Clinical research coordinator jobs in West Allis, WI

SiteBridge Description: Founded in 2021, SiteBridge Research is a community-focused integrated research organization, building a national network of community practices to deliver world-class industry sponsored clinical research on time and on budget, accelerating time to market and product adoption in communities that are the most vulnerable and the hardest to reach. The SiteBridge network extends reach further into these communities to empower a broader set of patients with some of the highest unmet needs to take part in clinical research to improve health outcomes. SiteBridge also helps with FDA diversity planning and building effective community engagement strategies. Responsibilitiies: Clinical Research Coordinator/Sr Clinical Research Coordinator - Contractor The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Clinical Principal Investigator (PI) on multiple ongoing research studies. While the PI is responsible for clinical trial conduct, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC works collaboratively with the entire site team, sponsors, and clinical monitors to ensure ICH/GCP compliance, site productivity, and timely completion of studies. In addition, this role represents our mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant. The position will be responsible for specific clinical site activities to maintain the operational excellence required of clinical sites/staff involved in clinical studies and to assure compliance with protocol-specific procedures, data acquisition, and records management. This role will report to the Director, Clinical Research Coordinators and Project Managers. ● Ensure clinical study compliance with local and federal laws and regulations according to ICH/GCP Guidelines ●Assist the Clinical/Site Ops leads on the set-up/start-up of research site to prepare for start-up and conduct of clinical trials ●Lead oversight of pre-study, site initiation, and close-out visits with sponsor or CRO ● Consult with Site Leads, sponsor, and CRO to determine the best recruitment practices for site and trials ● Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies ● Arrange screening and recruitment of potential study participants by scheduling visits to establish Informed Consent and perform intake assessments according to protocols ● Create and maintain all essential documents and records related to the study ● Acts as a point of reference for study participants by answering questions and keeping them informed on the study's progress ● Oversee and/or manage the inventory of equipment and supplies related to the study, including documentation, reporting of issues, and ordering clinical supplies as needed ● Communicate with laboratories and clinical investigators to ensure review and reporting of lab results and other clinical testing results ● Direct the request, collection, labeling, storage, or shipment of interventional products ● Ensure collection of specimens, questionnaire information, and input of data and patient information into electronic clinical systems ● Monitor the enrollment status of participants at the site for each specific clinical study Operate as primary contact for sponsors/CROs to schedule and coordinate site visits and answer queries ● Participate in meetings (Investigator Meetings, Site Trainings, etc.) and seminars to update knowledge of clinical research and related issues ● Prepare or participate in quality assurance audits and inspections performed by sponsors/CROs, regulatory authorities, or exclusively designated review groups ● Provide regular updates to Site Clinical Investigator(s) and Clinical/Site Ops Leads on study progress related to recruitment, compliance, and other study-related matters Qualifications ● Bachelor's degree in a relevant life science discipline; RN (BSN) is preferred; CCRC/CCRP is a plus ● 2+ years of previous experience working in a clinical research setting; number of years of clinical site/trials experience will determine position level ● Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required ● Strong preference for bilingual, Spanish-speaking candidate ● Strong preference for experience with late-phase and observational clinical research ● Managing necessary clinical study and staff records related to clinical study activities including case report forms, drug dispensation records, etc. ● Preparing advertising and other educational materials and conducting campaigns to recruit and enroll subjects ● Preparing trial-related document support such as protocol worksheets, adverse event reports, IRB documents, procedural manuals, and progress reports ● Experience identifying, reviewing, and reporting adverse events, protocol deviations, or other unanticipated problems appropriately to investigators and/or regulatory agencies ● Assessing risk factors in study protocols such as sample collection procedures, data management issues, and possible subject threats ● Clinical and laboratory skills, including the ability to perform phlebotomy and process samples are preferred ● Detail-oriented; strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative ● Capable of working independently with minimal supervision and as part of a team ● Understanding of medical terminology as well as standard clinical procedures and protocol ●Ability to lift approximately 20 pounds for a short period and capable of standing for extended periods of time Pay Range: The combined pay range for this role is $28 - $36/hour. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.

About the Job: The Research Coordinator's role is to help the research practice operate more efficiently. They do this by handling the logistics to make research run smoothly so that researchers can focus on what they do best - conduct research. Research Coordinator duties may include project and client management, creating and managing materials for research, participant recruitment and session scheduling, incentive management, tool and data management, etc. What You'll Do: Coordinate research participant recruitment o Identify and recruit research participants per researcher specifications o Coordinate schedules of research participants, researchers, and stakeholders o Manage incentives o Manage lists of past and future research participants Manage software systems used for data collection and analysis Coordinate with Design Program Managers, Design Leads, and other stakeholders Work as part of the larger Design Operations team and may be called upon to do operational work for the broader design organization. If capacity allows, manage projects across the research organization. Including o Prepare study materials and data collection tools for research sessions o Schedule planning, research, and report-out sessions for researchers o Prepare data for analysis o Create and manage data repositories and handle records retention Skills You Have: Bachelor's degree, or equivalent Experience providing operational support to fast-paced research teams. Experience with research participant recruitment Demonstrated skills in increasing team efficiency. Strong communication and organizational skills with attention to the right details to ensure operations run smoothly An ability to anticipate and proactively solve logistical issues so your team knows they'll never miss a beat when you're coordinating their work Additional Qualifications We'd Love: 2 years' experience collaborating with live research teams. Experience working in a highly regulated environment like healthcare or financial services. Professional association with the Research Ops community. #LI-Hybrid Compensation Range: Pay Range - Start: $60,340.00 Pay Range - End: $112,060.00 Geographic Specific Pay Structure: Structure 110: $66,360.00 USD - $123,240.00 USD Structure 115: $69,370.00 USD - $128,830.00 USD We believe in fairness and transparency. It's why we share the salary range for most of our roles. However, final salaries are based on a number of factors, including the skills and experience of the candidate; the current market; location of the candidate; and other factors uncovered in the hiring process. The standard pay structure is listed but if you're living in California, New York City or other eligible location, geographic specific pay structures, compensation and benefits could be applicable, click here to learn more. Grow your career with a best-in-class company that puts our clients' interests at the center of all we do. Get started now! Northwestern Mutual is an equal opportunity employer who welcomes and encourages diversity in the workforce. We are committed to creating and maintaining an environment in which each employee can contribute creative ideas, seek challenges, assume leadership and continue to focus on meeting and exceeding business and personal objectives.

Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive. Position Summary Under the direction of the Principal Investigators (PIs) and applicable sponsors, is responsible for planning and operationally leading the multi-site coordination of research trials from initiation to completion in compliance with applicable regulations and requirements. Manages trial budgets and implements and oversees systems to manage the conduct of the clinical trials and the flow of information among stakeholders and sites. Total Rewards Package Benefits Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others. Responsibilities Responsible for regulatory management including the development of IRB submissions, pharmacy control plans, training materials, questionnaires, case report forms, data analytics infrastructure, amendments, continuing review, study closeout, monitoring, and reporting of adverse events. Oversees review and approval at partner site(s). Coordination of all study activities with external and internal resources to complete research aims including managing vendor relationships as needed for the conduct of applicable trials (central lab, home health, etc.) Oversee compliance and conduct of the research protocol. Monitors safety and is involved in reviewing and analyzing adverse events and unanticipated events at participating sites. Provides oversight to ensure confidentiality of data, protocol compliance, evaluation of problems and complaints. Prepare and manage budgets and provide necessary financial information for grants, subcontracts, and sponsors. May complete study specific invoicing. Serves as a liaison between Principal Investigator (PI) and stakeholders (sponsors, IRB, sites, etc.) by assisting the PI in day-to-day operations of the projects. Determine data management plans and ensure that all data is collected, entered, analyzed and reported accurately. Performs quality checks and designs systems to monitor and extract data. May include site visits and auditing of data. Provide training and create documentation to support the research study (training manuals, educational, promotional materials). Design and maintain databases and systems to manage information, data and studies. Evaluate and improve processes for data entry, data extraction and record keeping. Generate, extract, analyze and, compose original scientific material for use in abstracts, publications, progress reports and grants. Participate and present at national and international research meetings and conferences. Supports in planning and conducting Investigator Meetings Reviews and approves release of investigational product or device shipments Maintains confidentiality of all subject-related records including written and verbal communications. Coordinates on-site and off-site meetings for project planning purposes and educational events as assigned. Serve as Project Manager (PM) for studies that do not have one also assigned and may provide coverage for others and/or may supervise, instruct and direct the work of others including Clinical Research Associates (monitors). As a skilled specialist, completes tasks in resourceful and effective ways. Tasks involve forward planning and anticipation of needs/issues. Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification Understands and performs in accordance with all applicable regulatory and compliance requirements Complies with all standard operating policies and procedures Qualifications Education Bachelor's Degree in a health sciences, biological sciences, nursing, pharmacy, or related field required Master's Degree in science or another related field preferred Experience 7-9 years Clinical Research Experience in regulatory and industry operations required 10+ years Healthcare/research experience required Less than 1 year Experience with related clinical research preferred Knowledge, Skills and Abilities Ability to be an effective liaison between study subjects and sponsors, investigators, health care workers, and collaborating professionals required Advanced verbal and written communication skills including the ability to write, interpret and explain research studies and procedures required Advanced ability to design, implement and manage projects that include planning, organization, prioritization, problem solving and performance of project tasks to ensure project completion within designated timeframes required Very strong attention to detail and ability to evaluate and ensure accuracy of data related to laboratory results, subject health history, and data collection and reporting required Ability to evaluate and extract data from medical records with ability to spot errors and trends and address promptly required Strong knowledge of regulations associated with human subject research required Ability to work in an independent manner while providing mentorship to others required Tasks involve a considerable degree of forward planning and anticipation of needs or issues required Licenses and Certifications ACRP CCRC or CCRA or SOCRA CCRP Certification upon hire required Tools and Technology Personal computer (laptop) required General office equipment (computer, printer, copy machine) required Microsoft Suite (Word, Excel, PowerPoint) required Electronic Data Capture systems such as Redcap, Medidata, Inform, etc. required Electronic Trial Master File systems such as Florence eBinders required Electronic consent platforms such as Redcap or Florence eConsent required EPIC medical record system preferred Not ready to apply? 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Department BSD NEU - Clinical Research Staff About the Department The Department of Neurology at The University of Chicago Medical Center has a great history and tradition, having made significant contributions to neurological training, clinical care, and the basic understanding of neurological disease. Job Summary The Clinical Research Coordinator II (CRC II) is an onsite, patient-facing, specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of the Clinical Research Manager. The CRC 2 supports, facilitates and coordinates independently the daily clinical trial activities and plays a critical role in the conduct of the study. Responsibilities Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of case report forms, and adverse event reports. Coordinates the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence and data integrity. Recruits and interviews potential study patients with guidance from PI and other clinical research staff. Obtains informed consent. Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules. Performs assessments at visits and monitors for adverse events. Organizes and attends site visits from sponsors and other relevant study meetings. Protects patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols. Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications. Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication. Understands the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently. Ensures compliance with federal regulations and institutional policies. May prepare and maintain protocol submissions and revisions. May assist in the training of new or backup coordinators. Accountable for all tasks in moderately complex clinical studies. Assists with various professional, organizational, and operational tasks under moderate supervision. Performs other related work as needed. Minimum Qualifications Education: Minimum requirements include a college or university degree in related field. Work Experience: Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline. Certifications: --- Preferred Qualifications Education: Bachelor's degree. Experience: Clinical research experience or relevant experience. Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials). Preferred Competencies Strong communication skills (verbal and written). Excellent interpersonal skills. Adaptability to changing working situations and work assignments. Ability to comprehend technical documents. Ability to develop and manage interpersonal relationships. Ability to exercise absolute discretion regarding confidential matters. Ability to follow written and/or verbal instructions. Ability to handle sensitive matters with tact and discretion. Ability to pay attention to detail. Ability to perform multiple tasks simultaneously. Excellent time management and ability to prioritize work assignments. Ability to train or teach others. Working knowledge of Good Clinical Practices (GCP). Application Documents Resume (required) Cover Letter (required) When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application. Job Family Research Role Impact Individual Contributor Scheduled Weekly Hours 40 Drug Test Required Yes Health Screen Required Yes Motor Vehicle Record Inquiry Required No Pay Rate Type Salary FLSA Status Exempt Pay Range $60,000.00 - $75,000.00 The included pay rate or range represents the University's good faith estimate of the possible compensation offer for this role at the time of posting. Benefits Eligible Yes The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook. Posting Statement The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination. Job seekers in need of a reasonable accommodation to complete the application process should call ************ or submit a request via Applicant Inquiry Form. All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position. The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: *********************************** Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.

Established in 1991, Collabera is one of the fastest growing end-to-end information technology services and solutions companies globally. As a half a billion dollar IT company, Collabera's client-centric business model, commitment to service excellence and Global Delivery Model enables its global 2000 and leading mid-market clients to deliver successfully in an increasingly competitive marketplace. With over 8200 IT professionals globally, Collabera provides value-added onsite, offsite and offshore technology services and solutions to premier corporations. Over the past few years, Collabera has been awarded numerous accolades and Industry recognitions including. • Collabera awarded Best Staffing Company to work for in 2012 by SIA. (hyperlink here) • Collabera listed in GS 100 - recognized for excellence and maturity • Collabera named among the Top 500 Diversity Owned Businesses • Collabera listed in GS 100 & ranked among top 10 service providers • Collabera was ranked: • 32 in the Top 100 Large Businesses in the U.S • 18 in Top 500 Diversity Owned Businesses in the U.S • 3 in the Top 100 Diversity Owned Businesses in New Jersey • 3 in the Top 100 Privately-held Businesses in New Jersey • 66th on FinTech 100 • 35th among top private companies in New Jersey *********************************************** Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance. Job Description Responsible for compliance with applicable Corporate and Divisional Policies and procedures. • Provides timely and accurate promotional reviews in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs. Ensures deliverables convey a clear and appropriate medical message. • Maintains in-depth understanding of product knowledge, associated disease states and treatment guidelines, labeling, and relevant data for assigned therapeutic area. • Has solid understanding of the Pharmacovigilance and Product Quality reporting requirements and their impact on promotional review activities. Reports events as appropriate. • Establishes and maintains cooperative relationships with US and AI counterparts across functional areas (eg, Marketing, Regulatory, Legal, Risk Management, Sales Training, Clinical Teams, and Public Affairs). • Applies knowledge across multiple therapeutic areas to support departmental initiatives. • Applies solid understanding of regulations, knowledge of current regulatory opinion/guidance, political/legal climate and industry practices/ trends to the promotion of pharmaceutical products. • Working with colleagues and manager, develops strategies and resources to address customer and department needs. Participates in strategic initiative planning and implementation and assists assigned manager with execution of therapeutic team strategies. • Leads team, departmental, or cross-functional goals and projects. Develops, implements, and evaluates appropriate work tools and methodologies to enable Global Medical Communications to continually improve processes, performance, and productivity. • Demonstrates leadership, communication, and people development skills, including the ability to effectively listen and provide appropriate feedback and coaching specific to the developmental needs of others. Serves as a role model to peers. • In an independent manner, critically evaluates literature, interprets complex data, writes effectively, articulates information to a variety of audiences, and effectively negotiates with counterparts from cross-divisional functional areas. • Recognizes and resolves project risks associated with content of promotional materials, and other medical communications. Develops medical defense and alternative solutions to medical presentations to mitigate business risks. Appropriately advises management of project risks and presents recommendations for resolution. • Serves as a subject matter expert for training purposes. Coordinates training across functional and global boundaries to ensure timely, accurate and quality medical communication. • Maintains composure and demonstrates leadership during times of change. • Ensures organizational compliance, serves as ethical leader, and proactively identifies and resolves gaps. • Recognizes politically sensitive situations and brings them to management's attention for appropriate navigation of organizational dynamics. • Uses problem-solving skills to identify areas for improvement and create a more efficient workflow. Makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment. • Prioritizes multiple activities to accomplish individual and departmental goals, while using resources effectively and efficiently. • Identifies and employs rigorous logic and methods to independently and effectively solve difficult problems, while encouraging innovative solutions. • Probes all fruitful sources for answers, looks beyond the obvious and doesn't stop at the first answers. Remains objective and cognizant of bias. • Can see hidden problems; is excellent at honest analysis; doesn't over-analyze. • Defends proposed or enacted solutions to more senior level management. • Identifies and anticipates potential departmental problems impacting ability to meet business goals; proactively develops and implements methods of improvement and resolution. Qualifications Minimum Education Bachelor's degree and graduation from an accredited Nursing, PA, Pharmacy, PhD in Health Sciences, or MD/DO program. Advanced degree preferred. Achieved licensure for professional practice, if appropriate for field. Minimum Experience / Training Required Minimum of 2 years work experience or 2 years postgraduate training in the pharmaceutical industry. OR Minimum of 4 years of licensed clinical practice experience Minimum requirement of 4 years of combined licensed clinical practice experience, postgraduate training, and/or postgraduate pharmaceutical industry experience. Additional Information All your information will be kept confidential according to EEO guidelines.

