[Hiring] Clinical Trial Management Associate @Ionis

Role Description

The Clinical Trial Management Associate (CTMA) works as part of the Study Management Team to contribute towards the successful management and execution of clinical trials.

Responsibilities

• Conducts 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 Investigator 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.
• 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.
• 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 meetings, distribute meeting agendas and minutes), as needed.
• Ensures timely 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 CRAs for pre-study, initiation, routine monitoring, and closeout visits.
• Assists with the tracking and management of study specific budgets.
• Participates in development of departmental processes, SOPs, and initiatives.
• Assists with facilitating resolution of data queries and requests from Clinical Data Management.
• Travel is variable and estimated at 20%.

Qualifications

• 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; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process.
• Proficiency in MS Office including Word, Excel, and PowerPoint.

Benefits

• Ionis offers an excellent benefits package!
• Highly competitive benefits.

Compensation

• The pay scale for this position is $88,776 to $133,156.

Company Description

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