Clinical research coordinator jobs in Warren, 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

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. 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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. JOIN OUR TEAM QUALITY CARE DELIVERED BY COMPASSIONATE PEOPLE We know it takes a special person to work in healthcare, and we are committed to providing our people with an enriching and rewarding environment. We deliver the resources, tools and support our employees need to serve our patients and customers in the best way possible - so we can create happier, healthier communities. COMMITTED TO DIVERSITY AND INCLUSION At Tenet, we believe in a diverse and inclusive environment, one that is grounded in our dedication to the health and well-being of all people. Respecting, nurturing and encouraging diversity of thought, background and experience contribute to positive work environments that result in exceptional patient care. We embrace diversity because it's our culture, and because it's the right thing to do. 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\: http\://********************** The employment practices of Tenet Healthcare and its companies comply with all applicable laws and regulations

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: ***********************************

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 Jan 5, 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.

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

DescriptionAlcanza 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 Clinical Site Director is responsible for driving operational performance for of the research site. Provides on-site oversight to help ensure execution and coordination of clinical research activities according to ICH guidelines, GCP, and FDA guidelines and follows company policies and procedures. Key ResponsibilitiesEssential Job Duties: Overall site management and leadership with a focus on driving site performance, enhancing efficiencies, pati,ent safety and protocol/GCP/regulatory compliance. Collaborating with department leaders in Business Development, Patient Recruitment, Finance, and Budgets Contracts and Quality to coordinate delivery expectations, meet expected study milestones (such as site activation targets, enrollment targets, etc.), meet budgets, and delivery quality data to sponsors. Reviewing the performance dashboards and other clinical trial systems to oversee site and patient activities, ensure proper staff coverage, and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency). Overseeing resourcing allocations, site assignments and study team members' output and performance, to ensure study deliverables are on track, identifying risks to delivery or quality, and escalating any risks to clinical trial management deliverables (timeline, quality and budget). Assisting with initial and ongoing trainings regarding protocol specificities, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study. Ensuring adherence to standard operating procedures, good clinical practice (GCP), FDA regulations, and company policies and procedures. Overseeing site staff assigned to the study and routinely assessing study-specific process and training compliance, CMP compliance, and identifies emerging risks. Develop and support execution of corrective action plans at site and study level. Overseeing people management activities including interviewing and selection, performance appraisals, job description preparation, employee counseling, career coaching and termination meetings. Managing site staff, proactively identify and resolve issues, and work to ensure successful site operations. Overseeing all payroll, absence tracking/approvals, new hire orientation, and training per operational needs. Collaborating with investigators to ensure patient safety and meeting client goals and timelines. Employing strategic thinking and problem-solving skills to propose and implement risk mitigations. Participating and presenting in management or site meetings. Perform all other duties as required or assigned. Skills, Knowledge and ExpertiseMinimum Qualifications: A Bachelor's degree AND 5+ years of clinical research experience or an equivalent combination of education and experience is required. 2+ years of management experience required. Clinical research site management experience highly preferred. Bi-lingual (English / Spanish) proficiency is preferred. 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, time management, problem solving, and project management skills to meet project deadlines. 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.

