Clinical research coordinator jobs in Westland, MI - 85 jobs

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

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

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

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

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

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

The Clinical Research Associate will focus primarily on data management for clinical trials and act as a backup for regulatory associates. Initially, the role involves working with Registry studies, including pre-screening, recruiting, consenting, and following up with participants. This will occupy approximately 40% of the time, with the remainder dedicated to data entry, data management, and assisting the Research Nurse during patient visits. Responsibilities * Manage data for clinical trials and serve as a backup for regulatory associates. * Work with Registry studies, including pre-screening, recruiting, consenting, and follow-up activities. * Perform data entry and data management tasks. * Assist the Research Nurse with patient visits. Required Skills & Experience * Minimum of 1 year of clinical research experience * Understanding of clinical trials terminology * Proficiency in EDC systems, with the ability to learn various systems Additional Skills & Qualifications * Experience in oncology is ideal * Willingness to undergo oncology training Job Type & Location This is a Contract position based out of Grosse Pointe Woods, MI. Pay and Benefits The pay range for this position is $20.00 - $31.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Grosse Pointe Woods,MI. Application Deadline This position is anticipated to close on Jan 16, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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!!!

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

The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants. Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned. Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation. Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46). Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information. Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable. Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights. Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times. Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed. Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed. Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner. Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research. Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections. Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed. Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution. Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial. Adheres to the USRC Research quality assurance program guidelines. Travel to Investigator Meetings or similar research related meetings is required. Travel may be required between dialysis facilities or nephrology practices within the community. Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications. May provide training and oversight of Clinical Research Coordinators and/or Research Assistants. Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization. Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures. Participate in staff meetings as required. Regular and reliable attendance is required for the job. Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization. Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures. Regular and reliable attendance is required for the job.

Zepf Center has been serving the Lucas County community for over 50 years. We are the leading provider of behavioral health and substance use disorder services in Northwest Ohio. Services include adult and child psychiatric, substance abuse, case management, residential, Crisis Care, and therapy programs, as well as career development and wellness services. Zepf Center also offers primary care medical services to our patients to contribute to their continuum of care. Zepf Center is a trauma-informed agency and environment for both patients and staff. Summary: The SUD Residential Clinical Coordinator Manager will assist in the day-to-day operations and staff connected to 24-hour, year-round residential and inpatient withdrawal services. They will assist the clinical manager in leading the multidisciplinary treatment team, ensuring quality, timeliness, and professionalism in the provision of services and interventions, engagement of family, and facilitation of aftercare and recovery management planning. They will provide leadership, provide direct supervision to staff, assist in coverage of open shifts as needed for a 24/7/365 program, completing evaluations, and managing staff development and training; providing emergency direction to staff when dealing with difficult situations; and ensuring there is a safe, supportive, and environment for consumers and staff. Hours: Monday - Friday; 8:30am - 4:30pm with one weekend a month Essential Duties and Responsibilities: Provide clinical supervision to direct line staff, ensuring adherence to best practices and evidence-based approaches in substance use treatment. Monitor and evaluate the implementation of individualized treatment plans, assessments, ASAMs for residents. Ensures adherence to and completion of daily schedule that provides a range of interventions and activities to support residents recovery (e.g., Group Therapy, Individual Therapy, Recovery Oriented Activities, Alternative and Holistic Approaches) Conduct regular supervision sessions and provide ongoing training to direct line staff. Foster a collaborative and supportive team environment, promoting professional growth and skill development. Participate in client assessments and assist in the development of comprehensive treatment plans. Oversee the coordination of case management, group and individual therapy services to support clients recovery goals. Monitor and ensure timely completion of prior authorizations, ASAM, and ISPs for all clients within the program Be available for crisis intervention during on-call rotations, providing guidance and support to staff in handling emergency situations. Collaborate with team members to develop and implement crisis response protocols Maintain effective communication with interdisciplinary team members, promoting a cohesive and integrated approach to care. Liaise with external partners, including referral sources and community resources. Leads and attends interdisciplinary meetings and participates in committees as assigned. Ensure accurate and timely documentation of client progress, treatment interventions, and any significant incidents. Oversee the maintenance of confidential client records in compliance with privacy regulations. Assist in the development and management of staff schedules to ensure 24/7 coverage. Address staffing needs and coordinate coverage during staff absences. Stay informed about the latest developments in the field of substance use treatment. Attending relevant training and conferences to enhance knowledge and skills. Maintains professional licensure/credentials and complies with related standards. Participates in regular training to advance knowledge, build skills, and flourish professionally. Perform other duties as assigned. Supervisory Responsibilities: Provide leadership and guidance to the CDCAs, Therapists, Certified Peer Supports Oversee the coordination of client care and assignments during shifts. Participate in training new staff, completing bi-weekly individual supervisions and developing effective workflows and procedures. Ensures that clinical records are comprehensive, demonstrate medical necessity, and comply with program practices. Assists Clinical Manager in reviewing all discharged patient files to ensure compliance with established protocols, policies, and procedures, and files are appropriately documented and in correct order. Work collaboratively with the team to ensure 24/7 coverage for the residential program. Assisting with managing call offs, ensuring coverage of shifts, and participating in an on-call schedule between SUD Residential & Crisis, and a on-call rotation for coverage of shifts within SUD Residential Address and resolve interpersonal conflicts within the team, promoting a healthy and productive work environment. Provide guidance and support in managing challenging situations or client-related issues Collaborate with the Clinical Manager to address staffing needs and optimize team performance. Participate in regular meetings with the Clinical Manager to discuss staff supervision and program operations. Facilitate the onboarding and orientation process for new clinical staff members. Provide guidance and support to ensure a smooth transition into their roles. Position Competencies: Possesses a strong clinical background with expertise in substance use disorder treatment modalities and evidence-based practices. Demonstrates advanced knowledge of assessment, diagnosis, and treatment planning for individuals with substance use disorders. Exhibits strong leadership qualities, inspiring and motivating clinical staff to achieve program goals. Effectively delegates responsibilities and empowers team members to contribute to the program's success. Demonstrates proficiency in supervisory responsibilities, including performance evaluation, staff development, and conflict resolution. Prior experience in effectively managing and leading a team of clinical professionals. Possesses excellent time management skills and the ability to prioritize tasks effectively. Adapts to changing priorities and is flexible in working hours to meet the demands of a 24/7 residential treatment program. Shows a comprehensive understanding of program operations, ensuring compliance with regulations, policies, and accreditation standards. Capable of contributing to the development and implementation of policies and procedures. Exhibits excellent communication skills, both written and verbal, to effectively convey information to clinical staff, leadership, and external stakeholders. Fosters open and transparent communication within the team. Upholds the highest ethical standards in decision-making and actions. Navigates complex ethical dilemmas with integrity and professionalism. Places a strong emphasis on client-centered care, ensuring that treatment plans are individualized and responsive to the unique needs of each resident. Advocates for a trauma-informed and culturally competent approach to care. Effectively manages workload demands, working more than 40 hours a week as required to ensure program coverage. Adjusts work schedules to address the dynamic and continuous nature of residential treatment. Demonstrates strong problem-solving skills, addressing challenges proactively and finding innovative solutions. Identifies and resolves issues that may impact the quality of client care or program operations. Organizational Competencies: Abide by the agency and professionals code of ethics, demonstrate consistent professionalism. Adherence to the organization's code of conduct and values. Demonstrate knowledge of the agencys mission, vision, goals, and philosophy as well as the policies and procedures. Ability to work effectively with colleagues, cross-functional teams, and external partners to achieve common goals. Demonstrated skills in fostering a collaborative work environment. Effectively mediate and resolve conflicts among nursing staff and other team members. Commit to cultivating a non-violent and trauma-informed environment for all employees and clients, through our pursuit of Sanctuary; a trauma-informed model. Commit to a deeper exploration of Sanctuary Values. Requirements: Position Qualifications: Minimum LCDC III; LSW/LPC/LICDC preferred 3-5 years of relevant experience including supervisory experience Able to drive company vehicle Work Schedule: This is a salaried position, and the Clinical Coordinator is expected to work more than 40 hours per week. Given the nature of the program, flexibility in working hours is essential to meet the demands of a 24-hour, 365-day operation. PIe0bd4f0a3cd3-31181-39230105

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

Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report. Location Outpatient Services at 1440 N Dayton Job Description General Summary: The Research Coordinator I will support a longitudinal cohort study by leading the collection and management of detailed social and risk network data from study participants. Responsibilities will include administering network-focused surveys and interviews, guiding participants through name-generator and name-interpreter instruments, ensuring data completeness and accuracy, and maintaining strict protocols for confidentiality and data security. This role requires prior experience with network data collection or social network research methods, strong interpersonal skills, and the ability to build rapport with participants while maintaining professional boundaries. The ideal candidate is highly organized, motivated, and committed to producing high-quality data. Essential Job Functions: * Assists with behavioral research projects, including study start-up, protocol coordination, and close-out activities. * Maintains adherence to study protocols and regulatory standards. * Coordinates with other departments to ensure effective implementation of research projects. * Supports the development, implementation, and tracking of studies with minimal supervision. * Assists with the preparation of protocols, informed consents, recruitment materials, modifications, renewals, and maintains study documentation via regulatory binders. * Identifies, recruits, and guides eligible study participants through the informed consent/assent process. * Assists in delivering behavioral interventions and arranging study visits; provide instructions to participants and their families. * Abstracts data from medical records and enter it into case report forms and electronic systems such as REDCap; prepares data for analysis. * Creates and updates research-related forms, templates, and assists in managing participant reimbursements. * Conducts literature searches, assists with QA/QC procedures, and tracks deadlines for grants and deliverables while adhering to research protocols and compliance regulations. * Promotes the ethical conduct of research by actively participating in research related educational meetings/conferences. * Other job functions as assigned. Knowledge, Skills and Abilities: * Bachelor's degree required. A combination of education and/or experience may be considered in lieu of the degree when the experience is directly related to the duties of the job. * Good organizational skills. * Good verbal and written communications skills. * Some knowledge of FDA, HSR, and GCP Guidelines. * Proficient analytical skills with the ability to remain agile and adaptable to various technological systems. Education Bachelor's Degree Pay Range $46,280.00-$75,670.40 Salary At Lurie Children's, we are committed to competitive and fair compensation aligned with market rates and internal equity, reflecting individual contributions, experience, and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions. In addition to base salary, Lurie Children's offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits. Benefit Statement For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes: Medical, dental and vision insurance Employer paid group term life and disability Employer contribution toward Health Savings Account Flexible Spending Accounts Paid Time Off (PTO), Paid Holidays and Paid Parental Leave 403(b) with a 5% employer match Various voluntary benefits: * Supplemental Life, AD&D and Disability * Critical Illness, Accident and Hospital Indemnity coverage * Tuition assistance * Student loan servicing and support * Adoption benefits * Backup Childcare and Eldercare * Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members * Discount on services at Lurie Children's facilities * Discount purchasing program There's a Place for You with Us At Lurie Children's, we embrace and celebrate building a team with a variety of backgrounds, skills, and viewpoints - recognizing that different life experiences strengthen our workplace and the care we provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care. Lurie Children's and its affiliates are equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law. Support email: ***********************************

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

The Clinical Research Associate will focus primarily on data management for clinical trials and act as a backup for regulatory associates. Initially, the role involves working with Registry studies, including pre-screening, recruiting, consenting, and following up with participants. This will occupy approximately 40% of the time, with the remainder dedicated to data entry, data management, and assisting the Research Nurse during patient visits. Responsibilities + Manage data for clinical trials and serve as a backup for regulatory associates. + Work with Registry studies, including pre-screening, recruiting, consenting, and follow-up activities. + Perform data entry and data management tasks. + Assist the Research Nurse with patient visits. Required Skills & Experience + Minimum of 1 year of clinical research experience + Understanding of clinical trials terminology + Proficiency in EDC systems, with the ability to learn various systems Additional Skills & Qualifications + Experience in oncology is ideal + Willingness to undergo oncology training Job Type & Location This is a Contract to Hire position based out of Grosse Pointe Woods, MI. Pay and Benefits The pay range for this position is $20.00 - $31.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Grosse Pointe Woods,MI. Application Deadline This position is anticipated to close on Jan 22, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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

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

The Clinical Research Associate will focus primarily on data management for clinical trials and act as a backup for regulatory associates. Initially, the role involves working with Registry studies, including pre-screening, recruiting, consenting, and following up with participants. This will occupy approximately 40% of the time, with the remainder dedicated to data entry, data management, and assisting the Research Nurse during patient visits. Responsibilities + Manage data for clinical trials and serve as a backup for regulatory associates. + Work with Registry studies, including pre-screening, recruiting, consenting, and follow-up activities. + Perform data entry and data management tasks. + Assist the Research Nurse with patient visits. Required Skills & Experience + Minimum of 1 year of clinical research experience + Understanding of clinical trials terminology + Proficiency in EDC systems, with the ability to learn various systems Additional Skills & Qualifications + Experience in oncology is ideal + Willingness to undergo oncology training Job Type & Location This is a Contract position based out of Grosse Pointe Woods, MI. Pay and Benefits The pay range for this position is $20.00 - $31.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Grosse Pointe Woods,MI. Application Deadline This position is anticipated to close on Jan 16, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

OVERVIEWThis role will coordinate research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and include the opportunity to help spearhead on-site efforts for Topography's partner healthcare groups. This role will be evaluated on provider success, patient experience, protocol management and adherence, and data quality. This role will require a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers. You will need to be able to thrive with multiple balls in the air, and where independent problem solving is a daily need. You will need to lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country. KEY RESPONSIBILITIES Act as study coordinator to execute trials conducted within physician practices, including but not limited to: Visit preparation activities Visit follow-up activities Supply and inventory management Third party vendor coordination Conduct patient recruitment and enrollment of eligible patients Conduct patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. Independently administer the informed consent process with care and quality Ensure protocol adherence and high data integrity Provide high quality source data capture and documentation Attend study start-up and planning meetings, including PSVs and SIVs 8. Facilitating monitoring visits (IMVs) and sponsor correspondence including assisting with follow-up items IP management, dispensation and accountability Adverse Event management, tracking, and follow-up Data entry to CRF/EDC and query resolution in a timely manner Support study close-out, including COVs Protocol deviation tracking, reporting, and reconciliation Using and helping improve Topography's proprietary tool set Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation Assist in Quality Control activities including routine QC checks during and following study visits Any other duties assigned by manager MINIMUM QUALIFICATIONS Bachelor's degree or equivalent combination of training and experience3+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role3+ years of experience independently coordinating studies, from study startup to close out3+ years of a demonstrated track record of delivering clean data and a high-quality patient experience 2+ years expert knowledge of FDA regulations and ICH/GCP guidelines