Clinical Research Associate II - Southeast Territory (FL/GA/LA/SC)
$65,500–$125,500 year
On-siteTampa, Florida, United States
Tampa, Florida, United StatesOn-siteFull Time$65,500–$125,500 yearEntry LevelEnterprise
Full TimeEntry LevelEnterprise
Job Summary
Partner with investigators and site staff as the primary point of contact to ensure appropriate trial conduct, data integrity, and compliance with GCPs and ICH guidelines. Align, train, and motivate site personnel on protocol goals and patient treatment principles while conducting site evaluations, routine monitoring, and closure activities. Customize site engagement strategies using CRM tools to track progress and measure impact, ensuring effective recruitment and retention. Proactively assess risks, resolve site signals, and develop corrective action plans to mitigate issues and promote compliance. Identify and evaluate potential investigators and sites for new studies, manage investigator payments, and maintain audit and regulatory inspection readiness.
Required Qualifications
- Minimum of 1 year of clinically related experience
- 6 months of clinical research monitoring of investigational drug or device trials
- Familiarity with risk-based monitoring approach
- Onsite and offsite monitoring experience
- Advanced knowledge on existing and emerging local regulatory and legal requirements
- Knowledge of ICH/GCP Guidelines
- Knowledge of applicable policies
- Ability to use functional expertise with appropriate guidance
- Ability to leverage critical thinking skills
- Ability to apply good judgement to address clinical site issues
- Ability to establish and leverage site relationships
- Ability to motivate and train site staff
- Ability to train principal investigators
- Ability to conduct site evaluation
- Ability to conduct site training
- Ability to conduct routine monitoring activities
- Ability to conduct site closure monitoring activities
- Ability to monitor activities conducted by clinical sites
- Ability to detect early overall study performance or patient safety issues
- Ability to ensure preventative and corrective action plans are put into place
- Ability to ensure audit and regulatory inspection readiness at assigned clinical site
- Ability to manage investigator payments
- Ability to identify, evaluate and recommend new/potential investigators/sites
- Ability to ensure quality of data submitted from study sites
- Ability to assure timely submission of data
- Ability to provide appropriate reporting and follow-up for all safety events
- Ability to align, train and motivate site staff and principal investigator
- Ability to conduct site engagement strategy
- Ability to gather local/site insights
- Ability to report and track progress
- Ability to measure impact of site engagement strategy
- Ability to connect study protocol, scientific principles and clinical trial requirements to day-to-day clinical trial execution activities
- Ability to evaluate and ensure effective recruitment and retention techniques/plans
- Ability to mentor and train less experienced CRAs
- Ability to provide input into CRA development
- Ability to participate in global/local task forces and initiatives
- Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
- Ability to leverage technology, tools and resources
- Ability to provide customer centric support
- Ability to think critically to resolve site risk signals
- Ability to drive study execution
- Ability to promote compliance using a customer centric approach
- Ability to ensure safety and protection of study subjects
- Ability to ensure appropriate conduct of the trial
- Ability to drive improvement in data integrity
- Ability to drive improvement in compliance
- Ability to drive improvement in overall study performance
- Ability to drive improvement in customer experience
- Ability to provide contextual information on the clinical trials
- Ability to connect stakeholder to the investigative sites
- Ability to strengthen AbbVie's positioning
- Ability to ensure a trusted partnership
- Ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
- Ability to develop solid knowledge of therapeutic area
- Ability to develop solid knowledge of asset
- Ability to develop solid knowledge of clinical landscape
- Ability to develop solid knowledge of patient journey
- Ability to enable successful patient recruitment
- Ability to ensure overall protocol compliance
- Ability to demonstrate strong cross-functional collaboration skills among internal and external stakeholders
- Ability to demonstrate strong planning and organizational skills
- Ability to demonstrate excellent written skills
- Ability to demonstrate excellent verbal skills
- Ability to demonstrate active listening skills
- Ability to demonstrate presentation skills
- Ability to act with integrity in accordance with AbbVie code of business conduct
- Ability to be self-motivated
- Ability to focus on delivering timely and quality outcomes
- Ability to work in a fast-paced environment
- Ability to be available for weekend shifts
- Ability to work in the southeast United States
- Ability to work in FL/GA/LA/SC
- Ability to work in US & Puerto Rico
Desired Qualifications
- Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing)
- Knowledge of appropriate therapeutic area indications
- Ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
- Advanced knowledge on existing and emerging local regulatory and legal requirements
- Knowledge of ICH/GCP Guidelines
- Knowledge of applicable policies
- Ability to leverage technology, tools and resources
- Ability to provide customer centric support
- Ability to think critically to resolve site risk signals
- Ability to drive study execution
- Ability to promote compliance using a customer centric approach
- Ability to ensure safety and protection of study subjects
- Ability to ensure appropriate conduct of the trial
- Ability to drive improvement in data integrity
- Ability to drive improvement in compliance
- Ability to drive improvement in overall study performance
- Ability to drive improvement in customer experience
- Ability to provide contextual information on the clinical trials
- Ability to connect stakeholder to the investigative sites
- Ability to strengthen AbbVie's positioning
- Ability to ensure a trusted partnership
- Ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
- Ability to develop solid knowledge of therapeutic area
- Ability to develop solid knowledge of asset
- Ability to develop solid knowledge of clinical landscape
- Ability to develop solid knowledge of patient journey
- Ability to enable successful patient recruitment
- Ability to ensure overall protocol compliance
- Ability to demonstrate strong cross-functional collaboration skills among internal and external stakeholders
- Ability to demonstrate strong planning and organizational skills
- Ability to demonstrate excellent written skills
- Ability to demonstrate excellent verbal skills
- Ability to demonstrate active listening skills
- Ability to demonstrate presentation skills
- Ability to act with integrity in accordance with AbbVie code of business conduct
- Ability to be self-motivated
- Ability to focus on delivering timely and quality outcomes
- Ability to work in a fast-paced environment
- Ability to be available for weekend shifts
- Ability to work in the southeast United States
- Ability to work in FL/GA/LA/SC
- Ability to work in US & Puerto Rico
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