Firma

Timshel Sp. z o. o.

Ogłoszenie

Clinical Research Associate

Miasto/województwo

Warszawa (woj. mazowieckie)
Gdańsk (woj. pomorskie)
Poznań (woj. wielkopolskie)

Publikacja

2019-01-07
 

Timshel is a niche consulting company focused on two important cores - professional recruitment and business coaching. We successfully support our clients within those two fields while delivering our expertise and the credibility of work.

 

Our offer is dedicated to those companies that seek high quality partnership relations, and believe in collaborative approach and open communication between both sides. We are pleased to provide you within the above-mentioned services as well as other counsulting solutions. Thanks to our passion we are able to do that.

For our Client, Global Pharmaceutical Company, we are currently looking for
 
Clinical Research Associates /Senior Clinical Research Associates
 
Depending on the position level we are looking for the candidates with at least two years of experience in clinical monitoring or with 3-6 years experience for senior position.

It's a home-based work with a direct contract with sponsor. 

The role:

 
The Clinical Research Associate will identify, select, initiate and close-out appropriate investigational sites for clinical studies. The successful candidate(s) will monitor these sites in order to ensure ensuring compliance to the study protocol, Standard Operating Procedures, applicable regulations, and the principles of ICH-GCP. The CRA will also be charged with ensuring the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.


Responsibilities of the Clinical Research Associate:
  • Monitor clinical trials to ensure absolute adherence to Good Clinical Practice
    in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures
  • Site management to ensure proper adherence to protocol, source data verification and assess CRF entries
  • Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists
  • Assist with study protocol design, development and / or review if required
  • Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required
  • Perform pre-study initiation, interim monitoring and close out visits as required
  • Carry out drug formulation administration procedures and documentation records
  • Ensure adequacy of drug shipment and drug accountability
  • Liaise with the Medical Monitor, Principal Investigator, clinical operations staff
    and sponsor representatives as required
  • Organise / attend investigator meetings as required
  • Provide support to the Project Manager / Country Manager with ad-hoc tasks
    as required
Requirements:
  • Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline
  • Clear understanding of the drug development process
  • Significant experience in performing a Clinical Research Associate role
  • Work experience within either a hospital, medical / research centre environment, Contract Research Organisation or Pharmaceutical company
  • Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials
  • Ability to contribute to the development of clinical trial related documents
    and materials
  • Ability to independently perform pre-study initiation, interim monitoring and close
    out visits as required
  • Good communication skills including the ability to present complex information
    both clinical and non-clinical disciplines
  • Excellent presentation skills including the ability to meet exacting standards
    and a keen attention to detail
  • Fluency in English and Polish (both written and spoken)
  • Willingness and ability to travel

Desirable Criteria:
  • Experience across a wide range of clinical indications / therapeutic areas
  • Ability and experience to work with an electronic case report form (eCRF)
  • Membership of local professional bodies or international clinical groups
  • Ability to mentor, train, supervise and inspire confidence in newcomers to the industry 
 

 
Prosimy do CV dodać klauzule:

Wyrażam zgodę na przetwarzanie moich danych osobowych w celu prowadzenia rekrutacji przez Timshel Sp. z o.o. na stanowisko Clinical Research Associate.  Wyrażam zgodę na przetwarzanie moich danych osobowych przez Timshel w celu rekrutacji na inne stanowiska odpowiadające moim kwalifikacjom, jednak nie dłużej niż w okresie trzech lat od dnia udostępnienia przez mnie danych osobowych Timshel.

Administratorem danych osobowych jest Timshel Sp. z o.o. z siedzibą w Warszawie, przy ul. Filtrowa 65/32, 02-055 Warszawa. Państwa dane osobowe są przetwarzane w celu rekrutacji prowadzonej przez Timshel na zlecenie i na rzecz jej Klienta na stanowisko wskazane w ogłoszeniu. Szczegółowe dane dot. przetwarzania Pańśtwa danych osobowych znajdziecie Państwo w polotyce prywatności.
 
INFOSMUJEMY, IŻ SKONTAKTUJEMY SIĘ Z WYSELEKCJONOWANYMI KANDYDATAMI.