Job details
Job type full-time
Not provided by employer
Full job description
For more than 30 years, ionis pharmaceuticals has been the leader in rna-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technologyScientific innovation began and continues at ionis with the understanding that sick people depend on us.
As the first company to fully harness the power of rna technology for human therapeutics, our platform continues to revolutionize drug discovery and transform the lives of patients with unmet needsOur medicines span multiple therapeutic areas, routes of administration and diverse patient populationsIonis innovation is driving meaningful progress for many of the most challenging health issues.
We are building upon our innovative research and drug development excellence to provide greater value to patientsBased on the breadth and remarkable progress of our pipeline, ionis is projecting to have a vast number of new transformational products on the market in the coming years and growing our commercial capabilitiesWe are well positioned financially to deliver on our strategic goals.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellenceOur success is a direct result of our outstanding employeesWe are interested in bringing together a diverse workforce, comprised of individuals from different backgrounds and with unique skill sets, into our creative and productive environmentJoin us and experience our unique culture while you develop and expand your career.
Clinical trial management associate
The in-house clinical research associate (cra) is part of the study management team that is responsible for successful management and execution of clinical trialsThis position is an in-house position, with minimal travel associated with co-monitoring activities.
Core responsibilities:
Works with internal and external team members (i.eClinical supplies, toxicology pk, regulatory affairs, clinical data management and cro/vendors) to deliver high quality trial execution
Performs study tracking (e.g., ctms, start-up, milestone, close-out); generates, reviews and distributes management reports from internal tracking systems at requested intervals
Collaborates with the clinical trial manager and/or the clinical project lead on the development of certain study-specific plans and/or processes
Presents at team meetings as needed (i.e., clinical trial team meeting, project team meeting, investigator meeting, project training, etc.)
Collects and reviews essential documents from investigational sites
Supports tmf set-up, maintenance, ongoing quality review, and final reconciliation of study documents
Participates in study specific tasks such as investigator identification, recruitment, collection of regulatory documents and site activation
Contributes to the development of the monitoring plan and assists with ensuring appropriate quality and timely monitoring of clinical sites
Assists in development of study materials, case report forms (crfs), informed consent documents for clinical studies
Prepares investigational site reference materials (i.e., screening/enrollment logs, delegation of site responsibilities form, site monitoring log, etc.)
Acts as primary contact for study contractors (e.g., contract ctms, field cras)
Keeps the clinical project lead (cpl) informed of the progress of projects
Develops and maintains good working relationships with investigators and study staff
Assists in the organization and preparation of and participates in investigator meetings (as applicable)
Performs document tracking and signature/approval follow-up, where applicable, including confidential disclosure agreements (cdas), contracts, proposals, invoices, and other study documentation
Executes meeting logistics (e.g., schedule meetin gs, distribute meeting agendas and minutes), as needed
May assist with study entry and updates to clinicaltrials.gov
Assists with design and preparation of study related materials for the training of internal and external staff
Participates in co-monitoring activities and oversight of cro or contract field cras for pre-study, initiation, routine monitoring and closeout visits
Assists with oversight of study vendors
Helps facilitate resolution of data queries and requests from clinical data management
Assists with the tracking and management of study specific budgets
Participates in development of departmental processes, sops, and initiatives
Travel is variable and estimated at 20%
Competencies identified for success:
Ability to work in a team or independently
Effective written and verbal communication skills
Able to critically evaluate job tasks and the impact on overall trial management objectives
Sound problem-solving capabilities
Good judgment in triaging issues from internal and external customers
Effectively collaborates with clinical trial team members
Outstanding organizational skills with the ability to multi-task and prioritize
Exceptional attention to detail
Proven flexibility and adaptability
Education, experience, and other requirements:
Bachelor’s degree preferred
Minimum of two (2) years in clinical research or healthcare related industry, or equivalent combination of education and experience; site monitoring experience a plus
Experience in scientific discipline and multiple therapeutic areas preferred
Experience/training in the following areas: gxp regulations, ich guidelines, good quality practices, 21 cfr part 11 and computer security (part 11, electronic records; electronic signatures-scope and application; 21 cfr 11 and industry guidance), hipaa, drug development and approval process
Proficiency in ms office including word, excel, and powerpoint
Excellent salary and benefits package offered.
For more information about ionis and to apply for this position, please visit our website, www.ionispharma.comReference requisition #ionis002965
No phone calls pleasePrincipals only.
Ionis pharmaceuticals, incAnd all its subsidiaries are proud to be eeo employers.
#li-jb1 #li-remote #li-hybrid #li-onsite
Hiring insights
Job activity
Posted 15 days ago
