clinical research coordinator

Key Clinical Research

Job Summary We are seeking an experienced Clinical Research Coordinator to join our growing research team. The Clinical Research Coordinator plays a pivotal role in the management and execution of clinical trials. This position involves overseeing the day-to-day operations of research studies, managing all aspects of assigned clinical trials in accordance with Good Clinical Practice (GCP), FDA regulations, IRB policies and internal standard operating procedures (SOP's). This role requires a detail-orientated, organized professional that thrives in a fast- paced environment and has strong interpersonal and problem -solving skills.Duties<ul><li>Coordinate and manage all aspects of assigned clinical trials from initiation through close out.</li><li>Ensure adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements.</li><li>Conduct patient recruitment, prescreening, screening, and informed consent processes.</li><li>Serve as the primary liaison between sponsors, CRO's, monitors and internal staff.</li><li>Monitor patient progress throughout the study, documenting any adverse events or changes in condition.</li><li>Collect, record and maintain accurate source documentation and case report forms.</li><li>Prepare for and participate in monitoring visits, audits and inspections</li><li>Maintain comprehensive records of study activities, including medical terminology relevant to the research.</li><li>Collaborate with physicians, nurses, and other healthcare professionals to facilitate effective communication regarding study protocols.</li></ul>Qualifications<ul><li>Bachelor&rsquo;s degree in a relevant field; nursing experience is a plus.</li><li>Strong understanding of clinical development processes and regulatory requirements.</li><li>Proficient in medical terminology and data collection methodologies.</li><li>Ability to perform blood sampling and phlebotomize patients safely and effectively is a plus.</li><li>Ability to manage multiple studies with minimal supervision from leadership.</li><li>Excellent organizational skills with the ability to supervise staff effectively.</li><li>Strong communication skills to interact with patients, healthcare professionals, and research teams.</li><li>Prior experience in a clinical research setting is highly desirable.</li><li>Certified Clinical Research Coordinator (CCRC) preferred.</li></ul>This role is essential for advancing medical knowledge through rigorous research practices while ensuring the safety and well-being of participants involved in clinical trials.Job Type: Full-timePay: $21.00 - $25.00 per hourBenefits:<ul><li>401(k)</li><li>Paid time off</li><li>Professional development assistance</li><li>Referral program</li></ul>Work Location: In person

