Clinical research coordinator jobs in Flint, MI

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 ************.

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. 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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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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.

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 Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desirable):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as required. + Valid driving license per country requirements, as applicable \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Job Description Unique opportunity to make an Impact in the healthcare industry… Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, Nebraska, & 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 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 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!!! Powered by JazzHR OflEhHws2m

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

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.

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

Posting Details: We are hiring a contingent / PRN workforce to assist with covering shifts at our Behavioral Health Urgent Care. General Statement: Under the direction of the Program Supervisor, conducts crisis and safety assessment, crisis intervention, and other clinical evaluations in the office, via telehealth, and the community; communicates and consults with a variety of agencies regarding program issues, assesses clinical needs and makes recommendations for support service and treatment; performs professional therapeutic crisis intervention; participates in and leads clinical team meetings for high risk cases; communicates and consults with staff from internal and external programs to assist with treatment recommendations; serves as a resource to staff; provides liaison, consultation and mental health education services for community agencies and resources persons; performs related work as required. Minimum Requirements: Educational Requirement License Requirements Year(s) of Experience Board Examination Masters in Social Work (LMSW) Michigan Master Level Social Worker (LMSW) credential, Clinical. One (1) year experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. Limited License Masters of Social Work (LLMSW) Limited License as a Masters Level Social Worker (LLMSW), credential. Three (3) years' experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. The employee with Limited License must take and pass the ASWB Examination within six (6) years in accordance with the State of Michigan requirements to retain employment. NOTE: GHS will follow all State of Michigan requirements. If the requirements change, the job description will be updated to reflect such changes. All licensed clinical staff must maintain licensure as a condition of employment. Master's in Psychology (LLP) Michigan Master Level Psychologist (LLP) credential. One (1) year experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. Temporary Limited License Psychologist (TLLP) Limited License as a Masters Level Psychologist (TLLP). Three (3) years' experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. The employee with a TLLP must pass the Exam for Professional Practice in Psychology (EPP) AND make application for the LLP within 18 months of hire OR prior to the expiration of the TLP, whichever is sooner to retain employment. Master's in Counseling (LPC) Michigan License Professional Counselor (LPC) credential. One (1) year experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. Limited License Master's in Counseling Limited License Professional Counselor (LLPC) credential. Three (3) years' experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. The employee with an LLPC must take and pass the National Counselor Examination (NCE) within six (6) years of hire to retain employment. The employee with an LLPC must also make application for the LPC upon passing the NCE. Registered Nurse(RN) Licensed as a Registered Nurse (RN) Three (3) years' experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. Additional Requirements: Minimum of 1 year of experience providing crisis services to include crisis assessment with level of care determination/recommendation, safety screening, and/or safety planning. Employee must maintain valid clinical licensure to retain employment. Must retain MDHHS qualifications as a Child Mental Health Professional. Must be willing and able to work weekends, holidays, various shifts, and irregular hours including on call responsibilities. Must be willing to provide services in person or via use of telehealth technology in office, community, or in the field including transporting consumers in crisis to services. If providing telehealth services, must have a work space in which service provision can occur in a confidential manner. Must have a valid Michigan driver's license, current automobile insurance, and the use of a vehicle during work hours. Ability to physically perform the tasks. Additional Requirements: Employee must maintain valid clinical licensure to retain employment. Must be willing and able to work weekends, holidays, or irregular hours including on call responsibilities. Must be willing to provide services via use of telehealth technology. Must have a valid Michigan driver's license, current automobile insurance, and the use of a vehicle during work hours. Ability to physically perform the tasks. If providing telehealth services, must have a work space in which service provision can occur in a confidential manner. Must retain MDHHS qualifications as a Child Mental Health Professional. Preferences: Minimum of 1 year of experience providing crisis services to include crisis assessment with level of care determination/recommendation, safety screening, and/or safety planning. Experience working with both adults and children with mental illness and/or developmental disabilities. Certification in Addiction Counseling (CAC) or in process to become a Certified Co-Occuring Disorders Professional - Diplomat (CCDP-D) OR a Certified Advanced Alcohol and Drug Counselor (CAADC) through the Michigan Certification Board for Addiction Professionals (MCBAP) within 30 days of hire, unless currently certified as a CCDP-D, CAADC, Certified Alcohol and Drug Counselor (CCADC), or a current Development Plan for CCDP-D or CAADC with MCBAP. Essential Physical Demands: Vision - Position requires the ability to visually assess details at both near and far distances, as well as to perceive depth and spatial relationships with or without reasonable accommodations. Hearing - Position requires the ability to receive and respond to verbal communication with or without reasonable accommodations. Lifting, Standing, and Walking With or Without Reasonable Accommodations: Position requires the ability to lift up to 35lbs on an occasional basis Position requires the ability to regularly stand for extended periods of time Position requires the ability to walk at a minimum of 35% up to a maximum of 65% Position will require the ability to occasionally stoop, bend, or reach to perform work tasks with or without reasonable accommodation Position must be able to perform tasks requiring manual dexterity, including the use of hands and fingers for handling, grasping, typing, writing, or operating equipment with or without reasonable accommodation. Veterans must submit Form DD214 to determine eligibility for Veterans' Preference Interested applicants must clearly show they meet the minimum qualifications. Resume must include the following information: Name of employer, month/year you were hired, month/year you left, if the position was part-time or full-time, and the job duties you performed while in the position. BARGAINING UNIT: Teamsters FLSA STATUS: NON-EXEMPT

