For a large international and dynamic pharmaceutical company, with a sales office in Houten, Checkmark is looking for a:
Clinical Research Associate
(32-40 uur)
You have at least 1 year relevant experience as a CRA.
The CRA is responsible for the timely execution of the study in compliance with the protocol in the investigational sites allocated to him/her and that sites meet the enrolment targets and quality criteria as agreed by the HCO and as required by current internal procedures and local laws and regulations. We are looking for a candidate for the term of 6 months (pregnancy leave), starting date at 1 September (at the latest 1 October). It is possible that the department will move to Haarlem in November, but from that moment working from home is possible. Candidate will get a company car.
Responsibilities:
The CRA devotes 100% of his/her time to Clinical Operations. Core job responsibilities fall into several areas:
1) Prepares the investigational site for study initiation, i.e. collects fully completed site specific documents as required and submit these for approval, informs and trains investigator and site staff adequately, ensures that clinical supplies can be dispatched in time for study start.
2) Monitors via on site visits and via review of data collected: if the protocol is adhered to, if the study is performed in compliance with GCP and Declaration of Helsinki, if safety reporting requirements are met, verifies data in (e)CRF against source documents, checks if drug dispense and return is adequately accounted for, checks if investigator and other site staff have maintained required training, checks if Ethics Committee and HA approvals are still valid and in place.
3) Reviews in time the eCRF data collection system on completeness and timely query resolution and closure. Reviews and reminds the investigator of proper reporting of (serious) adverse events.
4) Updates the relevant dbases and CTMS in a timely and adequately fashion and reports on relevant contacts and site visits.
5) Site management: builds and maintains good relations with investigators and site staff. Ensures that patient enrolment on site follows agreed recruitment plan, ensures that EC and HA approvals for the protocol and any subsequent amendments are implemented as required and in time, ensures that the informed consent procedure on site is followed in compliance with relevant procedures and rules and regulations and ensures that data collected from the study are reported by the site in time.
6) Checks the completeness of relevant files on site according to internal procedures and checks if study documents are submitted to Official Document Repository as required (‘file reconciliation’). Collects study documents from the site as needed in a timely manner and ensures that these are properly filed by the CTC.
7) Anticipates and monitors proactively potential problems. Proposes and provides adequate and practical solutions to problems arising during the study.
8) Identifies and addresses – in collaboration with other Clinical Operation colleagues – opportunities for improvement in internal processes and/or procedures.
REQUIREMENTS
· Professional education: University (Medical Biology, Medicines or Pharmaceutical).
· At least 1 year relevant experience as a CRA.
· Successfully completed ICH/GCP course.
· Drivers license BE.
· Independent, assertive, selfassured and stress resistant.
· Can effectively cope with change.
· Uses his/her time effectively and efficiently.
· Drive for Results and perseverance.
· Customer Focus and priority Setting .
· Motivating Others, stand up and be counted.
· Displays knowledge of company policies, procedures, and technology required to effectively carry out operations.
· Scientific Knowledge.
· Exhibits ability to convey and communicate information and findings in verbal and written form.
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