Compensation : $55,478 - 56,650.10, based on skills and experience. Provide administrative leadership and problem solving in support of research centers programs and mission. Provide lifecycle pre- & post-award research administration ensuring the fulfillment of all grant and/or contract & compliance requirements. Manage overall day-to-day research administration activities and ensure that all activities are completed in compliance with associated local, state, federal & institutional rules & regulations. Provide administrative support for the Center Director, PI's and Staff. Our generous benefits package includes medical, dental, and vision plans; paid parental leave; short term and long-term disability plans; life insurance; flexible spending accounts; and a 403(b) retirement plan which includes a 8% employer contribution after 2 years of service. RFUMS is committed to employee wellbeing and work-life balance. Full time staff are eligible for 3 weeks of vacation/ personal leave, 15 sick days, and 9 paid holidays, paid winter break, plus two floating holidays. This position is fully on-site with possibility of hybrid after 6-12 months. Who We Are Rosalind Franklin University of Medicine and Science (RFU) is a graduate health sciences university committed to serving the population through the interprofessional education of health and biomedical professionals and the discovery of knowledge dedicated to improving wellness. The university embodies the spirit of inquiry and excellence modeled by its namesake Dr. Rosalind Franklin, whose Photo 51 was crucial to solving the structure of DNA. Today, the university's 6 colleges continue Dr. Franklin's legacy through rigorous academics, pioneering research, and innovative community service. Our unique interprofessional education model allows students to learn from and with each other in a variety of settings, including our simulation labs, the student-led Interprofessional Community Clinic, and through partnerships with area hospitals and clinics. RFU is a national leader in interprofessional research and practices, and is nationally recognized for its research in areas including neuroscience, brain-related diseases, inherited disorders, proteomics, cancer cell biology and immunology, cardiac resuscitation, and gait and balance. Essential Duties & Responsibilities Administrative: Perform a wide range of administrative support functions for the Institute Director, Center Director, faculty members, staff, and more generally the RFU research enterprise. Completes and pre-approves all proposal components in Grant submission software (InfoEd or in other Sponsor's package forms), and obtains all essential approvals for routing sheets in preparation of Grant Submission Manages pre-award administration of grants and/or contracts, and manages effort commitments of key project personnel Schedule, prepare, and compile materials for meetings/conferences/seminars Arrange travel arrangements for the Director and personnel Coordinate with Human Resources and Student Financial Services for summer research Budget: Oversees the center's entire sponsored project portfolio and operating budgets for the Centers Monitors Center Project Account Balances ensuring that expenditures are done in according with Sponsors' rules Reviews award budget status, identifies issues and monitors/suggests changes and needs to PIs Provides OSR/PI with financial data needed for interim and final financial and technical progress reports Facilitates account close out activities, coordinating with OSR as needed Manages post-award administration of research grants and/or contracts from inception to closing of accounts Other Duties: All other duties as assigned by the Director, Research Administration (EVP office) and/or Institute/Center Director. CHP Grant Submission and Management Admin Tasks for all grants submitted and obtained by CHP faculty the Coordinator will be expected to fulfill the following tasks: Pre-award: Identify documents needed for grant submissions based on instructions and then create a timeline/task list for the grant submission to support an on-time submission Work with multiple PIs to ensure they will submit documents in a timely manner to facilitate a grant submission that meet OSR's timing requirements (i.e., track deadlines for different investigators and send reminders when necessary to ensure the grant is submitted on time). Assist with drafting grant budget (e.g., obtain salaries, supply costs…) and routing sheets Serve as a liaison with other institutions to obtain required information for subcontracts (e.g., request, budget justification, investigator biosketches, letters of support…), and to reciprocate when RFUMS is the subcontracting institution Input everything (e.g., budget, research strategy, personnel, forms…) into InfoEd for investigator review prior to sending to OSR for review (both for the initial OSR review and then for the final review prior to OSR submitting the grant). Post-award: Assist with JIT submission Providing monthly reports to PIs for financial management Set up and manage external accounts with vendors to facilitate research purchasing, complete grant purchases, cost-transfers, PAFs, and other relevant financial paperwork Help ensure grant expenses are allowable, per the budget justification Help ensure grant funds are spent, and ensure that the necessary funds are available Quarterly reports on Investigator research incentive account Submit initial and revised documentation to Clinicaltrial.gov for clinical trial management Assist with the completion and submission of grant reporting requirements Conditions of Employment Must achieve satisfactory results from a background check Required Education & Experience BA/BS Required Knowledge, Skills, & Abilities Microsoft office/Excel/InfoEd Preferred Qualifications Experience in administrative support for medical education 3-7 years Demonstration administrative background Typical Physical Demands & Working Conditions Selected candidate must have the mental and physical capabilities to perform the essential functions of the position with or without reasonable accommodations. EOE, Including Disability / Vets

Purpose Perform the day-to-day administrative activities of clinical research trial programs. Provide support to the team to facilitate the achievement of the program's goals. Assist with recruiting, training, and supervising staff and managing the program budget. Primary Functions • Recruit, screen, enroll and obtain consent from program participants. Conduct or coordinate education and training for program participants. • Project/patient coordination for research protocols including arranging necessary appointments and procedures, working collaboratively with other departments and institutions, and maintaining contact with study participants. • Monitor study related activities on patient and protocol level. Maintain patient calendars, screening and enrollment information utilizing the OnCore software tool. • Collect, analyze, and disseminate research data. Report clinical trial progress to study investigators. Work with Principle Investigator to develop, implement, and maintain comprehensive databases and files related to the program. • Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to the study investigators. Maintain program timeline including tracking deadlines for program components. • Assure compliance with all relevant IRB and other regulatory agency requirements. • Prepare IRB documents and reports. Evaluate and assist with writing of research protocols in collaboration with the study investigator. • Assist in recruitment and training of CTO staff. • Participate on CTO and other partner related committees. Collaborate on the development of program materials including educational materials, marketing materials, websites, forms, and reports. • Coordinate program outreach activities including acting as a liaison with community organizations. Organize internal and external meetings, site visits, and special events. • Monitor study related budgets. Participate in the development of program resources through literature searches, contact with outside programs, and review of funding opportunities. Knowledge - Skills - Abilities Knowledge of biology, chemistry, mathematics, documentation, and records management. Data utilization, complex problem solving, critical thinking, resource management, and writing skills. Preferred Schedule: M-F 8-4:30 Position Requirements: Specifications Appropriate experience may be substituted on equivalent basis Minimum Required Education: Bachelor's degree Minimum Required Experience: 2 years clinical research coordination Preferred Education: Science education; biology, biochemistry, immunology, etc. Preferred Experience: Previous oncology clinical research coordination Field: Sciences, clinical research Certification: CITI training within 90 days of hire. Certified Clinical Research Professional (ACRP or SoCRA) preferred. #LI-NI1 MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants, or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic. .

