临床协调员

* Knowledge of the protocols and through knowledge of the examinations and procedures in connection with the Study Nurse position as discussed in the protocols and in accordance with the study specific defined responsibility log.
* Thorough knowledge of CCBR procedures and quality control regulations (relevant for the Study Nurse position), which forms the basis of performing clinical studies.
* Knowledge of international/national regulations and instructions for performing clinical studies.
* Perform in a professional, kind and efficient manner, when taking care of study participants.
* Thorough knowledge to the content of the Study File and responsible for the document filling.
* Have a good grasp of the Patient File.
* Responsible for the content of the Patient File, general pages as well as study specific pages.
* Responsible for coordination concerning eligibility in the study enrolment phase.
* Update study staff members on current study procedures and other relevant information.
* Make appointments with Sponsors representative for monitoring.
* Always be updated on the current study status.
* Thorough knowledge of the time schedule.
* Handling of drug supplies.
* Handling of test results.
* Last check of Patient Files and CRF’s.
* To participate in and add information to planned clinic meetings.
* To participate in education and training planned by CCBR.
* To participate in arrangements planned by CCBR, with the purpose of nurturing the solidarity between individual demarcation groups and collaborating groups.
* To participate in subject recruitment program/community out reach.
* Participate in meetings arranged by Study Management Manager/GM; such as investigator meetings, initiation meetings etc.