Clinical research associate jobs in Toledo, OH - 42 jobs

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: * Act with integrity in everything we do. * Provide best-in-class customer experiences. * Develop superior talent and deliver expertise. * Respond with agility and provide timely results. * Embrace collaboration, diverse perspectives and ideas. Job Description: * Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. * Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. * May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. * Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. * Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. * Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. * Performs study-related training. * Manages the development and maintenance of study documents, processes and systems as assigned. * Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. * Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. * Attends internal and external meetings as required. * Provides all job-related progress reports and visit documentation as required. * May support safety activities such as narrative writing, managing the CEC/DSMB, etc. * OUS: Prepares and coordinates submissions to regulatory authorities. * May perform other activities as assigned. Qualifications & Technical Competencies: * Fluency in English and local language, if different, required. * Higher education degree or equivalent education, training, and experience. * Preferred 2 years clinical trial experience. * Preferred monitoring experience. * Able to work independently once trained. * Good verbal and written communication skills. * Strong organizational skills. * Basic computer proficiency. * Understanding of clinical research processes and regulations. * Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: * Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. * The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. * Extensive use of a computer keyboard. Pay Range Minimum: $54,400.00 Pay Range Target: $80,100.00 Pay Frequency: Annual Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: * May operate equipment * Records data timely and accurately * May analyze and interpret data * Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.

Under the clinical direction of the Residency Associate Director in the Department of Urology and Transplantation, the Clinical Research Manager (RN) will oversee and manage the conduct of all human subjects, research procedures, and related activities. Responsibilities will include collaborating with the Residency Associate Director to analyze and publish data from large databases, assist in the coordination and management of projects funded by various sources (industry, government, foundation), and ensure compliance with state and federal regulations. The manager will collaborate with the study team to maintain scientific integrity, oversee daily operations, and will assist with grant writing, as well as manuscript preparation and submission. They will assist in the hiring, supervision, and training of research team members, learners, and volunteer study staff as needed. Minimum Qualifications: •Associate degree in nursing required with •Current State of Ohio Registered Nurse licensure required. •Minimum of three to five (3-5) years of clinical research required •Experience with scientific writing. •Knowledge of clinical trials and IRB submission, preferred. •Experience teaching/supervising students and residents. •Knowledge of the methods, materials, and equipment used in research. •Must have excellent computer skills including Microsoft Office: Word, Excel, Outlook, PowerPoint required. •Current, active CPR certification at time of hire required and maintained. •CITI training through IRB is to be obtained within 90 days of hire. •HIPAA certification must be completed within 90 days of hire. Preferred Qualifications: •Bachelor's in nursing preferred. •Prior laboratory research or technician experience desirable. •Advanced Excel functions such as tables, graphs, statistical formulas, and Basic editor Conditions of Employment: To promote the highest levels of health and well-being, the University of Toledo campuses are tobacco-free. Pre-employment health screening requirements for the University of Toledo Health Science Campus Medical Center will include drug and other required health screenings for the position. Equal Employment Opportunity Statement: The University of Toledo is an equal opportunity employer. The University of Toledo does not discriminate in employment, educational programs, or activities on the basis of race, color, religion, sex, age, ancestry, national origin, sexual orientation, gender identity and expression, military or veteran status, disability, familial status, or political affiliation. The University is dedicated to attracting and retaining the best and brightest talent and fostering a culture of respect. The University of Toledo provides reasonable accommodation to individuals with disabilities. If you require accommodation to complete this application, or for testing or interviewing, please contact HR Compliance at ************************ or ************ between the hours of 8:30 a.m. and 5 p.m. or apply online for an accommodation request. Computer access is available at most public libraries and at the Office of Human Resources located in the Center for Administrative Support on the UToledo Main Campus.

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.