At Children's Wisconsin, we believe kids deserve the best. Our pediatricians and primary care offices offer parents a level of care that cannot be obtained at other places: Affiliation with the #4 children's hospital in the country (according to Parents magazine) Board-certified pediatricians (l earn what it means to be 'board-certified' ) Many locations spread throughout southeast Wisconsin Commitment to population health and an increased role for pediatricians in the care of children Doctors who are very active in their local communities Access to many health and wellness programs designed to keep kids safe and healthy We offer a wide variety of rewarding career opportunities and are seeking individuals dedicated to helping us achieve our vision of the healthiest kids in the country. If you want to work for an organization that makes a difference for children and families, and encourages you to be at your best every day, please apply today. Please follow this link for a closer look at what it's like to work at Children's Wisconsin: *********************************** This role is an active member of the front desk team and works to welcome patient families for their appointment and serves as liaison between patient families and the clinical team and works to align processes, provide support/education and ensures compliance of patient centered care. This position reports to the Primary Care Practice Manager and collaborates with Regional Access Specialist for optimal outcomes. Minimum Job Requirements Education High school diploma or equivalent. Experience One year related work experience in a healthcare setting. Knowledge / Skills / Abilities Exhibits guiding behaviors that reflect Children's values and support the Children's Wisconsin mission and vision. Knowledge of medical terminology, medical menu software, patient scheduling and business office procedures preferred. Requires excellent interpersonal skills in order to assist patients, parents, and physicians and other staff. Requires good concentration skills in order to serve a variety of people in a fast paced environment and to handle incoming calls in an efficient and accurate manner. Required flexibility in order to prioritize efforts to meet needs of the patients, parents, physicians and other staff. Requires the ability to sit for extended period of time while performing duties. May be required to stand for extended periods of time and may be required to lift up to 25 pounds. Ability to assist and support other primary care locations as requested by leaders and/or the Children's Medical Group float policy. Children's Wisconsin is an equal opportunity / affirmative action employer. We are committed to creating a diverse and inclusive environment for all employees. We treat everyone with dignity, respect, and fairness. We do not discriminate against any person on the basis of race, color, religion, sex, gender, gender identity and/or expression, sexual orientation, national origin, age, disability, veteran status, or any other status or condition protected by the law.

Compensation: $55,478 based on skills and experience. The Coordinator, Clinical Affairs provides administrative and operational support to the Associate Dean of Clinical Affairs/Associate Vice President for Medical Affairs (ADCA/AVPMA) in advancing clinical partnership strategies for Chicago Medical School (CMS) and Rosalind Franklin University of Medicine and Science (RFUMS). This role supports both school-level and University-level initiatives, including the development and management of affiliation agreements, clinical partnership projects, and other strategic initiatives. The Coordinator manages meeting logistics, correspondence, reports, budgets, and databases, serving as a key liaison with clinical partners and internal stakeholders to ensure efficient operations, program compliance, and alignment with accreditation standards. Additionally, the Coordinator establishes procedures and systems to enhance program efficiency and supports special projects across departments as needed. This role requires independent judgment and authority in working directly with clinical sites and the RFUMS compliance office to implement and update affiliation agreements to ensure they meet CMS and LCME standards. Our generous benefits package includes medical, dental, and vision plans; paid parental leave; short term and long-term disability plans; life insurance; flexible spending accounts; and a 403(b) retirement plan which includes an 8% employer contribution after 2 years of service. RFUMS is committed to employee wellbeing and work-life balance. Full time staff are eligible for 3 weeks of vacation/ personal leave, 15 sick days, and 9 paid holidays, paid winter break, plus two floating holidays. Who We Are Rosalind Franklin University of Medicine and Science (RFU) is a graduate health sciences university committed to serving the population through the interprofessional education of health and biomedical professionals and the discovery of knowledge dedicated to improving wellness. The university embodies the spirit of inquiry and excellence modeled by its namesake Dr. Rosalind Franklin, whose Photo 51 was crucial to solving the structure of DNA. Today, the university's 6 colleges continue Dr. Franklin's legacy through rigorous academics, pioneering research, and innovative community service. Our unique interprofessional education model allows students to learn from and with each other in a variety of settings, including our simulation labs, the student-led Interprofessional Community Clinic, and through partnerships with area hospitals and clinics. RFU is a national leader in interprofessional research and practices, and is nationally recognized for its research in areas including neuroscience, brain-related diseases, inherited disorders, proteomics, cancer cell biology and immunology, cardiac resuscitation, and gait and balance. Essential Duties & Responsibilities * Provide administrative and project support to the ADCA/AVPMA, including scheduling, travel coordination, correspondence, reports, and presentations. * Organize site visits and meetings with clinical partners on and off campus, including logistics such as room scheduling, agendas, materials, tours, catering, and coordination of RFUMS leadership participation. * Serve as liaison with clinical sites and health system partners; accompany the ADCA/AVPMA on visits, take meeting minutes, and assist with follow-up actions. * Manage and oversee the full lifecycle of affiliation agreements with clinical sites, including drafting, reviewing, and implementing agreements to ensure compliance with CMS, RFUMS, and LCME standards. * Collaborate directly with clinical sites and the RFUMS compliance office to resolve issues and implement updates to agreements, escalating only when institutional leadership input is required. * Maintain databases and records (e.g., InSite, Clinical Affiliation Agreement Metrics, SARA), and prepare reports as requested. * Monitor budgets, reconcile accounts, process expenses, and manage affiliate payments in collaboration with the CMS Dean's Office. * Assist with strategic projects such as the annual Clinical Partnerships Report, accreditation preparation, and development of communications or web content. * Support committees, including the Directors of Clinical Education, and coordinate with other RFUMS colleges on cross-University initiatives. * Evaluate and verify that affiliation agreements align with accreditation requirements, institutional policies, and risk management standards; proactively identify gaps and implement corrective actions. * Research and evaluate potential clinical sites in alignment with LCME standards; provide findings to the ADCA/AVPMA. * Recommend improvements to departmental processes and procedures to enhance efficiency and compliance. * Address emergent issues and facilitate resolution of such to ensure smooth operations for clinical partnership activities. * Oversee action items and provide follow-up and status updates to the ADCA/AVPMA as well as internal and external stakeholders. * Support Medical Student Onboarding: Assist with the coordination and tracking of student pre-placement requirements, onboarding processes, and compliance documentation for clerkships, sub-internships, and electives, ensuring continuity when the primary Coordinator is unavailable. * Provide Coverage and Cross-Training: Maintain familiarity with onboarding systems, student records, and communication protocols with clinical sites and Student Health; step in to manage daily tasks, site communications, and student inquiries as needed to ensure seamless operations. * Perform additional duties as assigned. Required Education & Experience * Bachelor's Degree or equivalent related experience * Five or more years of administrative experience with proven ability to manage complex tasks and coordinate multiple priorities Conditions of Employment * Must achieve satisfactory results from a background check Required Knowledge, Skills, & Abilities * Requires advanced verbal and a demonstrated high level of written communication skills; including, composing, editing and proofreading. * Ability to professionally represent the Associate Dean, Clinical Affairs and the medical school in addition to effectively presenting and/or facilitating activities at a senior administration level. * Experience with executing a position at a high level of confidentiality and discretion. * Must be adept at anticipating needs, a self-starter, self-directed, and possess excellent time management skills. * Ability to effectively handle multiple projects simultaneously, prioritize responsibilities and handle detailed job tasks with accuracy and efficiency within prescribed deadlines. * Strong project management and proven problem solving skills with ability to develop and implement process improvement plans with a drive for quality outcomes. * Demonstrated ability to work as part of a team and to interact effectively with all levels of university management. * Excellent organizational, planning and analytical skills Preferred Qualifications * Minimum of five years of relevant experience in a higher education and/or health care environment EOE, Including Disability / Vets

