Description:
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Clinical Trial Assistant to join our client-based team at a global medical technology company based in Houston.

The Clinical Trial Assistant (CTA) plays a fundamental role in the successful execution of global clinical trials. The CTA supports the logistics and operational aspects of a clinical study, by working with the clinical project managers and other study staff members. As a member of the global Clinical Affairs department and Clinical Operations team, the CTA will work under the supervision of a clinical operations manager or other line manager within clinical affairs and will back-up other CTAs.

Responsibilities

• Set-up of (electronic) Trial Master Files ((e)TMF) and in-house filing of TMF documents in the appropriate files according to the SOP and good clinical practices guidelines (i.e. ISO 14155)
• Support ongoing use of CTMS by maintaining and tracking overall contacts and relevant activities
• Support the study start-up and site selection process (e.g. preparation and follow-up of Confidentiality Agreements, retrieve completed site selection questionnaires, maintains site selection tracker)
• Coordinate translations of study documents
• Assist in preparation of submission package to Ethics Committees / Institutional Review Boards and/or Competent Authorities
• Prepare documents for Site Initiation Visits (creation of site specific documents) and compile Investigator Site Files (or supervise external supplier in preparation of these materials).
• Under general supervision, accountable for the timely filing and tracking of study essential documents and for ensuring completeness of the Trial Master File to ensure readiness for audits and inspections at all times
• Assist in preparation of and provide support during conduct of audits and inspections
• Logistic management of study (excluding non-investigational device) related supplies/services, including study material shipments to investigational sites
• Support of study team in general study conduct activities: meeting organization, newsletter and presentation preparation, mailing to sites and general correspondence
• Review and updates dashboards and tracking tools
• Maintain site and sponsor contacts for each study, including start & stop dates
• Maintain the study specific training matrix
• Track study insurance
• Track study agreements / contracts
• Prepare, track and process study site invoices and maintain payment overviews
• Participation in internal project meetings for note taking and documentation of action items
• Support and follow-up of local team meetings and local investigator meetings (e.g. attendee list, agenda, meeting materials, writing of minutes)
• Being the main point of contact of the project team and study monitors when the Clinical Project Manager is absent
• Other activities related to clinical projects

Education and Experience

• Minimal High school diploma required and Bachelor diploma preferred
• At least 5 years of administrative experience, preferably with companies within the biomedical field
• At least 1 year in an equivalent position in a biomedical context (industry, care facility or service provision) or justify having worked in the field of clinical research in a similar position
• Product development and Product Marketing understanding
• Standard Operating Procedures
• Good Clinical Practices and ISO 14155

Skills

• Autonomous in utilization of MS Office software package (Word, Excel, PowerPoint, Outlook)
• Mastery of IT tools and using Internet
• Knowledge of foreign languages is a plus
• Fundamentals of accounting activities is a plus
• Strong Interpersonal skills
• Must maintain discretion and work with confidentiality
• Expert level of organizational skills
• Organizational capacity to manage priorities in the context of conflicting priorities
• Attention to detail

The Benefits of Working for TalentSource in the US

• Full health insurance benefits that include health, dental and vision
• 401K Plan with 5% company match after satisfying 90 days of employment
• Short term and long term disability insurance
• Life insurance
• Paid vacation, sick leave and holidays
• Dedicated Line Manager
• Monthly meetings with line manager
• Full performance and development process with
• Team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002545

or please contact Vaia.Hixson@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Clinical Trial Assistant
Skills: Clinical Trial Assistant, Administration, clinical trials, EC Submissions, eTMF, e-TMF, GCP, ICH-GCP, IRB Submissions, MS Office, TMF Location: United States, Houston - TX Share:

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