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Job Details

Clinical Trials Assistant II

Company: SynteractHCR Deutschland GmbH
Location: Carlsbad, CA
Reference: 27166
Closing Date: 23 Sep 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Overview The Clinical Trials Assistant II provides administrative and trial support to the Clinical Operations and Project Management departments, thereby contributing to the overall management of clinical trials in accordance with the standards of ICH-GCP and applicable local regulations and Standard Operations Procedures (SOPs). This position will be focused on the financial aspects of the role.

Requirements:

Overview

The Clinical Trials Assistant II provides administrative and trial support to the Clinical Operations and Project Management departments, thereby contributing to the overall management of clinical trials in accordance with the standards of ICH-GCP and applicable local regulations and Standard Operations Procedures (SOPs). This position will be focused on the financial aspects of the role.

 

Responsibilities

  • Assists with processing of clinical investigator payments, client/vendor invoices, study expense reports and other financial items, which may include interaction with the study team and accounting.
  • Ensures finalized clinical trial agreements/contracts are properly tracked, maintained, filed and forwarded to the sponsor/clinical site.
  • Interfaces with client representatives and SynteractHCR study team to ensure timely initiation and completion of clinical trials.
  • Assists study teams with all aspects of trial management from start-up to close-out on one or more studies.
  • Provides guidance and mentoring to CTAs and/or support staff.
  • Creates the Trial Master File (TMF) and/or Investigator site files; supports maintenance for the duration of the study, assisting in the file review and reconciliation process in preparation for audits and archival.
  • Maintains and updates project-related data in an existing database i.e. CTMS, EDMS, etc., which involves contacting internal team members to gather information.  May assist with preparation of Status Reports for the study team, sponsor and study related parties.
  • May assist with the preparation, review, and submission of all relevant essential documents to the appropriate Regulatory Authorities, IRB/IECs.
  • Assists in the preparation, receipt, collection, tracking and review of essential documents to confirm completeness. Creates and maintains project-specific binders and related files as needed to house study records during the trial. 
  • May assist with the translation process of study documents.
  • Assists in the planning, organizing and executing of project-specific meetings including but not limited to client meetings, CRA training meetings and Investigator meetings.
  • Responsible for the shipment and tracking of trial materials (e.g. binders, manuals, etc.).
  • Maintains project-related web pages.
  • Prepares or contributes to study related correspondence, including but not limited to: meeting minutes, tracking spreadsheets and presentations.

Qualifications

Academic & Professional Qualifications:

  • High school/secondary level education required.
  • Minimum of 2 years related experience, or equivalent combination of education and apprenticeship.

Skills & Experience:

  • ICH-GCP knowledge and applicable regulations
  • Demonstrated Trial Master File (TMF) knowledge.
  • Basic/intermediate IT proficiency and skills including Microsoft Office.
  • Effective verbal and writing skills; English + local language, if relevant.

     

What We Have to Offer

Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations

 

Who We Are

SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our “Shared Work – Shared Vision” philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.

 

Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients’ safety and comfort helps us to establish ethical standards for everything we do.

 

SynteractHCR’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with SynteractHCR must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.

 


Apply for this job: Clinical Trials Assistant II

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

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