Work Setup: On-site Schedule: Part-time (20 hours per week) Shape the Future of Medicine with IQVIA! Are you passionate about advancing healthcare and improving patient outcomes? Join IQVIA as a Clinical Research Coordinator (CRC) and play a key role in supporting clinical research studies that drive innovation. This hands-on position combines clinical procedures, community outreach, and compliance to ensure the highest standards of care. About IQVIA IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services. We partner with top pharmaceutical, biotechnology, and medical device companies to accelerate innovation and improve lives. Our team blends scientific expertise with cutting-edge technology to deliver insights that transform clinical trials and healthcare worldwide. What You'll Do Perform complex clinical procedures, including ECG, spirometry, sample collection, and vital signs Phlebotomy required Coordinate clinical research studies and ensure compliance with protocols and Good Clinical Practice (GCP) Prepare study materials, set up equipment, and manage logistical activities Recruit, screen, and orient volunteers while prioritizing their safety and well-being Collect and accurately record clinical data in case report forms (CRFs) Collaborate with investigators and monitors to resolve queries and maintain data quality Act as a volunteer advocate and maintain a safe environment in line with Health and Safety policies What We're Looking For High School Diploma or equivalent education and experience Minimum 1 year of relevant clinical research experience (preferred) Working knowledge of clinical trials, GCP principles, and medical terminology Strong attention to detail and ability to build effective working relationships Advanced-level experience supporting site lead CRC with patient visits, data entry/query resolution, and prescreening physician referrals for eligibility Experience working in both research and clinical settings Please note: This position is not eligible for sponsorship. #LI-CES #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.

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.

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!!!

R&D Partners is seeking to hire a Research Study Coordinator / Clinical Research Coordinator in Detroit, MI. Your main responsibilities as a Research Study Coordinator / Clinical Research Coordinator: Coordinates research projects within guides of regulatory compliance and/or Code of Federal Regulation. Provides technical support to Principal Investigators. Interacting with both internal and external customers at all levels and oversight of recruitment and coordinating day-to-day operations of the study. Direct contact with potential and enrolled study participants expected. Provides other support as required. What we are looking for in a Research Study Coordinator / Clinical Research Coordinator: One (1) year of research project coordination experience. (But as per update from the AM- could be better if we can have someone with 3yrs experience) SOCRA or ACRP and IATA certification preferred. Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: Medical insurance PPO, HMO & HSA Dental & Vision insurance 401k plan Employee Assistance Program Long-term disability Weekly payroll Expense reimbursement Online timecard approval Pay Scale: $65,000 - $70,000 ( Dependent on Experience) R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.

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) Physical Requirements · Prolonged periods of sitting at a desk and working on a computer, standing and walking. · Must be able to lift 25 pounds at times. · Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. · Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly. · Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound. · The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.

Job Title: Research Coordinator Position Type: Full-time Department: Research, Evaluation, and Development Application Deadline: Tuesday, October 14 th , 2025 The Research, Evaluation, and Development (RED) Department at HighScope Educational Research Foundation (HighScope) is seeking an organized, reliable, and collaborative Research Coordinator to support ongoing early childhood education projects. This position is ideal for an early or mid-career researcher interested in developing and strengthening research skills and working at the intersection of research and practice. While the HighScope team often works remotely, this role requires working in-person at the HighScope campus approximately twice per month and occasional in-person visits to early childhood education sites for data collection. Key Responsibilities: Conduct literature reviews and summarize relevant literature. Support the design of measures, such as surveys and interview protocols. Monitor data collection (surveys, classroom observations, etc.). Clean, organize, and analyze quantitative and qualitative data. Prepare deliverables for external partners (reports, memos, and presentation materials). Support grant proposals and budgets. Support and oversee communications related to project recruitment and project events (i.e. courses). Oversee communications with various external partners (participants, schools, partner institutions). Develop an understanding of the HighScope approach and internal shared systems and tools (i.e., Qualtrics, TEAMS, etc.). Collaborate with the project manager(s) and administrative assistant to monitor project tasks and timelines. Other related duties as assigned. Qualifications: Required Minimum of bachelor's degree in education or related field. Strong organizational skills and attention to detail. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). Ability to work both independently and collaboratively. Preferred Master's degree in education or related field. Experience working with young children (birth to age 8) in educational or care settings. Demonstrated experience with research methods. Experience with Qualtrics and observational tools (CLASS, Classroom Coach, ECERS). Familiarity with research ethics and working with human subjects. Demonstrated experience partnering with educators and schools. Compensation The salary range for this position is $45,000-$60,000, based on qualifications and experience. Funding Note Please note that this is a grant funded position through October 1 st , 2027, with the possibility of extension based on performance and future funding. How to Apply Please email the application materials to Carolyn Bisby at ******************** by Tuesday, October 14 th , 2025. 1. Resume/CV 2. Cover Letter 3. 3 professional references DISCLAIMER - The preceding has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing in this restricts management's right to assign or reassign duties and responsibilities to this job at any time. Management reserves the right to revise the job description at any time.