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 Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk:** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Unique opportunity to make an Impact in the healthcare industry… Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, Nebraska, & 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 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 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!!!

Posting Details: We are hiring a contingent / PRN workforce to assist with covering shifts at our Behavioral Health Urgent Care. General Statement: Under the direction of the Program Supervisor, conducts crisis and safety assessment, crisis intervention, and other clinical evaluations in the office, via telehealth, and the community; communicates and consults with a variety of agencies regarding program issues, assesses clinical needs and makes recommendations for support service and treatment; performs professional therapeutic crisis intervention; participates in and leads clinical team meetings for high risk cases; communicates and consults with staff from internal and external programs to assist with treatment recommendations; serves as a resource to staff; provides liaison, consultation and mental health education services for community agencies and resources persons; performs related work as required. Minimum Requirements: Educational Requirement License Requirements Year(s) of Experience Board Examination Masters in Social Work (LMSW) Michigan Master Level Social Worker (LMSW) credential, Clinical. One (1) year experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. Limited License Masters of Social Work (LLMSW) Limited License as a Masters Level Social Worker (LLMSW), credential. Three (3) years' experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. The employee with Limited License must take and pass the ASWB Examination within six (6) years in accordance with the State of Michigan requirements to retain employment. NOTE: GHS will follow all State of Michigan requirements. If the requirements change, the job description will be updated to reflect such changes. All licensed clinical staff must maintain licensure as a condition of employment. Master's in Psychology (LLP) Michigan Master Level Psychologist (LLP) credential. One (1) year experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. Temporary Limited License Psychologist (TLLP) Limited License as a Masters Level Psychologist (TLLP). Three (3) years' experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. The employee with a TLLP must pass the Exam for Professional Practice in Psychology (EPP) AND make application for the LLP within 18 months of hire OR prior to the expiration of the TLP, whichever is sooner to retain employment. Master's in Counseling (LPC) Michigan License Professional Counselor (LPC) credential. One (1) year experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. Limited License Master's in Counseling Limited License Professional Counselor (LLPC) credential. Three (3) years' experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. The employee with an LLPC must take and pass the National Counselor Examination (NCE) within six (6) years of hire to retain employment. The employee with an LLPC must also make application for the LPC upon passing the NCE. Registered Nurse(RN) Licensed as a Registered Nurse (RN) Three (3) years' experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. Additional Requirements: Minimum of 1 year of experience providing crisis services to include crisis assessment with level of care determination/recommendation, safety screening, and/or safety planning. Employee must maintain valid clinical licensure to retain employment. Must retain MDHHS qualifications as a Child Mental Health Professional. Must be willing and able to work weekends, holidays, various shifts, and irregular hours including on call responsibilities. Must be willing to provide services in person or via use of telehealth technology in office, community, or in the field including transporting consumers in crisis to services. If providing telehealth services, must have a work space in which service provision can occur in a confidential manner. Must have a valid Michigan driver's license, current automobile insurance, and the use of a vehicle during