Clinical Research Associate
Position Description & Responsibilities
The Clinical Research Associate (CRA) is part of the Clinical Operations Department and will be assigned to project teams. They would be responsible for assisting the clinical study team in the design, execution and reporting of clinical studies. Roles and responsibilities include the following:
Roles and responsibilities include the following:
- May serve as Clinical Trial Leader for selected trials - lead multifunctional team through clinical studies activities, ensures that program supports upper management strategies and meets GCP and SOP requirements, and maintains all study related documents and correspondences.
- Assist in procuring and managing contracts with CROs and study vendors. Oversee and monitor CRO activities and review monitoring trip reports.
- Collaborate with medical experts, clinical study sites, and CROs as appropriate.
- Assist in site management.
- Assist development of clinical trial protocol summaries, protocols, and informed consent documents.
- Prepare and implement project specific training programs and training materials for internal and external staff.
- Work with multidisciplinary project teams in preparing and implementing clinical development plans and provides clinical research expertise in support of other departments and line functions.
- Participate in development of integrated clinical study reports to ensure accuracy, scientific excellence, and congruence of message between studies in a project.
- Contribute to preparation of IND and other regulatory documents and submissions.
- Review of clinical documents and templates.
- Develop knowledge related to projects of study indications and therapeutic areas to better interact with investigators and external study coordinators.
Position Requirements
Successful candidates will have the following:
- B.S./Nursing degree or equivalent required, M.S. preferred.
- 2-5 years of relevant clinical experience in the pharmaceutical industry.
- CNS experience a plus.
- Excellent oral and written communication skills, strong leadership skills, self-motivated, team-player, adaptable to a dynamic environment.
- Familiarity with the drug development process (including manufacturing and regulatory aspects) and medical/scientific writing experience preferred.
- Ability to adapt to changing needs of the program.
Vanda Pharmaceuticals offers a competitive compensation package with excellent benefits and a 401(k) matching program. Vanda is an equal opportunity employer, committed to the hiring, advancement and fair treatment of individuals without regard to race, color, religion, sex, sexual preference, age, national origin, ethnicity, disability, or any other protected status designated by law.
Applicants should submit a cover letter with their Curriculum Vitae or Resume together with the names, addresses and telephone numbers of 3 references to:
Human Resources
Reference #: C500
Vanda Pharmaceuticals Inc.
9605 Medical Center Drive, Suite 300
Rockville, Maryland 20850
E-mail: careers@vandapharma.com
Website: www.vandapharma.com
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