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.

Henry Ford Cancer offers a large number of clinical trials, which can offer new or developing treatments to patients before they are widely available. They also provide the opportunity to advance medical knowledge, prevent diseases and increase quality of life. Henry Ford researchers place a strong emphasis on clinical research. That means that most of our work investigates how research questions affect patient care directly. However, our oncology researchers also conduct lab or bench research (studies performed in the laboratory, sometimes at the cellular level), investigating new treatments or cell behaviors. GENERAL SUMMARY: Under minimal supervision the Research Study Coordinator II: * Coordinates research projects within guides of regulatory compliance and/or Code of Federal Regulation. * Provides technical support to Principal Investigators. Duties include but not limited to: * Interacting with both internal and external customers at all levels and oversight of recruitment and coordinating day-to-day operations of the study. * Direct contact with potential and enrolled study participants expected. * Provides other support as required. * May work on multiple studies at any given time. EXPERIENCE REQUIRED: * One (1) year of research project coordination experience. CERTIFICATIONS/LICENSURES REQUIRED: * SOCRA or ACRP and IATA certification preferred. Additional Information * Organization: Henry Ford Medical Group * Department: Cancer Clinical & Trans Resear * Shift: Day Job * Union Code: Not Applicable

Wayne State University is searching for an experienced Clinical Research Coordinator - Department of Psychiatry at its Detroit campus location. Wayne State is a premier, public, urban research university located in the heart of Detroit, Michigan where students from all backgrounds are offered a rich, high-quality education. Our deep-rooted commitment to excellence, collaboration, integrity, diversity and inclusion creates exceptional educational opportunities which prepare students for success in a global society. Essential functions (job duties): Recruit, screen, obtain informed consent, and enroll eligible participants according to protocol for clinical studies. Schedule and coordinate participants study visits and/or work with outpatient scheduler. Directly interact with subjects in a clinic setting, including subject interviews, administering survey instruments, etc., per protocol requirement. Collect and record participants study-related data into electronic and paper case report forms. Ensure all study related documentation is completed accurately, in a timely manner per sponsor requirements. Ensure compliance with protocol guidelines and regulatory agency requirements. Collect, process, label, store, and ship bio-specimens for clinical studies. May obtain blood samples (including blood draws), cultures, tissues, urine, stool, nasal swabs, plasma microbiological isolates and other specimens for laboratory analysis and processing, depending upon on the study. Track and monitor participants' condition and test results during the course of the clinical studies. Relay relevant results to the clinical team. Perform study drug accountability if needed, as per protocol. Manage all the regulatory activities and requirements relevant to the research. Manage the collection of essential regulatory documents and the execution of study protocol. Prepare IRB (Institutional Research Board) initial applications, amendments, continuations, closures and submit electronically (ePortal for example) as well as manually, as needed. Prepare for sponsor monitoring visits, site initiation and closeout visits. Assist the PrincipaI Investigator with the sponsor budget. Work with administrative staff to ensure appropriate billing for study-related care. Coordinate with billing department to make sure that all the research related activities are billed to the sponsor and paid by the sponsor. Review billing calendars and study budgets to ensure appropriate care designations and costs for clinical studies. Design source documents/ generic forms for data collection, recruitment materials, consent forms and other relevant documents for clinical studies as required. Perform general office and administrative duties related to clinical studies. Participate in recruitment strategy meetings to enhance subject awareness of studies and boost subject participation. Attend investigator meetings and training as a study team member. Other duties as assigned. Unique duties: Coordinate and participate in clinical research studies by performing activities involved in the collection, compilation, documentation of research data. The position will work with principal investigators and other research team members to accurately and efficiently carry out a range of tasks associated with a variety of clinical research studies. Qualifications: Education: Bachelor's degree in a medical or health science discipline or equivalent combination of education and experience. Years of Experience Required: Minimum one year experience working in a research or clinic environment and interaction with study populations. Knowledge, Skills and Abilities: Excellent interpersonal and communication skills. Experience with Microsoft Office products (i.e., Microsoft Word, Excel, Power Point) and Electronic Data Entry/Capture (EDC). Excellent multi-tasking, problem solving and record-keeping skills. Strong ability to work independently, exercising good judgement, with minimal supervision. Organizational and analytical and problem solving skills. Ability to function with diverse teams of people in a diplomatic, collaborative, and effective manner. Ability to work independently and adhere to established timelines to accomplish tasks. Understanding of ICH-GCP guidelines, OHRP, HIPAA, and FDA regulations. Ability to maintain data confidentiality and participant/subject/patient privacy. Working knowledge of medical terminology and assessment of laboratory values. Preferred qualifications: School/College/Division: H06 - School of Medicine Primary department: H0613 - Psychiatry Employment type: * Regular Employee * Job type: Full or Fractional Time * Job category: Staff/Administrative Funding/salary information: * Compensation type: Annual Salary * Salary minimum: 52,400 * Salary hire maximum: 62,877 Working conditions: Hospital, outpatient clinic and office environments. This position must be filled pursuant to the provisions of a collective bargaining agreement, and as such may be filled by a qualified bargaining unit member, should one apply. Job openings: * Number of openings: 1 Background check requirements: University policy requires certain persons who are offered employment to undergo a background check, including a criminal history check, before starting work. If you are offered employment, the university will inform you if a background check is required. Equal employment opportunity statement: Wayne State University provides equal employment opportunities to all employees and applicants for employment without regard to race, color, sex, national origin, religion, age, sexual orientation, familial status, marital status, height, weight, disability, veteran status, or any other characteristic protected by applicable law. The university welcomes applications from persons with disabilities and veterans. Wayne State is an equal opportunity employer.