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

Scheduled Hours40Under direction, participates in clinical research study activities; screens, obtains consent, and enrolls participants in study; performs a variety of duties involved in the collection, documentation, and reporting of clinical research data.Job Description Primary Duties & Responsibilities: Participates in the recruitment of study participants as identified in related protocol; visits with study participants to explain study, screens for eligibility and obtains informed consent of participants. Completes all necessary paperwork/documentation according to study protocol; obtains consent, interviews study subjects and schedules follow-ups as needed. Performs basic/scripted assessments to confirm eligibility to participate in study; explains and schedules laboratory and diagnostic procedures and/or treatment as required in the study; refers participants to basic resources as necessary. Collects data from study participants, medical records, interviews, questionnaires, diagnostic tests and other sources; performs basic evaluation and interpretation of collected data and prepares appropriate reports and documentation as necessary; prepares and distributes study packets and information. Performs other duties as assigned. Working Conditions: Job Location/Working Conditions: Normal office environment. Physical Effort: Typically sitting at desk or table. Repetitive wrist, hand or finger movement. Equipment: Office equipment. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.Required Qualifications Education: High school diploma or equivalent high school certification or combination of education and/or experience. Certifications: The list below may include all acceptable certifications and issuers. More than one credential or certification may be required depending on the role.Basic Life Support - American Heart Association, Basic Life Support - American Red Cross Work Experience: Administrative Or Research (2 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position.More About This JobRequired Qualifications: Basic Life Support certification must be obtained within one month of hire date Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Preferred Qualifications Education: Associate degree Certifications: No additional certification unless stated elsewhere in the job posting. Work Experience: No additional work experience unless stated elsewhere in the job posting. Skills: Interpersonal Communication, Oral Communications, Organizing, Written CommunicationGradeC07-HSalary Range$19.21 - $28.85 / HourlyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.Pre-Employment ScreeningAll external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.Benefits Statement Personal Up to 22 days of vacation, 10 recognized holidays, and sick time. Competitive health insurance packages with priority appointments and lower copays/coinsurance. Take advantage of our free Metro transit U-Pass for eligible employees. WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%. Wellness Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more! Family We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered. WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us. For policies, detailed benefits, and eligibility, please visit: ****************************** EEO StatementWashington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.

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 agency's 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.

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.

Title: Clinical Research HRPP Program Specialist Department Org: Jacobson Clinical Research Center - 107980 Employee Classification: U1 - Unclassified PSA FT Bargaining Unit: Professional Staff Association Shift: 1 Posted Salary: Salary will commensurate with experience Job Description: This role serves as a lead for monitoring regulations and guidance to identify and ensure implementation of changes to operational processes or best practices for clinical research. This position provides expert advice to principal investigators (PIs), Clinical Research Coordinators, leadership and other ORSP personnel involved in ensuring compliance throughout the lifecycle of clinical research and trials. Responsible for the ongoing education and training of clinical research personnel and on-site clinical research monitoring of industry funded and investigator-initiated clinical research studies within the institution. Quality management duties include development and ongoing review of standard operating procedures (SOPs) and training documents for new coordinators that adheres to Good Clinical Practice (GCPs) and all applicable regulations. Minimum Qualifications: Requires Bachelor's in nursing, public health, healthcare, clinical research, or a related discipline. * Minimum of four (4) years demonstrated professional and functionally relevant experience in an academic or regulatory setting as well as clinical research and trials. Including, but not limited to, human subject research, research processes, and compliance with appropriate regulations. * Demonstrated experience in direct or indirect management or training of personnel. * Knowledge of academic medical center standard practices and policies, including but not limited to Medicare Coverage Analysis, Fair Market Value and Standard of Care. * Working knowledge of FDA and Good Clinical Practice guidelines and regulations * Understanding of medical coding and knowledge of medical terminology * Proficient in electronic health information systems (i.e., EPIC), Microsoft Office suite, and ability to learn and use other software systems as required by the position. * Ability to define problems, collect data, establish facts, and draw valid conclusions. * Background with federal and non-federal regulations for grant and contract management Conditions of Employment: To promote the highest levels of health and well-being, the University of Toledo campuses are tobacco-free. To further this effort, the University of Toledo Health Science Campus Medical Center is requiring candidates for employment to be nicotine-free. Pre-employment health screening requirements will include cotinine (nicotine) testing, as well as drug and other required health screenings for the position. With the exception of positions within University of Toledo Main Campus and the University of Toledo College of Medicine and Life Sciences, the employment offer is conditional upon successful completion of a cotinine test and Occupational Health clearance. Equal Employment Opportunity Statement: The University of Toledo is an equal opportunity employer. The University of Toledo does not discriminate in employment, educational programs, or activities on the basis of race, color, religion, sex, age, ancestry, national origin, sexual orientation, gender identity and expression, military or veteran status, disability, familial status, or political affiliation. The University is dedicated to attracting and retaining the best and brightest talent and fostering a culture of respect. The University of Toledo provides reasonable accommodation to individuals with disabilities. If you require accommodation to complete this application, or for testing or interviewing, please contact the HR Compliance at ************************ or ************ between the hours of 8:30 a.m. and 5:00 p.m. or apply online for an accommodation request. Computer access is available at most public libraries and at the Office of Human Resources located in the Center for Administrative Support on the Main Campus of the University of Toledo. Advertised: 17 Dec 2025 Eastern Standard Time Applications close: 11 Jan 2026 Eastern Standard Time

