Sr. Associate, Clinical Research - Hayward, CA | Biospace
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Sr. Associate, Clinical Research

Impax Labs

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Location:
Hayward, CA
Posted Date:
5/17/2017
Position Type:
Full time
Job Code:
4884
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Product Manager,

Job Description


Summary of Duties and Responsibilities

Support the Generic Product Development Department and Biopharmaceutics Group in the initiation, maintenance and closure of Clinical Trials according to Good Clinical Practices (GCP), Good Laboratory Practices (GLP), the Code of Federal Regulations (CFR), and applicable Regulatory Guidance’s by performing the following duties.

Key Accountabilities

Serve as a central contact for communications/correspondence between the Generic Product Development, Biopharmaceutics Group, and CROs and other vendors.
Review the study protocols and if needed help to design data collection from known case report forms (CFRs).
Identify and assess the suitability of clinical and bioanalytical facilities for bioequivalence studies. Conducting general GCP and GLP audits.
Maintain study schedules, request proposals/contracts from CROs, compare competiveness and work quality of the CROs, maintain study budgets, initiates CDAs with different vendors, process vendor contracts and ensures payments are sent on time to vendors.
Monitor trials throughout their duration, which involves visiting the trial sites on a regular basis.
Verify that data entered onto the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV).
Write visit and audit reports.
Analyze and interpret scientific data using Phoenix WinNonlin and other databases.
Generate and track drug shipments and ensure timely delivery of final clinical and bioanalytical reports for regulatory submissions.
Ensure all unused trial supplies are accounted for and stored properly.
Perform duties such as bulk copying and faxing, and filing of correspondence, lab reports, Clinical Monitoring Reports, and other study documents.
Assist coordination of study logistics, documents, drug shipments, enrollment and safety             5%
Collect regulatory documents required for study initiation.
Maintain central study files in a state of audit-readiness.              
Maintain reference products inventory list and order products when needed. Maintain reference products inventory list and order products when needed.
Communicate regularly with Generic Products Development teams: provide information, track study randomization codes, reports, may follow up on problems identified during the study.
Perform all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, appropriate industry and Good Clinical Practices, Good Laboratory Practice and Applicable Regulatory Guidance standards.
Perform other duties as assigned by management.



Requirements

Work Requirements





Education

BS/BA degree required, health related field preferred.


Experience        

8 years of experience with medical terminology, GCP, GLP and Pharmaceutical Industry Regulatory guidelines is required.


Special Skills      

5+ years of demonstrated proficient with MS Office (Word, Excel, Access, and PowerPoint), email, internet, required.
2+ year of experience using computerized systems i.e., Phoenix WinNonlin, SAS, and other databases required.
2+ years of experience analyzing and interpreting scientific data and skilled use of computerized systems and databases required.


Experience        

8 years work experience in clinical and bioanalytical science environment required.


Core Competencies

Requires excellent organizational skills and ability to prioritize a variety of tasks.
Requires careful attention to detail to be successful.
Advanced understanding of data management processes required.
Ability to communicate and work effectively with a diverse team of professionals required.
Flexible and able to thrive in a fast-paced environment required.
Express information to individuals or groups taking into account the audience and the nature of the information (e.g., explain technical concepts to non-technical audiences) required.
Receive, attend to, interpret, understand, and respond to verbal messages and other cues required.