Clinical Research Documentation Administrator (TMF)
Medpace
We are currently hiring individuals seeking an exciting career in clinical research, managing our Trial Master File. The Trial Master File (TMF) is a collection of documents that stores all data and research collected on a given trial. The TMF allows us to conduct a clinical trial and ensures data integrity. It is an integral tool and helps teams manage trials more effectively. TMF oversight is important to the successful execution of a trial and ultimately plays a big role in a new drug or device receiving approval by the FDA. In this position, you will be working with a highly experienced team of other administrators and clinical research professionals that can help you grow your skillset while working for a growing and developing company. *This position is fully office-based in Cincinnati, OH. Responsibilities Manage electronic filing system for trial documentation; Track, maintain, and perform quality check of electronic documents; Communicate with internal associates globally regarding errors in trial documents; Prepare documents for shipment. Qualifications Associate's degree, or equivalent required; Bachelor's degree preferred; Some experience in document administration; High attention to detail; Excellent organizational skills; Strong written and verbal communication skills; Knowledge of MS Office. 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 our 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, we employ 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, eco‑friendly 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. #J-18808-Ljbffr Medpace
- ...of phase I through phase IV clinical research studies and Real World... ...track essential/regulatory documents Participate in and complete... ...Authorities or Institutions Administration Boards, and follow up on the... ...Manage ISF and TMF for all assigned study sites...SuggestedFull timeContract workInterim roleRemote workWork from homeRelocation package
- ...hiring Pharm Ds for the CRA role!The Clinical Research Associate position offers an exciting... ...medical and regulatory expertsIn-house administrative support for all levels of... ...staffMedical record and research source documentation verification against case report form...SuggestedContract workWork at officeRemote workWork from home
- Job SummaryExperienced Clinical Research Associate (CRA) - join our growing team!Medpace is... ...medical and regulatory expertsIn-house administrative support for all levels of... ...staffMedical record and research source documentation verification against case report form...SuggestedContract workWork at officeRemote workWork from home
$110.52k - $138.15k
...Senior Clinical Research Associate - Oncology - OhioICON is a global healthcare intelligence and clinical research organisation united... ...compliance with ICH-GCP, SOPs, and regulationsMaintain up-to-date documentation in CTMS and eTMF systemsSupport and track site staff...SuggestedLocal area- ...ranks among the nation’s best urban public research universities. Home to more than 53,600... ...research that improves the health and clinical care of patients. The College of... ...machines when due. Complete accurate documentation regarding ECG completion. Facilitate MD...SuggestedHourly payWork at officeFlexible hours
- ...Administrative Assistant Our global activities are growing rapidly... ...administrative assistant to join our Clinical Monitoring Training &... ...to facilitate tracking/documentation of departmental activities;... ...-service clinical contract research organization (CRO) providing...Full timeContract workWork at officeLocal areaWork from home
- The University of Cincinnati Cancer Center is seeking a Clinical Research Assistant to support its mission of excellence in education and... ...role involves coordinating research biospecimen collections, documenting data, and maintaining accurate records. A High School Diploma...Work at office
- ...hiring Pharm Ds for the CRA role! The Clinical Research Associate position offers an exciting... ...and regulatory experts In‑house administrative support for all levels of CRA Opportunity... ...Medical record and research source documentation verification against case report form...Contract workWork at officeRemote workWork from homeHome officeFlexible hours
- Experienced Clinical Research Associate - Sponsor Dedicated Updated: Yesterday Location: Remote,... ...consent has been adequately performed and documented for each subject/patient, as required/... ...of the ISF with the Trial Master File (TMF). Ensures the investigator/physician...Contract workInterim roleLocal areaImmediate startRemote work
- Clinical Research Assistant, UC Cancer Center The College of Medicine, University of Cincinnati Cancer Center, is looking for a Clinical... ...on study-provided ECG machines when due. Complete accurate documentation regarding ECG completion. Facilitate MD or NP review and signature...Hourly payWork at officeFlexible hours
- Senior Clinical Research Associate - Oncology - Ohio ICON plc is a world-leading healthcare intelligence and clinical research organization... ...with ICH-GCP, SOPs, and regulations Maintain up-to-date documentation in CTMS and eTMF systems Support and track site staff training...Local areaVisa sponsorshipFlexible hours
- Home-Based Experienced CRA (Clinical Research Associate)- Bonus/Equity Join to apply for the... ...medical and regulatory experts In‑house administrative support for all levels of CRAs... ...Medical record and research source documentation verification against case report form...Full timeContract workWork at officeLocal areaImmediate startRemote workWork from homeHome officeFlexible hours
- ...Join our team in Cincinnati, Ohio! The Clinical Research Associate position at Medpace offers... ...and regulatory experts; In-house administrative support for all levels of CRAs; and Opportunities... ...; Medical record and research source documentation verification against case report form...Contract workWork at officeLocal areaImmediate startRemote workWork from homeHome officeFlexible hours
- Clinical Research Associate - Full-Service Syneos Health is a fully integrated... ...adequately performed and documented for each subject/patient as... ..., verify dispensing and administration of IP to subjects/patients,... ...the Trial Master File (TMF), and ensure sites are aware...Interim roleLocal areaImmediate startRemote workFlexible hours
- ...SOPs; Maintain compliant laboratory documentation; Perform data analysis and data checking... ...degree, with previous experience in a research laboratory; Knowledge of GLP, cGMP,... ...Overview Medpace is a full-service clinical contract research organization (CRO)...Full timeContract workWork at officeWork from home
- ...Gastro Health is seeking a Full-Time Research Assistant to join our team! Gastro... ...will be responsible for: General Administrative Provides assistance to Clinical Research Coordinators, local site,... .../project teams; reviews source documents, reviews clinical procedures, drafts...Full timeLocal areaMonday to FridayAfternoon shift
- ...samples for subsequent testing as necessary. Be responsible for documenting all procedures meticulously, mentoring new staff and students,... .... Education Requirements ~ Bachelor's degree in Clinical or Medical Laboratory Science or an equivalent allied health qualification...Full timeLocal areaNight shiftDay shift
- ...Views Overview We are on the lookout for a dedicated Clinical Laboratory Technician -a professional who harmonizes inquisitiveness... ...and prepare samples for testing as necessary. Meticulously document all procedures, train new staff or students, and uphold...Full timeLocal areaWeekend workDay shift
- ...- What You'll Be Doing Conduct routine and advanced clinical lab tests-covering areas such as chemistry, hematology, and immunology... ...samples for testing whenever necessary. Keep meticulous documentation of all procedures, provide training to new staff or students,...Hourly payFull timeLocal areaWeekend workDay shift
- ...Your Responsibilities Conduct both routine and complex clinical laboratory tests-spanning chemistry, hematology, immunology, and... ...and prepare samples for analysis as necessary. Thoroughly document all procedures, mentor new team members or students, and contribute...Hourly payFull timeSummer workLocal areaWeekend workDay shift
- ...Description AMERICAN HEALTH ASSOCIATES is the premier long-term care clinical laboratory in the region, servicing over 4500 facilities.... .... Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations...Full timeImmediate start
- Job SummaryOur Clinical Packaging & Supplies team is growing rapidly, and we are currently seeking a full-time Clinical Packaging & Supply... ....Medpace OverviewMedpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development...Full timeContract workWork at officeWork from homeFlexible hours
- ...Conduct both routine and sophisticated clinical laboratory tests-covering chemistry, hematology... ...as required. Keep meticulous documentation of all procedures, facilitate training... ...become a key player in a future where research, care, and empathy intertwine, creating...Full timeLocal areaWeekend workDay shift
- Job SummaryOur Clinical Packaging & Supplies team is growing, and we are currently seeking a full-time, Clinical Packaging & Supplie Chain... ...pharmacy background towards an exciting career in clinical research, then this is the opportunity for you. *This position is office...Full timeContract workWork at officeWork from home
- ...Medpace is seeking a Clinical Research Associate in Cincinnati, Ohio, to play a vital role in drug and medical device development. This position offers a chance to make a substantial impact in healthcare while receiving necessary training. Ideal candidates have a background...Remote work
- ...ranks among the nation’s best urban public research universities. Home to more than 53,600... ...research that improve the health and clinical care of patients. A full-time Clinical... .... Click for a list of acceptable documents. Important : To apply you must create...Hourly payFull timeWork at officeFlexible hours
- ...Cincinnati, OhioAmerican Health Associates is the nation's largest clinical reference laboratory dedicated to long-term care — bringing 3... ...and follow procedures to correct problems including proper documentation and proper completion of all work.Must support Laboratory...
- Gastro Health in Cincinnati, Ohio is looking for a Full-Time Research Assistant to join their collaborative team. This role entails providing administrative support in clinical research settings, following federal regulations and research protocols, while ensuring effective...Full timeAfternoon shift
- ...EyeCare Partners is the nation's leading provider of clinically integrated eye care. Our national network of over 300 ophthalmologists... ...symptoms and ocular medications Accurately and thoroughly document medical visits and procedures as they are being performed by the...Full timeWork at officeMonday to FridayWeekend work
- ...ranks among the nation’s best urban public research universities. Home to more than 53,600... ...accepting applications for a Grant Administrator - Pre-Award position. This position will... ...with internal offices to ensure required documents are complete and accurate in time for...Contract workWork experience placementFlexible hours
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