Department BSD SUR - Research Services: Clinical Research About the Department Since the founding of the Department in 1927, many scientists, including our very own Nobel Prize-winning Charles B. Huggins, MD, have made important discoveries about various diseases and treatment protocols that still serve as a basis for standard clinical practice today. Today, our scientists continue to embody the ethos of the University of Chicago's commitment to open, rigorous, and intense inquiry. Our laboratories tackle some of today's most complex biomedical challenges, including research into immunotolerance, vaccine stabilization and bioengineering. This ongoing work and achievement would not be possible without the cohesive effort of the faculty and staff. We are always looking for individuals who are willing to work in our dynamic and collaborative environment. Job Summary The Clinical Research Coordinator 2 (CRC2) is a specialized researcher working with the Principal Investigator (PI), Co-Investigator(s) and other study personnel. Under limited direction of departmental leadership, the CRC2 supports and provides guidance on the administration of the compliance, financial and other related aspects of the clinical study. Responsibilities Research Conduct/Study Management: Manages multiple moderately complex clinical trials that may include national level and multi-institutional pharmaceutical. Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence. Conducts all sponsor-related visits and acts as a liaison between sponsor and PI. Reviews and meets regularly with PI to review study portfolio. Participates in study start-up activities. Works with the lab team to process and collect samples for internal processing. Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events. Collects, processes, ships, and stores specimens to appropriate laboratory according to established aseptic techniques. Identifies adverse events and protocol deviations or violations, reports findings to PI, sponsor, and IRB under general direction of clinical research manager. Organizes and actively participates in site visits from sponsors and other relevant study meetings. Maintains a safe research environment and ensures compliance with governmental and University policies, procedures, and regulations. Data Management: Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitates the exchange of data across projects and organizations. Protects patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols. Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications. Regulatory Compliance: Works closely with Regulatory Manager to maintain accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, and study related communication. Ensures compliance with federal regulations and institutional policies. May mentor CRC1 or other CRC2 staff on the basics of clinical research, Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs) and other related aspects of the clinical study. Other: Assists with various professional, organizational, and operational tasks under moderate supervision. Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and tasks. Performs other related work as needed. Minimum Qualifications Education: Minimum requirements include a college or university degree in related field. Work Experience: Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline. Certifications: --- Preferred Qualifications Education: Bachelor's degree. Continuing education such as ACRP, SoCRA, or the Graham School Clinical Trials. Experience: Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, and multi-site trials). Preferred Competencies Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines. Demonstrated ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others. Strong data management skills and attention to detail. Ability to participate in protocol review and clinical trials evaluations. Knowledge of medical terminology. Ability to handle competing demands with diplomacy and enthusiasm. Extensive knowledge of Microsoft Word, Excel, and Adobe Acrobat. Familiarity with Good Clinical Practices (GCP). Ability to read and understand clinical trials protocols. Understanding of the IRB submission and review process and when and how to apply for IRB review. Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation. Working Conditions Due to the nature of trauma-related research, occasional evening, night, and weekend work may be required to accommodate patient enrollment, data collection, or other study needs as they arise. Application Documents Resume (required) Cover Letter (required) When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application. Job Family Research Role Impact Individual Contributor Scheduled Weekly Hours 40 Drug Test Required Yes Health Screen Required Yes Motor Vehicle Record Inquiry Required No Pay Rate Type Salary FLSA Status Exempt Pay Range $60,000.00 - $75,000.00 The included pay rate or range represents the University's good faith estimate of the possible compensation offer for this role at the time of posting. Benefits Eligible Yes The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook. Posting Statement The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination. Job seekers in need of a reasonable accommodation to complete the application process should call ************ or submit a request via Applicant Inquiry Form. All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position. The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: *********************************** Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.

SiteBridge Description: Founded in 2021, SiteBridge Research is a community-focused integrated research organization, building a national network of community practices to deliver world-class industry sponsored clinical research on time and on budget, accelerating time to market and product adoption in communities that are the most vulnerable and the hardest to reach. The SiteBridge network extends reach further into these communities to empower a broader set of patients with some of the highest unmet needs to take part in clinical research to improve health outcomes. Job Description: Clinical Research Coordinator/Research Nurse - Contractor The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Clinical Principal Investigator (PI) on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC works collaboratively with the entire site team, sponsors, and clinical monitors to ensure ICH/GCP compliance, site productivity, and timely completion of studies. In addition, and most importantly, this role represents our mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant. The position will be responsible for specific clinical site activities to maintain the operational excellence required of clinical sites/staff involved in clinical studies and to assure compliance with protocol-specific procedures, data acquisition, and records management. This role will report to the Director, Clinical Site Development Operations and Study Management. Location: The position is located in Germantown, WI and will be required to be on-site. Job Type: This is an (1099) Independent Contractor position and is part-time to begin with potential to move into full-time based on study needs. Responsibilities: * Ensure clinical study compliance with local and federal laws and regulations according to ICH/GCP Guidelines * Ensure study feasibility assessments for contracted sponsor-initiated studies * Assist the Clinical/Site Ops Leads on the set-up/start-up of research site to prepare for start-up and conduct of clinical trials * Lead oversight of pre-study, site initiation, and close-out visits with sponsor or CRO * Consult with Site Leads, sponsor, and CRO to determine the best recruitment practices for site and trials * Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies * Arrange screening and recruitment of potential study participants by scheduling visits to establish Informed Consent and perform intake assessments according to protocols * Create and maintain all essential documents and records related to the study * Act as a point of reference for study participants by answering questions and keeping them informed on the study's progress * Oversee and/or manage the inventory of equipment and supplies related to the study, including documentation, reporting of issues, and ordering clinical supplies as needed * Communicate with laboratories and clinical investigators to ensure review and reporting of lab results and other clinical testing results * Direct the request, collection, labeling, storage, or shipment of interventional products * Ensure collection of specimens, questionnaire information, and input of data and patient information into electronic clinical systems * Monitor the enrollment status of participants at the site for each specific clinical study * Operate as primary contact for sponsors/CROs to schedule and coordinate site visits and answer queries * Participate in meetings (Investigator Meetings, Site Trainings, etc.) and seminars to update knowledge of clinical research and related issues * Prepare or participate in quality assurance audits and inspections performed by sponsors/CROs, regulatory authorities, or exclusively designated review groups * Provide regular updates to Site Clinical Investigator(s) and Clinical/Site Ops Leads on study progress related to recruitment, compliance, and other study-related matters Qualifications & Required Experience: * Candidates with pediatric experience strongly encouraged to apply. * Bachelor's degree in a relevant life science discipline is preferred; LPN/RN is preferred; certification as CCRC/CCRP is a plus; Education requirement exceptions can be made based on relevant clinical research experience * Minimum 1 year of experience in clinical research. Number of years of previous experience working in a clinical research setting; number of years of clinical site/trials experience will determine position level * Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required * Strong preference for experience with late-phase and observational clinical research * Managing necessary clinical study and staff records related to clinical study activities including: case report forms, drug dispensation records, etc. * Preparing advertising and other educational materials and conducting campaigns to recruit and enroll subjects * Preparing trial-related document support such as protocol worksheets, adverse event reports, IRB documents, procedural manuals, and progress reports * Experience identifying, reviewing, and reporting adverse events, protocol deviations, or other unanticipated problems appropriately to investigators and/or regulatory agencies * Assessing risk factors in study protocols such as sample collection procedures, data management issues, and possible subject threats * Clinical and laboratory skills, including the ability to perform phlebotomy and process samples are preferred * Detail-oriented and meticulous in all aspects of work * Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative * Superior organizational and time management skills * Capable of working independently with minimal supervision and as part of a team * Understanding of medical terminology as well as standard clinical procedures and protocol * Ability to lift approximately 20 pounds for a short period and capable of standing for extended periods of time Additional Qualifications: * Strong Project Management skills including risk assessment and contingency planning * High level of collaboration, customer-oriented awareness, and focus * Skilled with standard computer programs including the MS Office suite * Strong interpersonal and written and verbal communication skills * Therapeutic experience in alignment with primary protocol(s) and site practice preferred * Some travel may be required Pay Range: The combined pay range for this role is $28 - $36/hour. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role. SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing employees with a work environment free of discrimination and harassment. We respect and seek to empower each individual and value the diverse cultures, perspectives, skills and experiences within our workforce. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law. All employment decisions at SiteBridge are based on business needs, job requirements and individual qualifications and performance.

Purpose Perform the day-to-day administrative activities of clinical research trial programs. Provide support to the team to facilitate the achievement of the program's goals. Assist with recruiting, and training study staff. Primary Functions Recruit, screen, enroll and obtain consent (including Spanish Speaking) from participants in Maternal Fetal Medicine (MFM) and OB-GYN clinics. Conduct or coordinate training for program participants. Travel to affiliate hospitals to recruit participants. Weekend coverage required. Coordinate research protocols including arranging necessary appointments and procedures, working collaboratively with other departments such as neonatology, cardiology, radiology etc. and institutions such as Children's Hospital of Wisconsin, and maintaining contact with study participants. Collect, enter and disseminate research data. Report program data and progress to study investigators. Work with Principal Investigator to develop, implement, and maintain comprehensive databases and files related to the program. Collect samples from patients as needed. Process and transport samples as directed. Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to the study investigators. Assure compliance with all relevant IRB and other regulatory agency requirements. Prepare IRB documents and reports. Evaluate and write of research protocols in collaboration with the study investigator. Depending on studies working with MCW and CHW IRBs are imminent. Collaborate on the development of program materials including educational materials, marketing materials, websites, forms, and reports. Maintain program timeline including tracking deadlines for program components. Coordinate program outreach activities including acting as a liaison with community organizations. Organize internal and external meetings, site visits, and special events. Monitor study related budgets. Participate in the development of program resources through literature searches, contact with outside programs, and review of funding opportunities for MFMs. Attend investigator meetings and train the study staff on protocol. Knowledge - Skills - Abilities Knowledge of biology, chemistry, mathematics, documentation, Venipuncture and records management. Data utilization, complex problem solving, critical thinking, fluent in Spanish, resource management, and writing skills. Preferred Schedule: 7am to 5pm Position Requirements: Specifications Appropriate experience may be substituted on equivalent basis Minimum Required Education: Bachelor's degree Minimum Required Experience: 2 years Preferred Education: Bachelor's or equivalent Certification: CITI training within 90 days of hire #LI-NI1 MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants, or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic. .

