Clinical research associate jobs in Sterling Heights, MI

Full-Time Monday-Friday, Various shifts, 60-65k yearly Come and experience the difference with R+L Carriers Earn 1 week of vacation after 90 days of employment Requirements: Any type of LTL experience preferred but not required Ability to self-motivate and self-manage Willingness to learn Analytical skills Computer proficiency Able to work in a fast-paced environment Excellent Benefits R+L Carriers offers an excellent compensation and comprehensive benefits package, including Medical/Dental/Vision Insurance, 401(k) Retirement Plan with matching contributions, Paid Vacation & Holidays, and vacation lodging at our exclusive employee resorts in Daytona Beach, FL, Big Bear Lake, CA, Pigeon Forge, TN and Ocean Isle Beach, NC. Click here ****************************

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

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. Essential Skills * Chart review * Pre-screening patients * Clinical research experience * Clinical trial management * Data entry * Data management * 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 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 Dec 25, 2025. 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.

Royal Oak/Troy - Full time, day shift Scope of Work As part of the Corewell Health Research Institute (CHRI), the Clinical Research Manager provides leadership and oversight of the operational effectiveness and efficiency of the clinical research staff to assure compliance with federal, state and local regulations, protocols, and delivery system policies. Partners with CHRI, as well as clinical service line/hospital leadership and physician investigators to develop and manage key performance metrics for responsible research portfolios. Provides clinical operations support services to grow research within Corewell Health. Plans, organizes and educates other managers, investigators (physicians, nurses, scientists), and team members and is responsible for the overall development and growth of the individual research departments and programs. The manager partners with leadership to maintain a balanced research study/trial financial portfolio, providing expertise and guidance to optimize a research portfolio. Provides input on protocol development, regulatory interactions, patient enrollment to clinical studies, safety monitoring and reviews, as well as providing oversight and support for the education and training needed for research operations staff. * Assumes day-to-day accountability for the delivery of quality operations support for research studies and programs by managing the research team. May be the liaison for industry sponsored research. Measure and analyze key performance indicators/metrics for responsible clinical service lines/hospital/programmatic research portfolios, partnering with the office of sponsored programs (OSP) and data management teams. * Anticipates customer needs and manages the provisions of service to all customers, including patients, physicians, clinical services lines, clinical and ancillary departments, and staff. Assures direct reports respond to requests for services/support on a timely basis. Works to problem - solve needed support and creates business plans for additional infrastructure needed with attention to overall research portfolio performance. * Ensures compliance of all research areas under his/her purview with CHRI's research oversite committees - the Institutional Review Board, Biosafety Committee, Radiation Safety, etc. as well as other mandatory research requirements. Ensures research processes and services are continuously monitored for quality and efficiency in partnership with SHORA. * Engages in process and quality improvement activities as needed. Makes and implements recommendations to improve operational efficiency and to implement new research programs where appropriate for growth and compliance with Corewell Health policies and SOPs. * Performs such individual assignments as leadership may direct. Establishes and maintains collaborative working relationships within the organization and with collaborating institutions. Provides information to the leadership team regarding the implementation and practice of policies and processes; escalates issues/concerns appropriately. Recommends specific action when needed and includes key stakeholders in the decision. * Grows content expertise in the professional field, including best practices to maintain the professional competence, knowledge, and skills necessary for the satisfactory performance of all assigned responsibilities. Completes required continuous training and education including department specific requirements. Dependent on study need for successful enrollment of appropriate participant population hours outside the 'conventional business' hours may be required and will be determined on a study by study basis. * Works with the Director to grow research programs at Corewell Health as directed by the strategy and vision of the clinical services lines/hospital/program. Responsible for the research study/project budget, enrollment metrics and other key metrics. Holds research team members accountable for study/project metrics. Qualifications * Required Bachelor's Degree or equivalent Health care, business, science or other related field. * 3 years of relevant experience Formal or Informal Leadership Experience Required * 5 years of relevant experience Research or Related Experience Required * 3 years of relevant experience Experience working in an organization of a size and complexity comparable to Corewell Health. Preferred * CRT-Certified Professional (ASCRP-CP) - ACRP Association of Clinical Research Professionals Upon Hire preferred How Corewell Health cares for you * Comprehensive benefits package to meet your financial, health, and work/life balance goals. Learn more here. * On-demand pay program powered by Payactiv * Discounts directory with deals on the things that matter to you, like restaurants, phone plans, spas, and more! * Optional identity theft protection, home and auto insurance, pet insurance * Traditional and Roth retirement options with service contribution and match savings * Eligibility for benefits is determined by employment type and status Primary Location SITE - Research Building - 3811 W 13 Mile Road - Royal Oak Department Name Research Institute Infectious Disease Clinical Home RIINC Employment Type Full time Shift Day (United States of America) Weekly Scheduled Hours 40 Hours of Work 8:00 a.m.- 4:30 p.m. Days Worked Monday-Friday Weekend Frequency N/A CURRENT COREWELL HEALTH TEAM MEMBERS - Please apply through Find Jobs from your Workday team member account. This career site is for Non-Corewell Health team members only. Corewell Health is committed to providing a safe environment for our team members, patients, visitors, and community. We require a drug-free workplace and require team members to comply with the MMR, Varicella, Tdap, and Influenza vaccine requirement if in an on-site or hybrid workplace category. We are committed to supporting prospective team members who require reasonable accommodations to participate in the job application process, to perform the essential functions of a job, or to enjoy equal benefits and privileges of employment due to a disability, pregnancy, or sincerely held religious belief. Corewell Health grants equal employment opportunity to all qualified persons without regard to race, color, national origin, sex, disability, age, religion, genetic information, marital status, height, weight, gender, pregnancy, sexual orientation, gender identity or expression, veteran status, or any other legally protected category. An interconnected, collaborative culture where all are encouraged to bring their whole selves to work, is vital to the health of our organization. As a health system, we advocate for equity as we care for our patients, our communities, and each other. From workshops that develop cultural intelligence, to our inclusion resource groups for people to find community and empowerment at work, we are dedicated to ongoing resources that advance our values of diversity, equity, and inclusion in all that we do. We invite those that share in our commitment to join our team. You may request assistance in completing the application process by calling ************.

