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Summer Intern - Clinical Operations

Myokardia, Inc

Summer Intern - Clinical Operations

San Francisco, CA
Internship
Paid
  • Responsibilities

    Summer Intern - Clinical Operations Clinical Operations South San Francisco, California ------------ Description Summary: At MyoKardia, were ing precision medicine where we feel it is needed most: altering the course of cardiovascular disease. Become part of it all as a MyoKardia Summer Intern. Weve launched an exciting internship program for students who are looking to gain valuable work experience in a collaborative, values-based company on the cutting edge of precision medicine. MyoKardias summer internship program will take place over a 12 to 16-week period, with both science-based and general corporate roles. Summer interns have the opportunity to work on interesting projects with direct mentoring from an intern manager. We are driven by two great passions: improving the lives of our patients and engaging in innovative science to make it possible. Come help us make a difference as a MyoKardia Summer Intern. The Clinical Operations team is seeking a motivated individual who brings a passion for science as well as passion for learning about the conduct and execution of clinical trials. This individual will learn about the construct of the Trial Master File (TMF) and together withMyoKardia GXP Enterprise Applications will assist with the implementation of an electronic TMF. Having a complete and accurate TMF/eTMF is a regulatory requirement and is key during every clinical inspection by regulators. The Clinical Operations intern will have the opportunity to learn about clinical regulatory requirements, gain exposure to clinical documents, and gain an appreciation for quality processes, while participating in the implementation and management of an eTMF. Essential Duties and Responsibilities: * Assist with the establishment of an eTMF that contains the ICH/GCP required documents from MyoKardia clinical trials. * Establish a clear process for the transfer of TMF activities to others (Clinical Trial Assistant or TMF associate), to ensure continuity of this activity without interruption after the conclusion of the internship. * Undergo internal training to understand ICH E6, particularly part 8 Essential Documents, as well as training on the DIA Reference Model. * Provides support to Clinical Trial Assistants with maintaining the Trial Master File(s). * Attend eTMF, department, and study team meetings. Education/Experience/Skills:

    • Currently-enrolled undergraduate student, who has completed two or more years of undergraduate study before the beginning of the Summer Intern Program * An interest in the Sciences is a plus! * Desire to learn new systems, about clinical trials, and quality processes * Must be a team player and highly collaborating with internal and external stakeholders to accomplish a goal * Detail oriented and organized * Excellent verbal and written communication skills
  • Industry
    Biotechnology