Sr CRA (Level II)
Răspunde la anunț
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of
- changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
As a CRA you will perform and coordinate different aspects of the clinical monitoring and site management process, including audit readiness. Conduct remote or
- site visits to assess protocol and regulatory compliance and manage required documentation, procedures and guidelines from different sponsors and/or monitoring environments ( FSO, FSP, Government, etc. ). You will play a key role in ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights,
- being and data reliability.
Key responsibilities:
- based monitoring approach: applies root cause analysis (RCA), critical thinking and
- solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through
- site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Bring ups observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and
- up on findings as applicable.
- site file reviews as per project specifications.
Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Valid driver's license. Experience as a CRA for at least 1 year.
Knowledge, Skills and Abilities :
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100, 000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #Start
Your
Story with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Fii primul, care se va înregistra la oferta de muncă respectivă!
-
De ce să cauți de muncă pe Lucrezi.ro?
Alertă job![]()
În fiecare zi oferte noi de muncă ![]()
Puteți alege dintr-o gamă largă de locuri de muncă: Scopul nostru este de a oferi o gamă cât mai largă de opțiuni ![]()
Lasă să-ți fie trimise noile oferte prin e-mail ![]()
Fii primul care răspunde la noile oferte de muncă ![]()
Toate ofertele de muncă într-un singur loc (de la angajatori, agenții și alte portaluri) ![]()
Toate serviciile pentru persoanele aflate în căutarea unui loc de muncă sunt gratuite ![]()
Vă vom ajuta să găsiți un nou loc de muncă
