Sr. Clinical Research Associate

Location
Carlsbad, CA
Posted
Nov 01, 2018
Ref
18-0172
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.

Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.

SR. CLINICAL RESEARCH ASSOCIATE

SUMMARY:

The Sr. Clinical Research Associate is part of the Study Management Team that is responsible for successful management and execution of clinical trials. This position is an in-house position with minimal travel. 

JOB DUTIES/ RESPONSIBILITIES:

  • Works with internal and external team members (i.e. Clinical 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/leads in study specific tasks such as investigator identification, recruitment, collection of regulatory documents and site activation
  • Contributes to or leads the development of the Monitoring Plan and assists with ensuring appropriate quality and timely monitoring of clinical sites
  • Assists/leads in the 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/leads 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 meetings, distribute meeting agendas and minutes), as needed
  • May assist with study entry and updates to ClinicalTrials.gov
  • Assists with or leads the design and preparation of study related materials for the training of internal and external staff
  • Participates in or leads co-monitoring activities and oversight of CRO or contract field CRAs for pre-study, initiation, routine monitoring and closeout visits
  • Assists or leads with oversight of study vendors
  • Helps facilitate resolution of data queries and requests from Clinical Data Management
  • Assists with or leads the tracking and management of study specific budgets
  • Participates in or leads the 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 four (4) 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; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process
  • Proficiency in MS Office including Word, Excel, and PowerPoint

Excellent salary and benefits package offered.

Please visit our website, www.ionispharma.com, for more information about Ionis and to apply for this position; reference requisition # 18-0172

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.