How to Apply A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position. Job Summary The Mary H. Weiser Food Allergy Center is seeking a clinical research technician/assistant for an innovative and large prospective cohort study at the University of Michigan. Join our dynamic interdisciplinary team of experts in Allergy, Immunology, Epidemiology, Obstetrics, and Genetics as we investigate the pathogenesis of food allergy and other allergic conditions. As a clinical research technician/assistant for M-SIBS, a birth cohort examining the development of food allergies, you will play a key role in the study's data collection by helping with study participant recruitment, data and biospecimen collection, scheduling study visits and the family experience. We are looking for a candidate who can autonomously recruit participants, collect biospecimens, perform home visits, and schedule participants. The candidate will help to ensure compliance with pre-established work scope responsibilities with a focus on completion of duties within established periods to meet study objectives while utilizing study protocol standards. This individual will also collaborate with other study coordinators within a large team-based science initiative with the goal of professional growth as the study progresses. This is an exceptional opportunity to leverage your skills and contribute to groundbreaking research. This job is a 100% (40 hours/week) effort. 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 Michigan Medicine CRC Career Ladder

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 ****************************

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: • Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. • Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. • May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. • Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. • Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. • Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. • Performs study-related training. • Manages the development and maintenance of study documents, processes and systems as assigned. • Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. • Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. • Attends internal and external meetings as required. • Provides all job-related progress reports and visit documentation as required. • May support safety activities such as narrative writing, managing the CEC/DSMB, etc. • OUS: Prepares and coordinates submissions to regulatory authorities. • May perform other activities as assigned. Qualifications & Technical Competencies: • Fluency in English and local language, if different, required. • Higher education degree or equivalent education, training, and experience. • Preferred 2 years clinical trial experience. • Preferred monitoring experience. • Able to work independently once trained. • Good verbal and written communication skills. • Strong organizational skills. • Basic computer proficiency. • Understanding of clinical research processes and regulations. • Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: • Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. • Extensive use of a computer keyboard. Pay Range Minimum: $54,400.00 Pay Range Target: $80,100.00 Pay Frequency: Annual Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: • May operate equipment • Records data timely and accurately • May analyze and interpret data • Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.

Title: Clinical Research HRPP Program Specialist Department Org: Jacobson Clinical Research Center - 107980 Employee Classification: U1 - Unclassified PSA FT Bargaining Unit: Professional Staff Association Primary Location: MC AD Shift: 1 Posted Salary: Salary will commensurate with experience Job Description: This role serves as a lead for monitoring regulations and guidance to identify and ensure implementation of changes to operational processes or best practices for clinical research. This position provides expert advice to principal investigators (PIs), Clinical Research Coordinators, leadership and other ORSP personnel involved in ensuring compliance throughout the lifecycle of clinical research and trials. Responsible for the ongoing education and training of clinical research personnel and on-site clinical research monitoring of industry funded and investigator-initiated clinical research studies within the institution. Quality management duties include development and ongoing review of standard operating procedures (SOPs) and training documents for new coordinators that adheres to Good Clinical Practice (GCPs) and all applicable regulations. Minimum Qualifications: Requires Bachelor's in nursing, public health, healthcare, clinical research, or a related discipline. • Minimum of four (4) years demonstrated professional and functionally relevant experience in an academic or regulatory setting as well as clinical research and trials. Including, but not limited to, human subject research, research processes, and compliance with appropriate regulations. • Demonstrated experience in direct or indirect management or training of personnel. • Knowledge of academic medical center standard practices and policies, including but not limited to Medicare Coverage Analysis, Fair Market Value and Standard of Care. • Working knowledge of FDA and Good Clinical Practice guidelines and regulations • Understanding of medical coding and knowledge of medical terminology • Proficient in electronic health information systems (i.e., EPIC), Microsoft Office suite, and ability to learn and use other software systems as required by the position. • Ability to define problems, collect data, establish facts, and draw valid conclusions. • Background with federal and non-federal regulations for grant and contract management Conditions of Employment: To promote the highest levels of health and well-being, the University of Toledo campuses are tobacco-free. To further this effort, the University of Toledo Health Science Campus Medical Center is requiring candidates for employment to be nicotine-free. Pre-employment health screening requirements will include cotinine (nicotine) testing, as well as drug and other required health screenings for the position. With the exception of positions within University of Toledo Main Campus and the University of Toledo College of Medicine and Life Sciences, the employment offer is conditional upon successful completion of a cotinine test and Occupational Health clearance. Equal Employment Opportunity Statement: The University of Toledo is an equal opportunity employer. The University of Toledo does not discriminate in employment, educational programs, or activities on the basis of race, color, religion, sex, age, ancestry, national origin, sexual orientation, gender identity and expression, military or veteran status, disability, familial status, or political affiliation. The University is dedicated to attracting and retaining the best and brightest talent and fostering a culture of respect. The University of Toledo provides reasonable accommodation to individuals with disabilities. If you require accommodation to complete this application, or for testing or interviewing, please contact the HR Compliance at ************************ or ************ between the hours of 8:30 a.m. and 5:00 p.m. or apply online for an accommodation request. Computer access is available at most public libraries and at the Office of Human Resources located in the Center for Administrative Support on the Main Campus of the University of Toledo.