Compensation: $55,478 based on skills and experience.

Job Description Compensation: $55,478 based on skills and experience. The Coordinator, Clinical Affairs provides administrative and operational support to the Associate Dean of Clinical Affairs/Associate Vice President for Medical Affairs (ADCA/AVPMA) in advancing clinical partnership strategies for Chicago Medical School (CMS) and Rosalind Franklin University of Medicine and Science (RFUMS). This role supports both school-level and University-level initiatives, including the development and management of affiliation agreements, clinical partnership projects, and other strategic initiatives. The Coordinator manages meeting logistics, correspondence, reports, budgets, and databases, serving as a key liaison with clinical partners and internal stakeholders to ensure efficient operations, program compliance, and alignment with accreditation standards. Additionally, the Coordinator establishes procedures and systems to enhance program efficiency and supports special projects across departments as needed. This role requires independent judgment and authority in working directly with clinical sites and the RFUMS compliance office to implement and update affiliation agreements to ensure they meet CMS and LCME standards. Our generous benefits package includes medical, dental, and vision plans; paid parental leave; short term and long-term disability plans; life insurance; flexible spending accounts; and a 403(b) retirement plan which includes an 8% employer contribution after 2 years of service. RFUMS is committed to employee wellbeing and work-life balance. Full time staff are eligible for 3 weeks of vacation/ personal leave, 15 sick days, and 9 paid holidays, paid winter break, plus two floating holidays. Who We Are Rosalind Franklin University of Medicine and Science (RFU) is a graduate health sciences university committed to serving the population through the interprofessional education of health and biomedical professionals and the discovery of knowledge dedicated to improving wellness. The university embodies the spirit of inquiry and excellence modeled by its namesake Dr. Rosalind Franklin, whose Photo 51 was crucial to solving the structure of DNA. Today, the university's 6 colleges continue Dr. Franklin's legacy through rigorous academics, pioneering research, and innovative community service. Our unique interprofessional education model allows students to learn from and with each other in a variety of settings, including our simulation labs, the student-led Interprofessional Community Clinic, and through partnerships with area hospitals and clinics. RFU is a national leader in interprofessional research and practices, and is nationally recognized for its research in areas including neuroscience, brain-related diseases, inherited disorders, proteomics, cancer cell biology and immunology, cardiac resuscitation, and gait and balance. Essential Duties & Responsibilities Provide administrative and project support to the ADCA/AVPMA, including scheduling, travel coordination, correspondence, reports, and presentations. Organize site visits and meetings with clinical partners on and off campus, including logistics such as room scheduling, agendas, materials, tours, catering, and coordination of RFUMS leadership participation. Serve as liaison with clinical sites and health system partners; accompany the ADCA/AVPMA on visits, take meeting minutes, and assist with follow-up actions. Manage and oversee the full lifecycle of affiliation agreements with clinical sites, including drafting, reviewing, and implementing agreements to ensure compliance with CMS, RFUMS, and LCME standards. Collaborate directly with clinical sites and the RFUMS compliance office to resolve issues and implement updates to agreements, escalating only when institutional leadership input is required. Maintain databases and records (e.g., InSite, Clinical Affiliation Agreement Metrics, SARA), and prepare reports as requested. Monitor budgets, reconcile accounts, process expenses, and manage affiliate payments in collaboration with the CMS Dean's Office. Assist with strategic projects such as the annual Clinical Partnerships Report, accreditation preparation, and development of communications or web content. Support committees, including the Directors of Clinical Education, and coordinate with other RFUMS colleges on cross-University initiatives. Evaluate and verify that affiliation agreements align with accreditation requirements, institutional policies, and risk management standards; proactively identify gaps and implement corrective actions. Research and evaluate potential clinical sites in alignment with LCME standards; provide findings to the ADCA/AVPMA. Recommend improvements to departmental processes and procedures to enhance efficiency and compliance. Address emergent issues and facilitate resolution of such to ensure smooth operations for clinical partnership activities. Oversee action items and provide follow-up and status updates to the ADCA/AVPMA as well as internal and external stakeholders. Support Medical Student Onboarding: Assist with the coordination and tracking of student pre-placement requirements, onboarding processes, and compliance documentation for clerkships, sub-internships, and electives, ensuring continuity when the primary Coordinator is unavailable. Provide Coverage and Cross-Training: Maintain familiarity with onboarding systems, student records, and communication protocols with clinical sites and Student Health; step in to manage daily tasks, site communications, and student inquiries as needed to ensure seamless operations. Perform additional duties as assigned. Required Education & Experience Bachelor's Degree or equivalent related experience Five or more years of administrative experience with proven ability to manage complex tasks and coordinate multiple priorities Conditions of Employment Must achieve satisfactory results from a background check Required Knowledge, Skills, & Abilities Requires advanced verbal and a demonstrated high level of written communication skills; including, composing, editing and proofreading. Ability to professionally represent the Associate Dean, Clinical Affairs and the medical school in addition to effectively presenting and/or facilitating activities at a senior administration level. Experience with executing a position at a high level of confidentiality and discretion. Must be adept at anticipating needs, a self-starter, self-directed, and possess excellent time management skills. Ability to effectively handle multiple projects simultaneously, prioritize responsibilities and handle detailed job tasks with accuracy and efficiency within prescribed deadlines. Strong project management and proven problem solving skills with ability to develop and implement process improvement plans with a drive for quality outcomes. Demonstrated ability to work as part of a team and to interact effectively with all levels of university management. Excellent organizational, planning and analytical skills Preferred Qualifications Minimum of five years of relevant experience in a higher education and/or health care environment EOE, Including Disability / Vets

Department BSD MED - Hematology and Oncology - Clinical Research Staff - Cluster 8 About the Department The Section of Hematology/Oncology has a proud and long tradition of excellence in research-based patient care and clinical discovery. Ranked among the finest cancer programs in the country, the Section is comprised of nationally and internationally known faculty with expertise in all major types of malignancies, blood disorders, and experimental therapies. Job Summary The Clinical Research Coordinator I provides support to the faculty of the Section of Hematology/Oncology within the Biological Sciences Division. The CRC1 will be involved in multiple research trials types, multi-centered cooperative group and intergroup studies, at a national level, multi-institutional pharmaceutical trials, and multi-centered trials designed, implemented and coordinated in the Section. Responsibilities Coordinates all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports. Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication. Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules. Ensures standard operating procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications. Prepares and maintains protocol submissions and revisions. Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects. Performs assessments at visits and monitors for adverse events. Organizes and attends site visits from sponsors and other relevant study meetings. May recruit and interview potential study patients. May obtain, possess, and transport specimens to appropriate laboratory according to established aseptic techniques. Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups. Accountable for all tasks in basic clinical studies. Assists with various professional, organizational, and operational tasks under direct supervision. Performs other related work as needed. Minimum Qualifications Education: Minimum requirements include a college or university degree in related field. Work Experience: Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline. Certifications: --- Preferred Qualifications Education: Bachelor's degree. Experience: Knowledge of medical terminology/environment. Technical Skills or Knowledge: Proficient in Microsoft Word, Excel and Adobe Acrobat. Preferred Competencies Interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others. Communicate with tact and diplomacy. Strong organizational skills. Strong communication skills, verbal and written. Excellent interpersonal skills. Strong data management skills and attention to detail. Understand complex documents, such as clinical trials. Handle competing demands with diplomacy and enthusiasm. Absorb large amounts of information quickly. Adaptability to changing working situations and work assignments. Application Documents Resume/CV (required) Cover Letter (required) When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application. Job Family Research Role Impact Individual Contributor Scheduled Weekly Hours 37.5 Drug Test Required Yes Health Screen Required Yes Motor Vehicle Record Inquiry Required No Pay Rate Type Salary FLSA Status Exempt Pay Range $50,000.00 - $65,000.00 The included pay rate or range represents the University's good faith estimate of the possible compensation offer for this role at the time of posting. Benefits Eligible Yes The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook. Posting Statement The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination. Job seekers in need of a reasonable accommodation to complete the application process should call ************ or submit a request via Applicant Inquiry Form. All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position. The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: *********************************** Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.

