clinical research manager

TriHealth Inc.

<div><div><p><b>Join TriHealth as Clinical Research Manager and help shape the future of research at Bethesda North!</b></p><p></p><p><br>
The <b>Clinical Research Manager</b> 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 <b>TriHealth&rsquo;s</b> 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.</p><p></p><p><b><br>
Why Join Our Team:</b></p><ul><li><b>
Lead a growing research program</b> - Shape the future of clinical research in a respected, mission‑driven health system.</li><li><b>
High‑impact leadership</b> - Partner across disciplines and influence research operations, quality, and strategic direction.</li><li><b>
Advance patient access to innovation</b> - Support trials that bring cutting‑edge therapies and new care options to the TriHealth community.</li><li><b>
Build and develop a strong team</b> - Mentor research staff, strengthen capabilities, and foster a culture of accountability and growth.</li><li><b>
Drive strategic and operational excellence</b> - Lead protocol evaluation, process improvement, and partnerships that elevate research performance.</li><li><b>
Enjoy stability and strong benefits</b> - Day‑shift schedule with no weekends or holidays, plus comprehensive TriHealth benefits.</li></ul><p></p><p><br>
Apply today and grow your career with a team that truly values you.</p><p></p><p><b><br>
Location:</b></p><ul><li><p>
Bethesda North Hospital at 10500 Montgomery Road, Montgomery, OH 45242</p></li></ul><p></p><p><b><br>
Work Schedule:</b></p><ul><li><p>
Full-time (80 hours biweekly)</p></li><li><p>
Day Shift</p></li><li><p>
No Weekend or Holiday Commitment</p></li></ul><p></p><p><b><br>
Benefits:</b></p><p>
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</p><p></p><p><b><br>
Job Requirements:</b></p><ul><li><p>
Bachelor's Degree in Biology, Physiology, Business, Public Health, or related scientific/healthcare field</p></li><li><p>
Equivalent experience accepted in lieu of degree</p></li><li><p>
Knowledge of GCP, ICH guidelines/regulatory requirements for clinical trial management</p></li><li><p>
This position requires strong leadership skills and the ability to manage people, deliver on clinical projects, and align with business initiatives</p></li><li><p>
2-3 years&rsquo; experience in Professional Management</p></li><li><p>
3-4 years&rsquo; experience Professional Clinical Research</p></li></ul><p></p><p><b><br>
Job Overview:</b><br>
<br>
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.<br>
<br>
<b>Job Responsibilities:</b></p><ul><li><p>
Performs feasibility evaluations of accepting potential protocols through analysis of coordinator staffing requirements, resources requirements, clinical considerations and financial profitability.</p></li><li><p>
Evaluate need and appropriateness of requests by staff</p></li><li><p>
Complies with all IRB/IACUC/FDA requirements in study submission to a central or local IRB.</p></li><li><p>
Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment.</p></li><li><p>
Assures compliance with IRB/FDA standards and dead</p></li><li><p>
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.</p></li><li><p>
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.</p></li><li><p>
Develop educational programs for staff</p></li><li><p>
Help implement strategic plans, including developing strategic partnerships with foundations, sponsors, vendors, and clinicians.</p></li><li><p>
Lead the implementation of the plan.</p></li></ul><p></p><p><b><br>
Other Job-Related Information:</b><br>
<br>
<i>Working Conditions:</i><br>
<br>
Climbing - Rarely<br>
Concentrating - Frequently<br>
Continuous Learning - Frequently<br>
Hearing: Conversation - Consistently<br>
Hearing: Other Sounds - Frequently<br>
Interpersonal Communication - Consistently<br>
Kneeling - Rarely<br>
Lifting &lt;10 Lbs - Frequently<br>
Lifting 50+ Lbs - Rarely<br>
Lifting 11-50 Lbs - Rarely<br>
Pulling - Occasionally<br>
Pushing - Occasionally<br>
Reaching - Occasionally<br>
Reading - Frequently<br>
Sitting - Frequently<br>
Standing - Frequently<br>
Stooping - Occasionally<br>
Talking - Frequently<br>
Thinking/Reasoning - Consistently<br>
Use of Hands - Frequently<br>
Color Vision - Frequently<br>
Visual Acuity: Far - Frequently<br>
Visual Acuity: Near - Frequently<br>
Walking - Frequently<br>
<br>
<b>Leadership Performance Standards</b><br>
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:<br>
<br>
<b>Achievement of Annual Pillar Goals:</b><br>
1) Safety/Quality, 2) Service, 3) Growth, 4) Culture/People, 5) Finance<br>
<br>
<b>Leadership Competencies:</b></p><ul><li><p>
TriHealth Way of Leading</p></li><li><p>
TriHealth Way of Serving</p></li><li><p>
Transformation Change</p></li><li><p>
Drive for Results</p></li><li><p>
Build Organizational Talent</p></li></ul><p></p><p><b><br>
Leadership Tactics:</b></p><ul><li><p>
Conduct department huddles. Generally, clinical departments hold daily huddles, non-clinical hold weekly huddles.</p></li><li><p>
Regularly Round on Team Members, using questions from the rounding log.</p><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><p>
Lead monthly team meetings using meeting agenda template; review stoplight report; cascade key leadership messages.</p></li><li><p>
Model, coach and validate team members&rsquo; use of TriHealth Way behaviors (AIDET + Promise, Always Behaviors and Always HEARD).</p></li><li><p>
Recognize team members for safety wins, positive performance and demonstrating SERVE and ALWAYS behaviors, TriHealth Way of Leading, Serving and Delivering Care.</p></li></ul><p></p><div><br>
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><b><br>
Serve: ALWAYS...</b><br>
<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><b><br>
Excel: ALWAYS...</b><br>
<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><b><br>
Respect: ALWAYS...</b><br>
<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><b><br>
Value: ALWAYS...</b><br>
<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><b><br>
Engage: ALWAYS...</b><br>
<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><p></p><p><br>
Job keywords:</p><p>
Clinical Research Coordinator / Social Science Research Assistant / Clinical Data Manager</p></div></div>

