Research Associate Clinical I Jobs in Illinois

Job Knowledge & Skills, Education, Experience

Research Associate I- Social Sciences

About The University Of Illinois Chicago

Understand and apply applicable corporate and divisional SOPs. Maintain knowledge of relevant QSR and safety requirements.

Demonstrate working knowledge of basic technical theories and principles within area of expertise for routine tasks.

Develop knowledge and understanding of GxP and related regulations and guidance.

Bachelors degree in a science-related field with 0-1 years experience

Possess relevant laboratory (chemistry)/technical, writing, and computer skills.

Employ appropriate techniques and methods to successfully conduct specific assignments within negotiated deadlines after receiving general instruction.

Visiting Research Associate I - HCHS/SOL

About the University of Illinois Chicago

Required Employment Notices and Posters

The university provides accommodations to applicants and employees.

Oversee site management responsibilities for assigned sites.

Assist in the management of routine trial activities, adhering to industry and corporate standards.

Support the Study Team/Management in all phases of the clinical trial.

Manage trial-specific Trial Master File (TMF) and internal filing system, including regulatory and legal document tracking and archiving.

2+ years of experience in a sponsor or CRO setting (strongly preferred).

Knowledge of clinical research in Cardiology/Medical Devices

Must be detail-oriented and efficient in time management.

Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol.

Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff.

Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and

Basic knowledge in regulations for applicable geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.).

Minimum 1-year clinical research experience required.

Excellent organization skills with attention to details and time management, bringing forward ideas and paths for building on organizational tools

Excellent written and verbal communication and interpersonal skills

Consistently creates pathways for process improvement, streamline workflows and build efficiently for individual and project outcomes with little guidance from manager

Works within timelines with limited oversight from manager, informing managers of any potential issues with timelines, bringing solutions/mitigations as necessary

Manage drafting and finalization of protocol and associated documents, including identifying need for amendments

Collect, manage, file and archive study documentation and correspondence. Assist in the accuracy and completeness of the Trial Master Files (TMF)

Familiar with formulas in excel and advanced database management.

Bachelors with three to five years clinical research experience.

Strong oral and written communication skills in order to address large/diverse audiences. Strong customer service skills required.

Intermediate knowledge of Microsoft Office Suite (Excel, Work, Outlook, etc.).

Certification as a Clinical Research Professional (SOCRA) or Clinical Research Coordinator (ACRP) preferred.

Works collaboratively with all levels within the organization to advise on contractual negotiations, recommendations and processes.

College/University degree in Life Sciences or an equivalent combination of education, training & experience

Communication, collaboration, and problem-solving skills

To act as the main point of communication with Investigator and his team

When requested to support preparation of regulatory and / or EC submission

Participate in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance

Full working proficiency in English

Perform independent literature reviews or background research to become familiar with technical knowledge needed for this role.

Knowledge of fundamental research concepts, practices and procedures.

Entry level knowledge of research methods.

Strong writing and verbal communication skills

Experience or background in biology, restoration ecology, or related fields is a plus

Perform technical reviews of program applications and other documentation provided by industry participants.

College/University degree in Life Sciences or an equivalent combination of education, training & experience

Communication, collaboration, and problem-solving skills

To act as the main point of communication with Investigator and his team

When requested to support preparation of regulatory and / or EC submission

Participate in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance

Full working proficiency in English

M-F; working remotely from home, Midwest USA-based location, near a major airport; travel routinely 50-60% and up to 80% at times.

Bachelor's degree in a science or healthcare-related field or a registered nursing certification or equivalent certification/licensure from an appropriately accredited institution.

3 years of CRC experience or previous 1-year experience as a CRA.

Direct patient care or clinical research experience required.

Familiarity with clinical research and study development processes.

Valid Driver's License where applicable.

Collaborate with Data Manager and/or Clinical Affairs management to define data management plan and design CRFs.

Computer software skills (e.g., MS Word, Excel, PowerPoint and Google products experience).

Knowledge of FDA requirements for clinical validation and CLIA waiver.

Minimum 3 years of related experience, preferably including clinical research and clinical operations experience.

Experience working in IVD clinical studies highly preferred.

Strong attention to detail, self-motivation, and good organizational skills.