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MAP Pharmaceuticals, Inc.

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Position/Title: Senior CRA

Reports to: Clinical Program Manager

  1. Function
    Monitor clinical trials, study sites, and clinical data. Ensure compliance with protocol and overall clinical objectives and GCP. Provide project support to clinical programs with minimum supervision. Interfaces with all project/clinical groups and off-site personnel as needed in support of project and departmental goals and responsibilities.
  2. Specific Responsibilities and Activities
    1. Manage clinical study sites including study site start up and close-out.
    2. Ensure study sites follow MAP SOPs and GCP.
    3. Assist in management of relationships with vendors within and across studies.
    4. Provide mentoring and work leadership to junior CRAs.
    5. Assist in development of clinical study protocols and take ownership of their implementation where appropriate.
    6. Monitoring of clinical study sites (+/-CRO staff) as required
    7. Ensures identified clinical study issues are resolved; implements and monitors corrective action
    8. Provide input into development of Case Report Forms.
    9. Facilitate the development of study-specific clinical trial materials.
    10. Serve as primary point of contact for site questions relating to study conduct issues; liaise with appropriate study team members as needed.
    11. Assist with contract negotiation/review and management of vendors as needed
    12. Attend meeting(s) with external vendors, CROs, Investigative sites, Investigator meetings and scientific meetings.
  3. Requirements
    1. Education: Bachelor's degree or equivalent. RN with evidence of further study considered. Major course of study in Science or Health-related preferred.
    2. Training and Experience: 5 years experience in Clinical Research or related field. Proven track record to deliver key study deliverables in support of operational milestones. MUST be proficient in Microsoft Office/Windows, and Microsoft Outlook. Specifically: MS Word, MS Excel, MS Powerpoint and MS Project with excellent oral and written communication skills. Demonstrates good understanding of ICH/GCP, and US FDA regulations as applied to clinical research. Detail oriented with excellent organizational skills. Ability to prioritize and multi-task while remaining calm and sensitive to confidential/personal nature of material. Ability to interpret instructions and information under pressure and respond accordingly, with minimal supervision as appropriate.

Send resume to:

Career Opportunities
MAP Pharmaceuticals, Inc.
2400 Bayshore Parkway, Suite 200
Mountain View, CA 94043
Or e-mail resume to: hr@mappharma.com

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