Clinical Research Assistant- Medical Assistant - Urology of Indiana

U.S. Urology Partners•Greenwood, IN

31d•Onsite

About The Position

The Clinical Research Coordinator (CRC) is responsible for conducting and documenting clinical research and trials for the Research Division while adhering to Good Clinical Practice/ICH Guidelines and the Code of Federal Regulations. This role involves administratively and clinically coordinating a team to effectively conduct clinical trials, evaluating and analyzing clinical data and trial results. The CRC will schedule, plan, and participate in study monitoring visits, address queries or deviations, and act as a liaison between the sponsor and the research department. They will also advise treating physicians on clinical protocol opportunities and procedures, recruit study subjects based on trial criteria, and serve as a study resource for patients and families. This includes discussing study protocols, verifying informed consent, addressing patient questions, providing written communication, ensuring subject understanding and willingness to continue participation, and conducting study-specific procedures and assessments within their scope of practice. The role also involves dispensing study medications, performing investigative product accountability, collecting, processing, and shipping specimens, supervising patient visit scheduling, performing procedures like ECGs and vital signs, collecting and maintaining source documentation, completing case report forms, preparing for and participating in quality assurance audits, and reporting adverse events. Additionally, the CRC screens laboratory and radiographic results, contacts outside healthcare providers for follow-up information, ensures scientific integrity of data and patient safety, maintains regulatory documents, attends sponsor meetings, maintains continuing education hours, and adheres to OSHA standards, including MSDS. All other duties as assigned will also be performed.

Requirements

Associate's 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
Thorough knowledge in computer information systems

Nice To Haves

2-3 years of related Research Experience

Responsibilities

Administratively and clinically coordinates a team to effectively conduct a minimum of six clinical trials (level 1- 3 clinical research protocol)
Evaluates/analyzes clinical data and trial results
Schedule, plan, and participate in study monitoring visits and address any potential queries or deviations in accordance with the study contract
Acts as a liaison between the sponsor and the research department
In collaboration with the Clinical Manager advises treating physicians on 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 families
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
Dispenses study medications in accordance with protocol requirements with his/her scope of practice
Performs investigative product accountability for accurate compliance
Collects, processes, and ships blood/urine specimens at scheduled times
Supervises scheduling of research patient visits and procedures consistent with protocol requirements
Performs study-specific procedures, including but not limited to ECGs, 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