: Effective Writing and Communication: Capable of clear and concise documentation, and excellent interpersonal communication skills for interactions with study participants, team members, and regulatory bodies. Teamwork: Ability to work collaboratively within a research team, contributing positively to team dynamics and supporting team members. Multitasking: Proficiency in managing multiple tasks and priorities efficiently, adapting to changing demands with attention to detail and accuracy. Regulatory Knowledge: In-depth understanding of clinical trial regulations, ethical guidelines, and compliance standards, with the ability to apply these in practical settings. Organizational Skills: Strong organizational and project management skills to oversee study activities, manage documentation, and ensure compliance with study protocols Preferred Qualifications: The preferred qualifications for a Clinical Research Coordinator 1 (CRC 1) typically encompass a blend of educational achievements, practical experience, and specialized skills that equip the individual to effectively manage and coordinate clinical research studies. Here is a detailed outline of these qualifications: Educational Background Bachelor's Degree: A bachelor's degree in life sciences, nursing, public health, or a related field is often the minimum educational requirement. This background provides a foundational understanding of biological principles, research methodologies, and ethical considerations in clinical research. Master's Degree: A master's degree in a relevant field (such as clinical research, biostatistics, epidemiology, or healthcare management) may be preferred or allow candidates to enter the role with less practical experience, given the advanced knowledge and research skills acquired during their studies. Professional Experience For Bachelor's Degree Holders: Typically, 1-2 years of relevant experience in clinical research or a closely related field is preferred. This experience should demonstrate familiarity with clinical trial processes, regulatory compliance, patient interaction, and data management. For Master's Degree Holders: No practical experience is necessary, but any internships, training, or exposure to clinical research during academic studies will be advantageous. Skills Regulatory Knowledge: A thorough understanding of regulatory requirements and guidelines governing clinical research, including Good Clinical Practice (GCP), HIPAA, and IRB processes. Data Management Skills: Proficiency in data management software and systems, with the ability to perform accurate data entry, manage databases, and resolve queries. Communication Skills: Strong verbal and written communication skills are crucial for liaising with research participants, team members, regulatory bodies, and sponsors. Organizational and Multitasking Abilities: The capacity to efficiently manage multiple tasks and priorities, coordinate study activities, and maintain detailed records. Personal Attributes Attention to Detail: Essential for ensuring accurate data collection, regulatory compliance, and adherence to study protocols. Problem-Solving Skills: Ability to identify issues and develop effective solutions in a timely manner. Adaptability: Flexibility to adapt to changing study requirements, protocols, and research environments. Teamwork: Demonstrated ability to work collaboratively within a multidisciplinary team, supporting colleagues and contributing to a positive work environment. Additional Considerations Experience with Specific Populations or Therapeutic Areas: Depending on the focus of the research institution or the clinical trials being conducted, experience with specific patient populations or therapeutic areas may be preferred. Technology Proficiency: Familiarity with electronic health records (EHR), electronic data capture (EDC) systems, and other clinical research technologies. These qualifications ensure that a CRC is well-equipped to handle the complexities of clinical trials, contribute effectively to research objectives, and uphold the highest standards of ethical and scientific integrity. IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!
    $43k-64k yearly est. 60d+ ago
  • Clinical Research Assistant / Medical Assistant

    Alcanza Clinical Research

    Clinical research associate job in Farmington, MI

    Department: Operations Employment Type: Full Time Reporting To: Heather Fasczewski Description Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site. Key Responsibilities Essential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to: * Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol: * Assists with the basic screening of patients for study enrollment; * Assists with patient follow-up visits; * Documents in source clinic charts; * Enters data in EDC and answers queries; * Obtains vital signs and ECGs; * May perform blood draws; * Perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; * Request and track medical record requests; * Enters data in EDC and answers queries; * Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and * Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed; * Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner. * Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed; * Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and * Perform all other duties as requested or assigned. Skills, Knowledge and Expertise Minimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus. Required Skills: * Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm). * Must possess strong organizational skills and attention to detail. * Well-developed written and verbal communication skills. * Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers. * Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities. * Must be professional, respectful of others, self-motivated, and have a strong work ethic. * Must possess a high degree of integrity and dependability. * Ability to work under minimal supervision, identify problems and implement solutions. * Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines. Benefits * Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. * Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
    $31k-46k yearly est. 39d ago
  • Clinical Research Coordinator - Assistant

    University of Michigan (The Regents @ Ann Arbor 4.6company rating

    Clinical research associate job in Ann Arbor, MI

    This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder
    $35k-48k yearly est. 5d ago
  • Clinical Research Assistant / Medical Assistant

    Alcanza Clinical Research

    Clinical research associate job in Farmington, MI

    Department Operations Employment Type Full Time Location Quest Research Institute - Farmington Hills, MI Workplace type Onsite Reporting To Heather Fasczewski Key Responsibilities Skills, Knowledge and Expertise Benefits About Alcanza Clinical Research Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all. We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life. Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined. Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.
    $31k-46k yearly est. 38d ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Novi, MI?

The average clinical research associate in Novi, MI earns between $47,000 and $114,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Novi, MI

$73,000
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