Study Start-Up Specialist I W2 ONLY 7437882

South San Francisco, CA

Post Date: 08/30/2017 Job ID: 3129 Industry: Professional Positions

W2 ONLY   12 Month Contract

**2 Positions**

 

Position Purpose:

The Study Start-up (SSU) Specialist functions as a subject matter expert on all SSU-related activities in the country/region, oversees and leads SSU activities in collaboration with other clinical research stakeholders and serves as a leader for local/global SSU process improvements and patient recruitment strategies.

 

Main Responsibilities and Accountabilities:

 

Study Start-up Coordination and Execution:

·         Coordinates, guides and assists with all start up activities prior to site activation, including but not limited to:

o    Site Informed Consent Form (ICF) localization and guidance in line with regulatory / health authority requirements

o    Ethics Committee information, meeting dates & costs

o    Ethics applications & associated online systems

o    Ethics & Governance submission processes

o    Clinical Trial Health Authority application and regulatory submission process

o    Contracts & Indemnity request process

o    Localize global Informed Consent Form (ICF) with country requirements

o    Other materials and documentation used by the study requiring local governance approval

·         Maintains up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation
  • Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation
  • Ensures all start up information & requirements are kept up to date in a central repository for project teams
  • Assists with label preparation and approval (local label representative) for studies in collaboration with local regulatory department
  • Tracks metrics and study start-up timelines to identify trends and opportunities for improvement

 

Relationship management:
  • Liaises and collaborates with relevant authorities / bodies to further enhance clinical trial processes, government policies / laws, via innovative approaches

·         Maintains up-to-date understanding of  Start Up processes by liaising with key stakeholders, and looks for emerging trends across government, hospital, industry and other stakeholders  to evolve the unit and to resolve any issues
  • Proactively responds to information survey requests by government, health regulatory authorities and industry bodies
  • Provides continuous and proactive communication with ECs / hospital administration / industry bodies to obtain accurate and up to date information on clinical trial status and activities
  • Maintains communication with local legal/regulatory/medical affairs departments to ensure input is sought and all internal/external requirements are met
  • Provides guidance to CSMs on regulatory/ethics, track & drive site activations by regular review and monitoring status of submissions/activations

·         In collaboration with vendor management and procurement, provide input as required into vendor identification, selection, and RFI/RFP process. 

·         Liaises and shares best practices with other SSUs within CCO

 

New Site Identification:
  • Assist with identification and tracking of new sites in collaboration with CSMs

 

Recruitment:

·         Provides expertise and guidance to Local Study Team (LST) for identification, creation and implementation of specific recruitment/retention tactics & contingency planning

·         Initiates patient recruitment meetings with CSM and advise on study-specific recruitment & retention needs

·         Develops innovative patient recruitment/retention practices and share concepts with vendors as needed

·         Provides justification/recommendation of site closure in collaboration with CSM

·         Provides reports to local study teams on overall site performance as required

 

Contracts/Budget:

·         As needed, supports contract negotiations and study budgeting with sites during the study start-up phase to ensure finalization

·         Provides local fee structures and budgetary advice as required and ensure compliance to Fair Market Value (FMV) in the country
  • Collaborates with CSMs to maintain data to ensure FMV

·         Liaises with management / Country Study Managers (CSMs) to implement budget cost containment and implement contingencies as required

 

Qualifications
  • University Degree or Equivalent preferably in a medical/science-related field
  • Prior work experience demonstrating knowledge and understanding of clinical trials, such as that obtained in a clinical trial monitor capacity, and experience managing projects.
  • Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country

 

Skills, Experience and Competencies:
  • Demonstrated competence in analysis, planning and problem solving.
  • Excellent communications skills including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution
  • Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English
  • Experience working as part of a team with a proven ability to make an active contribution to the team' s performance and teamwork
  • Able to make effective decisions, self-motivated, assertive, and displays initiative
  • Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility
  • Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.

 

Other:

 
  • Availability to travel domestically and internationally if required.

 

Calley Molina


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