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

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

Title: Clinical Research HRPP Program Specialist Department Org: Jacobson Clinical Research Center - 107980 Employee Classification: U1 - Unclassified PSA FT Bargaining Unit: Professional Staff Association Primary Location: MC AD Shift: 1 Posted Salary: Salary will commensurate with experience Job Description: This role serves as a lead for monitoring regulations and guidance to identify and ensure implementation of changes to operational processes or best practices for clinical research. This position provides expert advice to principal investigators (PIs), Clinical Research Coordinators, leadership and other ORSP personnel involved in ensuring compliance throughout the lifecycle of clinical research and trials. Responsible for the ongoing education and training of clinical research personnel and on-site clinical research monitoring of industry funded and investigator-initiated clinical research studies within the institution. Quality management duties include development and ongoing review of standard operating procedures (SOPs) and training documents for new coordinators that adheres to Good Clinical Practice (GCPs) and all applicable regulations. Minimum Qualifications: Requires Bachelor's in nursing, public health, healthcare, clinical research, or a related discipline. • Minimum of four (4) years demonstrated professional and functionally relevant experience in an academic or regulatory setting as well as clinical research and trials. Including, but not limited to, human subject research, research processes, and compliance with appropriate regulations. • Demonstrated experience in direct or indirect management or training of personnel. • Knowledge of academic medical center standard practices and policies, including but not limited to Medicare Coverage Analysis, Fair Market Value and Standard of Care. • Working knowledge of FDA and Good Clinical Practice guidelines and regulations • Understanding of medical coding and knowledge of medical terminology • Proficient in electronic health information systems (i.e., EPIC), Microsoft Office suite, and ability to learn and use other software systems as required by the position. • Ability to define problems, collect data, establish facts, and draw valid conclusions. • Background with federal and non-federal regulations for grant and contract management Conditions of Employment: To promote the highest levels of health and well-being, the University of Toledo campuses are tobacco-free. To further this effort, the University of Toledo Health Science Campus Medical Center is requiring candidates for employment to be nicotine-free. Pre-employment health screening requirements will include cotinine (nicotine) testing, as well as drug and other required health screenings for the position. With the exception of positions within University of Toledo Main Campus and the University of Toledo College of Medicine and Life Sciences, the employment offer is conditional upon successful completion of a cotinine test and Occupational Health clearance. Equal Employment Opportunity Statement: The University of Toledo is an equal opportunity employer. The University of Toledo does not discriminate in employment, educational programs, or activities on the basis of race, color, religion, sex, age, ancestry, national origin, sexual orientation, gender identity and expression, military or veteran status, disability, familial status, or political affiliation. The University is dedicated to attracting and retaining the best and brightest talent and fostering a culture of respect. The University of Toledo provides reasonable accommodation to individuals with disabilities. If you require accommodation to complete this application, or for testing or interviewing, please contact the HR Compliance at ************************ or ************ between the hours of 8:30 a.m. and 5:00 p.m. or apply online for an accommodation request. Computer access is available at most public libraries and at the Office of Human Resources located in the Center for Administrative Support on the Main Campus of the University of Toledo.

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 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 experience 3+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role 3+ years of experience independently coordinating studies, from study startup to close out 3+ 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 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.

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