Senior Clinical Trial Associate

Job Description

POSITION SUMMARY:

Supports the Project Team by assisting in the administrative organization and management of projects ensuring compliance with Premier Research drug and/or device SOPs, Sponsor and ICH-GCP/ISO14155 requirements. This position may also involve general office administration tasks. The role involves high utilization of PC-based software packages for word processing, spreadsheets, and graphics.  Position will be office based.

PRIMARY JOB FUNCTIONS:

  • Manages administrative support and tasks for the Clinical Project Team, including but not limited to filing, faxing, memos, letters, photocopying and first-pass review of T&Es support for designated project team(s), as required
  • Site management communication for non-protocol related questions
  • Provides follow-up with Sponsor regarding study related issues as delegated by Project Manager or Clinical Manager
  • Prepares study documents at the direction and oversight of the Project Manager
  • Attends project team meetings, prepares meeting agendas and minutes, and maintains action item lists from meetings
  • Collects and tracks regulatory documents for submission to Central and/or Local IRB, Ethics Committees, Competent Authorities and/or other committees, as appropriate
  • Verifies IRB/EC approvals and collects and tracks other required regulatory documents; maintains study enrollment tracking and study status spreadsheets, as appropriate
  • Distributes study materials to investigator sites, Sponsors and team members, as needed
  • Prepares documents for and distributes various investigator, regulatory, operations, guidelines and training manuals
  • Assists in preparation for investigator and project launch meetings
  • Assists in preparation for and attends client meetings
  • Supports clinical monitoring staff for visit preparation regarding regulatory document tracking and other study file correspondences
  • Acts as the central contact for all members of the Clinical Project Team for the transmission, collation, tracking and filing of project documents, including but not limited to: site visit reports, status reports, CRFs, critical / regulatory documents, expense reports, financial reports, meeting minutes
  • Assists the Project Manager in facilitating verbal and written communication between Project Team members
  • Communicates with investigator sites for non-protocol related questions and possible query/monitoring related matters as delegated by Project/Clinical Manager
  • Creates and maintains Trial Master File according to Premier-Research Group or client SOPs
  • Where required, organises travel and logistical arrangements for client, investigator and internal meetings and attends as necessary; takes and distributes minutes
  • Arranges and attends Client and internal teleconferences or meetings; takes and distributes minutes
  • Assists with production and distribution of client status reports
  • Creates study documents, project tracking tools and other administrative tools as required by project team
  • Works with Project Manager to define study-specific process flow
  • Assists Sponsors, customers, or others with general project information
  • Gathers, compiles, and reports information relevant to departmental and project needs
  • Support the project team in liaising with third party vendors
  • Assist the project team in distribution of mailings, documents and other study materials to sites, IRB/Ethics Committees, Competent Authorities and others, as appropriate
  • Distributes necessary study budget / contract adjustment information to Project Team
  • Enters data into project databases and / or Excel spreadsheets in accordance with company standards and project specific guidelines
  • May assists with adverse event reporting, if required
  • May accompany CRAs on occasional site visits, if required
  • May conduct Study Close-Out Visits which require only regulatory document reconciliation
  • Assists CRAs in in-house monitoring activates such as CRF page separation, tracking and onward distribution, if required
  • Provides training and mentorship to newly hired or junior level Clinical Trial Associate, as requested
  • Contributes to SOP revisions and/or generation of related regulatory document management and study file maintenance
  • Supports the Start Up Manager in the feasibility process and in the submissions to Ethics Committees and Competent Authorities

OTHER RESPONSIBILITIES:

  • To update CV and Training records as necessary and make available for client review where appropriate
  • Remains alert for new business opportunities, network, and provides information to business development staff or manager
  • Communicates via electronic mail acknowledging and sending correspondence in a professional, timely manner
  • Responsible for the liaison with the Premier Research Archive, including management of the dispatch and retrieval of all documents to be archived
  • May be involved in general office logistical activities
  • May be responsible for line management and development of other CTAs
  • May support general office finance and administrative management
  • May assist in ensuring timely payment of invoices, cash flow, tax and social contribution payments
  • Performs other project related duties as assigned by the Project Manager
  • Performs other work-related duties as assigned

Required Skills

ESSENTIAL/ SKILL/EXPERIENCE REQUIREMENTS:

  • Ability to be productive and handle multiple tasks to meet deadlines in a dynamic environment is essential
  • Requires strong planning and organisational skills, verbal, written
  • Well developed communication skills, good at listening and sharing information with others
  • Ability to act on their own initiative
  • Collaborative approach to create an effective team and meet deadlines
  • Quality and detail oriented with high standards
  • Must be dependable and meet commitments
  • Applies clear and consistent performance standards and handles problems decisively and objectively
  • Strong computer skills in Word, Excel, and email are necessary
  • Fluent verbal and written English language is essential.
  • School certificate or equivalent required
  • Bachelors’ degree (BS, BA, or RN equivalent) in a biological- or science-related field preferred
  • 3 years minimum experience in clinical trials required
  • Some knowledge of FDA Guidance Documents/EU Directives/ICH Guidelines/ISO14155 regulations, drug/device development, and clinical monitoring procedures

Job Location

Quincy, MA US

Position Type

Full-Time/Regular

Contact

Interested candidates should submit their resume to: eugene.sidharto@premier-research.com