Clinical Research Manager

Innovative Clinical Research Institute, LLC

<p><b>Job Overview</b></p><p>We 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.</p><p><b>Responsibilities</b></p><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><p><b>Experience</b></p><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><p>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.</p><p>Pay: $29.00 - $33.00 per hour</p><p>Benefits:</p><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><p>Work Location: In person</p>

Assistant Clinical Research Manager

CenExel Clinical Research

<div><p><b>About Us:
</b></p><p>CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process.<br>
<br>
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.</p><br>
<p></p>
<p><b>
Job Summary:
</b></p><p>Manages all lab areas and personnel by overseeing daily operational and technical functions with a focus on project completion and resource management. Responsible for ensuring compliance with policies and procedures. Other responsibilities include supervising daily responsibilities of lab personnel, safety of participants, and study conduct.</p>
<p><b>
Compensation</b>: $78,642 - $90,000 annually depending on experience, education, and skillset.</p><br>
<p></p>
<p><b>
Essential Responsibilities and Duties:</b></p>
<ul>
<li>Ensures all lab processes for studies are carried out properly and accurately by the lab team.</li>
<li>Ensures all tracking systems are adhered to and all protocol required lab procedures are carried out appropriately.</li>
<li>Makes appropriate staffing assignments, ensuring delegated tasks are within an employee&rsquo;s scope of practice.</li>
<li>Responsible for the day-to-day operations of the medical testing laboratory.</li>
<li>Ensures the quality and accuracy of test results.</li>
<li>Oversees the inventory, maintenance, and validation of laboratory equipment.</li>
<li>Performs regular inventory of supplies and orders as needed to ensure the lab supplies are adequate and available for study visits.</li>
<li>Develops and implements procedures to ensure the safety and security of the laboratory.</li>
<li>Reads and understands protocol requirements for blood specimens including blood collection, labeling of samples, processing samples, storage of samples and shipping of samples.</li>
<li>Notifies the appropriate lab that the shipment has been sent, including the protocol number, site number and PI's name. Communicates required shipment information including protocol number, site number, PI's name, etc. Acts as a contact point for outside inquiries.</li>
<li>Ensures storage and tracking system is set up prior to starting the study, with a method of storing the samples in appropriate containers. Primary and back-up samples are stored independent of each other.</li>
<li>Hires, trains, supervises, and evaluates personnel. Champions and enforces the strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site Working Practices, protocol, and company guidelines and policies. Retrains and implements corrective and preventative actions, as needed.</li>
<li>Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.</li></ul><br>
<p></p>
<p><b>
Education/Experience/Skills:</b></p>
<ul>
<li>Must be a high school graduate or have GED equivalency.</li>
<li>Must have experience processing samples.</li>
<li>Must have experience supervising lab technicians.</li>
<li>Phlebotomist certification preferred.</li>
<li>Must have good interpersonal skills, demonstrated through interactions with patients, staff, Sponsor representatives, etc.</li>
<li>Must be self-motivated, organized and able to perform tasks independently.</li>
<li>Must be able to effectively communicate verbally and in writing.</li></ul><br>
<p></p>
<p><b>
Working Conditions
</b></p><div><ul><li>Indoor, Clinic environment.</li></ul>
<ul><li>Essential physical requirements include sitting, typing, standing, and walking.</li></ul>
<ul><li>Lightly active position, occasional lifting of up to 20 pounds.</li></ul>
<ul><li>Reporting to work, as scheduled, is essential.</li></ul>
<ul><li>This is an on-site work arrangement.</li></ul></div><br>
<p></p>
<p>
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.</p><p></p><p><br>
Equal Opportunity Employer<br>
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.</p></div>

