Role Description
Responsible for managing the activities of several global clinical studies including assisting in the development of study-related documents, study site management, and patient data monitoring. Provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
Essential Functions
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Assist Clinical Project Manager in the development and management of company-sponsored global clinical trials.
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Lead in reviewing completed assignments by members of the clinical development group.
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Lead/assist in the development and management of revisions to study-related documents such as the informed consent, laboratory manual, pharmacy manual, case report forms (CRFs) and other study execution tools.
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Provide support in site recruitment, site initiation, site payments and site close-out.
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Help to oversee the training of new clinical site staff or site training for protocol amendments.
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Liaise with the in-house team to ensure collection of updated regulatory documents as needed.
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Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
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Lead/Assist in the training of clinical development group staff.
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Assist CPM to prepare and update clinical trial updates for Clinical Development team.
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Provide support for summarizing and maintaining patient treatment, response and survival data for active studies.
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Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
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Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
Qualifications
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Bachelorβs degree with 7+ years of relevant experience in clinical research required.
Knowledge, Skills, & Abilities
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Proficiency in MS Word, Excel, PowerPoint, Outlook.
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Excellent written/oral communication skills as well as strong organizational and multi-tasking skills.
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Understand the job-specific system and processes as defined by the companyβs SOPs and adhere to the requirements listed in those documents.
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Maintain corporate confidentiality at all times.
Working Environment / Physical Environment
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This position works either on site in El Segundo, CA or remotely as noted in their offer letter.
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This position will be exposed to an in-lab environment.
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This position will travel approximately 20% of the time.
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Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
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Lift and carry materials weighing up to 20 pounds.
Compensation
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National Market: $143,000 (entry-level qualifications) to $157,300 (highly experienced) annually.
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Premium Market: $150,000 (entry-level qualifications) to $165,000 (highly experienced) annually.
Benefits
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Medical, Dental and Vision Plan Options.
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Health and Financial Wellness Programs.
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Employer Assistance Program (EAP).
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Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability.
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Healthcare and Dependent Care Flexible Spending Accounts.
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401(k) Retirement Plan with Company Match.
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529 Education Savings Program.
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Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks.
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Paid Time Off (PTO) includes: 11 Holidays.
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Exempt Employees are eligible for Unlimited PTO.
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Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day.