Clinical Research Associate 2 Job at AbbVie Inc., Illinois

NS93aTEzRWdiRDMySStXbzJqQjVLZTNqV1E9PQ==
  • AbbVie Inc.
  • Illinois

Job Description


Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at  . Follow @abbvie on  X ,  Facebook ,  Instagram ,  YouTube ,  LinkedIn and  Tik Tok .

Job Description

Purpose:

To enable AbbVie’ s emergence as a world class R&D organization, the position anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action ensuring successful protocol level execution of SMM deliverables involving start-up, execution, and close-out of studies.

Responsibilities:

The CRA2 monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.

Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes. Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance.

Ensures regulatory inspection readiness at assigned clinical sites. Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations. Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.

Qualifications

  • Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.
  • Minimum of 1 year of clinically related experience, as CRA.
  • Experience in on-site monitoring of investigational drug or device trials is required
  • Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
  • Current in-depth knowledge of regulations governing clinical research, ICH/GCP guidelines and applicable regulations.
  • Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
  • Ability to work, understand and follow work processes within the assigned function.
  • Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.
  • Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated.
  • Ability to use functional expertise and exercise good judgment.
  • Demonstrated business ethics and integrity.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job Tags

Full time, Interim role, Local area,

Similar Jobs

City of Maryville Government

Police Officer - P.O.S.T. Certified Job at City of Maryville Government

 ...consideration. Please visit our website, for a complete job description, required application, and directions on how to apply. Police Officer - P.O.S.T. Certified Position Type: Full-time; Non-exempt Starting pay rate for Non-Certified Police Officers: $25.69... 

Schlumberger

Local HazMat CDL Driver Job at Schlumberger

 ...mechanical and safety inspections Maintain driver's hours of service by using Turnpike and/...  ...resides Must have HazMat and Tanker Endorsements or be willing to be obtain within...  ...industry. Our world-class safety culture fuels our purpose to improve lives through our... 

Convoy Supply

Local Driver - Class A/B CDL Job at Convoy Supply

 ...Local Delivery Driver - Class A/B CDL Join Our Team at Convoy Where Your Career Builds as Strong as Our Materials! Founded in 1972, Convoy is North Americas trusted distributor of top-tier construction materials. With over 40 locations in US and Canada, weve grown... 

The Health Center at Adams Place

Housekeeping Assistant Job at The Health Center at Adams Place

 ...Full time Housekeeper at Adams Place Adams Place is looking for a FULL TIME Housekeeper to join our team working days who is able to deal tactfully and effectively with patients, families, fellow employees and visitors. The qualified applicant for this position must... 

Baylor Scott & White Healthcare

Submission for the position: Medical Laboratory Scientist II - (Job Number: 25020969) Job at Baylor Scott & White Healthcare

 ...to work in a team environment. BENEFITS Our competitive benefits package includes the following - Immediate eligibility for health and welfare benefit - 401(k) savings plan with dollar-for-dollar match up to 5%- Tuition Reimbursement - PTO accrual...