SiteBridge Description: Founded in 2021, SiteBridge Research is a community-focused integrated research organization, building a national network of community practices to deliver world-class industry sponsored clinical research on time and on budget, accelerating time to market and product adoption in communities that are the most vulnerable and the hardest to reach. The SiteBridge network extends reach further into these communities to empower a broader set of patients with some of the highest unmet needs to take part in clinical research to improve health outcomes. Job Description: Clinical Research Coordinator/Research Nurse - Contractor The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Clinical Principal Investigator (PI) on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC works collaboratively with the entire site team, sponsors, and clinical monitors to ensure ICH/GCP compliance, site productivity, and timely completion of studies. In addition, and most importantly, this role represents our mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant. The position will be responsible for specific clinical site activities to maintain the operational excellence required of clinical sites/staff involved in clinical studies and to assure compliance with protocol-specific procedures, data acquisition, and records management. This role will report to the Director, Clinical Site Development Operations and Study Management. Location: The position is located in Germantown, WI and will be required to be on-site. Job Type: This is an (1099) Independent Contractor position and is part-time to begin with potential to move into full-time based on study needs. Responsibilities: Ensure clinical study compliance with local and federal laws and regulations according to ICH/GCP Guidelines Ensure study feasibility assessments for contracted sponsor-initiated studies Assist the Clinical/Site Ops Leads on the set-up/start-up of research site to prepare for start-up and conduct of clinical trials Lead oversight of pre-study, site initiation, and close-out visits with sponsor or CRO Consult with Site Leads, sponsor, and CRO to determine the best recruitment practices for site and trials Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies Arrange screening and recruitment of potential study participants by scheduling visits to establish Informed Consent and perform intake assessments according to protocols Create and maintain all essential documents and records related to the study Act as a point of reference for study participants by answering questions and keeping them informed on the study's progress Oversee and/or manage the inventory of equipment and supplies related to the study, including documentation, reporting of issues, and ordering clinical supplies as needed Communicate with laboratories and clinical investigators to ensure review and reporting of lab results and other clinical testing results Direct the request, collection, labeling, storage, or shipment of interventional products Ensure collection of specimens, questionnaire information, and input of data and patient information into electronic clinical systems Monitor the enrollment status of participants at the site for each specific clinical study Operate as primary contact for sponsors/CROs to schedule and coordinate site visits and answer queries Participate in meetings (Investigator Meetings, Site Trainings, etc.) and seminars to update knowledge of clinical research and related issues Prepare or participate in quality assurance audits and inspections performed by sponsors/CROs, regulatory authorities, or exclusively designated review groups Provide regular updates to Site Clinical Investigator(s) and Clinical/Site Ops Leads on study progress related to recruitment, compliance, and other study-related matters Qualifications & Required Experience: Candidates with pediatric experience strongly encouraged to apply. Bachelor's degree in a relevant life science discipline is preferred; LPN/RN is preferred; certification as CCRC/CCRP is a plus; Education requirement exceptions can be made based on relevant clinical research experience Minimum 1 year of experience in clinical research. Number of years of previous experience working in a clinical research setting; number of years of clinical site/trials experience will determine position level Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required Strong preference for experience with late-phase and observational clinical research Managing necessary clinical study and staff records related to clinical study activities including: case report forms, drug dispensation records, etc. Preparing advertising and other educational materials and conducting campaigns to recruit and enroll subjects Preparing trial-related document support such as protocol worksheets, adverse event reports, IRB documents, procedural manuals, and progress reports Experience identifying, reviewing, and reporting adverse events, protocol deviations, or other unanticipated problems appropriately to investigators and/or regulatory agencies Assessing risk factors in study protocols such as sample collection procedures, data management issues, and possible subject threats Clinical and laboratory skills, including the ability to perform phlebotomy and process samples are preferred Detail-oriented and meticulous in all aspects of work Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative Superior organizational and time management skills Capable of working independently with minimal supervision and as part of a team Understanding of medical terminology as well as standard clinical procedures and protocol Ability to lift approximately 20 pounds for a short period and capable of standing for extended periods of time Additional Qualifications: Strong Project Management skills including risk assessment and contingency planning High level of collaboration, customer-oriented awareness, and focus Skilled with standard computer programs including the MS Office suite Strong interpersonal and written and verbal communication skills Therapeutic experience in alignment with primary protocol(s) and site practice preferred Some travel may be required Pay Range: The combined pay range for this role is $28 - $36/hour. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role. SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing employees with a work environment free of discrimination and harassment. We respect and seek to empower each individual and value the diverse cultures, perspectives, skills and experiences within our workforce. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law. All employment decisions at SiteBridge are based on business needs, job requirements and individual qualifications and performance.

Perform the day-to-day administrative activities of the clinical research trials program. Provide support to the team to facilitate the achievement of the program's goals. Primary Responsibilities Recruit, screen, enroll and obtain consent from program participants. Conduct or coordinate training for program participants. Coordinate research protocols including arranging necessary appointments and procedures, working collaboratively with other departments and institutions, and maintaining contact with study participants. Collect, analyze, and disseminate research data. Report program data and progress to program stakeholders. Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to the study investigators. Assure compliance with all relevant IRB and other regulatory agency requirements. Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols. Collaborate on the development of program materials including educational materials, marketing materials, websites, forms, and reports. Work with Principal Investigator to develop, implement, and maintain comprehensive databases and files related to the program. Maintain program timeline including tracking deadlines for program components. Organize internal and external meetings, and site visits. Other duties as assigned. Knowledge - Skills - Abilities Knowledge of biology, chemistry, mathematics, documentation, and records management. Data utilization, complex problem solving, critical thinking, resource management, and writing skills. Preferred Schedule: Full-time role with expectations for coverage during core business hours and flexibility required as necessary to accommodate business needs. Position Requirements: Qualifications Appropriate experience may be substituted on equivalent basis. Minimum Required Education: Bachelor's Degree Minimum Required Experience: 1 year Required Certification/Licensure(s): CITI training within 90 days of hire MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants, or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic. .

