Clinical Research Associate/Senior Clinical Research Associate

Clinical Research Associate/Senior Clinical Research Associate
Req#: 51410096




At Elan, we hold a fundamental belief that our science has the potential to improve patients? lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the areas of neurodegenerative diseases, autoimmune diseases and severe pain.


Elan?s commitment to patients is reflected in all that we do: we are a company driven by the knowledge that our work is important and the desire to make a difference. Elan offers prospective employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.



PRIMARY OBJECTIVE:
Supports the implementation and monitoring of clinical trials/research activities.

DUTIES/RESPONSIBILITIES:
- Assists upper level clinical development management with monitoring of clinical trial operations.
- Coordinates activities of associates and investigators to ensure GCP compliance with protocols and overall clinical objectives.
- Maintains high level of professional expertise through familiarity with clinical protocol and project as appropriate, and participates in team meetings as appropriate.
- Travels to field sites to supervise and coordinate clinical studies as appropriate. May write protocols.
- Works on problems of moderate to diverse scope on studies where analysis of situation or data requires a review of identifiable factors as appropriate for level of expertise.
- Exercises judgment within generally defined procedures and practices in selecting methods and techniques for obtaining solutions within level of expertise.


MINIMUM EDUCATION/EXPERIENCE:
BS in scientific discipline or RN/BSN and 0-2 years clinical trials experience.

PREFERRED EDUCATION/EXPERIENCE:
BS in scientific discipline or RN/BSN and 4 years clinical trials experience or MS and 1-2 years experience. Knowledge of FDA regulatory requirements.

SKILLS/ABILITIES:
- Knowledge of pharmaceutical clinical development and ability to effectively apply technical principles, theories, and concepts to clinical drug development.
- Knowledge of FDA requirements and good clinical practices.
- Ability to interpret and evaluate clinical data.
- Ability to audit and edit written summaries of data reports, presentations, or publications.
- For supervisory positions: leadership skills and ability to effectively manage projects and timelines.




 

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