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

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 This position will serve as a Clinical Research Coordinator Intermediate in the Oncology Clinical Trial Support Unit (O-CTSU) - Clinic Research Group located in the Rogel Cancer Center providing administrative study coordination and clinic support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN). We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 150 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III. As a team member, we will invest in your education, training, career development and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want Michigan Answers TM. Help discover them. This Clinical Research Coordinator (CRC) position my 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-Associate position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support. 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* Characteristic Duties and Responsibilities: Independent knowledge, skills, and abilities 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 Due to the complex nature of Oncology Clinical Trials, a team comprised of clinical research coordinators specializing in data management, regulatory, or clinic coordination work together to cover all aspects of the clinical research coordinator role. The clinical research coordinator hired for this posting will specialize in Clinic and will be working with patients as part of the team that provides care for the patients. Examples of duties a successful candidate in this role will perform: * Performs study procedures with accuracy. * Demonstrates ability to triage complex study concerns appropriately. * Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently * Contributes to the development of processes and tools to capture data in accordance with ALCOA-C principles. * Provides logistic and regulation guidance on Investigator Initiated Studies for adherence to University and Federal guidelines. * Provide other administrative support for study activity including management of subject reimbursement and payments. * Participates in training's specifically for maintaining certification as a Clinical Research Professional. * Monitors site compliance with subject safety reporting, escalates issues, and contributes to the development of tools and processes to enhance subject safety during the conduct of a clinical study. * Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes. This position reports directly to a O-CTSU Manager. This position could provide functional supervision (likely in limited capacity such as training) of staff in titles within the CRC Career Ladder. Required Qualifications* * Bachelor's degree in Health Science or an equivalent combination of related education and experience. * Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA