AdressMeet a Student är en jobbplattform för juniora talanger.
För kunds räkning har vi publicerat denna annons, vill du komma i kontakt med den slutgiltiga arbetsgivaren kan du klicka dig vidare till annonsen:
We are looking for an Entry level CRA to work in our company. The employee will be a trainee(praktik) for the first 3-6 months for learning and then will receive employment.
This job is based in Lomma, Skåne. So candidates who can come to office atleast 3 times a week to office will have preference.
Responsibilities
- Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
- Communication with the medical site staff including coordinators, Clinical Research physicians and their site staff;
- Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
- Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
- Verification that the investigator is enrolling only eligible subjects;
- Regulatory document review;
- Medical device and/or investigational product/drug accountability and inventory;
- Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
- Assessing the Clinical Research site’s patient recruitment and retention success and offering suggestions for improvement;
- Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Qualifications
- Minimum of a bachelor’s degree; Health or life science related field;
- Excellent communication skills in English and Swedish
- Familiarity with Microsoft® Office; and
- Strong communication and presentation skills a plus.