work hours. Ability to physically perform the tasks. Additional Requirements: Employee must maintain valid clinical licensure to retain employment. Must be willing and able to work weekends, holidays, or irregular hours including on call responsibilities. Must be willing to provide services via use of telehealth technology. Must have a valid Michigan driver's license, current automobile insurance, and the use of a vehicle during work hours. Ability to physically perform the tasks. If providing telehealth services, must have a work space in which service provision can occur in a confidential manner. Must retain MDHHS qualifications as a Child Mental Health Professional. Preferences: Minimum of 1 year of experience providing crisis services to include crisis assessment with level of care determination/recommendation, safety screening, and/or safety planning. Experience working with both adults and children with mental illness and/or developmental disabilities. Certification in Addiction Counseling (CAC) or in process to become a Certified Co-Occuring Disorders Professional - Diplomat (CCDP-D) OR a Certified Advanced Alcohol and Drug Counselor (CAADC) through the Michigan Certification Board for Addiction Professionals (MCBAP) within 30 days of hire, unless currently certified as a CCDP-D, CAADC, Certified Alcohol and Drug Counselor (CCADC), or a current Development Plan for CCDP-D or CAADC with MCBAP. Essential Physical Demands: Vision - Position requires the ability to visually assess details at both near and far distances, as well as to perceive depth and spatial relationships with or without reasonable accommodations. Hearing - Position requires the ability to receive and respond to verbal communication with or without reasonable accommodations. Lifting, Standing, and Walking With or Without Reasonable Accommodations: Position requires the ability to lift up to 35lbs on an occasional basis Position requires the ability to regularly stand for extended periods of time Position requires the ability to walk at a minimum of 35% up to a maximum of 65% Position will require the ability to occasionally stoop, bend, or reach to perform work tasks with or without reasonable accommodation Position must be able to perform tasks requiring manual dexterity, including the use of hands and fingers for handling, grasping, typing, writing, or operating equipment with or without reasonable accommodation. Veterans must submit Form DD214 to determine eligibility for Veterans' Preference Interested applicants must clearly show they meet the minimum qualifications. Resume must include the following information: Name of employer, month/year you were hired, month/year you left, if the position was part-time or full-time, and the job duties you performed while in the position. BARGAINING UNIT: Teamsters FLSA STATUS: NON-EXEMPT

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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 a full-time Clinical Research Coordinator with a minimum of 1 year of clinical 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. Clinical Research Coordinators here at Revival Research Institute, should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results. Clinical Research Coordinators are responsible to coordinate and manage multiple studies. They are also responsible for assisting the Investigators along with other clinical staff, with any study related tasks as follows but not limited to: Participates in 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. Documents 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. Maintains 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 about Clinical trials. Research participant/family communication, protect patient confidentiality. Preferred Qualifications: Education/ Training: Bachelor's degree in health-related field with one to two years relevant clinical experience OR Master's degree in medical related field with no research experience. Individuals with more experience are preferred, if qualifications exceed entry level, higher positions available. Phlebotomy skills preferred. Certifications, Licensures, and Registrations: National Certification (CRA or ACRP), BLS Certification. Additional Qualifications: Expert 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. IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!