Clinical Research Coordinator

University of Wisconsin–Madison

<div>Current employees: if you are currently employed at any of the universities of wisconsin, log in to workday to apply through the internal application process.
Job category:
Academic Staff
Employment type:
Regular
Job profile:
Clin Res Coord I
Job summary:
The Clinical Research Coordinator is an academic staff position in the Wisconsin Alzheimer's Disease Research Center (ADRC) at UW Madison. The ADRC is a highly successful research center focused on improving early detection of Alzheimer's disease (AD), identifying risk and protective factors, and understanding the disease process. The ADRC Clinical Core enrolls adults over 45 years of age ranging from healthy individuals with and without a family history of Alzheimer's disease to those diagnosed with mild cognitive impairment and dementia. Our teams are dedicated to creating a welcoming environment for participants and staff.
The Clinical Research Coordinator will work in the ADRC Outreach, Recruitment, and Engagement (ORE) Core in a collaborative role that works closely with team members across multiple ADRC cores. The coordinator will be responsible for screening, obtaining informed consent, and enrolling study participants in the ADRC Recruitment Registry (the center's research data base that matches eligible people to AD research studies connected to the ADRC). The coordinator will also provide recruitment support for ancillary research studies utilizing the ADRC Recruitment Registry. Additional responsibilities include scheduling visits for Clinical Core research study participants, assisting with the delivery of the ORE Core's signature education outreach events (for example, Healthy Living with Mild Cognitive Impairment and the Fall Community Conversation), and engaging with the Clinical Core Participant Advisory Council (PAC). The coordinator will be expected to perform other related duties as assigned and maintain confidentiality in all aspects of the job.<ul>
<li>
This position is full or part-time, 50%-100%</li>
<li>
This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.</li>
<li>
This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years.</li>
</ul>
Candidates who demonstrate the following knowledge, skills, and abilities will be given first consideration:<ul>
<li>
Communication with potential participants is a very important aspect of this role, so a successful candidate will demonstrate strong verbal and written English language skills. Attention to detail with strong organizational and interpersonal skills is essential.</li>
<li>
Highly qualified candidates will be able to handle multiple priorities and research study needs, have strong critical thinking and problem-solving skills, work collaboratively across teams, and demonstrate excellent time management skills.</li>
</ul>
Key job responsibilities:<ul><li>
Schedules logistics, determines workflows, and secures resources for a defined clinical research trial(s)</li></ul><ul><li>
Serves as an initial point of contact for clinical research participants and clinical staff, providing information regarding research procedures, expectations, and informational inquiries. Ensures participants follow the research protocol and alerts Principal Investigator of issues</li></ul><ul><li>
Recruits, screens, selects, determines eligibility and enrolls trial participants, collects information, and answers questions under supervision of a medically licensed professional. May perform basic medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy</li></ul><ul><li>
Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols</li></ul><ul><li>
Participates in community based outreach activities representing the ADRC as needed</li></ul><ul><li>
Identifies work unit resources needs and manages supply and equipment inventory levels</li></ul>
Department:
School of Medicine and Public Health, Department of Medicine, Division of Geriatrics and Gerontology, Alzheimer&rsquo;s Disease Research Center
Fueled by innovation yet grounded in kindness, the Department of Medicine empowers leaders to transform medicine and improve lives everywhere. We are committed to professional fulfillment and health equity. We strive to ensure that everyone in our department understands the importance of social impact and belonging&mdash;and is empowered to champion it in all they do. Join us and be a part of supporting our nationally recognized faculty, innovative medical education programs and exceptional clinical care as we work towards our vision of healthy people and healthy communities!
At the Division of Geriatrics and Gerontology, we help older adults live their healthiest lives. We lead comprehensive education, research and clinical programs&mdash;in partnership with our world-class university, remarkable health system and regional Veterans hospital. We are innovative, collaborative and compassionate. We strive for excellence and health equity. And we make an impact in Wisconsin and beyond.
Compensation:
The starting salary for the position is $45,000 annually; but is negotiable based on experience and qualifications.
Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits.
Effective July 1, 2024, the U.S. Department of Labor Fair Labor Standards Act (FLSA) requires that positions earning less than $43,888 annually be considered non-exempt under FLSA provisions for overtime. Based on these rules, if the person selected for this recruitment will earn less than the new salary threshold at July 1, 2024 ($43,888 annually), they will be an academic staff non-exempt employee, will be paid hourly and will receive overtime compensation for any hours worked over 40 in a workweek.
Required qualifications:<ul><li>
Experience in customer relations</li></ul>
Preferred qualifications:<ul>
<li>
Two or more years of relevant experience in a health care or human subjects clinical research setting or an equivalent combination of education and experiences</li>
<li>
Experience working with individuals from communities historically underrepresented in research</li>
</ul>
Education:<ul><li>
Bachelor&rsquo;s Degree preferred</li></ul>
How to apply:
For the best experience completing your application, we recommend using Chrome or Firefox as your web browser.
To apply for this position, select either &ldquo;I am a current employee&rdquo; or &ldquo;I am not a current employee&rdquo; under Apply Now. You will then be prompted to upload your application materials.
Important: The application has only one attachment field. Upload the following documents in that field, either as a single combined file or as multiple files in the same upload area.<ul>
<li>
Cover letter preferred</li>
<li>
Resume</li>
</ul>
Your cover letter should address how your training and experience aligns with the required and preferred qualifications listed above. Application reviewers will rely on these written materials to determine which applicants move forward in the process. References will be requested from final candidates. All applicants will be notified once the search concludes and a candidate is selected
University sponsorship is not available for this position, including transfers of sponsorship and TN visas. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. If you are selected for this position you must provide proof of work authorization and eligibility to work.
Contact information:
Jennifer McAlister, jmcalister@medicine.wisc.edu, 608-262-9640
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.
Institutional statement on diversity:
Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. 
 
