Clinical research coordinator entry level jobs

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!

Title: Research Administrator Biomedical Department Org: Jacobson Clinical Research Center - 107980 Employee Classification: J1 - Salaried Full Time HSC Bargaining Unit: Professional Staff Association Primary Location: HSC C Job Description: This position will support the administrative research enterprise within the College of Medicine & Life Sciences and the Jacobson Center for Clinical & Translational Research (JCCTR) and will work in collaboration with the Director of the JCCTR to develop, promote, and facilitate clinical research for all the College of Medicine & Life Science research programs. Minimum Qualifications: • Bachelor's degree in management preferred. Applicable administrative work experience will be considered in lieu of education (4+ years), required. • Experience working in Grants Accounting or Accounting in an academic institution preferred. • Experience working with NIH, DOD, other non-profit sponsors, for-profit sponsors in research administration preferred. • Exceptional organizational skills, detail oriented and the ability to keep organized and accurate records, required. • Ability to create, present, defend, and execute a budget, required. • Ability to work independently, self-starter. • Ability to work well with staff of all levels. 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.

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.

Medpace is the leading CRO for Biotech companies and is continuing to add established Clinical Trial Managers / Project Managers to join our Clinical Trial Management Group in Cincinnati, OH. Our therapeutic areas of focus include Oncology/Hematology, Cardiovascular/Metabolic, Infectious Disease, Neuroscience, and more. We have just expanded our campus in Cincinnati and have offices in Dallas and Denver and provide remote flexibility with relevant experience. We offer a very competitive salary/bonus program, plus equity grants which have become very lucrative for our associates. Responsibilities * Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations * Serve as primary Sponsor contact for operational project-specific issues and study deliverables * Maintain in depth knowledge of protocol, therapeutic area, and indication * Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided * Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable * Develop operational project plans * Manage risk assessment and execution * Responsible for management of study vendor * Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables Qualifications * Bachelor's degree in a health-related field; Advanced degree in a health-related field preferred * Experience in Phases 1-4; Phases 2-3 preferred * 5+ years as a project/clinical trial manager within a CRO; required for home-based * Management of overall project timeline * Strong leadership skills 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.