Senior Clinical Research Associate

  • Location:

    Dundee, Scotland

  • Sector:

    Scientific

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Robyn Clendinning

  • Contact email:

    robyn.clendinning@search.co.uk

  • Job ref:

    Req/507252

  • Published:

    5 days ago

  • Expiry date:

    2019-01-05

  • Startdate:

    06/12/2018 09:44:42

Search consultancy have a position available for a SCRA in our clients growing business.
The SRA will participate in the design and writing of protocols, case report forms and informed consent forms for clinical trials. The SCRA will be available to assist the PM with any other documentation and submission required for the clinical trials.
They will be productive in recruitment and be part of the selection process of new investigators, and outside vendors, if required.

Responsibilities

* Planning and implementing all activities required to conduct and monitor complex clinical trials and ensures that Good Clinical Practices (GCP) are followed.
* Conducting site visits pre-study for site setup, study initiation and at regular intervals during the study and at study closeout. Monitors investigator performance and adherence to protocol, and proactively addresses conduct issues and enrolment problems, as necessary.
* Ensure that Case Report Forms (CRF) are written in a timely fashion (within 5 working days of visit to site) and sent to CPM for review and submitted to the data management group.
* Be involved in the compilation/writing of reports and clinical sections of INDs, IDEs, New Drug Applications (NDAs) and Biological License Applications (BLAs), etc.
* Be involved with the Archiving of studies if required.
* assist the Clinical Project Manager as required.
* assist in preparation of presentations and manuscripts of scientific meetings and technical journals. Attends scientific/professional meetings and training courses as appropriate.
* Be available to travel in the UK and out with the UK when required
* Assist the CTA when required
* management/supervisory responsibilities of Junior CRA and CTA.


Requirements:
* BSc in a scientific, health care
* Up to 4 years + experience for senior CRA role
* experience in the pharmaceutical and /or device industry including relevant clinical research experience.
* Knowledge of EMA / FDA regulatory requirements is preferred for both Senior and Intermediate levels.

Please apply here or call Robyn Clendinning on 0141 272 7793

Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.