The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. 
The University of Wisconsin-Madison is an Equal Opportunity Employer.
Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgrounds and encourage all qualified individuals to apply.
To request a disability or pregnancy-related accommodation for any step in the hiring process (e.g., application, interview, pre-employment testing, etc.), please contact the Divisional Disability Representative (DDR) in the division you are applying to. Please make your request as soon as possible to help the university respond most effectively to you.
Employment may require a criminal background check. It may also require your references to answer questions regarding misconduct, including sexual violence and sexual harassment. 
 
The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7). 
 
The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.</div>

Evolution Research Group

<div>
 
 
 
 About Company:
 
 
 
 
 Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I&ndash;IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. &nbsp;ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
 
 
 
 
 Why join us?
 
 We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.&nbsp;
 
 
 
 
 Job Description:
 
 
 
 
 The Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.
 
 
 
 
 Responsibilities:
 
 
 
 
 
 General
 
 
 
 <ul>
 
 <li>
 Obtain&nbsp;detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.
 </li>
 
 <li>
 Assist to develop draft source documents and review the documents for accuracy and clarity prior to study start up.
 </li>
 
 <li>
 Review&nbsp;with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.
 </li>
 
 <li>
 Manage&nbsp;studies with direct oversight from Site Director, and Principal Investigator to ensure compliance with protocol requirements.
 </li>
 
 <li>
 Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.&nbsp;
 </li>
 
 <li>
 Contribute to the SOP review and development as delegated by the Site Director.&nbsp;
 </li>
 
 </ul>
 
 
 
 Study Management
 
 &nbsp;
 
 
 <ul>
 
 <li>
 Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.
 </li>
 
 <li>
 Attend the investigator meeting for each assigned protocol, as appropriate with directive from Site Director.&nbsp;
 </li>
 
 <li>
 In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.
 </li>
 
 <li>
 Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator
 </li>
 
 <li>
 Review and obtain informed consent from with potential study volunteer
 </li>
 
 <li>
 Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations
 </li>
 
 <li>
 Maintain organized, accurate and complete study records
 </li>
 
 <li>
 Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.
 </li>
 
 <li>
 Enter data as appropriate for protocol (paper-electronic data capture)
 </li>
 
 <li>
 In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol.
 </li>
 
 <li>
 Perform study close-out procedures.
 </li>
 
 <li>
 Store study records appropriately
 </li>
 
 <li>
 Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG&rsquo;s objectives.
 </li>
 
 </ul>
 
 
 
 Skills and Qualifications:
 
 
 
 <ul>
 
 <li>
 
 Education and experience
 
 
 <ul>
 
 <li>
 High School Diploma or its equivalent; College degree preferred.
 </li>
 
 <li>
 Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.&nbsp;
 </li>
 
 <li>
 Knowledgeable in medical terminology to communicate with physician office and laboratory staff.&nbsp;
 </li>
 
 <li>
 Demonstrate&nbsp;the initiative to act independently, initiate activity as required and make appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
 </li>
 
 <li>
 Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.
 </li>
 
 </ul>
 </li>
 
 <li>
 
 Requirements
 
 
 <ul>
 
 <li>
 Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.&nbsp;
 </li>
 
 <li>
 Excellent communication skills (interpersonal, written, verbal)&nbsp;
 </li>
 
 <li>
 Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)
 </li>
 </ul>
 </li>
 </ul>
</div>

Children's National Hospital

<div>Kids Are Our Everything. 
 
