CHEManager International · 3 days ago
Clinical Research Assistant
U.S. Urology Partners is one of the nation's largest independent providers of urology and related specialty services. The Clinical Research Assistant (CRA) is responsible for conducting and documenting clinical research and trials while adhering to Good Clinical Practice and federal regulations.
Responsibilities
Administratively and clinically help coordinate with a team to work on a minimum of six clinical trials (level 1-3 clinical research protocol). Help schedule, plan and participate in study monitoring visits and address any potential queries or deviations in accordance to the study protocol. 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
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
Required
Associates or Bachelor's Degree from an accredited college or university
Good Clinical Practice (GCP) Certificate
International Air Transport Association (IATA) Certificate
CCRC certification through an accredited organization (ACRP/SoCRA) is required
2-3 years related Research experience
Benefits
Comprehensive medical, dental and vision plans
HSA / FSA
401(k) matching
Employee Assistance Program (EAP)
Company
CHEManager International
Wiley’s leading media brand providing first-hand information on the global chemical, life science and process industries
Funding
Current Stage
Growth StageCompany data provided by crunchbase