Our clinical operations activities are growing rapidly, and we are currently seeking full-time, office-based Regulatory Submissions Coordinators to join our Study Start-up team. This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process at Medpace. We are seeking entry level employees. If you want an exciting career where you can build a foundation in industry knowledge through our robust training program and develop and grow your career even further, then this is the opportunity for you.
Responsibilities
* Communicate with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential documents required before the site begins to screen patients to participate in the clinical trial;
* Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF);
* Collect, review, organize, and assemble regulatory start-up submissions (including submissions to Institutional Review Boards (IRB);
* Maintain timelines for study start-up through both internal and external collaboration; and
* Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
SITE ACTIVATION & MAINTENANCE (SAM) TRAINING PROGRAMMedpace training programs are curated to educate and support experienced associates, as well as those that are new to the industry. The SAM Training Program embraces evidence- based learning & development models to advance professional learning and employee performance. In the program, you will…• Complete independent learning modules, interactive exercises, and team workshops through the core curriculum;• Gain exposure to real-world tasks through a robust mentoring program; and• Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.
Qualifications
* A minimum of a PharmD is required (preferably in a Life Sciences field);
* 3.5 GPA and above preferred;
* Some experience in an office setting is preferred;
* Excellent organizational and prioritization skills;
* Knowledge of Microsoft Office; and
* Great attention to detail and excellent oral and written communication skills.
Travel: None
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Cincinnati Perks
* Cincinnati Campus Overview
* Flexible work environment
* Competitive PTO packages, starting at 20+ days
* Competitive compensation and benefits package
* Company-sponsored employee appreciation events
* Employee health and wellness initiatives
* Community involvement with local nonprofit organizations
* Discounts on local sports games, fitness gyms and attractions
* Modern, ecofriendly campus with an on-site fitness center
* Structured career paths with opportunities for professional growth
* Discounted tuition for UC online programs
Awards
* Named a Top Workplace in 2024 by The Cincinnati Enquirer
* Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
* Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
$45k-61k yearly est. Auto-Apply 6d ago
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Clinical Research Manager - 500142
Utoledo Current Employee
Toledo, OH
Under the clinical direction of the Residency Associate Director in the Department of Urology and Transplantation, the Clinical Research Manager (RN) will oversee and manage the conduct of all human subjects, research procedures, and related activities. Responsibilities will include collaborating with the Residency Associate Director to analyze and publish data from large databases, assist in the coordination and management of projects funded by various sources (industry, government, foundation), and ensure compliance with state and federal regulations. The manager will collaborate with the study team to maintain scientific integrity, oversee daily operations, and will assist with grant writing, as well as manuscript preparation and submission. They will assist in the hiring, supervision, and training of research team members, learners, and volunteer study staff as needed.
Minimum Qualifications:
•Associate degree in nursing required with
•Current State of Ohio Registered Nurse licensure required.
•Minimum of three to five (3-5) years of clinical research required
•Experience with scientific writing.
•Knowledge of clinical trials and IRB submission, preferred.
•Experience teaching/supervising students and residents.
•Knowledge of the methods, materials, and equipment used in research.
•Must have excellent computer skills including Microsoft Office: Word, Excel, Outlook, PowerPoint required.
•Current, active CPR certification at time of hire required and maintained.
•CITI training through IRB is to be obtained within 90 days of hire.
•HIPAA certification must be completed within 90 days of hire.
Preferred Qualifications:
•Bachelor's in nursing preferred.
•Prior laboratory research or technician experience desirable.
•Advanced Excel functions such as tables, graphs, statistical formulas, and Basic editor
Conditions of Employment:
To promote the highest levels of health and well-being, the University of Toledo campuses are tobacco-free. Pre-employment health screening requirements for the University of Toledo Health Science Campus Medical Center will include drug and other required health screenings for the position.
Equal Employment Opportunity Statement:
The University of Toledo is an equal opportunity employer. The University of Toledo does not discriminate in employment, educational programs, or activities on the basis of race, color, religion, sex, age, ancestry, national origin, sexual orientation, gender identity and expression, military or veteran status, disability, familial status, or political affiliation.
The University is dedicated to attracting and retaining the best and brightest talent and fostering a culture of respect.
The University of Toledo provides reasonable accommodation to individuals with disabilities. If you require accommodation to complete this application, or for testing or interviewing, please contact HR Compliance at ************************ or ************ between the hours of 8:30 a.m. and 5 p.m. or apply online for an accommodation request.
Computer access is available at most public libraries and at the Office of Human Resources located in the Center for Administrative Support on the UToledo Main Campus.
$66k-101k yearly est. 59d ago
Manager Clinical Research
Trihealth, Inc. 4.6
Cincinnati, OH
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 Requirements: Bachelor's Degree in Biology, Physiology, Business, Public Health, or related scientific/healthcare field Equivalent experience accepted in lieu of degree Knowledge of GCP, ICH guidelines/regulatory requirements for clinical trial management This position requires strong leadership skills and the ability to manage people, deliver on clinical projects, and align with business initiatives 2-3 years experience Professional Management 3-4 years experience Professional Clinical Research Job Responsibilities: Performs feasibility evaluations of accepting potential protocols through analysis of coordinator staffing requirements, resources requirements, clinical considerations and financial profitability. Evaluate need and appropriateness of requests by staff fo Complies with all IRB/IACUC/FDA requirements in study submission to a central or local IRB. Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment. Assures compliance with IRB/FDA standards and dead 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 reco 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. Develop educational programs for staff and Help implement strategic plan, including developing strategic partnerships with foundations, sponsors, vendors, clinicians. Lead the implementation of the plan. Other Job-Related Information: Working Conditions: Climbing - Rarely Concentrating - Frequently Continous Learning - Frequently Hearing: Conversation - Consistently Hearing: Other Sounds - Frequently Interpersonal Communication - Consistently Kneeling - Rarely Lifting
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 & 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: TriHealth Way of Leading TriHealth Way of Serving Transformation Change Drive for Results Build Organizational Talent Leadership Tactics: Conduct department huddles. Generally, clinical departments hold daily huddles, non-clinical hold weekly huddles. Regularly Round on Team Members, using questions from the rounding log. * 25 or fewer team members = monthly * 26-50 team members = every other month * 51+ (and optional team members) = quarterly Lead monthly team meetings using meeting agenda template; review stoplight report; cascade key leadership messages. Model, coach and validate team members' use of TriHealth Way behaviors (AIDET + Promise, Always Behaviors and Always HEARD). Recognize team members for safety wins, positive performance and demonstrating SERVE and ALWAYS behaviors, TriHealth Way of Leading, Serving and Delivering Care.
$57k-75k yearly est. 27d ago
Clinical Research Coordinator
Gastro Health 4.5
Cincinnati, OH
Gastro Health is seeking a Full-Time Clinical Research Coordinator to join our team!
Gastro Health is a great place to work and advance in your career. You'll find a collaborative team of coworkers and providers, as well as consistent hours.
This role offers:
A great work/life balance
No weekends or evenings - Monday thru Friday
Paid holidays and paid time off
Rapidity growing team with opportunities for advancement
Competitive compensation
Benefits package
Duties you will be responsible for:
General Administrative
Coordinates with Principal Investigator, local site, and Central Hub to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures.
Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
Assists Principal Investigator to assure that all key personnel or persons ‘engaged' in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
Cooperates with compliance and monitoring efforts related to sponsored program administration and respond to any audit findings and implement approved recommendations.
Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors.
Protocol Preparation & Review
Attends investigator meetings as required or requested by the PI.
Collaborates with the Regulatory Specialist to prepare IRB and any other regulatory submission documents as required by the protocol.
Prepares other study materials as requested necessary. These study materials include, but are not limited to, the informed consent document, source documents, enrollment logs, and drug/device accountability logs.
Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
Conduct of Research
Reviews and comprehends the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
Develops and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.
Conducts or participates in the informed consent process and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
Registers each participant in CTMS to ensure billing of study procedures to the appropriate funding source.
Coordinates participant tests and procedures.
Collects data as required by the protocol. Assures timely completion of Source Documents.
Maintains study timelines.
Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Gastro Health Research Policy on Investigational Drug/Device Accountability.
Completes study documentation and maintains study files in accordance with sponsor requirements and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
Retains all study records in accordance with sponsor requirements and Gastro Health Research policies and procedures.
Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.
Project Closeout
Assists the Principal Investigator and Regulatory Specialist in submission of accurate and timely closeout documents to applicable federal agencies, and the sponsoring agency in accordance with federal regulations and sponsoring agency policies and procedures.
Arranges secure storage of study documents that will be maintained according to Gastro Health Research policy or for the contracted length of time, whichever is longer.
Minimum Requirements
Clinical research experience preferred
Previous phlebotomy skills
High School Diploma
Interested in learning more? Click here to learn more about the location.
Gastro Health is the one of the largest gastroenterology multi-specialty groups in the United States, with over 130+ locations throughout the country. Our team is composed of the finest gastroenterologists, pediatric gastroenterologists, colorectal surgeons, and allied health professionals. We are always looking for individuals that share our mission to provide outstanding medical care and an exceptional healthcare experience. We offer a comprehensive benefits package to our eligible employees.
Gastro Health is proud to be an Equal Opportunity Employer. We do not discriminate based on race, color, gender, disability, protected veteran, military status, religion, age, creed, national origin, gender identity, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.
We thank you for your interest in joining our growing Gastro Health team!
$48k-63k yearly est. Auto-Apply 60d+ ago
Clinical Research Manager - 500142
University of Toledo 4.0
Toledo, OH
Under the clinical direction of the Residency Associate Director in the Department of Urology and Transplantation, the Clinical Research Manager (RN) will oversee and manage the conduct of all human subjects, research procedures, and related activities. Responsibilities will include collaborating with the Residency Associate Director to analyze and publish data from large databases, assist in the coordination and management of projects funded by various sources (industry, government, foundation), and ensure compliance with state and federal regulations. The manager will collaborate with the study team to maintain scientific integrity, oversee daily operations, and will assist with grant writing, as well as manuscript preparation and submission. They will assist in the hiring, supervision, and training of research team members, learners, and volunteer study staff as needed.
Minimum Qualifications:
•Associate degree in nursing required with
•Current State of Ohio Registered Nurse licensure required.
•Minimum of three to five (3-5) years of clinical research required
•Experience with scientific writing.
•Knowledge of clinical trials and IRB submission, preferred.
•Experience teaching/supervising students and residents.
•Knowledge of the methods, materials, and equipment used in research.
•Must have excellent computer skills including Microsoft Office: Word, Excel, Outlook, PowerPoint required.
•Current, active CPR certification at time of hire required and maintained.
•CITI training through IRB is to be obtained within 90 days of hire.
•HIPAA certification must be completed within 90 days of hire.
Preferred Qualifications:
•Bachelor's in nursing preferred.
•Prior laboratory research or technician experience desirable.
•Advanced Excel functions such as tables, graphs, statistical formulas, and Basic editor
Conditions of Employment:
To promote the highest levels of health and well-being, the University of Toledo campuses are tobacco-free. Pre-employment health screening requirements for the University of Toledo Health Science Campus Medical Center will include drug and other required health screenings for the position.
Equal Employment Opportunity Statement:
The University of Toledo is an equal opportunity employer. The University of Toledo does not discriminate in employment, educational programs, or activities on the basis of race, color, religion, sex, age, ancestry, national origin, sexual orientation, gender identity and expression, military or veteran status, disability, familial status, or political affiliation.
The University is dedicated to attracting and retaining the best and brightest talent and fostering a culture of respect.
The University of Toledo provides reasonable accommodation to individuals with disabilities. If you require accommodation to complete this application, or for testing or interviewing, please contact HR Compliance at ************************ or ************ between the hours of 8:30 a.m. and 5 p.m. or apply online for an accommodation request.
Computer access is available at most public libraries and at the Office of Human Resources located in the Center for Administrative Support on the UToledo Main Campus.
$49k-65k yearly est. 59d ago
Study Start-Up Coordinator- PhD
Medpace 4.5
Cincinnati, OH
Our clinical operations activities are growing rapidly, and we are currently seeking full-time, office-based Regulatory Submissions Coordinators to join our Study Start-up team. This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process at Medpace. We are seeking entry level employees. If you want an exciting career where you can build a foundation in industry knowledge through our robust training program and develop and grow your career even further, then this is the opportunity for you.
Responsibilities
* Communicate with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential documents required before the site begins to screen patients to participate in the clinical trial;
* Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF);
* Collect, review, organize, and assemble regulatory start-up submissions (including submissions to Institutional Review Boards (IRB);
* Maintain timelines for study start-up through both internal and external collaboration; and
* Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
SITE ACTIVATION & MAINTENANCE (SAM) TRAINING PROGRAMMedpace training programs are curated to educate and support experienced associates, as well as those that are new to the industry. The SAM Training Program embraces evidence- based learning & development models to advance professional learning and employee performance. In the program, you will…• Complete independent learning modules, interactive exercises, and team workshops through the core curriculum;• Gain exposure to real-world tasks through a robust mentoring program; and• Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.
Qualifications
* A minimum of a PhD is required (preferably in a Life Sciences field);
* 3.5 GPA and above preferred;
* Some experience in an office setting is preferred;
* Excellent organizational and prioritization skills;
* Knowledge of Microsoft Office; and
* Great attention to detail and excellent oral and written communication skills.
Travel: None
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Cincinnati Perks
* Cincinnati Campus Overview
* Flexible work environment
* Competitive PTO packages, starting at 20+ days
* Competitive compensation and benefits package
* Company-sponsored employee appreciation events
* Employee health and wellness initiatives
* Community involvement with local nonprofit organizations
* Discounts on local sports games, fitness gyms and attractions
* Modern, ecofriendly campus with an on-site fitness center
* Structured career paths with opportunities for professional growth
* Discounted tuition for UC online programs
Awards
* Named a Top Workplace in 2024 by The Cincinnati Enquirer
* Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
* Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
$45k-61k yearly est. Auto-Apply 6d ago
Clinical Research Manager
University of Toledo 4.0
Toledo, OH
Under the clinical direction of the Residency Associate Director in the Department of Urology and Transplantation, the Clinical Research Manager (RN) will oversee and manage the conduct of all human subjects, research procedures, and related activities. Responsibilities will include collaborating with the Residency Associate Director to analyze and publish data from large databases, assist in the coordination and management of projects funded by various sources (industry, government, foundation), and ensure compliance with state and federal regulations. The manager will collaborate with the study team to maintain scientific integrity, oversee daily operations, and will assist with grant writing, as well as manuscript preparation and submission. They will assist in the hiring, supervision, and training of research team members, learners, and volunteer study staff as needed.
Minimum Qualifications:
* Associate degree in nursing required with
* Current State of Ohio Registered Nurse licensure required.
* Minimum of three to five (3-5) years of clinical research required
* Experience with scientific writing.
* Knowledge of clinical trials and IRB submission, preferred.
* Experience teaching/supervising students and residents.
* Knowledge of the methods, materials, and equipment used in research.
* Must have excellent computer skills including Microsoft Office: Word, Excel, Outlook, PowerPoint required.
* Current, active CPR certification at time of hire required and maintained.
* CITI training through IRB is to be obtained within 90 days of hire.
* HIPAA certification must be completed within 90 days of hire.
Preferred Qualifications:
* Bachelor's in nursing preferred.
* Prior laboratory research or technician experience desirable.
* Advanced Excel functions such as tables, graphs, statistical formulas, and Basic editor
Conditions of Employment:
To promote the highest levels of health and well-being, the University of Toledo campuses are tobacco-free. Pre-employment health screening requirements for the University of Toledo Health Science Campus Medical Center will include drug and other required health screenings for the position.
Equal Employment Opportunity Statement:
The University of Toledo is an equal opportunity employer. The University of Toledo does not discriminate in employment, educational programs, or activities on the basis of race, color, religion, sex, age, ancestry, national origin, sexual orientation, gender identity and expression, military or veteran status, disability, familial status, or political affiliation.
The University is dedicated to attracting and retaining the best and brightest talent and fostering a culture of respect.
The University of Toledo provides reasonable accommodation to individuals with disabilities. If you require accommodation to complete this application, or for testing or interviewing, please contact HR Compliance at ************************ or ************ between the hours of 8:30 a.m. and 5 p.m. or apply online for an accommodation request.
Computer access is available at most public libraries and at the Office of Human Resources located in the Center for Administrative Support on the UToledo Main Campus.
Advertised: 20 Nov 2025 Eastern Standard Time
Applications close: