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Site Start-Up Specialist

Novella Clinical


Location:
Research Triangle Park, North Carolina
Date:
10/24/2017
2017-10-242017-11-23
Categories:
  • Clinical Operations
Novella Clinical
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  • Research Salary

Job Details

BASIC FUNCTIONS:

 Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents  (ED) and Investigator Site Files (ISF) during start-up and/or during the file maintenance period of the study.  Work with both internal and external teams to assure good communication, regarding documentation processing.  Assure documents maintained for a study are in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by Novella and its clients.  A Site Start-Up Specialist may be assigned to start-up or ongoing file maintenance projects.  A Site Start-Up Specialist will work in conjunction with or under the supervision of a more senior Site Start-Up Specialists. 

 

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

 Start-Up:

  • Supports the Site Start-Up lead or representative to provide updates during weekly client teleconferences and internal team meetings, as required.
  • Participates in the drafting of the feasibility questionnaire for a study.
  • Assists in the dissemination of Confidential Disclosure Agreements (CDAs) and feasibility questionnaires to sites and follows up with sites accordingly to ascertain interest and to meet study timelines.
  • Participates in the review and negotiation of the CDAs according to country specific requirements.
  • Sends regulatory packets to selected sites and documents/follows-up with sites on the start-up process at the site.
  • Supports sites to answer any questions required for their local IRB/ethics committee submissions.
  • Depending on the country, may support the review and negotiate Informed Consent Forms and follows up with sites and sponsors accordingly.
  • Contacts sites directly, or through local representative (country dependent), as required to resolve issues before IRB/ethics committee submission and final review.
  • Collects and reviews essential regulatory documents required to activate a site according to the study specific Regulatory Management Plan.
  • Notifies Regulatory Affairs department when initial essential documents are available for review. Works with Regulatory Department to resolve any concerns.
  • Adheres to study timelines, documents/escalates study challenges, and communicates updates to Project Manager and Site Start- Up Lead/Management.
  • Maintains up to date and accurate tracking on the start-up status for each site in applicable system(s) for the study.

 

 

 

 

 Ongoing File Maintenance:

  • Reviews documents received from sites, IRBs and CRAs to ensure compliance with GCP and Novella’s standard operating procedures.
  • Manages ongoing IRB/ethics continuing renewals, where applicable, and reviews investigator study files for expired documents.
  • Communicates directly with the site, or with local CRAs in various countries, to obtain corrections to incomplete/incorrect/expired documents.  Tracks any action items to CRAs/sites in CTMS.
  • Reviews eTMF reports on a regular basis to ensure all documents have been filed according to Novella SOPs.
  • Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required.
  • Supports the review of site specific ICFs as changes occur during the study.  Completes ICF checklists and files IRB approved ICFs throughout the study.  Maintains accurate and complete site specific ICF template tracking.
  • Distributes reportable expedited safety reports and cross reports to sites, as needed, and tracks and files reports in appropriate system(s).
  • Submit ongoing regulatory documents to clients as needed.
  • Follows the appropriate Novella and/or sponsor SOPs during conduct of the study.
  • Ensures all project documentation is appropriately filed per Novella SOPs, or Sponsor SOPs if required.
  • Provides updates to ISSC manager on a regular basis, and communicates any out of scope activities.
  • Uploads final documents in eTMF.
  • Supports in creating study specific template documents, per Novella SOP.
  • Performs other duties as required.

KNOWLEDGE, SKILLS & ABILITIES:

 

  • Knowledge of clinical research process and medical terminology
  • Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members
  • Excellent organizational and interpersonal skills
  • Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
  • Ability to manage multiple competing priorities within various clinical trials
  • Working knowledge of current ICH GCP guidelines and applicable regulations
  • Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor entry level Site Start-Up staff

 

MINIMUM RECRUITMENT STANDARDS:

 

  • BS/BA/BSc, or equivalent, with a minimum of 6 months clinical research experience.
  • Excellent verbal and written communication skills required.
  • Ability to work independently, prioritize and work with a matrix team environment is essential.
  • Working knowledge of Word, Excel is required.

 

 CRITICAL JOB FUNCTIONS:

 

  1. Ability to travel
  2. Very limited physical effort required to perform normal job duties

 

CLASSIFICATION (US):

 

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

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