The Trial Specialist is responsible for the comprehensive management, coordination, and facilitation of stamping and material trials within the organization. This role serves as the primary point of contact for internal and external stakeholders regarding trial requests and ensures the efficient execution, tracking, and reporting of all trial activities. The specialist also leads efforts for critical "special project" trial-related matters, addressing significant business interruptions and strategic resourcing initiatives. Trial Specialist, reporting to Stamping Engineering Manager is responsible for the comprehensive management, coordination, and facilitation of stamping and material trials within the organization. Key Responsibilities: * Manage all stamping trial actions from initiation to completion. * Facilitate the development and submission of trial proposals. * Serve as the Single Point of Contact (SPOC) for other organizations, mills, and material processors concerning trial requests. * Establish and maintain clear points of contact for each phase of every trial. * Manage and update trial tracking sheets to ensure accurate status reporting. * Coordinate the timing of material orders effectively with Material Planning & Logistics (MP&L). * Collect and synthesize trial feedback from all designated points of contact. * Facilitate Material Trial Cost Reimbursement Requests, ensuring timely processing. * Schedule and coordinate regular trial meetings (monthly or bi-weekly) with trial administrators across eleven stamping facilities to monitor and update trial statuses. * Act as the lead for "special project" trial-related matters, including critical resourcing initiatives (e.g., Cliffs, Constellium), responses to significant events (e.g., Novelis fire, Tariff actions), and recovery from business interruptions (e.g., SET Enterprises bankruptcy, Cliffs Dearborn Works BOF shutdown). Key Responsibilities: * Manage all stamping trial actions from initiation to completion. * Facilitate the development and submission of trial proposals. * Serve as the Single Point of Contact (SPOC) for other organizations, mills, and material processors concerning trial requests. * Establish and maintain clear points of contact for each phase of every trial. * Manage and update trial tracking sheets to ensure accurate status reporting. * Coordinate the timing of material orders effectively with Material Planning & Logistics (MP&L). * Collect and synthesize trial feedback from all designated points of contact. * Facilitate Material Trial Cost Reimbursement Requests, ensuring timely processing. * Schedule and coordinate regular trial meetings (monthly or bi-weekly) with trial administrators across eleven stamping facilities to monitor and update trial statuses. * Act as the lead for "special project" trial-related matters, including critical resourcing initiatives (e.g., Cliffs, Constellium), responses to significant events (e.g., Novelis fire, Tariff actions), and recovery from business interruptions (e.g., SET Enterprises bankruptcy, Cliffs Dearborn Works BOF shutdown).

General Motors Research Labs is an applied research center focusing on creating and evaluating innovations for future vehicles. Our researchers conduct independent technical work, while initiating and leading collaborative projects with colleagues at academia and industry globally. As a member of General Motors Research Labs, the Vehicle Controls group offers exciting opportunities for motivated researchers with outstanding capabilities to conduct research in applied AI and Controls for developing cutting edge, world changing technologies for GM's future vehicles. The focus of this position will be to maximize contributions to the whole organization. **The Role:** In this **Senior Researcher position** , you will lead research and/or experiments to validate research ideas in development. Write timely and high-quality research reports, external publications, and records of invention to document new ideas and research results in your area of research. **What You Will Do** As a part of the GM Research team, you will lead novel applied AI and Controls research. You will develop AI/ML/Controls technologies that will change the future of mobility. You will collaborate with world-class universities / industry partners while publishing research outcomes internally and externally. Broader research areas include: + Explore, invent, innovate, implement, evaluate and test algorithms as an independent yet integral member of a research team + Identify research gaps, propose, plan and execute complex research projects + Maintain state-of-the-art technical expertise in AI/ML/Controls + Generate intellectual property, document results and publish papers + Demonstrate strong interpersonal skills and ability to work in a team environment including cross-functional global teams and research Universities + Develop requirements and evaluation metrics for AI/ML/Controls + Travel to GM's Milford location as needed to conduct experiments and testing **Your Skills & Abilities (Required Qualifications)** + U.S. Citizenship + PhD or MSc with 3+ years of experience in AI, ML, computer science, engineering, physics or relevant areas. + Expert-level knowledge in one or more of these areas: Control theory, autonomous agents, Robotics, and reinforcement learning + Must have experience creating and implementing control algorithms + Expertise in manipulating high-volume, high-dimensional data from varying sources with machine learning techniques + Experience in prototyping algorithms, implementing and testing software on hardware + Programming background: Python, AI/ML environments (PyTorch, TensorFlow, sklearn, etc.), Matlab, dSPACE + Strong analytical capabilities + Excellent verbal/written communication in English along with strong interpersonal skills + Passion for applying AI and Controls to impact the future of mobility **What Will Give You a Competitive Edge (Preferred Qualifications)** + Experience in applying reinforcement learning to real world problems. + Experience in applying ML techniques to control theory problems. + Expertise in vehicle dynamics **About GM** Our vision is a world with Zero Crashes, Zero Emissions and Zero Congestion and we embrace the responsibility to lead the change that will make our world better, safer and more equitable for all. **Why Join Us** We believe we all must make a choice every day - individually and collectively - to drive meaningful change through our words, our deeds and our culture. Every day, we want every employee to feel they belong to one General Motors team. **Benefits Overview** From day one, we're looking out for your well-being-at work and at home-so you can focus on realizing your ambitions. Learn how GM supports a rewarding career that rewards you personally by visiting Total Rewards resources (************************************************************* . **Non-Discrimination and Equal Employment Opportunities (U.S.)** General Motors is committed to being a workplace that is not only free of unlawful discrimination, but one that genuinely fosters inclusion and belonging. We strongly believe that providing an inclusive workplace creates an environment in which our employees can thrive and develop better products for our customers. All employment decisions are made on a non-discriminatory basis without regard to sex, race, color, national origin, citizenship status, religion, age, disability, pregnancy or maternity status, sexual orientation, gender identity, status as a veteran or protected veteran, or any other similarly protected status in accordance with federal, state and local laws. We encourage interested candidates to review the key responsibilities and qualifications for each role and apply for any positions that match their skills and capabilities. Applicants in the recruitment process may be required, where applicable, to successfully complete a role-related assessment(s) and/or a pre-employment screening prior to beginning employment. To learn more, visit How we Hire (********************************************* . **Accommodations** General Motors offers opportunities to all job seekers including individuals with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, email (Careers.Accommodations@GM.com) us or call us at ************. In your email, please include a description of the specific accommodation you are requesting as well as the job title and requisition number of the position for which you are applying. We are leading the change to make our world better, safer and more equitable for all through our actions and how we behave. Learn more about: **Our Company (************************************************** **Our Culture** **How we hire (************************************************ Our diverse team of employees bring their collective passion for engineering, technology and design to deliver on our vision of a world with Zero Crashes, Zero Emissions and Zero Congestion. We are looking for adventure-seekers and imaginative thought leaders to help us transform mobility. Explore our global locations (******************************************** We are determined to lead change for the world through technology, ingenuity and harnessing the creativity of our diverse team. Join us to help lead the change that will make our world better, safer and more equitable for all by becoming a member of GM's Talent Community (beamery.com) (*********************************************** . As a part of our Talent Community, you will receive updates about GM, open roles, career insights and more. Please note that filling out the form below will not add you to our Talent Community automatically; you will need to use the link above. If you are seeking to apply to a specific role, we encourage you to click "Apply Now" on the job posting of interest. The policy of General Motors is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual's age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity/expression or veteran status. Additionally, General Motors is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including individuals with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, email us at Careers.Accommodations@GM.com .In your email, please include a description of the specific accommodation you are requesting as well as the job title and requisition number of the position for which you are applying.

