Clinical Research Intern
Job Summary
Job Description
The Clinical Research Intern assists in implementing clinical research projects, adhering to good clinical practices and FDA regulations. Responsibilities include data analysis, report preparation, regulatory submission assistance, Independent Sponsored Studies (ISS) workflow management (intake, literature review, data collection, analysis, editing), spreadsheet/graphic creation, electronic system oversight, legal document support, financial report compilation, clinical training development, study kickoff support, new hire training path creation, literature reviews, document management (SOPs, work instructions), quality & compliance projects, and ensuring QMS adherence. The role requires collaboration, communication skills, and proficiency with MS Office Suite.
Must have:
- Data analysis and report writing
- Good clinical practices (GCP) knowledge
- FDA regulations familiarity
- MS Office Suite proficiency
- Collaboration and communication skills
Good to have:
- Biology/Nursing coursework
- Prior office experience
- Experience with electronic systems
Perks:
- Collaborative teamwork environment
- Opportunity to work on impactful projects
- Medical, dental, vision insurance
- 401(k) with employer match
- Paid parental leave
- Paid holidays and vacation time
5 skills required
Job Details
Under general supervision, the Clinical Research Intern will assist with the implementation of clinical research projects. They will develop and maintain a high level of professional expertise through familiarity with good clinical practices, FDA regulations, and guidelines of other health agencies.
What You'll Work On
The internship will include one or more of the following:
• Assist in the compilation and analysis of clinical data and preparation of study reports.
• Assist in the preparation of summaries of clinical research results for regulatory submissions.
• Assist with Independent Sponsored Studies (ISS) intake workflow of new request tasks, literature search, data collection, disease state analysis, and editing.
• Assist with creation, edits, and maintenance of spreadsheets and graphics.
• Assist the ISS clinical team with oversight of the electronic systems
• Support staff with process workflow for legal ISS agreements, amendments, and study closure.
• Assist with compiling updates and reports for finance meetings
• Assist with clinical training projects such as developing and organizing training materials
• Assist with new study kickoff summit, such as development and implementation of kickoff activities
• Assist with development of New Hire Learning Paths
• Assist with literature searches, and summarize the information obtained from the searches.
• Assist in creating, organizing, and updating documents such as standard operating procedures, work instructions, process tools, templates, and the directory of such documents
• Assist with clinical quality & compliance projects, such as Quality Readiness Plans
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
• Ensure other members of the department follow the QMS, regulations, standards, and procedures. *
• Perform other work-related duties as assigned.
2 of 3
*Indicates an essential function of the role
What You Contribute
Minimum education and experience:
• High school diploma with 1+ years of college education and 1+ years of related experience, or an equivalent combination of education and experience.
Preferred Qualifications:
• Coursework in Biology, Nursing or a related field preferred.
• Excellent interpersonal and communication skills, both oral and written.
• Proficiency with computers and common office software, such as MS Office Suite, as well as other standard office tools.
• Prior experience in an office environment where collaboration and teamwork were paramount to the successful completion of assigned responsibilities.
Location and Pay
•Alameda, CA
•$21.00 to $33.00
•Individual compensation will vary over time based on factors such as performance, skill level, competencies, work location, and shift.
$21 - $33 an hour
What We Offer
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
What We Offer
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
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