CLINICAL TRIAL MANAGEMENT ASSOCIATE (CTMA)SUMMARY: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%
COMPETENCIES IDENTIFIED FOR SUCCESS:- Ability to work in a team or independently as required
- Effective written and verbal communication skills
- Critically evaluates 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
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; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process
- Proficiency in MS Office including Word, Excel, and PowerPoint
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004035
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis BenefitsFull Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
The pay scale for this position is $88,776 to $133,156
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
