| United Therapeutics Corporation |
| Biotech and Pharmaceuticals |
| Existing work authorization required for United States |
| Direct Hire, Full-Time |
|
****** |
401(k) -
Health Insurance -
Paid Vacation -
|
| Not specified |
Health - Research
Biotechnology
Nursing - Other
Science
|
| 50 - 100% |
| from anywhere |
|
English - Fluent
Spanish - Fluent
|
| Bachelor Degree |
| 2 |
English
|
| No cover letter requested |
|
No questions which require answers when applying for this job posting. |
| BiLingCRA062608 / Latpro-1759051 |
| Jul-03-2008 |
| North Carolina, 27709 |
|
Description |
United Therapeutics Corporation is a publicly traded biotechnology company focused on the development and commercialization of innovative therapeutic products for patients with chronic diseases. We are looking for an experienced bilingual CRA to join our team in North Carolina.
Role Purpose/Position Overview:
The clinical research associate will be based in Research Triangle Park, North Carolina. The individual will work creatively with research sites to facilitate and supervise the conduct of clinical trials, build relationships, and effectively communicate ideas and results throughout a broad spectrum of organizational levels. Fluency in Spanish and English is required as well as the ability to travel internationally.
Major Accountabilities / Responsibilities:
- Participates in the identification of potential investigators and clinical sites, conducting pre-study site visits, collecting and reviewing data, and preparing evaluative reports
- Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools
- Conducts clinical site initiation visits, advising and training site personnel on sponsor and regulatory requirements for study conduct and preparing reports
- Conducts site monitoring visits to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with GCP and ICH guidelines
- Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required
- Provides site support for remote data capture, monitoring data capture remotely, reviewing for completeness and consistency, and generating and resolving queries in between monitoring visits
- Assists in the termination of clinical studies through the oversight of clinical sites through data lock, resolving final queries and completing closeout visits
- All other duties as assigned
|
Requirements |
Experience/Skill Requirements:
- 2-3 years relevant clinical research experience
- Previous monitoring experience in Mexico strongly preferred
- Knowledge of regulatory and clinical practices
- Demonstrated aptitude and knowledge in relevant therapeutic area and ability to learn and integrate new/different therapeutic areas
- Superior written and verbal communication skills - both English and Spanish
- Ability to travel internationally - travel requirements a minimum of 50%.
- Strong computer skills to include Microsoft Office Suite and related software programs.
- Strong interpersonal skills to facilitate external interaction with clinical investigators and clinical site coordinators as well as other members of the project team.
- Demonstrated understanding of the clinical research process, regulations pertaining to good clinical practice, and the requirements to successfully take a candidate drug through registration.
- Ability to work independently with occasional oversight
- Team oriented attitude
- Ability to work effectively and diplomatically with supervisors, peers, and support personnel both internal and external to the organization.
United Therapeutics is an Equal Opportunity Employer
|
|
