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| Reference: |
2807 |
| Date Posted: |
4/21/2008 |
| Organization: |
Sterling-Hoffman Life Sciences |
| Employment Type: |
Full Time |
| Location: |
Massachusetts, MA |
Description:
Our client is a rapidly growing pharmaceutical company headquartered in Massachusetts that is focused on the development and commercialization of various pains therapeutics. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees.
Job Responsibilities:
1) Handle the operational activities involved in the planning, conduct and completion of clinical trials, including CRF development, ordering clinical supplies, collection, review and filing of clinical trial and regulatory documents
2) Prepare monitoring guidelines and correspondence with investigative sites on routine matters concerning ongoing clinical trials
3) Assist with identification of potential investigators and clinical sites
4) Conduct study visits (pre-study through closeout)
5) Mentor less experienced CRAs (as needed)
6) Review on-site files and records, Case Report Forms and source documents for completeness, accuracy, consistency and compliance
7) Identify deficiencies and discrepancies as well as provide remedial training (as required)
8) Develop and implement study-specific monitoring and reporting procedures, methods, guidelines and tools
9) Train site personnel on sponsor and regulatory requirements for study conduct
10) Oversee clinical site-study activities through database lock
11) Assist with resolving queries and complete closeout visits
12) Implement patient recruitment and retention strategies
13) Assist with the preparation of IND serial submissions
14) Develop and maintain effective working relationships with Clinical Study Team members
15) Participate in data-review process
16) Maintain in-house clinical study files
17) Participate in Clinical Study Team meetings
18) Ensure that all clinical aspects of studies are being carried out in accordance with GCP and ICH guidelines
19) Perform other activities as assigned
Job Requirements:
1) Bachelor’s degree (Biology or Life Sciences preferred)
2) Minimum 3 years CRA monitoring experience at CRO or Sponsor (or equivalent experience)
3) Knowledge of FDA regulatory requirements and good clinical practices
4) Ability and desire to work in a team-oriented environment
5) Good organizational skills
6) Proficiency in MS Word, Excel and PowerPoint
7) Excellent written and verbal communication skills
8) Ability to travel (as needed) – up to 25%
Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-02807.html
Salary: $70k-$90k
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| Healthcare Field: |
Biotechnology |
| Category: |
Clinical Research Associate |
| SubCategory: |
None |
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Job Posted By:
Similee Harvey
Sterling-Hoffman Life Sciences
800 West El Camino Real ,Suite 180
Mountain View
United States
94040
View more jobs posted by Similee Harvey |