Senior CRA

Job description

For one of our clients in Brussels, we are looking for a Senior CRA. 

Responsibilities

General Tasks

  • Gain/maintain knowledge in protocol, monitoring manual, IMP and other relevant documents
  • Check prerequisites for a trial in preparation for pre study visits, initiations etc.
  • Arrange local meetings with (as applicable) PM, Clinical Project Assistant (CPA), Clinical Trial Application (CTA) officer.
  • Ensures cross-functional collaboration, e.g. point of contact for medical affairs regarding investigators, as applicable.
  • Company's representative for both internal and external communication.
  • Support in inspections and audits.
  • Identify academic networks and local treatment guidelines within the Therapeutic area in collaboration with the local ClinOps team.
  • Identify and propose National coordinator, appropriate trial sites and investigators for clinical studies in collaboration with the Clinical Operations Lead.
  • Provide input to the line managers of their study team members' performance relative to trial tasks.
  • Prepare and present trial information at internal and external meetings e.g. local investigator meetings.

In preparation phase

  • Participate in team meetings e.g. Trial Preparation Meeting, and provide information on the status of the study.
  • Ensure that local adaptations to the monitoring manual are made (if needed).
  • If a local vendor is needed, collaborate with the PM to identify, select and manage vendors on local level (e.g. Central laboratory, equipment,...).
  • Maintain Trial Master File (TMF) up to date on OPU and site level.
  • Ensure input is timely given for completeness of CTMS entries by CML or delegate.
  • Check pre requisites and prepare on-site logistics e.g. complete IRT shipping forms.
  • Collect essential documents for submission in collaboration with CRA, CTA officer and PM.
  • Preparation of local Subject Information (SI)/Informed Consent Form (ICF) and other required trial documents for submission, TMF and Investigator Site Files (ISFs).
  • Conduct and document Pre-trial contacts and supports the CML in site selection
  • Arrange supplies/materials/NIMP/equipment in collaboration with the study team
  • Provide site and trial information for budget and contract negotiations.

In initiation phase

  • Ensure proper handover of trial to CRO-CRA
  • Participates in the Trial Initiation visi at site together with the CRO-CRA and ensures that the site staff is trained in protocol and related documents and procedures.
  • Ensure that all essential documents are available before initiation, maintain TMF up to date
  • Ensure input is timely given for completeness of CTMS entries

In conduct phase

  • Support CTA officer with adaptation of documents for substantial amendment submission.
  • Adjustment of local SI/ICF and other required trial documents for submission (substantial amendment).
  • Support audits and inspections on site level.
  • Providing support in overview, reviewing and informing CTM of changes for budget in collaboration with the study team.  
  • Participates in field training and mentoring of (new) CRAs. Can provide input relative to performance review and development opportunities of (new) CRAs.
  • May coordinate local CRAs team working on the same project, when applicable.
  • Ensure safety and protection of trial subjects through compliance with the monitoring plan, SOPs, ICH-GCP and applicable regulations
  • Collaboration with internal (e.g medical affairs, purchasing) and external (e.g vendors) to identify and evaluate issues on the project and ensure the implementation of timely solution.
  • Gain/ maintain knowledge and expertise in the therapeutic areas through clinical and scientific literature review, ongoing awareness and trends of industry practices and participation in activities.
Profile
  • University degree or Bachelor in medical/paramedical sciences, or equivalent through experience.
  • Minimum of 3-5 years of monitoring experience.
  • Flexible attitude.
  • Willing to work in a start-up team.
  • Knowledge of GCP guidelines & EU Directives.
  • Language skills: native Dutch or French and fluent in English.
  • Well organized, accurate, detailed...
Our offer
  • An attractive salary in line with your experience and skills.
  • Fringe benefits including a company car, medical insurance, pension plan and a care plan.
  • A supporting environment.
  • Respect for the life-work balance.
  • Career planning.
  • A focus on professional and personal growth through training and coaching.
  • Room for personal engagement to help shape our company's future.
Location
Brussels
Contact person

Rafael Hoebrechts

Personal profile
Attachments
PDF, DOC, DOCKX (5MB)
Contact details
Tim
Janssen
Managing Partner

Do you want to learn more about Fern Valley? Are you interested in seeing how we can help your company grow? Let's get acquainted. I'll be delighted to hear your story and to share our vision. Experience the personal & open approach of Fern Valley and embark on a journey with us.

+32 487 10 61 46
tim.janssen@fern-valley.com