Department
10259 Neurology Research Admin 
 
Pay Range
$51,584.00 - $85,987.20 
 
 
The Clinical Research Coordinator participates in or leads day-to-day operations of clinical research studies conducted by a principal investigator. The Research Coordinator performs a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. The Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This position may direct the work of junior staff, train personnel and direct the work of a Clinical Research Assistant as assigned. 
 
Minimum Education
 
B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required)
 
 
Minimum Work Experience
 
1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required)
 
 
Functional Accountabilities
 
Responsible Conduct of Research
<ul><li>Consistently demonstrates adherence to the standards for the responsible conduct of research.
</li><li>Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
</li><li>Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information.
</li><li>Uses research funds and resources appropriately.
</li><li>Maintains confidentiality of data as required.
</li><li>Meets all annual job-related training and compliance requirements.
</li></ul>Research Administration
<ul><li>Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
</li><li>Accurately creates, completes, maintains and organizes study documents.
</li><li>Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.
</li><li>Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.
</li><li>Reviews current literature to obtain information relevant to clinical research program, as directed.
</li><li>Attends study meetings, which could include overnight travel, as requested by principal investigator.
</li><li>Works well with other members of the research team and seeks and provides input when appropriate.
</li><li>Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center.
</li></ul>Participant Enrollment
<ul><li>Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan.
</li><li>Screens subjects for eligibility per the protocol and institutional policies.
</li><li>Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
</li><li>Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction.
</li><li>Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.
</li><li>Engages participants/LARs in the informed consent process according to institutional policies.
</li><li>Follows procedures for documentation of study payments and participation incentives.
</li></ul>Study Management
<ul><li>Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member.
</li><li>Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies.
</li><li>Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks.
</li><li>Suggests improvements to specimen handling processes, when needed.
</li><li>Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses.
</li><li>Registers and records participant visits in the appropriate tracking system.
</li><li>Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.
</li><li>Coordinates, prepares for and responds to routine oversight body visits and audits.
</li><li>Performs query resolution and assists with addressing and correcting audit findings.
</li></ul>Data Collection
<ul><li>Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources.
</li><li>Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).
</li><li>Ensures that queries are resolved within sponsor and institutional timelines.
</li><li>Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.
</li><li>Ensures secure storage of study documents.
</li></ul>Benefits That Support You:
<ul><li>Comprehensive health coverage, including medical, prescription, infertility, and transgender health services.
</li><li>Generous paid time off, including vacation accrual from
</li><li>day one, sick leave, holidays, and a personal day.
</li><li>Financial wellness support, including a 401(k) plan and healthcare and dependent care spending accounts.
</li><li>Employer-paid life, AD&amp;D, and long-term disability coverage, with optional supplemental plans.
</li><li>Additional perks, including tuition assistance, fitness resources, employee assistance, commuter benefits, and more.
</li></ul>Why Join Us:
<ul><li>Nationally Recognized Excellence &ndash; Consistently ranked among the Top 10 Children&rsquo;s Hospitals in the nation by U.S. News &amp; World Report.
</li><li>Leading Pediatric Care &ndash; One of the largest and most comprehensive children&rsquo;s hospitals in the country, offering nationally ranked specialties and cutting-edge treatments.
</li><li>Innovation &amp; Research &ndash; A premier academic medical center with a strong commitment to pediatric research, education, and advancing the future of child health.
</li><li>Mission-Driven Culture &ndash; Dedicated to providing family-centered care while fostering a collaborative, supportive environment for clinical teams. 
</li></ul> 
The disclosed salary range includes the minimum and maximum rates within which Children&rsquo;s National believes an individual&rsquo;s base pay rate will fall for this position. It is not typical for an individual to be hired at or near the maximum of the pay range. The exact pay rate for this position will be based on a variety of factors in alignment with the Children&rsquo;s National compensation philosophy. These factors are legitimate and non-discriminatory including, but not limited to, the current market conditions; organizational needs; the individual&rsquo;s combination of prior work experience, level of education, knowledge, skills, and other qualifications. Children&rsquo;s National is committed to providing a fair and competitive total rewards package to each of our employees. This base salary range does not include our comprehensive benefits package or any additional compensation for which this position may be eligible. 
 
Childrens National Hospital is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law. The &ldquo;Know Your Rights&rdquo; poster is available here: and the pay transparency policy is available here: Know Your RightsPay Transparency Nondiscrimination Poster. 
 
Please note that it is the policy of Children's National Hospital to ensure a &ldquo;drug-free&rdquo; work environment: a workplace free from the illegal use, possession or distribution of controlled substances (as defined in the Controlled Substances Act), or the misuse of legal substances, by all staff (management, employees and contractors). Though recreational and medical marijuana are now legal in the District of Columbia, Children's National and its affiliates maintain the right, in accordance with our policy, to enforce a drug-free workplace, including prohibiting recreational or prescribed marijuana.</div>

StrideCare

<div>
 Job Type
 
 
 Full-time
 
 
 
 Description
 
 
 
 Job Summary: The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and conduct of clinical research studies at the assigned StrideCare site. Working under the supervision of the Principal Investigator (PI) and in collaboration with Clinical Operations leadership, the CRC ensures compliance with study protocols, FDA regulations, ICH Good Clinical Practice (GCP) guidelines, sponsor requirements, and organizational standards while supporting participant safety and study success.
 
 
 Supervisory Responsibilities: N/A
 
 
 
 Essential Duties / Responsibilities
 
 
 
 <ul>
 <li>
 Screen patients for study enrollment and eligibility.
 </li>
 <li>
 Conduct and document patient consent activities.
 </li>
 <li>
 Coordinate patient follow-up visits and study schedules.
 </li>
 <li>
 Document study activities in source documents and clinic charts.
 </li>
 <li>
 Enter data into EDC systems and resolve study queries.
 </li>
 <li>
 Obtain vital signs and ECGs per protocol requirements.
 </li>
 <li>
 Perform basic laboratory procedures including specimen collection, processing, storage, shipment, and accountability.
 </li>
 <li>
 Request and track medical records.
 </li>
 <li>
 Maintain study logs, regulatory files, and chart documentation.
 </li>
 <li>
 Maintain and order study-specific supplies.
 </li>
 <li>
 Schedule study participants and conduct appointment reminders.
 </li>
 <li>
 Build and update source documentation as needed.
 </li>
 <li>
 Coordinate monitoring visits and resolve findings in a timely manner.
 </li>
 <li>
 Ensure study reports and patient results are reviewed by the Investigator.
 </li>
 <li>
 File SAE and protocol deviation reports with Sponsors and IRBs as required.
 </li>
 <li>
 Document and report adverse events and safety concerns.
 </li>
 <li>
 Report non-compliance concerns to appropriate personnel.
 </li>
 <li>
 Maintain positive communication with sponsors, monitors, participants, investigators, and team members.
 </li>
 <li>
 Adhere to ALCOA-C documentation principles.
 </li>
 <li>
 Assist with recruitment, enrollment, and participant tracking activities.
 </li>
 <li>
 Complete study start-up activities, training requirements, and regulatory documentation.
 </li>
 <li>
 Prepare for and participate in Site Initiation Visits (SIVs) and Investigator Meetings (IMs).
 </li>
 <li>
 Assist with setup and maintenance of study-related technology.
 </li>
 <li>
 Perform other duties as assigned.
 
 
 </li>
 </ul>
 
 Required Skills / Abilities
 
 
 
 <ul>
 <li>
 Proficiency with Microsoft Office applications, email, EHR/EMR systems, and web-based applications.
 </li>
 <li>
 Accurate data entry and typing proficiency.
 </li>
 <li>
 Ability to perform vital signs, ECGs, phlebotomy, and other basic clinical procedures.
 </li>
 <li>
 Strong organizational skills and attention to detail.
 </li>
 <li>
 Well-developed written and verbal communication skills.
 </li>
 <li>
 Strong interpersonal and active listening skills.
 </li>
 <li>
 Ability to work independently and collaboratively with investigators, participants, sponsors, and team members.
 </li>
 <li>
 Ability to manage multiple priorities and adapt to changing workloads.
 </li>
 <li>
 Professional demeanor, dependability, and strong work ethic.
 </li>
 <li>
 High degree of integrity and confidentiality.
 </li>
 <li>
 Strong problem-solving and critical-thinking abilities.
 </li>
 <li>
 Ability to handle sensitive information in compliance with HIPAA requirements.
 
 
 </li>
 </ul>
 
 Education And Experience
 
 
 
 <ul>
 <li>
 Medical Assistant diploma, LPN/LVN credential, EMT credential, Associate degree, or equivalent combination of education and experience required.
 </li>
 <li>
 Minimum one year of clinical research or clinical healthcare experience preferred.
 </li>
 <li>
 Experience with phlebotomy, vital signs, ECGs, specimen handling, and clinical documentation preferred.
 </li>
 <li>
 Current GCP certification or ability to obtain certification required.
 </li>
 <li>
 Bilingual English/Spanish skills are a plus.
 </li>
 <li>
 StrideCare is an Equal Opportunity Employer and is committed to diversity and inclusion in our workforce. We encourage applications from candidates of all backgrounds and experiences.
 </li>
 </ul>
</div>

CLINICAL RESEARCH COORDINATOR

The University of Chicago

<div>Department
BSD MED - Cardiology - Clinical Research Staff 
About the Department
The Section of Cardiology was founded in 1950 and has a proud history. We are now charting a new course that will propel us to the forefront of cardiovascular medicine. The strength of the Section reflects the quality and dedication of its faculty, trainees and support staff and is enhanced by the rich environment at the University of Chicago. 
Job Summary
The Clinical Research Coordinator 1 provides support to the faculty of the Section of Cardiology within the Biological Sciences Division.
Responsibilities<ul><li>
Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.</li><li>
Collect, process, ship &amp; store specimens to appropriate laboratory according to established techniques.</li><li>
Coordinate the conduct of the study from startup through closeout, including recruiting, interviewing and &amp; screening of study subjects, obtaining informed consent, collecting research data, &amp; ensuring protocol adherence.</li><li>
Plan &amp; coordinate patient schedule for study procedures, return visits, and study treatment schedules.</li><li>
Educate patients about study procedures to be performed, visit schedule, what to report between &amp; during visits, and the risks / benefits of the procedures.</li><li>
Perform assessments at patient study visits and monitor for adverse events.</li><li>
Serve as a resource person to patients on trials.</li><li>
Act as a collaborator within the department/unit through improving clinical research practice and serving as a resource.</li><li>
Maintain working knowledge of current protocols, and internal SOPs.</li><li>
Be accountable for high standards of clinical research practice and assist in the development of accountability in others.</li><li>
Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.</li><li>
Assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.</li><li>
Provide support to other CRCs and research-related staff, as needed.</li><li>
Maintain accurate and complete records which may include (but are not limited to) signed informed consents, source documentation, Case Report Forms, drug dispensing logs, and study related communication.</li><li>
Analyze study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, progress reports, etc.</li><li>
Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.</li><li>
Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.</li><li>
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.</li><li>
Accountable for all tasks in basic clinical studies.</li><li>
Performs other related work as needed.</li></ul> 
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field. 
Work Experience:
Minimum requirements include knowledge and skills developed through &lt; 2 years of work experience in a related job discipline. 
Certifications:
-
Preferred Qualifications<div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div>
Education:
<ul><li>Bachelor's degree.</li></ul> 
Experience:
<ul><li>Knowledge of medical terminology/environment.</li></ul>
Preferred Competencies<ul><li>
Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.</li><li>
Ability to communicate with tact and diplomacy.</li><li>
Strong organizational skills.</li><li>
Strong communication skills (verbal and written).</li><li>
Excellent interpersonal skills.</li><li>
Strong data management skills and attention to detail.</li><li>
Knowledge of Microsoft Word, Excel and Adobe Acrobat.</li><li>
Ability to understand complex documents (e.g., clinical trials).</li><li>
Ability to handle competing demands with diplomacy and enthusiasm.</li><li>
Ability to absorb large amounts of information quickly.</li><li>
Adaptability to changing working situations and work assignments.</li></ul>
Application Documents<ul><li>
Resume (required)</li><li>
Cover Letter (required)</li></ul></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div> 
The University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions. 
 