Compensation: $55,478 based on skills and experience. The Coordinator, Clinical Affairs provides administrative and operational support to the Associate Dean of Clinical Affairs/Associate Vice President for Medical Affairs (ADCA/AVPMA) in advancing clinical partnership strategies for Chicago Medical School (CMS) and Rosalind Franklin University of Medicine and Science (RFUMS). This role supports both school-level and University-level initiatives, including the development and management of affiliation agreements, clinical partnership projects, and other strategic initiatives. The Coordinator manages meeting logistics, correspondence, reports, budgets, and databases, serving as a key liaison with clinical partners and internal stakeholders to ensure efficient operations, program compliance, and alignment with accreditation standards. Additionally, the Coordinator establishes procedures and systems to enhance program efficiency and supports special projects across departments as needed. This role requires independent judgment and authority in working directly with clinical sites and the RFUMS compliance office to implement and update affiliation agreements to ensure they meet CMS and LCME standards. Our generous benefits package includes medical, dental, and vision plans; paid parental leave; short term and long-term disability plans; life insurance; flexible spending accounts; and a 403(b) retirement plan which includes an 8% employer contribution after 2 years of service. RFUMS is committed to employee wellbeing and work-life balance. Full time staff are eligible for 3 weeks of vacation/ personal leave, 15 sick days, and 9 paid holidays, paid winter break, plus two floating holidays. Who We Are Rosalind Franklin University of Medicine and Science (RFU) is a graduate health sciences university committed to serving the population through the interprofessional education of health and biomedical professionals and the discovery of knowledge dedicated to improving wellness. The university embodies the spirit of inquiry and excellence modeled by its namesake Dr. Rosalind Franklin, whose Photo 51 was crucial to solving the structure of DNA. Today, the university's 6 colleges continue Dr. Franklin's legacy through rigorous academics, pioneering research, and innovative community service. Our unique interprofessional education model allows students to learn from and with each other in a variety of settings, including our simulation labs, the student-led Interprofessional Community Clinic, and through partnerships with area hospitals and clinics. RFU is a national leader in interprofessional research and practices, and is nationally recognized for its research in areas including neuroscience, brain-related diseases, inherited disorders, proteomics, cancer cell biology and immunology, cardiac resuscitation, and gait and balance. Essential Duties & Responsibilities Provide administrative and project support to the ADCA/AVPMA, including scheduling, travel coordination, correspondence, reports, and presentations. Organize site visits and meetings with clinical partners on and off campus, including logistics such as room scheduling, agendas, materials, tours, catering, and coordination of RFUMS leadership participation. Serve as liaison with clinical sites and health system partners; accompany the ADCA/AVPMA on visits, take meeting minutes, and assist with follow-up actions. Manage and oversee the full lifecycle of affiliation agreements with clinical sites, including drafting, reviewing, and implementing agreements to ensure compliance with CMS, RFUMS, and LCME standards. Collaborate directly with clinical sites and the RFUMS compliance office to resolve issues and implement updates to agreements, escalating only when institutional leadership input is required. Maintain databases and records (e.g., InSite, Clinical Affiliation Agreement Metrics, SARA), and prepare reports as requested. Monitor budgets, reconcile accounts, process expenses, and manage affiliate payments in collaboration with the CMS Dean's Office. Assist with strategic projects such as the annual Clinical Partnerships Report, accreditation preparation, and development of communications or web content. Support committees, including the Directors of Clinical Education, and coordinate with other RFUMS colleges on cross-University initiatives. Evaluate and verify that affiliation agreements align with accreditation requirements, institutional policies, and risk management standards; proactively identify gaps and implement corrective actions. Research and evaluate potential clinical sites in alignment with LCME standards; provide findings to the ADCA/AVPMA. Recommend improvements to departmental processes and procedures to enhance efficiency and compliance. Address emergent issues and facilitate resolution of such to ensure smooth operations for clinical partnership activities. Oversee action items and provide follow-up and status updates to the ADCA/AVPMA as well as internal and external stakeholders. Support Medical Student Onboarding: Assist with the coordination and tracking of student pre-placement requirements, onboarding processes, and compliance documentation for clerkships, sub-internships, and electives, ensuring continuity when the primary Coordinator is unavailable. Provide Coverage and Cross-Training: Maintain familiarity with onboarding systems, student records, and communication protocols with clinical sites and Student Health; step in to manage daily tasks, site communications, and student inquiries as needed to ensure seamless operations. Perform additional duties as assigned. Required Education & Experience Bachelor's Degree or equivalent related experience Five or more years of administrative experience with proven ability to manage complex tasks and coordinate multiple priorities Conditions of Employment Must achieve satisfactory results from a background check Required Knowledge, Skills, & Abilities Requires advanced verbal and a demonstrated high level of written communication skills; including, composing, editing and proofreading. Ability to professionally represent the Associate Dean, Clinical Affairs and the medical school in addition to effectively presenting and/or facilitating activities at a senior administration level. Experience with executing a position at a high level of confidentiality and discretion. Must be adept at anticipating needs, a self-starter, self-directed, and possess excellent time management skills. Ability to effectively handle multiple projects simultaneously, prioritize responsibilities and handle detailed job tasks with accuracy and efficiency within prescribed deadlines. Strong project management and proven problem solving skills with ability to develop and implement process improvement plans with a drive for quality outcomes. Demonstrated ability to work as part of a team and to interact effectively with all levels of university management. Excellent organizational, planning and analytical skills Preferred Qualifications Minimum of five years of relevant experience in a higher education and/or health care environment EOE, Including Disability / Vets

SiteBridge Description: Founded in 2021, SiteBridge Research is a community-focused integrated research organization, building a national network of community practices to deliver world-class industry sponsored clinical research on time and on budget, accelerating time to market and product adoption in communities that are the most vulnerable and the hardest to reach. The SiteBridge network extends reach further into these communities to empower a broader set of patients with some of the highest unmet needs to take part in clinical research to improve health outcomes. Job Description: Clinical Research Coordinator/Research Nurse - Contractor The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Clinical Principal Investigator (PI) on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC works collaboratively with the entire site team, sponsors, and clinical monitors to ensure ICH/GCP compliance, site productivity, and timely completion of studies. In addition, and most importantly, this role represents our mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant. The position will be responsible for specific clinical site activities to maintain the operational excellence required of clinical sites/staff involved in clinical studies and to assure compliance with protocol-specific procedures, data acquisition, and records management. This role will report to the Director, Clinical Site Development Operations and Study Management. Location: The position is located in Germantown, WI and will be required to be on-site. Job Type: This is an (1099) Independent Contractor position and is part-time to begin with potential to move into full-time based on study needs. Responsibilities: Ensure clinical study compliance with local and federal laws and regulations according to ICH/GCP Guidelines Ensure study feasibility assessments for contracted sponsor-initiated studies Assist the Clinical/Site Ops Leads on the set-up/start-up of research site to prepare for start-up and conduct of clinical trials Lead oversight of pre-study, site initiation, and close-out visits with sponsor or CRO Consult with Site Leads, sponsor, and CRO to determine the best recruitment practices for site and trials Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies Arrange screening and recruitment of potential study participants by scheduling visits to establish Informed Consent and perform intake assessments according to protocols Create and maintain all essential documents and records related to the study Act as a point of reference for study participants by answering questions and keeping them informed on the study's progress Oversee and/or manage the inventory of equipment and supplies related to the study, including documentation, reporting of issues, and ordering clinical supplies as needed Communicate with laboratories and clinical investigators to ensure review and reporting of lab results and other clinical testing results Direct the request, collection, labeling, storage, or shipment of interventional products Ensure collection of specimens, questionnaire information, and input of data and patient information into electronic clinical systems Monitor the enrollment status of participants at the site for each specific clinical study Operate as primary contact for sponsors/CROs to schedule and coordinate site visits and answer queries Participate in meetings (Investigator Meetings, Site Trainings, etc.) and seminars to update knowledge of clinical research and related issues Prepare or participate in quality assurance audits and inspections performed by sponsors/CROs, regulatory authorities, or exclusively designated review groups Provide regular updates to Site Clinical Investigator(s) and Clinical/Site Ops Leads on study progress related to recruitment, compliance, and other study-related matters Qualifications & Required Experience: Candidates with pediatric experience strongly encouraged to apply. Bachelor's degree in a relevant life science discipline is preferred; LPN/RN is preferred; certification as CCRC/CCRP is a plus; Education requirement exceptions can be made based on relevant clinical research experience Minimum 1 year of experience in clinical research. Number of years of previous experience working in a clinical research setting; number of years of clinical site/trials experience will determine position level Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required Strong preference for experience with late-phase and observational clinical research Managing necessary clinical study and staff records related to clinical study activities including: case report forms, drug dispensation records, etc. Preparing advertising and other educational materials and conducting campaigns to recruit and enroll subjects Preparing trial-related document support such as protocol worksheets, adverse event reports, IRB documents, procedural manuals, and progress reports Experience identifying, reviewing, and reporting adverse events, protocol deviations, or other unanticipated problems appropriately to investigators and/or regulatory agencies Assessing risk factors in study protocols such as sample collection procedures, data management issues, and possible subject threats Clinical and laboratory skills, including the ability to perform phlebotomy and process samples are preferred Detail-oriented and meticulous in all aspects of work Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative Superior organizational and time management skills Capable of working independently with minimal supervision and as part of a team Understanding of medical terminology as well as standard clinical procedures and protocol Ability to lift approximately 20 pounds for a short period and capable of standing for extended periods of time Additional Qualifications: Strong Project Management skills including risk assessment and contingency planning High level of collaboration, customer-oriented awareness, and focus Skilled with standard computer programs including the MS Office suite Strong interpersonal and written and verbal communication skills Therapeutic experience in alignment with primary protocol(s) and site practice preferred Some travel may be required Pay Range: The combined pay range for this role is $28 - $36/hour. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role. SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing employees with a work environment free of discrimination and harassment. We respect and seek to empower each individual and value the diverse cultures, perspectives, skills and experiences within our workforce. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law. All employment decisions at SiteBridge are based on business needs, job requirements and individual qualifications and performance.