Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life?s potential. Today, we have 11,400+ employees highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, and urologics, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.
About the Position:
The Lead Clinical Research Associate supports Regional Study Management on trial execution and provide monitoring expertise to the team and ensures adequate protection of the rights of human subjects and the safety of all subjects involved in Allergan- sponsored clinical trials. Through training and co-monitoring, the Lead CRA helps to ensure the quality and integrity of the data collected in Allergan-sponsored clinical trials. The Lead CRA aligns execution activities with agreed-upon project priorities, timelines and quality/productivity specification, in compliance with GCP and local laws and regulations governing the conduct of clinical research.
The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements
Study Specific Monitoring Oversight
* Provide oversight on monitoring activities associated with the site-level feasibility, evaluation, initiation, patient recruitment and retention, monitoring and collection of data, and closeout of clinical trial sites in the therapeutic area assigned
* Act as the first line of contact between the study team and the field based monitors.
* Attend and participate in study team calls as the GMO representative to provide status updates and facilitate information sharing.
* Is a field-based position, requiring up to at least 50% travel to clinical study sites, Investigator meetings and regional offices
* Coordinate and conduct regular Monitor Meetings to share information and provide training to ensure successful monitoring of the trial
* The LCRA will co-monitor as needed.
* Submit study specific quality assessment visit reports.
* The LCRA ensures that site transitions occur in a seamless manner.
* As part of the monitoring function, the role might conduct Investigator/site evaluation visits, clinical site Initiation visits, clinical site monitoring visits and clinical site close-out visits.
* The role will lead the CRAs on site issues and helps with corrective actions with the support of the Global Monitoring Operations Management leadership.
Communication and Training
* Collaborate, coordinate and provide study specific training to monitors and sites
* Conduct training of monitoring plan, CRF completion and other monitoring tools at Monitor and Investigator Meetings, as well as ongoing training opportunities
* Assist with corrective and preventative action responses to monitoring-related observations on audits and inspections and provide study specific audit lessons learned at monitor meetings/calls
* Build and maintain study specific FAQ for trial and ensure Study team provides timely feedback
Preferred candidates will have:
* B.A/B.S with 6 years of experience; M.S./MD/PhD with 4 years of experience
* B.A./B.S. (Life Sciences) or related field
* Six (6) years clinical study site monitoring experience
* Four (4) years work experience in life science or medically related field including one (1) year clinical research experience (eg, study coordinator), preferred.
* Previous experience as a Sr. Regional CRA in the pharmaceutical industry preferred
* One year of monitor leadership experience preferred.
* Ability to travel at least 50% of time
* Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
* Good understanding of the drug development process
* Knowledge of concepts of clinical research and drug development
* General therapeutic area education and training
* Competencies and essential skills in the following: cross functional relationships, communication, decision making, execution/results/process improvement, interpersonal and training skills.
* Self-starter with ability to work independently with remote or minimal supervision
* Ability to work effectively in a team/matrix environment
* Ability to influence others without direct reporting relationships
* Ability to understand technical, scientific and medical information
* Demonstrated strengths in the following areas:
* Planning, organizational, project management and analytical skills
* Oral and written communication
* Time management
* Conflict management and resolution
* Problem solving
* Attention to detail
* Interpersonal and networking skills
* Relationship building
* Motivational skills
* Cross-cultural sensitivity
* Customer Service Orientation
* Advanced computer skills (word processing, spreadsheets, graphics, presentation slides, electronic data capture)
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