clinical research manager

TriHealth Inc.

<div><div>Join TriHealth as Clinical Research Manager and help shape the future of research at Bethesda North! 
The Clinical Research Manager plays a pivotal role at the intersection of patient care, research strategy, operational leadership, and team development. In this position, you influence both the daily success of clinical trials and the long‑term growth of TriHealth&rsquo;s research program. Few roles offer this level of breadth and impact&hellip;you shape patient outcomes, drive medical innovation, partner closely with physicians, develop future research professionals, and contribute directly to the strategic advancement of the Hatton Research Institute. 
Why Join Our Team:<ul><li>
Lead a growing research program - Shape the future of clinical research in a respected, mission‑driven health system.</li><li>
High‑impact leadership - Partner across disciplines and influence research operations, quality, and strategic direction.</li><li>
Advance patient access to innovation - Support trials that bring cutting‑edge therapies and new care options to the TriHealth community.</li><li>
Build and develop a strong team - Mentor research staff, strengthen capabilities, and foster a culture of accountability and growth.</li><li>
Drive strategic and operational excellence - Lead protocol evaluation, process improvement, and partnerships that elevate research performance.</li><li>
Enjoy stability and strong benefits - Day‑shift schedule with no weekends or holidays, plus comprehensive TriHealth benefits.</li></ul> 
Apply today and grow your career with a team that truly values you. 
Location:<ul><li>
Bethesda North Hospital at 10500 Montgomery Road, Montgomery, OH 45242</li></ul> 
Work Schedule:<ul><li>
Full-time (80 hours biweekly)</li><li>
Day Shift</li><li>
No Weekend or Holiday Commitment</li></ul> 
Benefits:
TriHealth offers a comprehensive benefits package which includes medical, dental, vision, paid time off, retirement plans, and tuition reimbursement. Please view our benefits page: https://careers.trihealth.com/what-we-offer/benefits 
Job Requirements:<ul><li>
Bachelor's Degree in Biology, Physiology, Business, Public Health, or related scientific/healthcare field</li><li>
Equivalent experience accepted in lieu of degree</li><li>
Knowledge of GCP, ICH guidelines/regulatory requirements for clinical trial management</li><li>
This position requires strong leadership skills and the ability to manage people, deliver on clinical projects, and align with business initiatives</li><li>
2-3 years&rsquo; experience in Professional Management</li><li>
3-4 years&rsquo; experience Professional Clinical Research</li></ul> 
Job Overview: 
 
The Manager of Clinical Research is responsible for establishing and maintaining a Research Program for the TriHealth Hatton Research Institute. The Manager shall have 24-hour accountability for planning, organizing, directing, and coordinating the department's activities. This includes human resources, financial management, program development, department environment and customer service issues. Additionally, this position requires ongoing monitoring and evaluation of FDA/HHS, USDA, AAALAC regulations and requirements specific to human subject (as appropriate) in order to maintain departmental compliance with these regulatory agencies. This position provides departmental support for Hatton and the TriHealth strategic plans and fosters continuous quality improvement and staff development. The Manager of Clinical Research stays informed of national trends and clinical research initiatives at other leading centers. This position possesses knowledge of research operations across a healthcare system or pathophysiology, pharmacology, medical diagnostics and treatment. The Manager of Clinical Research thinks strategically, evaluating where to put the most effort to achieve optimal results. 
 
Job Responsibilities:<ul><li>
Performs feasibility evaluations of accepting potential protocols through analysis of coordinator staffing requirements, resources requirements, clinical considerations and financial profitability.</li><li>
Evaluate need and appropriateness of requests by staff</li><li>
Complies with all IRB/IACUC/FDA requirements in study submission to a central or local IRB.</li><li>
Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment.</li><li>
Assures compliance with IRB/FDA standards and dead</li><li>
Recognize logistical and technical challenges with respect to the assigned specialty's clinical trial planning and implementation, recommending solutions and alternatives. Identify opportunities for timeline improvements for office-based research and recommendations.</li><li>
Responsible for identifying training needs of the specialty area's research staff along with the orientation of new employees, ensuring all are properly oriented and aware of the expectations of their position.</li><li>
Develop educational programs for staff</li><li>
Help implement strategic plans, including developing strategic partnerships with foundations, sponsors, vendors, and clinicians.</li><li>
Lead the implementation of the plan.</li></ul> 
Other Job-Related Information: 
 
Working Conditions: 
 
Climbing - Rarely 
Concentrating - Frequently 
Continuous Learning - Frequently 
Hearing: Conversation - Consistently 
Hearing: Other Sounds - Frequently 
Interpersonal Communication - Consistently 
Kneeling - Rarely 
Lifting &lt;10 Lbs - Frequently 
Lifting 50+ Lbs - Rarely 
Lifting 11-50 Lbs - Rarely 
Pulling - Occasionally 
Pushing - Occasionally 
Reaching - Occasionally 
Reading - Frequently 
Sitting - Frequently 
Standing - Frequently 
Stooping - Occasionally 
Talking - Frequently 
Thinking/Reasoning - Consistently 
Use of Hands - Frequently 
Color Vision - Frequently 
Visual Acuity: Far - Frequently 
Visual Acuity: Near - Frequently 
Walking - Frequently 
 
Leadership Performance Standards 
TriHealth leaders create a culture of engagement, safety &amp; reliability and high performance by consistently modeling and utilizing the following TriHealth Way leadership competencies, tactics and ALWAYS Behaviors to drive strategic pillar results: 
 
Achievement of Annual Pillar Goals: 
1) Safety/Quality, 2) Service, 3) Growth, 4) Culture/People, 5) Finance 
 
Leadership Competencies:<ul><li>
TriHealth Way of Leading</li><li>
TriHealth Way of Serving</li><li>
Transformation Change</li><li>
Drive for Results</li><li>
Build Organizational Talent</li></ul> 
Leadership Tactics:<ul><li>
Conduct department huddles. Generally, clinical departments hold daily huddles, non-clinical hold weekly huddles.</li><li>
Regularly Round on Team Members, using questions from the rounding log.<ul><li><div>
25 or fewer team members = monthly</div></li><li><div>
26-50 team members = every other month</div></li><li><div>
51+ (and optional team members) = quarterly</div></li></ul></li><li>
Lead monthly team meetings using meeting agenda template; review stoplight report; cascade key leadership messages.</li><li>
Model, coach and validate team members&rsquo; use of TriHealth Way behaviors (AIDET + Promise, Always Behaviors and Always HEARD).</li><li>
Recognize team members for safety wins, positive performance and demonstrating SERVE and ALWAYS behaviors, TriHealth Way of Leading, Serving and Delivering Care.</li></ul><div> 
TriHealth SERVE Standards and ALWAYS Behaviors</div><div>
At TriHealth, we believe there is no responsibility more important than to SERVE our patients, our communities, and our fellow team members. To achieve our vision and mission, ALL TriHealth team members are expected to demonstrate and live the following:</div><div></div><div> 
Serve: ALWAYS... 
<ul><li>Welcome everyone by making eye contact, greeting with a smile, and saying &quot;hello&quot;</li><li>Acknowledge when patients/guests are lost and escort them to their destination or find someone who can assist</li><li>Refrain from using cell phones for personal reasons in public spaces or patient care areas</li></ul></div><div></div><div> 
Excel: ALWAYS... 
<ul><li>Recognize and take personal responsibility to address and recover from service breakdowns when a customer's expectations have not been met</li><li>Offer patients and guests priority when waiting (lines, elevators)</li><li>Work on improving quality, safety, and service</li></ul></div><div></div><div> 
Respect: ALWAYS... 
<ul><li>Respect cultural and spiritual differences and honor individual preferences.</li><li>Respect everyone's opinion and contribution, regardless of title/role.</li><li>Speak positively about my team members and other departments in front of patients and guests.</li></ul></div><div></div><div> 
Value: ALWAYS... 
<ul><li>Value the time of others by striving to be on time, prepared and actively participating.</li><li>Pick up trash, ensuring the physical environment is clean and safe.</li><li>Be a good steward of our resources, using supplies and equipment efficiently and effectively, and will look for ways to avoid waste.</li></ul></div><div></div><div> 
Engage: ALWAYS... 
<ul><li>Acknowledge wins and frequently thank team members and others for contributions.</li><li>Show courtesy and compassion with customers, team members and the community</li></ul></div> 
Job keywords:
Clinical Research Coordinator / Social Science Research Assistant / Clinical Data Manager</div></div>

Clinical Research Manager

Innovative Clinical Research Institute, LLC

Job OverviewWe are seeking a highly motivated and detail-oriented Assistant Clinical Research Manager to join our dynamic research team. In this vital role, you will support the planning, execution, and oversight of clinical trials, ensuring adherence to regulatory standards and ethical guidelines. Your energetic approach will help drive research projects forward, facilitate compliance, and maintain high-quality data collection. This position offers an exciting opportunity to contribute to groundbreaking healthcare advancements while developing your expertise in clinical research management.Responsibilities<ul><li>Assist in coordinating all phases of clinical trials, from protocol development to study completion, ensuring timely progress and compliance with regulatory standards.</li><li>Supervise research staff and study coordinators, providing guidance on clinical procedures, documentation review, and data collection methods, and at the same time, step in as study coordinator when needed.</li><li>Monitor patient safety and well-being throughout the trial process, including blood sampling, patient monitoring, and adverse event reporting.</li><li>Review study documentation for accuracy and completeness, ensuring adherence to FDA regulations, ICH GCP guidelines, and clinical ethical standards.</li><li>Manage data entry and analysis using statistical software and ensure data management practices align with CDISC standards.</li><li>Oversee compliance with healthcare regulations and clinical quality assurance standards across all research activities.</li><li>Collaborate with cross-functional teams to ensure proper use of EMR systems and adherence to project timelines in a fast-paced research setting.</li></ul>Experience<ul><li>Proven supervising experience in a clinical research environment or healthcare setting.</li><li>Strong knowledge of medical terminology, clinical laboratory procedures, and blood sampling techniques.</li><li>Experience reviewing documentation for accuracy and compliance within clinical trials or research projects.</li><li>Familiarity with statistical software tools used for data analysis in clinical studies.</li><li>Understanding of FDA regulations, ICH GCP guidelines, and healthcare compliance standards related to clinical research.</li><li>Hands-on experience with EMR systems, project management tools, and data management platforms such as CDISC standards.</li><li>Certification in ICH GCP (Good Clinical Practice) from a recognized issuer is required; valid CA certification is preferred for applicable regions.</li><li>Demonstrated ability to manage multiple projects simultaneously while maintaining attention to detail and quality assurance standards.</li><li>Minimum 2 to 5 years clinical research experience</li><li>Foreign Medical Graduate or Bachelor's Degree</li></ul>Join us in advancing healthcare through innovative research! We are committed to fostering a collaborative environment where your skills can thrive while making a meaningful impact on patient care worldwide. All roles are paid positions that support your professional growth within a vibrant research community dedicated to excellence.Pay: $29.00 - $33.00 per hourBenefits:<ul><li>401(k)</li><li>Dental insurance</li><li>Employee assistance program</li><li>Employee discount</li><li>Flexible spending account</li><li>Health insurance</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Work Location: In person

Assistant Clinical Research Manager

Premiere Health and Wellness

Lead Clinical Research Coordinator Job DescriptionJob Title: Clinical Research CoordinatorReports To: Clinical Research Site ManagerDepartment: Clinical OperationsLocation: On-site (SKYCRNG Network Site)Position SummaryThe Lead Clinical Research Coordinator (Lead CRC) provides operational leadership and oversight of clinical research studies conducted at the site. This role is responsible for ensuring protocol compliance, subject visit execution, investigational product (IP) accountability, regulatory maintenance, and serving as a DEXA technician, while serving as a manager to CRCs. The Lead CRC works closely with the Site Manager to support study start-up, execution, study maintenance, and close-out activities in accordance with ICH-GCP, IRB requirements, sponsor protocols, and SKYCRNG&rsquo;s Standard Operating Procedures (SOPs).Key ResponsibilitiesStudy Operations &amp; Compliance<ul><li>Maintain and oversee subject visit schedules, ensuring protocol-required visits and procedures are completed accurately and on time.</li><li>Ensure subject visit compliance across all CRCs, including source documentation, protocol adherence, and timely data, imaging, and lab query resolution by CRC staff.</li><li>Oversee and maintain investigational product (IP) accountability, ensuring accurate documentation, storage, reconciliation, and compliance.</li><li>Maintain the regulatory binder, ensuring all essential documents are complete, current, and audit-ready.</li><li>Attend and actively participate in Site Initiation Visits (SIVs) and other required sponsor or CRO meetings.</li></ul>Data Quality &amp; Query Management<ul><li>Oversee the resolution of data, lab, and imaging queries, ensuring timely, accurate responses and appropriate follow-up.</li><li>Collaborate with CRCs to identify trends, recurring errors, or training needs related to source quality and visit compliance.</li><li>Provide ongoing subject study status updates to the Site Manager, including enrollment, visit completion, and outstanding issues.</li></ul>Study Start-Up &amp; Close-Out &amp; Systems Readiness<ul><li>Work closely with the Site Manager to collect, organize, and submit study start-up documents, including regulatory and training materials.</li><li>Create and maintain study-specific checklists to support efficient study execution and consistent CRC workflows.</li><li>Complete continuing review and study termination IRB submissions in accordance with IRB requirements and established timelines.</li></ul>Leadership, Mentorship &amp; Team Development<ul><li>Serve as a manager and subject-matter resource for CRCs, providing guidance on protocol requirements, documentation standards, and best practices.</li><li>Support training, onboarding, and professional development of CRC staff.</li><li>Ensure all site staff have appropriate access to study systems, including EDC, IRT/IXRS, ePRO, imaging platforms, and sponsor portals.</li><li>Monitor and support staff training completion, system access readiness, and protocol-required certifications.</li><li>Promote a culture of compliance, accountability, collaboration, and continuous improvement across the site and SKYCRNG network.</li></ul>&middot;DEXA &amp; Specialized Procedure Oversight<ul><li>Perform and/or coordinate DEXA scans, including the completion, tracking, and documentation of all outside DEXA scans, as required per protocol.</li></ul>QualificationsRequired<ul><li>Minimum 3&ndash;5 years of clinical research coordination experience.</li><li>Strong working knowledge of ICH-GCP, IRB requirements, and FDA regulations.</li><li>Proven experience with regulatory binders, IP accountability, and subject visit management.</li><li>Experience working with EDC systems, IRB portals, and sponsor systems.</li><li>Excellent organizational, communication, and leadership skills.</li></ul>Preferred<ul><li>Prior experience in a Lead CRC or Senior CRC role.</li><li>Experience with DEXA scans and imaging-based clinical studies.</li><li>Multi-protocol and multi-therapeutic area experience.</li><li>Professional certification (CCRC, CCRP, or equivalent).</li></ul>Core Competencies<ul><li>Attention to detail and regulatory compliance</li><li>Leadership and team mentorship</li><li>Time management and prioritization</li><li>Data quality oversight and query resolution</li><li>Cross-functional collaboration</li><li>Audit and inspection readiness</li></ul>Work Environment<ul><li>Clinical research site environment</li><li>May require extended hours based on study needs and sponsor visits</li><li>Occasional travel for meetings, monitoring visits, or training, if applicable</li></ul>SKYCRNG is committed to excellence, integrity, and community-focused research. This role is critical to maintaining our reputation as an audit-ready, enrollment-ready, high-performing clinical research network.Job Type: Full-timeWork Location: In person

Clinical Research Coordinator

University of Alabama, Birmingham

<div></div><div><div><div><div><div>Description<div></div>
The University of Alabama at Birmingham (UAB), Department of Psychology, is seeking a Manager-Clinical Research Coordination.
General Responsibilities<ul><li>
To manage all aspects of research program and clinical studies including education/teaching.</li><li>
To oversee and manage multiple clinical research protocols and the associated personnel.</li><li>
To design best practices for management of IP for drug, device, and biologic studies.</li><li>
To prepare study budgets.</li><li>
To manage research staff within area including all applicable human resources functions.</li></ul>
Key Duties &amp; Responsibilities<ul><li>
Creation of SOP's and training manuals.</li><li>
Assuring protocol consistency across trials.</li><li>
Coordinating with vendors/contractors.</li><li>
Interacting with participants.</li><li>
Supervising students and other study staff.</li><li>
Working with Data Management (EDC) systems.</li><li>
Managing adverse events.</li><li>
Tracking participant compliance.</li><li>
Leading team meetings/trainings.</li><li>
Preparing progress reports.</li><li>
Performs other duties as assigned.</li></ul>
Annual Salary Range: $77,640 - $126,170<div> 
</div></div><div>
Qualifications<div></div>
Bachelor's degree in a related field and eight (8) years of related experience required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification strongly preferred. 
UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.<div> 
</div></div><div>
Primary Location: University</div><div>
Job Category: Clinical Research</div><div>
Organization: 481600000 Psychology</div><div>
Employee Status: Regular</div><div>
Shift: Day/1st Shift</div><div>
Work Arrangement (final schedule to be determined by the department/hiring manager): Onsite</div></div></div></div></div><div></div>

MANAGER-CLINICAL RESEARCH COORDINATION

Sarah Cannon Research Institute

<div>It&rsquo;s More Than a Career, It&rsquo;s a Mission. 
 
Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.
Our Mission 
 
People who live with cancer &ndash; those who work to prevent it, fight it, and survive it &ndash; are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.
<div><div>Job Description
</div></div><div><div><div><div><div><div><div><div><div>Our Research Quality Manager is responsible for implementing the quality assurance program, managing and performing consult/support visits at investigative sites, assisting with onsite external audits and inspections, and providing routine quality support for assigned investigative sites.
This is a fully remote position in the US; relocation assistance and visa sponsorship are not available.
Duties include but are not limited to:
<ul><li>Develops and maintains effective relationships with investigative sites and other SCRI departments and colleagues
</li><li>Monitors and modifies policies and procedures
</li><li>Utilizes quality tools that assess the quality indicators of study operations
</li><li>Monitors quality indicators for all sites using Risk-Based approach and within framework of QBD &ndash; Quality by Design - and prioritizes quality indicators depending on severity/urgency
</li><li>Identifies areas of deficiency in quality and reports those deficiencies to SC Directors and other appropriate colleagues
</li><li>Assists the business in development and modification of process documents
</li><li>Assists with preparation and hosting of external audits
</li><li>Assists research staff in maintaining regulatory compliance
</li><li>Performs process / focused audits (as needed) of research sites utilizing research audit tools to ensure quality and reports audit findings to the appropriate leadership.
</li><li>Ensures timely and appropriate follow-up in areas of deficiency.
</li><li>Communicates observations and deficiencies to the Site Director / Manager and study PI, as appropriate.
</li><li>Assists sites with Root Cause analysis and responses to external audits and CAPAs.
</li><li>Maintains records of audits and reports.
</li><li>Communicates with monitors and auditors of clinical trials, as needed.
</li><li>Educates staff in quality improvement methods and industry trends
</li><li>Other duties as assigned
</li></ul>Qualifications needed
<ul><li>Bachelor&rsquo;s Degree required, Master&rsquo;s Degree preferred
</li><li>Minimum 3 years&rsquo; work experience in Quality Assurance, Quality Management, or Quality Auditing preferably in a clinical research, healthcare or life sciences field
</li><li>Expertise in GCP, FDA and other applicable regulations in a risk-based environment
</li></ul></div></div></div></div></div></div></div></div></div>About Sarah Cannon Research Institute 
 
Sarah Cannon Research Institute (SCRI) is one of the world&rsquo;s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI&rsquo;s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S.
 
 
We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That&rsquo;s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves.
 
 
As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson&rsquo;s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:
 
 
McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application. 
 
McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.
McKesson job postings are posted on our career site: careers.mckesson.com .
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.</div>

Research Clinical Quality Manager - Remote US

Spatium Urgent Care

Job Summary We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our dynamic research team. In this pivotal role, you will oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory standards and ethical guidelines. Your expertise will facilitate the successful conduct of research projects that contribute to advancing healthcare solutions. This position offers an exciting opportunity to work in a collaborative environment dedicated to innovation and excellence in clinical research.Duties<ul><li>Coordinate all aspects of clinical trials, including participant recruitment, screening, enrollment, and follow-up procedures.</li><li>Ensure adherence to FDA regulations, ICH GCP guidelines, and institutional policies throughout the study lifecycle.</li><li>Review and verify study documentation, including consent forms, case report forms, and regulatory submissions for accuracy and completeness.</li><li>Monitor patient progress by tracking vital signs, blood sampling, and other clinical assessments while maintaining meticulous records.</li><li>Manage data collection and entry using electronic medical record (EMR) systems and ensure data integrity in compliance with CDISC standards.</li><li>Supervise research staff and collaborate with healthcare professionals to facilitate smooth trial operations.</li><li>Conduct clinical laboratory procedures such as phlebotomy and blood sampling while maintaining safety protocols.</li><li>Prepare reports for regulatory agencies, sponsors, and internal stakeholders; assist in audit preparations and compliance management.</li></ul>Skills<ul><li>Proven supervising experience in a clinical research or healthcare setting with strong project management skills.</li><li>Extensive knowledge of clinical trials management, including patient monitoring and data management processes.</li><li>Proficiency in medical terminology, clinical laboratory techniques, and analysis skills related to research data.</li><li>Familiarity with FDA regulations, ICH GCP standards, HIPAA compliance, and healthcare ethical guidelines.</li><li>Experience with EMR systems, statistical software tools, and CDISC data standards for clinical research data analysis.</li><li>Strong documentation review skills ensuring accuracy in research documentation and regulatory submissions.</li><li>Ability to manage multiple projects efficiently while maintaining high-quality standards; excellent organizational skills are essential.</li></ul>Join us to be part of a forward-thinking organization committed to transforming healthcare through innovative research! We value energetic professionals who thrive in collaborative environments and are passionate about making a difference in patient care through rigorous scientific inquiry. All roles are paid positions that support your professional growth within the vibrant field of clinical research.Pay: $32.00 - $36.00 per hourWork Location: In person

Biological Sciences Division at the University of Chicago

<div>
 
 Department
 
 
 
 BSD OBG - Research Staff
 
 
 
 
 About The Department
 
 
 
 
 The Department of Obstetrics and Gynecology has 136 clinical providers providing care at the main hospital in Hyde Park and multiple offsite locations. We have more than 68,000 outpatient visits, 28,000 ultrasound visits, 2,800 deliveries, and 3,300 surgeries per year. Teaching, research, and the highest quality clinical care are top priorities for the Department. The residency and fellowship programs are highly ranked and have a history of training leaders in healthcare. The Department also has a significant research enterprise, engaging in population health studies, as well as research conducted in wet laboratories on tumor biology, fibroid research, and hypertensive diseases in pregnancy.
 
 
 
 
 Job Summary
 
 
 
 
 The job compiles, documents, analyzes, and reports on moderately complex clinical studies. Provides input to support the administrative and operational decisions that impact clinical research conducted across the University.
 
 
 The Clinical Research Coordinator II independently manages and executes moderately complex clinical research studies from start up through close out. This role serves as a central operational lead, ensuring scientific integrity, regulatory compliance, and seamless coordination across investigators, sponsors, and multidisciplinary teams. The Coordinator plans and conducts clinical and non clinical research activities, oversees participant recruitment and study visits, manages data collection and reporting, and supports dissemination of findings through publications and presentations.
 
 
 This position exercises professional judgment in navigating regulatory requirements, financial considerations, and study logistics, while maintaining strict adherence to institutional, state, and federal guidelines. The role contributes directly to advancing research initiatives across the University by ensuring studies are executed efficiently, ethically, and in alignment with sponsor expectations.
 
 
 
 
 Responsibilities
 
 
 
 
 <ul>
 <li>
 Develop study protocols, CRFs, and other study documents.
 </li>
 <li>
 Working closely with Principal Investigators (PIs) and laboratory team members.
 </li>
 <li>
 Technical proficiency and ability to operate, troubleshoot, and maintain specialized laboratory machinery.
 </li>
 <li>
 Sample preparation, including collecting, labeling, and processing biological samples for testing.
 </li>
 <li>
 Setting up experiments, running protocols (e.g., cell culturing, DNA extraction, PCR, ELISA, and staining slides and microscopy), and assisting with animal care and study design.
 </li>
 <li>
 Data management, collecting, recording, and analyzing data, often using computerized equipment.
 </li>
 <li>
 Keep detailed documentation of lab notebooks that document every step of an experiment. Lab maintenance, cleaning equipment, managing inventory, and handling hazardous materials.
 </li>
 <li>
 Develop instructional regulatory body (IRB) protocols, amendments and other documents as well as respond to IRB stipulations and requirements.
 </li>
 <li>
 Collect, archive subjects&rsquo; data. Assist in scientific data dissemination. Develop, write, edit, submit and publish scientific manuscripts and present scientific abstracts at national and international conferences.
 </li>
 <li>
 Participate in local and national meetings related to multi center trials and participate in regular phone/skype meetings related to clinical research.
 </li>
 <li>
 Assist in developing and submitting regular progress reports to NIH and other sponsors of clinical research studies.
 </li>
 <li>
 This job provides technical and administrative support in a laboratory environment performing basic laboratory techniques, research and analysis under direction.
 </li>
 <li>
 Provides routine or standardized laboratory duties by collecting data in support of research projects under direct supervision.
 </li>
 <li>
 Complies with institution, state and federal regulatory policies, procedures, directives, and mandates.
 </li>
 <li>
 Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, subject consenting, subject recruitment, perform and supervise various study visit procedures, and participate in program audits.
 </li>
 <li>
 Prepares program conference lists for multidisciplinary conferences and workshops.
 </li>
 <li>
 Participates in all pharmaceutical site visits. Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.
 </li>
 <li>
 Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
 </li>
 <li>
 Interprets the data needed for insurance submissions. Gathers pre-testing results if obtained at an outside facility.
 </li>
 <li>
 Accountable for all tasks in moderately complex clinical studies.
 </li>
 <li>
 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.
 </li>
 <li>
 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.
 </li>
 <li>
 Performs other related work as needed.
 
 
 </li>
 </ul>
 
 
 Education:
 
 
 
 
 
 Minimum Qualifications
 
 
 
 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:
 
 
 
 
 <ul>
 <li>
 College or university degree in related field.
 </li>
 <li>
 Advanced degree in research or a related field strongly preferred.
 
 
 </li>
 </ul>
 
 
 Experience:
 
 
 
 
 <ul>
 <li>
 2-5 years of work experience in a related job discipline.
 </li>
 <li>
 Previous clinical trials experience.
 </li>
 <li>
 Previous IRB protocol experience.
 
 
 </li>
 </ul>
 
 
 Preferred Competencies
 
 
 
 
 <ul>
 <li>
 Ability to independently coordinate and manage moderately complex clinical research studies from start up through close out.
 </li>
 <li>
 Knowledge of IRB processes, regulatory requirements, and institutional, state, and federal research policies.
 </li>
 <li>
 Strong data management and analytical skills, including experience with REDCap, Excel, and other research data systems.
 </li>
 <li>
 Understanding of research methodologies and basic laboratory techniques applicable to clinical and non clinical studies.
 </li>
 <li>
 Sound problem solving skills with the ability to exercise professional judgment in resolving study related operational, compliance, and financial issues.
 </li>
 <li>
 Effective collaboration and communication skills when working with investigators, sponsors, multidisciplinary teams, and external partners.
 </li>
 <li>
 Strong organizational skills and attention to detail with the ability to manage multiple studies and competing priorities.
 
 
 </li>
 </ul>
 
 Working Conditions
 
 
 
 <ul>
 <li>
 Work is performed primarily in an outpatient clinical setting with additional responsibilities in a laboratory environment.
 </li>
 <li>
 Requires travel between multiple clinical sites as needed to support study activities.
 </li>
 <li>
 Requires prolonged periods of standing during clinical or study related activities.
 </li>
 <li>
 Requires extended periods of computer use for data entry, documentation, and reporting.
 
 
 </li>
 </ul>
 
 Application Documents
 
 
 
 <ul>
 <li>
 Resume (required)
 </li>
 <li>
 Cover Letter (preferred)
 
 
 </li>
 </ul>
 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&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.
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Clinical Research Coordinator II - OBG - Research Staff

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