The Trial Specialist is responsible for the comprehensive management, coordination, and facilitation of stamping and material trials within the organization. This role serves as the primary point of contact for internal and external stakeholders regarding trial requests and ensures the efficient execution, tracking, and reporting of all trial activities. The specialist also leads efforts for critical "special project" trial-related matters, addressing significant business interruptions and strategic resourcing initiatives. Qualifications (Desired): Proven experience in project management or coordination, preferably within a manufacturing or engineering environment. Strong organizational and time management skills with the ability to manage multiple complex trials simultaneously. Excellent communication and interpersonal skills to effectively liaise with diverse internal and external stakeholders. Ability to facilitate meetings, gather feedback, and drive consensus. Proficiency in tracking and reporting tools. Knowledge of stamping processes, material trials, and supply chain logistics is highly desirable. Problem-solving skills with a proactive approach to addressing challenges and business interruptions. Key Responsibilities: Manage all stamping trial actions from initiation to completion. Facilitate the development and submission of trial proposals. Serve as the Single Point of Contact (SPOC) for other organizations, mills, and material processors concerning trial requests. Establish and maintain clear points of contact for each phase of every trial. Manage and update trial tracking sheets to ensure accurate status reporting. Coordinate the timing of material orders effectively with Material Planning & Logistics (MP&L). Collect and synthesize trial feedback from all designated points of contact. Facilitate Material Trial Cost Reimbursement Requests, ensuring timely processing. Schedule and coordinate regular trial meetings (monthly or bi-weekly) with trial administrators across eleven stamping facilities to monitor and update trial statuses. Act as the lead for "special project" trial-related matters, including critical resourcing initiatives (e.g., Cliffs, Constellium), responses to significant events (e.g., Novelis fire, Tariff actions), and recovery from business interruptions (e.g., SET Enterprises bankruptcy, Cliffs Dearborn Works BOF shutdown).

Detroit Medical Center Shared Services is committed to providing exceptional patient care in a supportive and collaborative environment. As a member of our team, you will have the opportunity to work with advanced technology and be part of a healthcare community dedicated to making a positive impact on the lives of our patients. Benefits Statement At Tenet Healthcare, we understand that our greatest asset is our dedicated team of professionals. That's why we offer more than a job - we provide a comprehensive benefit package that prioritizes your health, professional development, and work-life balance. The available plans and programs include: * Medical, dental, vision, and life insurance * 401(k) retirement savings plan with employer match * Generous paid time off (PTO) * Career development and continuing education opportunities * Health savings accounts, healthcare & dependent flexible spending accounts * Employee Assistance program, Employee discount program * Voluntary benefits include pet insurance, legal insurance, accident and critical illness insurance, long term care, elder & childcare, auto & home insurance. Note: Eligibility for benefits may vary by location and is determined by employment status Job Summary The GME QI/Research Coordinator will support in translating clinical needs into analytic questions, designing and conducting rigorous analyses of health-related data, and translating analytic findings into actionable intelligence for our faculty and residents/fellows. Principle Duties: * Collaborates with faculty and residents to stimulate scholarly productivity of faculty and residents. * Assist multidisciplinary team in research activities. * Schedule and participate in monitoring visits and participate in multidisciplinary team program meetings as required. * Coordinate/participate in the Institute Review Board (IRB) process for new protocol submissions, amendments, renewals, revisions, adverse events, and final reports. * Assists on the development and implementation of quantitative measurement systems for clinical and/or laboratory use. * Assists with and participates in special projects focusing on various aspects of specialty. * Prepares detailed reports and/or abstracts and participates in presentations. * Track scholarly activity projects for the program in residency management system. * Oversee, mentor, and guide a dedicated and team of data analysts and other research support staff * Ensuring compliance with federal, state and DMC regulations, policies, procedures, and audit requirements in the use of patient data for research purposes * Contribute to the development of training, tools, and process documentation for both the department and for assigned projects * Perform data analyst functions that generate knowledge via data mining, visualization, or other analytics. Serve as a resource to others performing this work. Lead the creation of best practices, resources, and tools that enable new analytical capabilities. * Constructing and manipulating large electronic claims datasets, knowledge in domain modeling, relational database design, programming language(s), SAS, data transfer methods, and electronic health record and health care claims standards and/or analytical techniques used in research programs. * Developing study designs and analytic solutions based on available data sources and timelines. * Managing multiple projects related to a wide variety of business settings and clinical needs. * Collaborating with key internal and external stakeholders to gather and analyze needs and requirements. * Presenting data or analytic findings in a variety of formats (reports, PPT, graphs, figures, and tables) * Develop and maintain a working knowledge of statistical principles and analysis considerations during planning of research. * Consult on and provide direct technical support for research projects of high complexity and often requiring solutions not previously used by the project team or work group. * Develop and maintain knowledge of terminologies and coding procedures used in research and the health care environment. * Other duties as assigned. Qualifications: Qualifications * Bachelor's degree. Master's degree preferred. * Two years prior research experience in area of research focus. * Three to four years of progressively more responsible related administrative experience. * Basic understanding of regulatory guidelines. * Ability to utilize computer software to access and input data. * Education in medical and/or science experience/education. * Excellent written and interpersonal skills to effectively deal with patients, clinicians, administrators, regulators, and sponsors * Collaborative Institutional Training Initiative (CITI) Program Certification (or equivalent) Facility Description The Detroit Medical Center (DMC) is a nationally recognized health care system that serves patients and families throughout Michigan and beyond. A premier healthcare resource, our mission is to help people live happier, healthier lives. The hospitals of the Detroit Medical Center are the Children's Hospital of Michigan, Detroit Receiving Hospital, Harper University Hospital, Hutzel Women's Hospital, the DMC Heart Hospital, Huron Valley-Sinai Hospital, the Rehabilitation Institute of Michigan and Sinai-Grace Hospital. DMC's 150-year legacy of medical excellence and service provides patients and families world-class care in cardiovascular health, women's services, neurosciences, stroke treatment, orthopedics, pediatrics, rehabilitation, organ transplant and other general and specialty services. DMC is a key partner in Detroit's resurgence, which continues to draw national and international attention. A dedicated corporate citizen with strong community ties, DMC is one of the largest and most diverse employers in Southeast Michigan. EEO Statement Employment practices will not be influenced or affected by an applicant's or employee's race, color, religion, sex (including pregnancy), national origin, age, disability, genetic information, sexual orientation, gender identity or expression, veteran status or any other 13 legally protected status. Tenet will make reasonable accommodation for qualified individuals with disabilities unless doing so would result in an undue hardship. Tenet participates in the E-Verify program. Follow the link below for additional information. E-Verify: ***************************** The employment practices of Tenet Healthcare and its companies comply with all applicable laws and regulations Job: Process Improvement Primary Location: Detroit, Michigan Facility: Detroit Medical Center Shared Services Job Type: Full Time Shift Type: Day Employment practices will not be influenced or affected by an applicant's or employee's race, color, religion, sex (including pregnancy), national origin, age, disability, genetic information, sexual orientation, gender identity or expression, veteran status or any other legally protected status. Tenet will make reasonable accommodations for qualified individuals with disabilities unless doing so would result in an undue hardship. Tenet participates in the E-Verify program. Follow the link below for additional information. E-Verify: ***************************** The employment practices of Tenet Healthcare and its companies comply with all applicable laws and regulations. ********** Apply Now Save Job

