Clinical Research Assistant- Medical Assistant - Urology of Indiana

Urology of Indiana LLC•Greenwood, IN

33d•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 a minimum of six clinical trials (level 1-3 clinical research protocol) and evaluating/analyzing clinical data and trial results. The CRC will schedule, plan, and participate in study monitoring visits and address any potential queries or deviations in accordance with the study contract, acting as a liaison between the sponsor and the research department. In collaboration with the Clinical Manager, the CRC advises treating physicians on clinical protocol opportunities and procedures. The role includes recruitment of study subjects, discussing study protocols with patients, verifying the informed consent process, addressing patient questions, and providing written communication of participation. The CRC ensures subjects' understanding and willingness to continue participation, conducts study-specific procedures and assessments, and provides patients with treatment option information. The CRC also dispenses study medications, performs investigative product accountability, collects and processes specimens, supervises scheduling of research patient visits, and performs study-specific procedures like ECGs and vital signs. Additionally, the CRC collects, compiles, and maintains source documentation, completes case report forms, prepares for quality assurance audits, and is responsible for reporting adverse events. The CRC screens laboratory and radiographic results, contacts outside healthcare providers for follow-up information, ensures scientific integrity of data, protects patient rights, safety, and well-being, and maintains regulatory documents. The CRC attends sponsor meetings for education and understanding of protocols and maintains required continuing education hours. Adherence and knowledge of OSHA, including MSDS, and maintaining patient confidentiality are also key responsibilities. Other duties as assigned.

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
Schedules, plans, and participates in study monitoring visits and addresses any potential queries or deviations in accordance with the study contract
Acts as a liaison between the sponsor and the research department
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
Provides patients with all treatment option information within their scope of practice such as pamphlets and protocol direction
Dispenses study medications in accordance with protocol requirements within 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
Collects, compiles, and maintains 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