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
$50,000.00 - $65,000.00
The included pay rate or range represents the University&rsquo;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 773-702-5800 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 &amp; 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: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.</div>

Clinical Research Coordinator 1

Duke University

<div>
 School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.
 
 
 
 Be You.
 
 
 
 The Department of Surgery is looking for a Clinical Research Coordinator to join our team. This critical role will participate in the day-to-day operations of clinical research for the Cardiovascular and Thoracic Division. The Surgery Office of Clinical Research (SOCR) is staffed with experienced individuals who are dedicated to patient safety while conducting innovative research with the hope of advancing medicine and improving clinical care.
 
 
 
 Minimum Requirements
 
 
 
 <ul>
 <li>
 Completion of an Associate&rsquo;s Degree
 </li>
 <li>
 A minimum of two years of relevant research experience. A Bachelor&rsquo;s degree may substitute for two years required experience.
 
 
 </li>
 </ul>
 
 Preferred Qualifications
 
 
 
 <ul>
 <li>
 Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).
 
 
 </li>
 </ul>
 
 Other Requirements
 
 
 
 The position is onsite.
 
 
 
 Be Bold.
 
 
 
 
 Position Description
 
 
 
 <ul>
 <li>
 Applies knowledge to assist with study documentation, protocol submissions, and standard operating procedures (SOPs). Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants.
 </li>
 <li>
 Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings.
 </li>
 <li>
 Identifies all AEs, and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. Conducts and documents consent for participants for all types of studies, including those that are greater than minimal risk or complex in nature and/or require any orders in Maestro Care.
 </li>
 <li>
 Enters and collects research data. Develops research data entry or collection tools. May provide oversight or training to study team members collecting or entering research data. Ensures accuracy and completeness of data for all studies, including those that are greater than minimal risk or complex in nature.
 </li>
 <li>
 Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking of financial milestones, and all aspects of study visits. Uses required EHR functionalities to manage participants and study visits.
 </li>
 <li>
 Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job.
 
 
 </li>
 </ul>
 
 Choose Duke.
 
 
 
 The Duke Department of Surgery has gained a reputation as one of the leading surgery programs in the world. The number and variety of active clinical trials in the Department of Surgery allows us to offer our patients access to treatments and therapies that are available at only a few medical centers nationwide. Join our award-winning team and be part of an inclusive culture that is committed to providing outstanding patient care, training tomorrow&rsquo;s leaders, and conducting innovative research. You'll also benefit from Duke's competitive benefits package, including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.
 
 
 
 Screening of Applications:
 
 Screening continues until the position is filled.
 
 
 
 Anticipated Pay Range:
 
 Duke University provides an annual base salary range for this position as USD $59,829.00 to USD $99,960.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.
 
 
 Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/
 
 
 
 Equal Opportunity Employer:
 
 Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.
 
 
 Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas&mdash;an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
 
 
 
 Essential Physical Job Functions
 
 
 
 Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: DAAS@duke.edu; phone: 919-668-1267).
</div>

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