Clinical research associate jobs in Clinton, MI

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

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

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

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

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

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

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

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

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

Profound Research:Profound Research seeks to drive clinical innovation by partnering with community physicians to offer clinical research as a therapeutic option to their patients. Profound enables providers with the right people and tools to launch clinical research operations, often for the first time, to offer new care pathways to patients. Profound Research is looking to grow its energetic team inspired by changing how patients and providers engage in clinical research. Our Mission: Improving Lives by Providing Advanced Therapeutic Options Our Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research Our Values: Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions. Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues. Solution Orientation: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. Excellence: We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards. Profound Ethos o Physicians are the Vanguard o All Decisions Improve Patient Care o Never Compromise Quality Why this Role Exists The Clinical Research Coordinator will manage all clinical trial activities under supervision in compliance with all applicable laws, regulations, and procedures of study protocol while maintaining company mission, vision and values. Responsibilities-Conduct and manage all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. -Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner. -Mentor and train staff in the conduct of clinical trials, protocol requirements, communication and trial management skills. -Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up. -Ensure good documentation practices are applied by all team members when collecting, maintaining and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms. -Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. -Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products. -Other duties as assigned. Requirements-Bachelor's degree and 2 years relevant experience in the life science industry OR -Associate's degree with 4 years relevant experience in the life science industry OR -High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year -Clinical Research Coordinator experience -Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification within 6 months of being in the role -Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens -Proficient ability to work independently, plan and prioritize with minimal guidance -Excellent attention to detail, organization, and communication with varied stakeholders -Ability to work as a team player with the ability to adapt to changing schedules and assignments Travel RequirementsDaily commute to site(s) Physical Requirements · Prolonged periods of sitting at a desk and working on a computer, standing and walking. · Must be able to lift 25 pounds at times. · Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. · Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly. · Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound. · The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.

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

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!!!

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.

The Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study. To consistently embody AMR Clinical's Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Clinical Research Coordinator reports to the Site Manager/Team Lead. Classification: Non-Exempt Primary Responsibilities: Focuses on compliance responsibilities, including protocol deviations, SAE reporting, and informed consent. Strong focus on compliance responsibilities, including managing protocol deviations, SAE reporting, and ensuring proper informed consent procedures. Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols. Manage and document Adverse Event and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution. Establish understanding of SOP's and implement the SOP's Gain understanding of the pharmaceutical drug per clinical trial. Develop detailed knowledge of protocol and procedures per clinical research study. Communicate effectively with study sponsors, CROs, monitors/CRA's, IRBs, laboratories, and clinical personnel within the research industry. Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study. Establish and maintain patient rapport. Clinical data collection (vital signs, EKG recording, weight, height, etc.) Obtain medical records and review as required. Phlebotomy Specimen collection, processing, and storage Transporting clinical specimens to the laboratory. Educate subjects on diaries and oversees compliance with diary completion. Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.) Responsible for completing patient phone call visits in accordance to the standard protocol period. Ensure documentation follows ALCOA standards and is completed in a timely manner. Ensure all necessary documents are completed, signed and dated. Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required. Manage study inventory and order supplies as needed. Prepare and assist study monitors during onsite visits. Maintain familiarity with all ongoing clinical research studies. Travel to Investigator meetings as needed. Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties Position may require occasional weekend and/or overtime hours. Other duties as assigned Desired Skills and Qualifications: 1 year of experience in clinical research. Completion of formal medical training, educational program, or healthcare experience Strong medical terminology Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.). Ability to work independently and lead study-related tasks. Ability to multi-task in a high-paced evolving environment. Exceptional listening, written, and verbal communication skills as well. Demonstrate proficiency in office equipment and software programs. Excellent organizational and task management skills. Ability to be ambulatory most of the workday. Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination. AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor. ** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.

