Clinical Research Associate I - Little Rock, Arkansas/Memphis, Tennessee/ Shreveport, Louisiana

About the role

This is a field based / remote position. Candidates must reside in Little Rock, Arkansas or Dallas, Texas area and be willing to travel.

Responsibilities

• Considered as the primary point of contact for the investigative site, providing contextual information on the clinical trials, connecting stakeholders to the investigative sites, and strengthening AbbVie's positioning.
• Aligns, trains, and motivates the site staff and principal investigator under supervision on the goals of the clinical trial program, protocol, and patient treatment principles for the trial, ensuring a trusted partnership.
• Conducts site evaluation, training, routine, and site closure monitoring activities under supervision, in compliance to the protocol and monitoring plans and according to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards in conducting clinical research, ensuring safety and protection of study subjects.
• Customizes site engagement strategy for assigned studies under supervision. Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool to report/track progress and measure impact of that strategy.
• Develops solid knowledge of therapeutic area, asset, and clinical landscape/patient journey to enable successful patient recruitment and overall protocol compliance.
• Responsible for continuous risk assessment proactively, and in collaboration with Central Monitoring team, monitors activities conducted by clinical sites to detect early overall study performance or patient safety issues. Ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution.
• Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer-centric approach.
• Identifies, evaluates, and recommends new/potential investigators/sites under supervision and support from more experienced CRAs.
• 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 audit and regulatory inspection readiness at assigned clinical site at all times.
• Manages investigator payments as per executed contract obligations, as applicable.

Qualifications

• Education: Bachelors degree or equivalent degree; health-related preferred (e.g., Medical, Scientific, Nursing, Pharmacy).
• Clinically related experience, preferably in clinical research coordinating or data management.
• Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
• Knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
• Able to work collaboratively and cross-functionally to develop and sustain working relationships.
• Demonstrate planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Able to leverage technology, tools, and resources to provide customer-centric support based on the health of the site. Ability to use functional expertise with appropriate guidance, leverage critical thinking skills, and apply good judgment to address clinical site issues.
• Interpersonal skills with strong written, verbal, active listening, and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Benefits

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

  We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.

  This job is eligible to participate in our short-term incentive programs.

  Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

  Additional Information

  Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
  • This job is eligible to participate in our short-term incentive programs.

  Contact

  For more information, visit www.abbvie.com.

  To learn more about reasonable accommodations, visit here.