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.

Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report. Location Outpatient Services at 1440 N Dayton Job Description Coordinates all behavioral research activities with moderate supervision. Adheres to the service values and principles as well as the principles of research ethics. The balance between patient-facing and administrative data tasks varies according to the specific requirements of each research program. Essential Job Functions: * Manages research projects, including study start-up, protocol coordination, monitoring, and close-out activities. * Maintains strict adherence to study protocols and regulatory standards throughout all phases of the study. * Manages study regulatory activities by preparing and maintaining all regulatory documents and regulatory agencies, including protocols, informed consent documents, recruitment materials, initial submissions, modifications, and renewals. * Maintains comprehensive study documentation such as regulatory binders and correspondence. * Coordinates the conduct of behavioral research projects with various departments, adheres to standard operating procedures (SOPs) to ensure adherence to research protocols and regulatory standards, and track deadlines for grants and deliverables. * Identifies and recruits eligible study subjects, manage the informed consent/assent process, coordinate the reimbursement of study participants, and serve as the primary liaison for participant inquiries. * Arranges and conducts research visits, including delivering behavioral interventions, such as administering surveys, facilitating interviews, and leading focus groups. * Abstracts and enters data from medical records onto protocol-specific case report forms and electronic systems, record data on source documents and CRFs, and conduct statistical analysis under PI supervision. * Conducts quality assurance activities by adhering to research protocols and applicable regulations (OHRP, FDA, GCP), performing QA/QC checks for database validity, and ensuring ongoing data monitoring to maintain high standards of research integrity. * Attends research meetings and actively participate in educational conferences to promote the ethical conduct of research and stay informed about best practices. * Participates in the preparation and presentation of research findings through abstract and poster development and assists in the writing and editing manuscripts. * Other job functions as assigned. Knowledge, Skills, and Abilities: * Bachelor's degree and one year research experience required. A combination of education and/or experience may be considered in lieu of the degree when the experience is directly related to the duties of the job. * Proficient organizational skills with ability to manage multiple studies. Proficient verbal and written communications skills. * Proficient knowledge of FDA, HSR, and GCP Guidelines. * Proficient analytical skills with the ability to recognize quantitative and qualitative research methods and remain agile and adaptable to various technological systems. * Proficient entry level leadership skills. * Recognizes the need to prioritize tasks, problem solve, and work with others. * Assists to foster an inclusive environment where all team members feel valued and respect Education Bachelor's Degree (Required) Pay Range $49,920.00-$81,619.20 Salary At Lurie Children's, we are committed to competitive and fair compensation aligned with market rates and internal equity, reflecting individual contributions, experience, and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions. In addition to base salary, Lurie Children's offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits. Benefit Statement For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes: Medical, dental and vision insurance Employer paid group term life and disability Employer contribution toward Health Savings Account Flexible Spending Accounts Paid Time Off (PTO), Paid Holidays and Paid Parental Leave 403(b) with a 5% employer match Various voluntary benefits: * Supplemental Life, AD&D and Disability * Critical Illness, Accident and Hospital Indemnity coverage * Tuition assistance * Student loan servicing and support * Adoption benefits * Backup Childcare and Eldercare * Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members * Discount on services at Lurie Children's facilities * Discount purchasing program There's a Place for You with Us At Lurie Children's, we embrace and celebrate building a team with a variety of backgrounds, skills, and viewpoints - recognizing that different life experiences strengthen our workplace and the care we provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care. Lurie Children's and its affiliates are equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law. Support email: ***********************************

