Associate Clinical Research Specialist Jobs in Illinois

Supplemental Life, AD&D and Disability

Critical Illness, Accident and Hospital Indemnity coverage

Student loan servicing and support

Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members

Discount on services at Lurie Children’s facilities

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

Manages the analysis of complex imaging data.

Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

Performs other related work as needed.

Motor Vehicle Record Inquiry 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)

§ Create the protocol schedule of events/calendar within the Clinical Trial Management system.

§ Transcribe existing negotiated budgets into the Clinical Trial Management system.

§ Cross-reference the budget with the contract, payment terms, coverage analysis and informed consent to ensure consistency.

§ Set up financial and operational data of clinical studies in the CTMS

§ Other miscellaneous duties as needed.

Advance-level computer skills, and the ability to multitask without the direct oversight of manager required

 OR minimum of 2 years of related professional experience (engineering, or procedural hospital setting) is required with an Associate’s degree

OR a minimum of 1 year of EP mapping experience with an Associate’s degree is required

Please note: For the ACAS role, we do not offer work visa sponsorships and we do not accept OPT/CPT

Attend all portions of the ACAS fellowship training program without exception.

Engage in dialogue with multiple internal and external business partners and stakeholders, and formulate solutions based on dialogue and input gained during training.

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

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.