$5,000 Signing Bonus Come join our team and make a difference in the lives of those in our community! Genesee Health System (GHS) is looking for energetic and caring people to join our dynamic clinical team. We value our staff and think they deserve the best! Medical, vision and dental benefits available at no premium for our staff and their dependents. We also provide an annually loaded HSA of up to $2,500, a 5% match towards your retirement, generous paid time off (19 ½ days per year) and paid Holidays. POSITION SUMMARY: We are seeking a full-time night shift Clinical Coordinator for our Behavioral Health Urgent Care. Currently, this position will work five (5), eight (8) hour shifts per week, within current programming hours, including rotating weekends and holidays. The current program hours of operation are 8:00 a.m. - 10:30 p.m., and weekend hours of operation are 10:00 a.m. - 6:30 p.m. When the program moves to 24-hour operation, all full-time shifts will be 12-hour shifts, 8:00 a.m. - 8:00 p.m. three (3) days per week, but will still be paid for 40 hours of work. GENERAL STATEMENT: Under the direction of the Program Supervisor, conducts crisis and safety assessment, crisis intervention, and other clinical evaluations in the office, via telehealth, and the community; communicates and consults with a variety of agencies regarding program issues, assesses clinical needs and makes recommendations for support service and treatment; performs professional therapeutic crisis intervention; participates in and leads clinical team meetings for high risk cases; communicates and consults with staff from internal and external programs to assist with treatment recommendations; serves as a resource to staff; provides liaison, consultation and mental health education services for community agencies and resources persons; performs related work as required. Minimum Requirements: Master's in Social Work and Michigan Master's Level Social Worker (LMSW) credential, Clinical AND one (1) year experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. OR Master's Degree in Psychology and Michigan Limited License Psychologist (LLP) credential or Licensed Psychologist (LP) AND one (1) year experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. OR Master's in Counseling and Michigan License Professional Counselor (LPC) credential AND one (1) year experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. OR Bachelor's in Nursing (preferred) OR graduation from an accredited school of Nursing, and licensed as a registered nurse (RN) in the State of Michigan AND three (3) years of experience working with both adults and children with mental illness, developmental disabilities and/or co-occurring disorders. Additional Requirements: Minimum of 1 year of experience providing crisis services to include crisis assessment with level of care determination/recommendation, safety screening, and/or safety planning. Employee must maintain valid clinical licensure to retain employment. Must retain MDHHS qualifications as a Child Mental Health Professional. Must be willing and able to work weekends, holidays, various shifts, and irregular hours including on call responsibilities. Must be willing to provide services in person or via use of telehealth technology in office, community, or in the field including transporting consumers in crisis to services. If providing telehealth services, must have a work space in which service provision can occur in a confidential manner. Must have a valid Michigan driver's license, current automobile insurance, and the use of a vehicle during work hours. Ability to physically perform the tasks. Preferences: Certification in Addiction Counseling (CAC) or in process to become a Certified Co-Occurring Disorders Professional - Diplomat (CCDP-D) OR a Certified Advanced Alcohol and Drug Counselor (CAADC) through the Michigan Certification Board for Addiction Professionals (MCBAP) within 30 days of hire, unless currently certified as a CCDP-D, CAADC, Certified Alcohol and Drug Counselor (CCADC), or a current Development Plan for CCDP-D or CAADC with MCBAP. Essential Physical Demands: Vision - Position requires the ability to visually assess details at both near and far distances, as well as to perceive depth and spatial relationships with or without reasonable accommodations. Hearing - Position requires the ability to receive and respond to verbal communication with or without reasonable accommodations. Lifting, Standing, and Walking With or Without Reasonable Accommodations: Position requires the ability to lift up to 35lbs on an occasional basis Position requires the ability to regularly stand for extended periods of time Position requires the ability to walk at a minimum of 35% up to a maximum of 65% Position will require the ability to occasionally stoop, bend, or reach to perform work tasks with or without reasonable accommodation Position must be able to perform tasks requiring manual dexterity, including the use of hands and fingers for handling, grasping, typing, writing, or operating equipment with or without reasonable accommodation. Veterans must submit Form DD214 to determine eligibility for Veterans' Preference Interested applicants must clearly show they meet the minimum qualifications. Resume must include the following information: Name of employer, month/year you were hired, month/year you left, if the position was part-time or full-time, and the job duties you performed while in the position. BARGAINING UNIT: Teamsters FLSA STATUS: NON-EXEMPT

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!!!