Scheduled Hours40Functions as the lead person on a research project; coordinates enrollment of study subjects; ensures adherence to study procedures consistent with the study protocol and verifiable source documentation; may supervise personnel assigned to work on the study. Coordinates with multidisciplinary teams to maintain continuity of care and human subject protection with a commitment to research integrity. May perform duties inclusive of those delegated to a Research Nurse Coordinator I.Job Description Primary Duties & Responsibilities: Works under the Principal Investigator's (PI) guidance to meet the research objective of the project. Facilitates and implements study start-up activities including (but not limited to): trial feasibility assessment; study logistics; IRB (both local and central) submissions and other applicable regulatory requirements; budgetary and contract review and approval. Provides direct patient care, including assessment, planning, implementation and evaluation of patients; documents, collects data and assists physicians. Works with research team to identify, screen and enroll study subjects. Ensures protocol requirements are met including (but not limited to): direct contact with research participants; collection of basic health information; coordination of study related procedures; handling, processing and shipping of research specimens, source documentation and data entry. May train and supervise staff assigned to work on the research project(s). Coordinates handling of specimens, administration of clinical trials, collection of source information and case reporting. Prepares/submits reportable event reports to sponsor(s), IRBs and regulatory agencies in accordance with the study protocol and established policies, procedures, and regulations. Collaborates with sponsor's research associates during monitoring activities by providing study documentation, data clarifications and reports as necessary. Authorizes payments to ancillary organizations for services rendered and reconciles payments from organizations serviced. Demonstrates experience in clinical trials management including strong organizational skills, independence and resourcefulness and an increased responsibility for the day-to-day conduction and oversight of multiple clinical trials. Provides oversight of administration of study medications and/or study interventions, as appropriate. Administers investigational products in approved settings. Educates staff nurses caring for research patients by providing necessary information about the research study including intervention and potential adverse events and required study procedures. Performs other duties incidental to the work described above. Working Conditions: Job Location/Working Conditions Normal office environment Exposure to blood-borne pathogens Requires protective devices Patient care setting Direct patient care setting Physical Effort Typically sitting at desk or table Typically bending, crouching, stooping Occasional lifting (25 lbs or less) Equipment Office equipment Clinical/diagnostic 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: A diploma, certification or degree is not required. Certifications/Professional Licenses: The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certification or professional license may be required depending on the role.Basic Life Support - American Heart Association, Basic Life Support - American Red Cross, Registered Nurse - Illinois Department of Financial and Professional Regulation, Registered Nurse - Missouri Division of Professional Registration Work Experience: Related Nursing 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 (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements). Preferred Qualifications: Clinical Research Certification. Preferred Qualifications Education: B.S. - Bachelor of Science, B.S.N. - Bachelor of Science in Nursing Certifications/Professional Licenses: No additional certification/professional licenses unless stated elsewhere in the job posting. Work Experience: Academic Research Setting () Skills: Active Listening, Clinical Research Coordination, Clinical Research Management, Clinical Research Methods, Clinical Research Operations, Clinical Techniques, Database Management, Detail-Oriented, Effective Written Communication, Electronic Health Records (EHR), Nursing Fundamentals, Oral Communications, Patient Recruitment, Reporting Tools, Spreadsheet Software, Statistical Analysis Software (SAS), Team CollaborationGradeS26Salary Range$60,800.00 - $105,700.00 / AnnuallyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.Pre-Employment ScreeningAll external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.Benefits Statement Personal Up to 22 days of vacation, 10 recognized holidays, and sick time. Competitive health insurance packages with priority appointments and lower copays/coinsurance. Take advantage of our free Metro transit U-Pass for eligible employees. WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%. Wellness Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more! Family We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered. WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us. For policies, detailed benefits, and eligibility, please visit: ****************************** EEO StatementWashington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.

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 Arizona. 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. We are seeking International Medical Graduates with a minimum of 1 year of research experience. Additionally, someone with a strong interest in the Clinical Research field would be an excellent fit for our entry level position, with room to grow. However, this interest and background is not necessary, as our ideal candidate is an individual who is detail orientated, being able to maintain organized records, as well as someone who is motivated to learn new things, as our company is always growing and expanding into new therapeutic areas. We are looking for individuals that want the opportunity to learn and grow with us. New Staff should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results. Some responsibilities will include coordinating and managing multiple studies. They are also responsible for assisting the Principal Investigators and other clinical staff, with any study related tasks as follows but not limited to: Research participant screening, recruitment and enrollment. Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight. Responsible for collecting, processing and shipping of research specimens, where applicable. Document study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits. Obtain, review and maintain source documents. Maintain organization of all trial related documents and correspondence. Implement quality control and assurance methods. Communicate with study sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting. Maintain professional and technical knowledge of Clinical trials and Standards of Care. Protect patient confidentiality. Preferred Qualifications Education/ Training: International Medical Graduate; MBBS, BMBS, MBChC, MBBCh, MD, DO, MCM, DM, MCM, MMSc, MMedSc, MM, MMed, MS, MSurg, MChir, MCh, ChM, CM, MSc, DCM, DClinSurg, DMSc, DMedSc, DS, DSurg Radiology experience is preferred. Phlebotomy skills are also preferred. Additional Qualifications: Database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Maintain data integrity within the department. Must be able to work in a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff. Knowledge of FDA Regulations and Good Clinical Practices. JOIN US & GROW YOUR KNOWLEDGE & EXPERIENCE!!!

Internal Job Description Job Title: Clinical Research Coordinator Work Set-Up: Working On-site Schedule: 16 hours per week. Responsibilities: * Phlebotomy is required, and pediatric experience is also needed. Additionally, community outreach will be part of the role. * Perform a variety of complex clinical procedures on subjects including but not limited to ECG, sample collection including spirometry, and vital signs. * Coordinate clinical research studies conducted by a supervising principal investigator. * Update and maintain skills, training, and knowledge of current best nursing practices and topics related to clinical research. * Safeguard the well-being of the subjects and ensure and maintain high standards: * Maintain a safe environment in accordance with Health and Safety policies. * Act as a volunteer advocate. * Address volunteer and visitor concerns proactively and take remedial action as required. * Assist staff, both registered and unregistered, in clinical coordinator practices and the delivery of care to the volunteer. * Report any deviation from normal practice to senior staff. Support Study Conduct By: * Reviewing the study protocol, case report form (CRF), other study documents, and electronic data capture systems. * Participating in project meetings with the project team as needed. * Performing clinical set-up and preparation for the study including labeling specimen collection tubes and containers, setting up equipment and documents. * Planning logistical activity for procedures as per protocol. * Generating volunteer instructions. * Identifying and obtaining required supplies and equipment. * Preparing and delivering study-specific training materials, documents, and records. * Troubleshooting study issues. * Participating in huddles to ensure daily tasks assigned to team members are executed to the expected standards. * Assisting with data quality checking and query resolution to ensure that data collected on study volunteers adhere to study protocol and ensuring quality control for content accuracy and completeness. * Recruiting and screening volunteers for inclusion in the study based on pre-determined criteria. * Orienting volunteers to the study and the site including the purpose of the study, procedures, and practical issues such as timelines for visits. * Responsible for the correct administration and custody of study drug according to site standard operating procedures. * Collecting, recording, and reporting clinical data and findings appropriately in case report forms (CRFs). Collaborating closely with the study investigator, informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol. * Cooperating with the study monitor and reserving sufficient time for questions during monitoring. * Following ICH GCP guidelines with regards to all study and patient activities. Qualifications: * Equivalent education and experience - High School Diploma and 1 years' relevant work experience in clinical research * At least 1 year experience working in a clinical research setting preferred. * Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies. * Working knowledge of clinical trials. * Working knowledge of the principles of Good Clinical Practices (GCP). * In-depth knowledge of protocol and study-specific operating procedures, consent forms, and study schedules. * Skill in carrying out required clinical procedures. * Working knowledge of medical terminology. * Ability to pay close attention to detail. * Ability to establish and maintain effective working relationships with coworkers, managers, patients, physicians, and clients. Please note, this position is not eligible for sponsorship. #LI-CES and #LI-DNP #LI-HCP #ONSITE IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role is $35.00-$42.00 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

The Director Clinical Sciences, Hematology, leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Director leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and late phase development. The Director reports to the Senior Director Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. The director will be responsible for managing a team of clinical scientists. As a Director in Hematology, a typical day may include the following: * May function as lead Clinical Scientist (CS) for program, and/or as delegate of Therapeutic area (TA) Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical SubTeam * Line Manager for CS team and serves as key functional advisor or representative for the CS group; ensures alignment of process and procedures for CS across assigned assets/programs in alignment with TA expectation; Guides assigned Program teams/direct reports * Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments * Applies advanced scientific expertise to propose, design, and execute clinical research and development studies for early and late stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature * Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and resolve cross functional comments independently; Independently leads planning and prepares information for external /stakeholder meetings (IM, Governance, IDMCs, Regulatory Authorities) * Performs and mentors direct reports in clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety * Applies advanced analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies; Identifies areas of potential inconsistent data review * Ensures consistent first line medical/clinical data review techniques and conventions across studies/programs; leads drafting/updating/review of clinical data review plan and medical monitoring plans; ensures execution where appropriate for assigned studies/programs This role may be for you if: * Exhibits high level of skill in building team and mentoring direct reports * Ability to lead activities within a matrix environment; Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally; Demonstrated ability to influence within team and department and may influence across functionally * Demonstrates exceptional initiative, creativity and innovation skills. Directly contributes to the development of innovations. Identifies opportunities to initiate operational changes * Strong direct-line and cross-functional management, interpersonal and problem-solving skills To be considered for this position, you must have a bachelor's degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc). Additionally, ≥ 10 years of pharmaceutical clinical drug development experience. We are specifically seeking experience with lymphoma/hematology oncology, and a minimum of 4 years of direct and/or indirect management experience. Proven understanding of therapeutic disease areas and drug candidates including underlying disease biology, clinical manifestations and therapeutic standard practice, compounds including mechanism of action and drug landscape. Other levels considered depending on experience. #Hematology Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $202,000.00 - $336,600.00

Job Description We are seeking a Full Time on-site Clinical Trials Study Coordinator. The Clinical Research Coordinator is responsible for managing clinical trial performance and ensuring the conduct of their clinical trials is congruent with the vision and mission of the company. The CRC plans, coordinates, evaluates, and manages the care of both the participants and the data for their assigned trials. The CRC follows study specific protocol guideline and communicates and interacts with Investigators, clinic staff, CROs and Sponsors to effectively perform clinical research and coordinate research activities. All duties carried out by the CRC are done so in accordance with company policies, SOPs, and Good Clinical Practice (GCP) as well as all applicable local, state and federal regulations. Primary Responsibilities: · Coordinate clinical trials conducted by a supervising Principal Investigator in accordance with FDA, GCP and protocol guidelines. · Identify potential problems or inconsistencies and take action as appropriate. · Articulate protocol issues to CRO and/or Sponsor, Site Lead, Manager, Principal or Sub-Investigator, and other members of the study team. · Collect initial subject health and demographic information by interviewing subjects and accessing other appropriate sources. · Review subject comprehensive medical documentation to determine protocol eligibility under the supervision of the Principal Investigator. · Ensure a flow of communication including telephone conferences between subject, study staff, referral sources and recruitment team, Sponsor and/or CRO, Monitor(s) and Auditors, if applicable. · Perform clinical tasks including, but not limited to: vital signs, height and weight, ECG, phlebotomy, specimen processing and packaging. · Maintain timely internal source documentation as well as sponsor-required information. · Maintain timely EDC data entry and query resolution. · Maintain timely CTMS data entry of patient visits and study information. · Complete Verification of subjects before consenting. · Report hospital census data, if applicable. · Dispense and maintain accurate records of investigational and study product. · Educate subject and family members regarding specific studies and clinical drug trials in general. · Complete all monitor and sponsor queries in a timely manner. · Perform Quality Control (QC) checks on all trials per company SOP and interface with QA Director as needed. Recruitment Responsibilities: · Send “All Users” email upon enrollment activation or enrollment closure · Participate in recruitment planning meetings prior to study start · Provide weekly updates to Active Studies Report · Communicate all advertising needs to recruitment team · Maintain weekly communication with recruitment team in order to maximize recruitment in all enrolling trials · Communicate the need for study or company flyers Secondary Responsibilities: Maintains Quality Service and Departmental Standards by · Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”) · Assisting in establishing and enforcing departmental standards Contributes to team effort by · Working with internal staff to resolve issues · Exploring new opportunities to add value to the organization and departmental processes · Helping others at the site to achieve site goals · Performing other duties as assigned · Support the organization's mission and goals Maintains Technical and Industry Knowledge by · Attending and participating in applicable company-sponsored training · Attending and participating in Sponsor investigator meetings, recruitment meetings, and trainings Skills And Qualifications: CCRC or CCRP certification preferred · Strong motivational skills and abilities - promoting a team-based approach · Strong interpersonal and communication skills, both verbal and written · Strong organizational and leadership skills · Goal oriented · Ability to maintain a professional and positive attitude · Detail Oriented · Strong critical thinking skills · Strong ability to multi-task · Strong computer skills · Ability to support and demonstrate the mission and goals of the company · Excellent interpersonal and customer service skills · Knowledge of medical terminology and clinical practices Experience: At least 2 years of experience as a CRC in clinical research or relevant clinical role Nothing in this position description restricts management's rights to assign or reassign duties and responsibilities to this position at any time.

Join our growing Clinical Trials Unit (CTU) in Plymouth, MI, where we conduct innovative, high-impact clinical trials across expanding therapeutic areas. Since 2014, our collaborative team has thrived in a fast-paced environment focused on accuracy, participant safety, and operational excellence. We anticipate continued growth and offer opportunities for advancement to skilled Clinical Research Coordinators. This is a full-time position; however, part-time scheduling may be considered for highly qualified candidates. While most work will require on-site presence, there is opportunity to work 1 day remote dependent on project needs. Most shifts occur during daytime hours, though occasional evening, overnight, or weekend coverage may be required depending on study needs. Job Summary The Clinical Research Coordinator III (CRC III) is an advanced-level role responsible for independently coordinating complex clinical research studies from startup through closeout. This position requires strong clinical research knowledge, clinical trial experience, advanced protocol management skills, and the ability to support multiple studies simultaneously. The CRC III plays a critical role in participant recruitment, enrollment, visit execution, data management, and biospecimen handling while ensuring compliance with ICH-GCP, FDA, and sponsor requirements. The CRC III may also support regulatory submissions and serve as a resource to junior staff. Responsibilities Actively participates in participant recruitment, screening, informed consent, and enrollment. Coordinates complex study visits and procedures in accordance with protocol requirements. Oversees accurate data collection, source documentation, and entry into EDC systems. Performs data cleaning and resolves queries within sponsor-required timelines. Collects, processes, labels, stores, and ships biospecimens per laboratory manual specifications. Monitors participant safety, clinical status, and adverse events; ensures timely reporting. Ensures compliance with ICH-GCP, FDA, OHRP, HIPAA, and sponsor requirements. Manages regulatory components of studies, including maintaining the electronic Investigator Site File (eISF). Prepares for and participates in monitoring visits, SIVs, SQVs, and closeout visits. Provides mentorship and guidance to CRC I and CRC II team members. Participates in team meetings, investigator meetings, and sponsor-required trainings. Collaborates with investigators, clinicians, and research staff to support study execution. Assists in developing recruitment materials, source documents, and study tools. Maintains awareness of industry best practices and evolving research regulations. Qualifications Required Qualifications Bachelor's degree in health science, medical, or related discipline. 4-6 years of experience working with commercial clinical trials. BLS and/or ACLS certification. Proficiency with Microsoft Office and common EDC systems. Strong understanding of ICH-GCP, FDA, OHRP, and HIPAA regulations. Experience with biospecimen collection, processing, and shipping. Excellent organizational and problem-solving skills with ability to manage multiple studies. Strong communication and leadership ability. Ability to maintain strict confidentiality and data security. U.S. Citizenship or Permanent Residency required. Preferred Qualifications ACRP-CCRC or SOCRA certification. Extensive knowledge of medical terminology, clinical lab assessments, and pharmacovigilance. Experience with IRB processes and regulatory submission platforms (e.g., ePortal). Candidate Traits Highly detail-oriented with exceptional organizational skills. Strong leadership abilities with experience mentoring junior staff. Proactive problem solver with ability to work in a dynamic environment. Strong interpersonal skills and ability to collaborate with cross-disciplinary teams. Self-motivated and able to work independently while upholding ethical standards. The salary range is: $64,396-$82,400/annually. Salary ranges will vary and are based on several factors, including geographic location, market competitiveness and equity amongst internal employees in similar roles. Positions may also qualify for SRI's Pay for Outstanding Performance program or the annual Performance Based Compensation program. SRI also has a competitive benefits package, to view details please go to **************************************** SRI will accept applications until the position is filled. SRI is an independent nonprofit research institute headquartered in Menlo Park, Calif., with a rich history of supporting government and industry. We create and deliver world-changing solutions for a safer, healthier, and more sustainable future. For more than 75 years, we have collaborated across technical and scientific disciplines to discover and develop groundbreaking products and technologies and bring innovations and ideas to the marketplace.

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 We are seeking a highly motivated and organized Clinical Research Coordinator Senior/Intermediate to support the federally funded projects grant in the department of obstetrics and gynecology. The studies are a collaboration among multiple institutions: Some of the aims of these studies include: eliminating disparities in the fibroid experience through academic and community partnership, invitro fertilization study to understand the best timing of embryo transfer, and other reproductive endocrinology and related areas of research. The successful candidate will coordinate and streamline study operations, move the study operations forward incrementally, ensure efficient project execution, and assist with the management of clinical research activities. Working closely with principal investigators, community members, and research staff, including the communications director, community engagement manager, and Sr. CRCs. This role will coordinate multiple studies and may provide functional supervision for 1-2 junior team members. The ideal applicant is proactive, an effective problem-solver, and excels at independent work, communication, and collaboration. Experience and foresight in anticipating project needs and recommending solutions is essential. We value diverse perspectives and are committed to fostering a collaborative environment where every team member can thrive and contribute to our collective success. Mission Statement Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society. Why Join Michigan Medicine? Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good. What Benefits can you Look Forward to? * Excellent medical, dental and vision coverage effective on your very first day * 2:1 Match on retirement savings Responsibilities* Contribute to the development of process and tools within all 8 competency domains is expected: * Scientific Concepts and Research Design * Ethical Participant Safety Considerations * Investigational Products Development and Regulation * Clinical Study Operations (GCPs) * Study and Site Management * Data Management and Informatics * Leadership and Professionalism * Communication and Teamwork Clinical Research Coordination * Collaborate closely with the PIs, Director of Operations & Director of Communications; program manager, and study team in planning and executing study activities. * Organize and facilitate recurring federally funded NIH & /OR PCORI study meetings (e.g., MPI, Steering Committee, Project PI). Ensure agendas are ready and minutes and next steps are distributed and documented. * Collaborate with the on WHARD team and supervisors on logistics for the annual national study meetings and/or Open House events. * Serve as a key administrative contact for daily study operations, tabling events, recruitment plans, maintaining communication with team members and collaborators, internal and external stakeholders, etc. * Participate in study start-up, active, and closeout phases; maintain inventory and coordinate related tasks as directed. * Lead study recruitment in the community and/or clinics as appropriate. Research Data Coordination * Support creation and upkeep of study databases. Develop survey instruments and CRFs in REDCap and/or support staff working on REDCap. * Ensure accurate data entry and documentation through established processes and quality checks. * Oversee scheduling of qualitative interviews, support survey development, REDCap build, and assist with qualitative analysis using NVIVO. * Train and support staff on data management; help resolve data discrepancies. Regulatory Coordination * Prepare and submit IRB applications, amendments, and continuing reviews. * Maintain regulatory documentation in compliance with guidelines, collaborating with study leadership. * Monitor adherence to study protocols; escalate issues as needed. * Stay current on regulatory requirements and participate in quality assurance activities. Research Administration * Coordinate communication among research teams, sponsors, and stakeholders. * Proactively and independently manage project tasks in a timely fashion such as document filing, meeting scheduling, milestone tracking, and database management. * Draft slides and minutes for meetings and send to team for review; track follow-up items. * Support logistical needs for boards/committees, preparing presentations and reports as needed. * Assist with financial and personnel documentation, monitor staff time and expenses under supervision. * Help develop and update protocols, SOPs, and study documents. * Manage aspects of federally funded NIH/PCORI app development, coordinating with the programming team. * Perform additional administrative tasks as needed for the NIH/PCORI grants. Other Duties * Reconciling expenses following University policies, ensuring reimbursement and payment for all applicable parties are completed in a timely manner. Coordinate with external vendors (e.g., PO, Contracts, MarketSite, QTO orders). * Under supervision, assist with Pilot Grant processes, including application management and accurate and timely award communications. * Collaborate with Communications and Community Engagement teams to maintain a database of project materials. * Support documentation, manuscript preparation, and compliance with NIH requirements. * Help orient and mentor new research staff and students; and other study related tasks as assigned. Required Qualifications* * Education: Bachelor's degree in Public Health, Social Work, Psychology, Research Administration, Business, Education, Social Sciences, or a related field, or equivalent combination of education and experience. * Experience: Minimum of 3 years (Intermediate) to 5 years (Senior) directly related experience in clinical or public health research coordination, including study management and regulatory compliance in an academic or health care setting. * Certification: Certification is required through Association of Clinical Research Professionals (ACRP

Full-time Description Clinical Research Coordinator, RN's are primarily responsible for study coordination and data management, with a central focus on managing subject recruitment and enrollment, consistency of study implementation, data management and integrity, and compliance with regulatory requirements and reporting. Requirements ESSENTIAL JOB FUNCTION/COMPETENCIES The responsibilities and duties described in this job description are intended to provide a general overview of the position. Duties may vary depending on the specific needs of the affiliate or location you are working at and/or state requirements. Responsibilities include but are not limited to: Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner. Educates and directs protocol compliance with physicians and staff. Assists in developing tools to meet requirements of new protocols. Manages protocols with increased clinical complexities including translational investigator-initiated research as well as multi center trials. 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. Acts as a patient advocate by providing education to and responding to questions from patients about protocols. Works with patients to ensure adherence with the protocol. Collaborates with scheduling staff to assure that future appointments for the patients (follow up visits and diagnostic testing) are scheduled correctly and timely. Collaborates with the physician to assure orders for treatment are written per protocol and delivered at the prescribed protocol intervals. Performs other position related duties as assigned. Employees shall adhere to high standards of ethical conduct and will comply with and assist in complying with all applicable laws and regulations. This will include and not be limited to following the Solaris Health Code of Conduct and all Solaris Health and Affiliated Practice policies and procedures; maintaining the confidentiality of patients' protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA); immediately reporting any suspected concerns and/or violations to a supervisor and/or the Compliance Department; and the timely completion the Annual Compliance Training. CERTIFICATIONS, LICENSURES OR REGISTRY REQUIREMENTS BLS certification required, ACLS preferred. RN licensure and certifications as required by State. Clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) preferred. KNOWLEDGE | SKILLS | ABILITIES Ability to Start IVs and Administer IV medications Ability to draw blood Understanding of all aspects of biomedical research protocols, ensuring applicable regulations, and guidelines. Maintains patient confidentially. Excellent verbal and written communication skills. Skill in using computer programs and applications. Maintains current knowledge and awareness of organizational and regulatory standards, policies and procedures. Excellent organizational skills and attention to detail. Ability to build relationships with patients and display empathy and compassion to patients Skill in using computer programs and applications including Microsoft Office. Complies with HIPAA regulations for patient confidentiality. Complies with all health and safety policies of the organization. EDUCATION REQUIREMENTS Must be a Registered Nurse (RN) with a current and valid license. Associate's or Bachelor's degree in Nursing (ASN or BSN) required. EXPERIENCE REQUIREMENTS 2 or more years Nursing experience in ICU, ER, oncology or clinical trial experience, preferred. REQUIRED TRAVEL May require travel to other site locations in practice. May require travel to Investigator and other meetings. PHYSICAL DEMANDS Carrying Weight Frequency 1-25 lbs. Frequent from 34% to 66% 26-50 lbs. Occasionally from 2% to 33% Pushing/Pulling Frequency 1-25 lbs. Seldom, up to 2% 100 + lbs. Seldom, up to 2% Lifting - Height, Weight Frequency Floor to Chest, 1 -25 lbs. Occasional: from 2% to 33% Floor to Chest, 26-50 lbs. Seldom: up to 2% Floor to Waist, 1-25 lbs. Occasional: from 2% to 33% Floor to Waist, 26-50 lbs. Seldom: up to 2% Version 6.2.25

Job Description We are seeking a highly organized and motivated Clinical Research Coordinator (CRC) to join our research team. The CRC will coordinate and support all aspects of clinical trials and research studies, including subject recruitment, data collection, regulatory compliance, and specimen handling. Candidates with current Phlebotomy certification or Medical Assistant (MA) certification are strongly preferred, as this role may include specimen collection and basic clinical procedures. Key Responsibilities: Coordinate day-to-day clinical research activities to ensure study protocols are followed. Recruit, screen, and enroll study participants. Obtain informed consent and ensure ethical conduct in all study interactions. Collect, process, and ship biological specimens per protocol (e.g., blood draws, urine samples). Perform basic clinical procedures as permitted by certification (e.g., vital signs, EKGs). Maintain accurate and timely documentation in case report forms and electronic databases. Communicate with sponsors, monitors, and IRBs regarding study progress and compliance. Schedule participant visits and follow-ups; ensure visit windows are met. Ensure proper storage, handling, and accountability of investigational products, if applicable. Maintain regulatory documents and assist with IRB submissions. Qualifications: Bachelor's degree in a health-related field or equivalent experience. At least 2 years of experience in clinical research preferred. State Phlebotomy license required MA certification preferred Knowledge of Good Clinical Practice (GCP) and regulatory guidelines. Excellent organizational skills and attention to detail. Strong interpersonal and communication skills. Proficiency in Microsoft Office and electronic data capture systems (e.g., REDCap, EDC platforms). Ability to work independently and as part of a multidisciplinary team. Preferred Qualifications: Experience working in clinical trials at the research site level Familiarity with IRB processes and clinical trial documentation. Bilingual skills (depending on patient population) may be a plus.