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Central Ohio Urology Group · 1 day ago

Clinical Research Coordinator

Columbus, OH

Full-time

Onsite

Entry, Mid Level

2+ years exp

Central Ohio Urology Group is a part of U.S. Urology Partners, one of the nation’s largest independent providers of urology services. The Clinical Research Coordinator is responsible for conducting and documenting clinical research and trials while ensuring adherence to Good Clinical Practice and relevant regulations.

Hospital & Health Care

Responsibilities

Administratively and clinically coordinates a team to effectively conduct a minimum six clinical trials (level 1-3 clinical research protocol) and evaluates/analyzes clinical data and trial results

Schedule, plan and participate in study monitoring visits and addresses any potential queries or deviations in accordance to the study contract

Acts as a liaison between sponsor and the research department

In collaboration with the Clinical Manager advises treating physicians of clinical protocol opportunities and procedures

Recruitment of study subjects, including use of professional experience, discretion and judgment to include or exclude potential subjects based on trial criteria

Acts as a study resource for patients and family

Discusses study protocols with patients and verifies the informed consent process and documentation

Addresses any questions or concerns the research patient may have regarding the study

Provides patient with written communication of their participation

Ensures subjects understanding and willingness to continue participation as well as conduct study specific procedures and assessments (within his/her scope of practice) at each visit

This includes providing patients all treatment option information within their scope of practice such as pamphlets and protocol direction

Dispenses study medications in accordance to protocol requirements within his/her scope of practice

Performs Investigational Product accountability for accurate compliance

Collects, processes and ships blood/urine specimens at scheduled times

Supervisors scheduling of research patient visits and procedures consistent with protocol requirements

Performs study specific procedures, including but not limited to ECG’s, vital signs, height, weight, injections etc. within his/her scope of practice

Collect, compile and maintain source documentation

Completes and maintains case report forms per FDA guidelines while ensuring source completeness and accuracy

Prepares and participates in quality assurance audits by study sponsors, federal agencies, or specially designated review groups

Responsible for the reporting of and follow up on adverse events and serious adverse events per study protocol

Screens all laboratory and radiographic results following protocol procedures regarding abnormal results assuring that all results are reviewed by a physician, PI or SI for clinical significance

Contacts outside health care providers and communicates with subjects to obtain follow up information

Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials

Ensures filing and maintenance of all regulatory documents

Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums

Maintains required continuing education hours required for certifications

Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS)

Maintains a high level of patient confidentiality

Performs all other duties as assigned

Qualification

Clinical Practice (GCP)CCRC certificationInternational Air Transport Association (IATA)Clinical research experiencePatient confidentialityProblem-solvingCollaboration