Clinical Research Associate (CRA) - B

Abbott • Contract • Lake Forest, IL, US • $31 - $35 / hour • 1w ago

Title: Clinical Research Associate (CRA) - B

Location: Lake Forest, Illinois

Duration: 12 Month

Primary Job Function

The Clinical Research Associates manages sites through life of trial and close-out, including, the implementation, coordination and conduct of clinical research activities in compliance with applicable Corporate and Divisional Policies and Procedures. Participate in site selection, provide feedback in the protocol development and database development, investigator meetings.

Core Job Responsibilities

Under supervision of the Clinical Manager, responsible for the following:

Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol.
Ensures compliance with protocol and all regulatory policies, procedures, and/or guidelines during clinical studies by training/guidance of investigators/study coordinators and site staff.
Communication with site staff including coordinators, clinical investigators, and their site staff.
Verify adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff.
Source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.
Verification that the investigator is enrolling only eligible subjects/samples.
Ensures timely collection and review of study and regulatory documentation by obtaining, maintaining, and controlling all necessary records and documentation according to procedures and regulations.
Responsible for investigational product accountability and inventory.
Verification and review of adverse events to confirm accurate data reporting in accordance with the protocol.
Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement.
Timely completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Builds and maintains relationships with sites.
Intermediate knowledge in regulations for applicable geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.).
Ensures validity of study by identifying/resolving discrepancies and obtaining missing data.
Basic knowledge of Abbott Platforms, assays, and assay data.
Basic knowledge of statistics
Contributes to developing and writing clinical protocols, informed consent forms, case report forms, and other study aids for investigational products by addressing issues by interacting with appropriate personnel.
Demonstrates initiative and problem-solving skills; critical-thinking skills.
Aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.
Performs Quality Assurance Verification.
Responsible for training peers
Serves as a trainer for contract research organizations (CROs) needed for additional monitoring support.
Participates on at least 2 projects

Position Scope

Begins establishing and cultivating a network of internal resources to facilitate completion of tasks. Will perform this job in a quality system environment. Completes daily work to meet established schedule with guidance from supervisor on prioritization of task. May exercise authority within pre-established limits and approval; some independent decision making. Individual influence is typically exerted at the peer level.

Minimum Education

Bachelor's (life sciences or clinical research preferred) or equivalent combination of education and work experience.

Minimum Experience / Training Required

2-4 years clinical research experience required or equivalent related work experience with a good understanding of specified functional area, application of business concepts, regulations, procedures, and practices.
Clinical Research certification (e.g., ACRP, SOCRA) desired.
Must be detail-oriented and able to multitask, prioritize, and efficient in time management.
Must have excellent written and verbal communication, and presentation skills.
Must have strong organizational and project management skills.
Must be able to work independently and in groups; ability to work cross-functionally.
Self-directed and able to work within a fast paced and constantly changing environment.
Strong computer skills, including Microsoft Office Suite (Word, Excel, Outlook, etc.).

Consultants Eligible Benefits Upon Waiting Period:

Medical and Prescription Drug Plans
Dental Plan
Vision Plan
Health Savings Account (for High Deductible Health Plans)
Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
Supplemental Life Insurance
Short Term Disability (coverage varies by state)
Long Term Disability
Critical Illness, Hospital coverage, Accident Insurance
MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.

Related Jobs

Sr. Procurement Specialist

Abbott • Contract • Lake Bluff, IL, US • $39 - $43 / hour • 1d ago

Our Abbott Park, Illinois location currently has an opportunity for a Sr. Procurement Specialist. Title: Sr. Procurement Specialist Location: Abbott Park, Illinois Duration: 3+ Months (possibility of extension) Responsib...

1d ago

Apply

Project Manager I

Abbott • Contract • Des Plaines, IL, US • $50 - $52 / hour • 1d ago

Project Manager

Title: Project Manager I Location: Des Plaines, IL 60018 Duration: 12 Months | 100% Onsite Overview: We are seeking a skilled Project Manager I with a strong background in Regulatory Affairs to join our onsite team. This...

1d ago

Apply

Business HR Manager

Abbott • Contract • North Chicago, IL, US • $45 - $50 / hour • 4d ago

Our Abbott Park, Illinois location currently has an opportunity for a BHR Manager. The BHR Manager executes the delivery of the employee relations services to provide a single point of contact for efficiently providing h...

4d ago

Apply

Web Analytics / Adobe Manager

Motion Recruitment • Lincolnshire, Illinois, United States • $50 - $70 / hour • 4d ago

We are seeking a seasoned Web Analytics professional to serve as the subject matter expert (SME) for our digital analytics and marketing measurement ecosystem. This role will lead initiatives to optimize and evolve web a...

4d ago

Apply

Administrative Assistant

Addison Group • Contract • Vernon Hills, Illinois, United States • 1w ago

Job Title: Administrative Assistant (Contract) Location: Vernon Hills, IL – Onsite Industry: Corporate Office Support / Administrative Pay: $28 - $30 / hour (contract role, 3 months with possible extension or temp-to-per...

1w ago

Apply

Customer Service Operations Specialist II

Abbott • Contract • Lake Bluff, IL, US • $20 - $24 / hour • 1w ago

Title : Customer Service Operations specialist II Location : Abbott Park, Illinois Duration : 3+ Months, conversion to Fulltime after probation Shift : 6:00 pm - 06.30 am Working days : 4 days on and 4 days off, through...

1w ago

Apply

Administrative Support Specialist

Addison Group • Contract • Lincolnshire, Illinois, United States • 1w ago

Job Title: Administrative Support Specialist Location: Lincolnshire, IL Industry: Non-Profit Compensation: $20.00 – $25.00 / Hourly (contract) Work Schedule: Monday–Friday, 9:00 AM–4:45 PM (100% on-site, 37.5 hours/week)...

1w ago

Apply

Regulatory Affairs Project Manager

Abbott • Contract • Des Plaines, IL, US • $44 - $50 / hour • 1w ago

Project Manager

Title : Regulatory Affairs Project Manager Location : Des Plaines, IL Duration : 6 Month 100% Onsite Qualifications: Regulatory history, guidelines, policies, standards, practices, requirements and precedents Submission/...

1w ago

Apply

HR Coordinator

Abbott • Contract • North Chicago, IL, US • 1w ago

Below is a sample job description for the contract job opportunity at Abbott: The HR Coordinator supports the divisional candidate interview process by scheduling interview activities and partnering with internal and ext...

1w ago

Apply

HR People Operations Coordinator

Corps Team • Morton Grove, IL, US • 1w ago

Our client, a water technology provider, is seeking an HR People Operations Coordinator for a 6+ contract opportunity located in Morton Grove, IL. This role is fully onsite. Overview The HR People Operations Coordinator...

1w ago

Apply