The Michigan Alzheimer's Disease Center is an NIH-funded research center focused on conducting and supporting Alzheimer's disease and related dementia research. A key aim of the center's research is to work with underrepresented communities to address racial and ethnic disparities in Alzheimer's disease and related dementias. The center also spans beyond research by promoting state-of-the-art care and wellness for individuals and families affected by dementia and increasing dementia awareness through education and outreach across the state. The Michigan Alzheimer's Disease Center (MADC) is seeking a full-time MADC Research Coordinator to join its research team. Location is at the Michigan Alzheimer's Disease Center in Ann Arbor and the University of Michigan Detroit Center in Detroit. We are seeking an experienced, positive, highly motivated, organized, autonomous person with excellent multi-tasking ability and record-keeping skills to work with principal investigators and other research team members to accurately and efficiently carry out a range of tasks associated with a variety of research studies. The candidate will be expected to work closely with faculty and staff and be able to administer standardized and computer-based cognitive, behavioral, and motor assessments to research participants and score neuropsychological examinations. The candidate will be able to operate in a semi-independent manner to assist in clinical research and related projects. The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities. This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder

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

Clinic Research Coordinator I The Clinical Research Coordinator I, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. Duties & Responsibilities: Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: a. Sponsor-provided and IRB-approved Protocol Training b. All relevant Protocol Amendments Training c. Any study-specific Manuals Training, as applicable d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Submitting required administrative paperwork per company timelines. Participating in subject recruitment and retention efforts. Engaging with Research Participants and understanding their concerns. Any other matters, as assigned by management. Knowledge & Experience: Education: High School Diploma or equivalent required Bachelor's degree a plus Foreign Medical Graduates preferred Experience: At least one years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. At least two years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting Credentials: ACRP or equivalent certification is preferred Registered Medical Assistant certification or equivalent is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Bilingual in Spanish is preferred

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!!!

Full-time Description The Clinical Research Assistant will play a crucial role in supporting clinical research activities aimed at enhancing medical treatments and therapies. You will work closely with our team of study coordinators and medical professionals to ensure the smooth execution of clinical trials and studies. Requirements ESSENTIAL JOB FUNCTION/COMPETENCIES Responsibilities include but are not limited to: Responsible for Study Specific Training which includes initial study start-up information/ requirements, dissemination of updated Investigator's Brochures, protocols and informed consent information, online training initiated by sponsor, review of correspondence throughout study. Collects patient vital signs including height, weight, blood pressure, respirations, pulse temperature, O2 saturation. Source Document Completion which includes completing and uploading all necessary documents to CRIO and maintaining all charts properly. Concomitant Medication Assessment by obtaining information from patient or chart regarding name of medication, start and stop dates, dose, and indication. Responsible for Biological Sampling Collection/Packaging/Shipping this includes serum and/or tissue collection, processing, packaging and shipping per study specific requirements. Case Report Form (CRF) Entries and Management data entry, query resolution in paper and/or electronic CRFs. Investigational Product (IP) Management - includes receiving IP supplies, IP accountability, monitoring of temperature controls, destructions or return of IP. Develop and/or Maintain Essential Documents including study specific training documents, study specific logs, patient questionnaires, patient pill diaries, lab requisition forms, other study specific forms. Supply Chain Maintenance including supplies inventoried, stocking, organizing, and resupply order placed as required. Responsible for study coordination, rooming, administer questionnaires, scheduling scans, set up room for procedures and wipe and clean equipment after procedures and visits. Obtain/Maintain all required training- GCP, IATA,CPR and occasionally help the study coordinators at other offices. 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 N/A KNOWLEDGE | SKILLS | ABILITIES Ability to function in a team-oriented environment, display strong analytical, investigative, interpersonal and organizational skills, pay high attention to detail with consistent follow-through and be able to productively manage high volumes of work. Proficiency skills with Microsoft Word and Excel. Excellent computer skills. Ability to deal compassionately, professionally, and courteously with patients, their families, physicians, and staff. EDUCATION REQUIREMENTS High School Diploma or equivalent required. Associate's degree or higher in a related field (biology, psychology, nursing or healthcare) preferred. EXPERIENCE REQUIREMENTS Previous healthcare experience strongly preferred. Previous Research Assistant experience preferred. REQUIRED TRAVEL Minimal travel required. 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%