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Miles
Km80.5

Senior Clinical Research Associate

myoscience

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Location: Redwood City, CA Posted Date: 4/11/2013 Position Type: Full time Job Code: 2013-04-10 SR CRA Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Research

Description

The Clinical Research Associate monitors activities of a clinical study and at clinical study site to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols.  
- Review regulatory documents as required and prepare site visit reports.  
- Responsible for multiple projects and must work both independently and in a team environment.  
- Participates in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific PI/CRC/CRA training.  
- May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed.

Additional duties will include, but are not limited to:
1. Conducts clinical monitoring of field sites to supervise and coordinate clinical studies.
2. Ensuring implementation in accordance with appropriate SOPs, ICH/GCP guidelines and federal, state and/or local regulations.
3. Contribute to study concept documents, protocols, clinical study reports, etc.
4. Serve as the primary study contact during trial conduct including regular phone conferences and meetings with appropriate functional areas and vendors as necessary.
5. Provide management with routine updates regarding the status of program.
6. Manage clinical trial and/or sites from start-up through maintenance to close out.
7. Assist Vendor Management - selection, negotiation, implementation and management of vendor Statements of Work (SOW).
8. Assist in management of study budget, timelines, and insourcing/outsourcing partners.
9. Assist in the planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution or escalation of issues, and communication of study timelines/deliverable.
10. Collect, track and report established KPIs such as query resolution, AE/SAE data collection, drug reconciliation/shipment, site and patient enrollment, etc.
11. Ensuring adequate protocol related and process training of all study team members.
12. Management of protocol deviation/violation documentation.
13. Tracking steps and preparation for interim and primary analysis reports.
14. Assist in preparation and oversight/coordination of Investigator Meetings.

Requirements

Skills:
1. Must have knowledge in reference to good clinical practices, regulations, and standard operating procedures.
2. Ability to maintain a high level of professional expertise through familiarity with clinical literature, education and experience.
3. Excellent customer service orientation.
4. Sound knowledge of medical terminology and clinical monitoring process.
5. In depth therapeutic and protocol knowledge as provided in company training.
6. Excellent interpersonal and organizational skills and attention to detail.
7. Computer literacy, proficiency in MS Office.

Requirements:
1. Prefer BS/BA.
2. 4-5 years monitoring experience of on-site monitoring and/or in-house monitoring.
3. 2-3 years of study management experience.
4. Ability to travel ~30% as study demands.


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