Clinical Trial Assistant Jobs

Precirix is a clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing novel radiopharmaceuticals, using camelid single-domain antibody fragments labelled with radioisotopes. The company’s lead product, CAM-H2, is being evaluated in a Phase I/II trial targeting metastatic HER2-positive cancer. In addition, the company has several pre-clinical programs leveraging the technology strengths.

For the expansion of our Clinical Operations Team, we are currently looking for an enthusiastic and experienced Clinical Trial Assistant.

Purpose of the Position

As a Clinical Trial Assistant you will be responsible for providing administrative and project management support to the Clinical Study Team to help ensure that Precirix’s Clinical Studies run in and effective and GCP compliant manner.You will be a key member of the clinical operations team and will report to the Director of Clinical Operations.

Key Responsibilities

The CTA supports the CSM and other team members though the life cycle of the clinical study from the study start up to the study closure.Tasks may include but are not limited to:

Preparation and review of documentation

·Assist with eTMF reconciliation

·Prepare and execute eTMF quality control plan where applicable, or ensure CROs plan is implemented appropriately

·Regularly review content of eTMF to ensure it is up to date

·Obtain translations of documents where required

·Arrange and track system access for project team where necessary

·Maintain and regularly review content of shared folders to assure the most recent revisions of documents are available on Project Sharepoint sites

·Maintain version and quality control of project documentation and submit to eTMF when it falls under the responsibility of the sponsor

·Initial review and tracking of relevant clinical study plans manuals and triage to the relevant internal subject matter experts as appropriate through approval

·Support collating information for dashboards etc.

Clinical trial, site, CRO and vendor administration

·Tracking (e.g. essential documents, site activation lists) and reporting (e.g. safety reports)

·Ensure collation and distribution of study tools and documents

·Update any clinical trial databases and trackers

·Tracking review of monitoring reports/ oversight visits etc

·Assist with the tracking and maintenance of project related information

·Provision and collation of information in feasibility questionnaires during study start up

·Support tracking and reporting on contract and budget negotiations

·Maintenance of relevant tracking tools

Meeting planning

·Arranging a range of clinical study related meetings including investigator meetings and internal study team meeting

·Generate and distribute agendas and minutes

·Follow up and track actions and decisions from relevant meetings

Training

·Tracking of clinical study related training

·Provision of training in areas of expertise where require

Quality

·Support preparing for audits and inspections

·Supporting clinical study team respond to audit findings and putting in place appropriate CAPAs

·Support where applicable developing or reviewing clinical operations SOPs, working practices or processes

The responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Qualifications & Expertise

·Expected educational qualifications: BSc or equivalent

·Minimum 2 years’ experience in with a clinical trial related role

·Experience with digital clinical trial systems such as eTMF, EDC, IRT etc

·Experience with GCP

Skills & Competences

·Excellent communication skills (verbal, written and interpersonal) and negotiation skills

·Capable of working independently as well as in teams

·Sense of urgency and ability to be adaptable in a fast-paced and rapidly changing environment

·Ability to handle multiple tasks and exercise independent judgment

·Strong attention to detail and focus on quality of work

·Strong organizational and problem-solving skills

·Excellent skills in MS Office applications including Outlook, Word, Excel and PowerPoint

·Knowledge and understanding of ICH GCP

Our offer

·Homeworking will be standard

·Scale up company with a lot of opportunities and entrepreneurial atmosphere

·Company with the mission to improve the life quality of patients

·Small clinical team in the US where your expertise brings real added value

·Possibilities to build up the clinical operations team in the future, together with us

·Company headquartered in Europe (Belgium), with different nationalities

·Salary package according to your qualifications and your wish to work as an independent or on payroll