Clinical Research Physician

Are you a Research Physician/Doctor who wants to improve patient's lives for the better?

Are you looking to advance your career into the clinical trials space?

We are currently looking to recruit a Clinical Research Physician for our
site in Clinical Research Centre (CRC) in Ballerup, Denmark.

Working Monday to Friday, 40 hours per week, our Clinical Research Physicians are responsible for ensuring the commercial success of the site through the safe performance of local clinical studies.

Acting as the principal investigator (PI) or co-investigator for some or all of the studies at the site they have the responsibility for all sponsor
research studies while also ensuring ICH/GCP and local regulations are
met.

Role Responsibility

Key roles and responsibilities for a Clinical Research Physician are:

  • A Overall ensure the clinical trial at site is performed in accordance with the latest update of ICH-GCP
  • Obtain
    thorough knowledge of the clinical trial protocols. To the extent
    possible - participate in the review of the clinical trial protocol
    drafts prior to approval
  • Thoroughly familiar with the
    appropriate use of the investigational product(s) as described in the
    clinical trial protocol, the Investigator's Brochure, and other
    study-related documents
  • Assist in recruitment in collaboration
    with PI and recruitment manager. Outreach and contact to potential
    subjects by phone or during visit at the clinic
  • In co-operation
    with the Managing Director of Clinical Research Centre (CRC) to go
    through the examinations listed in the clinical trial protocol
  • Obtain thorough knowledge of agreements made with Sponsors representative, and update the information concerning the agreements
  • Obtain thorough knowledge of quality regulations, that form the basis for performing clinical trials
  • Obtain
    knowledge of the relevant national and international regulations,
    guidelines and instructions for performing clinical trials
  • Perform in a professional, kind and efficient manner, when taking care of clinical trial subjects
  • Aim to the result that subjects do not leave the clinical trial without weighty reason
  • Obtain
    thorough knowledge of the clinical trial time schedule for the clinical
    trial. Responsible for performing the clinical trial as per schedule
  • To participate in -and add information to participate in planned CRC meetings
  • Assure that the clinical trials are updated in close co-operation with the Study Nurse/Coordinator
  • Daily tasks in the clinic:
  • To decide subject eligibility before randomization
  • Obtain informed consent
  • Perform medical examinations at the CRC and fill in the relevant sections in the CRF/eCRF and the patient file
  • Go through, enter and sign data in CRF/eCRF
  • Report Adverse Events (AEs) and follow up on these in close co-operation with the responsible Study Nurse/Study Coordinator
  • Report Serious Adverse Events (SAE) and follow up on these according to the clinical trial protocol and local legislation
  • Evaluate
    clinical trial symptoms and signs in releation to a subject's health
    and the ongoing study/studies. Evaluate and approve test results
    according to the clinical trial protocol. Conclude on abnormal test
    results, and make sure adequate treatment (if deemed necessary) is
    initiated
  • Handle phone-calls from clinical trial subjects and physician practices
  • Answer queries from sponsor in co-operation with the clinical trial responsible Study Nurse/Study Coordinator
  • Complete the visits for the clinical trial subjects, including dropouts and final visits


Ideal Candidate
To be considered for this exciting opportunity you will need the following skills and experience:
  • Danish Health and Medicines Authority (Sundhedsstyrelsen) for License/Registration to practice medicine in Denmark
  • Ideally an exposure to a specialism such as Neurology, Cardiology and/or General Medicine
  • Danish fluency with good English language skills
  • Have working knowledge of GCP (ICH/GCP and local regulations compliance)
  • Be team player, capable of building and sustaining relationships with colleagues as well as patients
  • Demonstrate
    the inclination to provide practical help and guidance to colleagues,
    providing practical solutions for any problems and supporting their
    development
  • Show meticulous attention to detail in recording
    patient information and data ensuring any queries are acted upon in a
    timely and efficient manner


Package Description

Competitive + Benefits.

About Synexus


Accelerated
Enrollment Solutions (AES) is a business unit of PPD that offers both
sponsors and contract research organizations best-in-class site and
enrolment solutions, with tiered offerings combining the expertise, as
needed, of industry leaders PPD, Synexus, Acurian and Optimal Research.
These solutions are available as discrete services or integrated to
provide a cohesive and highly differentiated trial acceleration strategy
for insourced or outsourced clinical studies, all under
performance-based commercial terms.

The array of integrated
solutions includes PatientAdvantage, PPD's global clinical development
services optimized with Acurian and Synexus enrollment capabilities.
Acurian and Synexus have proven track records for enrolling patients and
study conduct through proprietary, direct-to-patient recruitment
methodologies and a global site network. When combined, these services
provide a new standard of clinical trial productivity that delivers more
patients from fewer sites in less time.



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Oprettet d: 07/11/2019
Redigeret d 07/11/2019
  • Land: All

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