Clinical Research Laboratory Manager

Spartanburg Regional Healthcare System

<div><b>Job Requirements<br>
</b><br>
<p><b>Position Summary</b></p><p>
The Clinical Research Program Manager is responsible for the management, coordination, and support of non-sponsored, resident-led clinical research and quality improvement (QI) initiatives across Spartanburg Regional Healthcare System. The role is responsible for building research and QI capacity among faculty, residents and trainees, including those in Family Medicine, Surgery, OB/GYN, and other residency programs by providing education, operational guidance, and infrastructure to support successful project development and execution. The manager oversees day-to-day operation of the resident research and QI support program, including workflow coordination, process development, and strategic planning to ensure consistent and high-quality support for resident-fellow scholarly activity and quality improvement work.</p><p>
This position serves as the primary liaison for residents/fellows, students, and faculty mentors engaged in non-sponsored research and QI projects. The Manager provides hands-on guidance in research design, protocol development, regulatory navigation, implementation, data management, and dissemination, while ensuring compliance with institutional policies and applicable regulatory requirements</p><p>
A central component of this role is the delivery of education and mentorship to residents/fellows to promote research literacy and successful project execution. This includes instruction on protocol development, IRB processes, ethical research conduct, data collection methods, analysis planning, and preparation of abstracts, posters, or manuscripts. In addition, the Manager provides structured support for resident-led quality improvement projects including those submitted to satisfy residency program or accreditation requirements, ensuring alignment with institutional priorities and accepted QI methodologies.</p><p>
The Manager of Clinical Research Program (Non-Sponsored) works closely with the Director of Clinical Research, Graduate Medical Education (GME) leadership, residency program directors, faculty mentors, Research Compliance, and health system leadership to develop and sustain a scalable model for resident/fellow research and quality improvement support. This role requires a self-directed, detail-oriented, and collaborative professional with a commitment to fostering a culture of inquiry, scholarship, and continuous improvement across the organization.</p><p><b><br>
Minimum Requirements</b></p><p><b><br>
Education</b></p><ul><li>
Bachelor&rsquo;s degree in health-related or scientific field (e.g., Public Health, Clinical Research, Nursing, health sciences or related discipline)</li></ul><p><b><br>
Experience</b></p><ul><li>
Minimum of 3 years&rsquo; experience supporting clinical research in a healthcare, academic medical center or research setting</li><li>
Demonstrated experience with non-sponsored investigator-initiated research, including IRB processes and regulatory documentation</li></ul><p><b><br>
License/Registration/Certifications</b></p><p><b><br>
Preferred Requirements</b></p><p><b><br>
Preferred Education</b></p><ul><li>
Master&rsquo;s Degree in Clinical Research, Public Health, Health Sciences, Healthcare Administration, or related field</li></ul><p><b><br>
Preferred Experience</b></p><ul><li>
5+ years of experience in clinical research operations, academic research support, or healthcare quality improvement</li><li>
Experience supporting resident scholarly activity and quality improvement projects, preferably within a GME or teaching hospital environment</li></ul><p><b><br>
Preferred License/Registration/Certifications</b></p><ul><li>
Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or equivalent</li><li>
Lean Six Sigma or other Quality Improvement Certification</li><li>
Project Management Certification</li></ul><p><b><br>
Core Job Responsibilities</b></p><ul><li>
Coordinate and track non-sponsored, resident-led research and quality improvement projects across participating residency programs</li><li>
Serve as the first point of contact for students and residents/fellows seeking research or quality improvement experience within the health system</li><li>
Educate residents/fellows on research methodology, protocol development, and project execution</li><li>
Provide guidance on IRB submissions, regulatory documentation, and compliance</li><li>
Educate and assist students, residents/fellows, and new investigators in navigating research and QI requirements, credentialing, and institutional processes</li><li>
Collaborate with GME leadership and residency programs (Family Medicine, Surgery, OB/GYN, and others) to align research and QI activities with training and accreditation expectations</li><li>
Serve as the primary liaison between residents/fellows, faculty investigators, and institutional research leadership for non-sponsored research and QI activities</li><li>
Provide continuity support for resident projects by ensuring effective handoff and documentation when learners rotate off a project prior to completion</li><li>
Maintain and update an institution-wide tracking and progress report for non-sponsored resident research and QI projects, including in-progress, completed, and disseminated work</li><li>
Support research and QI audits as applicable and assist with preparation and documentation for non-sponsored projects</li><li>
Promote the accuracy, completeness, and timeliness of project documentation, milestones, and reporting</li><li>
Collaborate with the Office of Research Compliance to ensure all non-sponsored research and QI projects adhere to institutional, ethical, and regulatory standards</li><li>
Stay informed of and communicate updates to research and compliance policies relevant to resident scholarly activity and quality improvement</li><li>
Promote shared learning, best practices, and continuous improvement related to resident/fellow research and quality improvement</li><li>
Assists with study feasibility in cooperation with the Protocol Review Committee (PRC)</li><li>
Other duties as assigned</li></ul></div>

Program Mgr-Non-Sponsored Clinical Research

Children's Healthcare of Atlanta

<div><p>Note: If you are CURRENTLY employed at Children's and/or have an active badge or network access, STOP here. Submit your application via Workday using the Career App (Find Jobs).</p><p><b>
Work Shift</b></p>
Day<p></p><p><b>
Work Day(s)</b></p>
Monday-Friday<p></p><p><b>
Shift Start Time</b></p>
8:30 AM<p></p><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><p><b>
Shift End Time</b></p></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>
5:00 PM<p></p><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><p><b>
Worker Sub-Type</b></p></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>
Regular<p></p><p>
Children&rsquo;s is one of the nation&rsquo;s leading children&rsquo;s hospitals. No matter the role, every member of our team is an essential part of our mission to make kids better today and healthier tomorrow. We&rsquo;re committed to putting you first, and that commitment is at the heart of our company culture: People first. Children always. Find your next career opportunity and make a difference doing what you love at Children&rsquo;s.</p><p></p><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><p><b>
Job Description</b></p></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>
Provides oversight for all aspects of clinical research occurring within the specified program and training and mentoring for clinical research personnel at site. Provides guidance and assistance in protocol development, serving as back-up coordinator to provide ongoing support for all trials in the specified program as needed. Communicates all relevant policy and procedure updates/revisions as directed by Manager, Research. Provides routine auditing/monitoring of ongoing trials for quality assurance purposes.<p></p><p><b>
Experience
</b></p><ul><li>4 years of experience in clinical research or 3 years of experience in clinical research with advanced degree</li></ul><p></p><p><b>
Preferred Qualifications
</b></p><ul><li>2 years of experience in supervising staff</li><li>
Experience in creating and negotiating study budgets</li><li>
Experience in financial management</li><li>
Advanced degree</li></ul><p></p><p><b>
Education</b></p><ul><li>
Bachelor&rsquo;s degree in a scientific or health-related field</li></ul><p></p><p><b>
Certification Summary
</b></p><ul><li>Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Certified Research Associate (CRA), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or comparable within 1 year of employment</li><li>
ARUP Handling, Packaging and Shipping Infectious Substances or similar within 30 days of employment if role requires specimen acquisition.</li><li>
Collaborative Institutional Training Initiative (CITI) within 30 days of employment</li></ul><p></p><p><b>
Knowledge, Skills and Abilities</b></p><ul><li>
Broad knowledge of federal regulations and regulatory requirements for conducting research with the ability to mentor</li><li>
Self-directed and motivated to work independently toward short- and long-term goals</li><li>
Good communication, organization, and interpersonal skills</li></ul><p></p><p><b>
Job Responsibilities</b></p><p><b>
Develops, conducts, and facilitates research protocols at an expert level</b></p><ul><li>
Collaborates with manager to assess data management needs.</li><li>
Assists with development of source and case report form tools.</li><li>
Provides back-up data entry services and ensures data integrity.</li><li>
Assists with participant screening, enrollment, study activities, and communication.</li><li>
Provides substantial support to investigators in writing study protocols.</li><li>
Ensures protocol feasibility within ancillary departments.</li><li>
Works collaboratively with manager to monitor metrics.</li><li>
Manages a large or multiple smaller clinical trial projects.</li><li>
Administers various research surveys in accordance with research study requirements.</li><li>
Assists with identifying suitable grants for investigators.</li><li>
Identifies and completes research grant applications.</li><li>
Serves as back-up coordinator within identified service lines for all studies conducted in that service line.</li><li>
Authorizes purchases for research supplies and equipment maintenance if applicable.</li><li>
Leads others in sponsor correspondence, monitoring, and study meetings.</li><li>
Serves as a resource for facilitating grants, contracts, and financial tasks for research and clinical trials.</li><li>
Monitors expenditures and adherence to budget.</li><li>
Assists research administration, financial Operations, and grants accounting in racking research billing to ensure research procedures are billed appropriately and resolves invoice-related issues with all parties involved.</li><li>
Serves as resource for research administrative duties according to Children&rsquo;s policies regarding Epic enrollment, Clinical Trial Management System data entry, patient care invoice accuracy</li></ul><p></p><p><b>
Provides leadership for coordination of patient care to conduct research protocols</b></p><ul><li>
Provides leadership and training related to all clinical research activities.</li></ul><ul><li>
Provides research study education to participants as part of a study protocol.</li><li>
Performs phlebotomy if trained to do so.</li><li>
Completes research-only testing as required and applicable per-study and system requirements including electrocardiograms.</li><li>
Completes documentation as needed within the medical record.</li></ul><p></p><p><b>
Facilitates regulatory processes related to clinical research activities at an expert level</b></p><ul><li>
Oversees the maintenance of all coordinators&rsquo; regulatory documents.</li><li>
Conducts interdepartmental auditing for quality assurance purposes.</li><li>
Trains coordinators on all Institutional Review Board-related activities such as submission, modifications, reporting, and termination activities.</li></ul><p></p><p><b>
Leads education activities and quality initiatives to support specific research activities and primary role at Children&rsquo;s Healthcare of Atlanta</b></p><ul><li>
Assists with departmental policy and quality projects.</li><li>
Maintains all licensure, certification, and system education requirements for role.</li><li>
Serves as an instructor and mentor for quality and education activities.</li><li>
Coordinates educational activities related to study needs for study staff, investigator team, and patient care staff.</li><li>
Provides training and assistance for research protocol development, conduct, and facilitation at an expert level.</li><li>
Provides leadership, training, and assistance for data management activities.</li><li>
Provides leadership, training, and assistance for direct patient care interaction.</li><li>
Provides leadership and expertise in study budgeting, sponsor interactions, budget and contract routing, feasibility assessments, account management, and reconciliation.</li><li>
Orients, supervises, and evaluates staff.</li><li>
Assist Supervisor and/or Manager with development of staff by: being available to teammates, acting as a resource to help complete complicated/complex tasks, providing on the job training to team, and seeking out opportunities to become actively involved in staff workflow and development.</li><li>
Provide Supervisor and/or Manager feedback on staff performance, educational needs, and workflow status.</li><li>
Leads or chairs committees or task forces.</li><li>
Collaborates with manager to incorporate system initiatives into departmental practices.</li></ul><p></p><p><i>
Children&rsquo;s Healthcare of Atlanta is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, sex, religion, national origin, citizenship, age, veteran status, disability or any other characteristic covered by applicable law.</i></p><p></p><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><p><b>
Primary Location Address</b></p></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>
1575 Northeast Expy NE<p></p><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><p><b>
Job Family</b></p></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>
Research</div>

Team Lead Research Coordinator- Clinical Trials

Rady Children's Hospital

<div><p><b>This is not a remote position. Must be on campus.</b></p><p>
JOB SUMMARY:</p><p>
Under supervision, the Clinical Research Coordinator will be assigned to assist with multiple clinical research studies involving human subjects within the research unit/department. Assist with initiation, implementation and management of research projects in accordance with GCP, FDA, HIPAA &amp; all required regulatory guidelines, with an emphasis on pediatric clinical research studies. Responsibilities may include initiating &amp; managing multiple research projects, including but not limited to clinical trials, PI-initiated studies, and other research projects. Responsibilities may include but are not limited to: submission of protocols &amp; renewals to IRB &amp; scientific review boards; management &amp; submission of electronic data forms to Sponsors, CROs &amp; regulatory agencies; screening for eligibility; monitoring and timely reporting of adverse events; toxicities and protocol deviations; scheduling subjects' visits; coordinating clinical, laboratory and data management activities; processing and submitting laboratory specimens. Interfaces with patients/subjects &amp; the Principal Investigators (PI) as well as working with assigned division's inpatient &amp; outpatient clinical staff &amp; other departments within the Institution. Coordinates preparation for monitor visits, regulatory &amp; data audits. May support and/or supervise interns or staff depending on nature of study. If needed under study-specific research protocol, may collect basic vitals and clinical data based on study needs under the supervision and training of the study PI.</p><p></p><p><br>
MINIMUM QUALIFICIATONS:</p><p>
Bachelor's Degree</p><p>
Area of Study in a Field Related to the Position</p><p>
2 Years of Experience</p><p>
At least 2 years of experience in research/research-related activities</p><p>
Excellent oral and written skills</p><p></p><p><br>
General understanding of computer software and hardware: Word, Excel, data entry (ex. Any EDC platform such as REDCap, Medidata, Rave)</p><p></p><p><br>
PREFERRED QUALIFICATIONS:</p><p>
Master's Degree</p><p>
3 Years of Experience</p><p>
Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or equivalent Clinical research certification through SOCRA for ACRP</p><p>
Demonstrated ability and past experience in complex analysis, familiarity with statistical methodology</p><p>
Additional experience with preparation and submission of IRB applications, regulatory correspondence, and/or specific content of study related research</p><p>
1-2 years of clinical trial experience</p><p></p><p><b><br>
The current salary range for this position is $34.14 to $46.94</b></p><p></p><p><br>
Rady Children&rsquo;s Hospital is committed to compensation that is externally competitive and internally equitable. We demonstrate this commitment by conducting regular market reviews to remain competitive with organizations of similar size in the nonprofit, healthcare sector. The range listed above does not represent the full salary range for the position but is the expected hiring range for qualified candidates. Compensation decisions consider a variety of factors including experience, education, licensure, unique skillsets, organizational need, and internal equity. This posting will remain open from the &ldquo;date posted&rdquo; until the hiring manager has determined there is a sufficient applicant pool or until the position is filled.</p></div>

Clinical Research Coordinator (Non-RN) - Research & Clinical Management - Genomics (In-Person Role)

Medical University of South Carolina

<div><div><div><ul><li>R-0000065740
</li><li>Remote
</li></ul></div><div><ul><li>South Carolina
</li></ul></div><div><ul><li>Administrative, Operations, Program, &amp; Project Management
</li></ul></div><div><ul><li>Business Operations
</li></ul></div><div><ul><li>Full Time
</li></ul></div><div><ul><li>University (UNIV)</li></ul></div></div><p></p><div><div><br>
</div>
</div><div><p><b>Job Description Summary</b></p>
This is a central research administration position, reporting to the Corporate Budgeting &amp; ClinCard Manager in the Office for Clinical Research (OCR) under the Office for the Vice President for Research (OVPR). This position is responsible for key research finance deliverables for the Office of Clinical Research Industry Sponsor Budgeting and Negotiations program. In collaboration with department/division Grants Administrators, Principal Investigators and study teams, Research Administration and Grants and Contracts Accounting Offices, this position will lead industry sponsored study internal budget development to ensure all clinical research provider fees, MUSC Health, ancillary service provider and personnel costs are covered and the final negotiated budget is financially feasible under this OCR fee for service program. Services will include pre-award and post-award industry sponsored research budget development, analysis, reporting, and communication processes within SPARCRequest or the appropriate system (i.e. Clinical Trials Management System &ndash; CTMS).
<p></p><p><b>Entity</b></p>
Medical University of South Carolina (MUSC - Univ)
<p></p><p><b>Worker Type</b></p>
Employee
<p></p><p><b>Worker Sub-Type
</b></p>Classified
<p></p><p><b>Cost Center</b></p>
CC002113 Office of Clinical Research (OCR)
<p></p><p><b>Pay Rate Type</b></p>
Salary
<p></p><p><b>Pay Grade</b></p>
University-GEN11<br>
<p><br>
<b>Pay Range</b>
</p>66,400.00 - 92,900.00 - 119,500.000
<p></p><p><b>Scheduled Weekly Hours</b></p>
40
<p></p><p><b>Work Shift</b></p>
<p></p><p><b>Job Description</b></p>
<p>This is a central research administration position, reporting to the Corporate Budgeting &amp; ClinCard Manager in the Office for Clinical Research (OCR) under the Office for the Vice President for Research (OVPR). This position is responsible for key research finance deliverables for the Office of Clinical Research Industry Sponsor Budgeting and Negotiations program. In collaboration with department/division Grants Administrators, Principal Investigators and study teams, Research Administration and Grants and Contracts Accounting Offices, this position will lead industry sponsored study internal budget development to ensure all clinical research provider fees, MUSC Health, ancillary service provider and personnel costs are covered and the final negotiated budget is financially feasible under this OCR fee for service program. Services will include pre-award and post-award industry sponsored research budget development, analysis, reporting, and communication processes within SPARCRequest or the appropriate system (i.e. Clinical Trials Management System &ndash; CTMS).</p><br>
<p></p><br>
<br>
<p><b>Job Duties and Responsibilities:</b></p><br>
<br>
<p><b>30%</b> Internal Clinical Research Budget Development: Analyze clinical research study documents including clinical trial agreements (CTAs/contract), budget, protocol, informed consent, lab and pharmacy manuals, identify services and procedures required to conduct a corporate clinical research study and identify the associated costs to develop an internal clinical research budget that will provide the funding to support the time and effort required to conduct the study.</p>
<p>1. In collaboration with PIs and study teams and utilizing centralized and streamlined OCR intake tools to minimize study team burden, verify study logistics to calculate budget costs. Select services and obtain pricing from SPARCRequest or the appropriate system (i.e. CTMS) service catalog for studies selecting the OCR budget development / sponsor invoicing service.</p>
<p>2. Partner with OCR PRA Managers if MUSC Health services are identified to obtain pricing from Charge Master to support budget development. Verify research record to include protocol and study personnel information, type and source of funding, add the appropriate study assessments and ancillary services (i.e. SCTR, Core Facility), and build study billing calendar/budget template including visits, windows and services to support budget development, sponsor negotiation, invoicing and reporting.</p>
<p>3. Once all costs are captured, analyze the internal budget to identify the breakeven and the potential research contingency funds.</p>
<p>4. Review the internal budget with study teams to ensure that costs are accounted for and adequate research contingency funds are included.</p>
<ul><li>Work collaboratively and develop effective working relationships with Investigators, key study personnel, departmental finance teams to and Research Administration to accomplish effective budgeting and negotiations.</li>
</ul><p>6. Effectively prioritize tasks, and follow-up to ensure completion of sponsor budgeting activities in a compliant and timely manner.</p>
<ul><li>Participate in CTMS planning, testing and development to optimize industry sponsored clinical research revenue in alignment with institutional goals.</li></ul><br>
<p></p><p><b>30% </b>Budget Negotiations with the Sponsor: Translate the research team approved MUSC internal study budget into the sponsor&rsquo;s format for budget negotiations. Analyze clinical trial agreements (CTAs) to ensure that payment terms are aligned with MUSC research team needs and incorporate those requests during budget negotiations (e.g. holdback percentage, data entry timelines).</p><p><br>
</p><p>Ensure that the internal budget analysis, review and approval process is completed during each round of budget negotiations with the sponsor. Provide budget justification documentation to support the budget negotiation process. Once a budget agreement is reached, complete internal routing documentation for contract terms review by ORSP.</p>
<p>1. Work collaboratively and professionally with OCR staff, the Medical University of South Carolina research community, and external research customers such as pharmaceutical companies and Contract Research Organizations (CRO).</p>
<p>2. Work with the department/division business managers to ensure efficiency in the internal routing process.</p>
<p>3. Provide superior customer service to effectively meet the needs of internal and external customers.</p>
<p>4. Ensure that budgeting and negotiation processes are consistent with federal and state regulations and MUSC policies and practices.</p>
<p>5. Upon budget agreement and contract execution, inform sponsor invoicing team and work to ensure budget amounts and terms are effectively communicated for incorporation into study tracker to support sponsor invoicing process.</p><p><br>
</p><p><b>25%</b> OCR Budgeting Program Continuous Quality Improvement (CQI) initiatives: Optimize the MUSC OCR budeting fee for service program for corporate funded clinical research; identify and develop tools, resources, and training for corporate sponsor budgeting, internal budget development, analysis, communication and reporting.</p>
<p>1. Monitor program performance and analyze operational data to drive Continuous Quality Improvement (CQI) initiatives, including reducing study start-up timelines, enhancing budget negotiation outcomes, and improving payment terms to strengthen invoicing processes and revenue recovery.</p>
<p>2. Develop tools to optimize budget development and negotiations steps and develop / update work instructions to support the process.</p>
<p>3. Serve as an industry sponsored clinical research subject matter expert, develop educational presentations, work on communication templates to support the budget development and negotiation process steps start to finish, website resource development, and budgeting and negotiation methodology supporting documentation.</p><br>
<p></p>
<p></p><p><b>10%</b> Sponsor Invoicing / Post Award Transition Activities: Transition newly executed clinical trial budgets and Clinical Trial Agreements (CTAs) to invoicing operations by analyzing finalized budget and payment terms and providing feedback and insight to the Invoicing Analyst translating them into study tracking and invoicing workflows within the Clinical Trial Management System (CTMS). Collaborate with invoicing personnel and study teams to ensure accurate interpretation of sponsor payment provisions, invoicing milestones, invoiceable procedures, and pass-through costs. Serve as a resource to the OCR invoicing team by facilitating knowledge transfer, validating study billing requirements, and supporting the timely invoicing, collection, and reconciliation of sponsor payments. Deliver exceptional customer service to internal and external stakeholders while promoting compliance with contractual requirements and institutional processes.</p><p><br>
</p><p><b>5%</b> Participate in cross-functional, multi-disciplinary OCR work teams based upon institutional and departmental priorities and performs other pre- and post-award, as needed.</p><p><br>
<br>
</p><br>
<p><b>Minimum Experience and Training Requirements:</b></p>
<p>Minimum of a bachelor's degree and three years relevant program experience. Employee must have the ability to prioritize and complete required tasks with minimal supervision, interpret and apply regulations and policies, and use resources effectively to complete job tasks</p><br>
<p></p><br>
<br>
<p><b>Preferred Experience and Training</b>:</p>
<p>A bachelor's degree in business administration, public administration or the social sciences and 2-5 year<b>s</b> experience in budget development, contracts and grant administration activities. Experience as a clinical research coordinator, research nurse coordinator, research/sponsored programs accountant, grants administrator, or professional accountant/financial analyst with direct industry sponsored research experience preferred, or an equivalent combination of experience, education and training. Strong project management and organizational skills required. Certification as clinical research professional or equivalent preferred. Knowledge of SPARCRequest, Epic, eIRB, proposal pricing, SmartStream, Darkwing, and research billing highly desirable. Proficient working knowledge of Microsoft office required. Knowledge of grants administration processes, industry sponsored research invoicing, and the clinical research life cycle required.</p><br>
<p></p><br>
<br>
<p><b>Physical Requirements:</b></p>
<p>Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position.(Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoorsin all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform jobfunctions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching'operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows andshoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactilesensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lift objects, up to 15 lbs., from floor levelto height of 36 inches, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/20vision, corrected. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at adistance. (Frequent) Ability to match or discriminate between colors. (Frequent) Ability to determine distance/relationship between objects;depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction.(Continuous) Ability to hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motorfunctions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent)</p>
<p></p><p><b>Additional Job Description</b></p>
Minimum Requirements: A bachelor's degree and three years relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lift objects, up to 15 lbs., from floor level to height of 36 inches, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to match or discriminate between colors. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent)
<p></p><p><i>If you like working with energetic enthusiastic individuals, you will enjoy your career with us!</i></p>
<p></p><p>The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.</p>
<p></p><p>Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees</p></div></div>

UNIV - Clinical Research Sponsor Budgeting Manager - Office of Clinical Research, OVPR

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