任职要求/岗位职责
OverviewAs a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.ResponsibilitiesWorking fully outsourced at one of our global pharmaceutical clients, the Clinical Trial Assistant plays a fundamental role in the successful execution of global clinical trials. Operating within the scope of the Clinical Development Plan, ICH-GCP guidelines and in accordance with the study protocol, local and international regulatory requirements and company procedures, the Clinical Trial Assistant (CTA) works to support the completion and coordination of various logistical and administrative tasks.The Clinical Trial Assistant’s (CTA) work is varied, fast-paced and quality focused. Typical duties will include supporting other members of the local study team, including Clinical Research Associates and Lead Monitors, collecting data required for regulatory submissions, document tracking (contracts, financial agreements, patient informed consent forms, insurance certificates) and managing the delivery of non-drug related study supplies. Maintaining constructive relationships with site staff (eg Investigators, Study Coordinators etc) as well as with colleagues within the organisation, the Clinical Trial Assistant is responsible for tracking site budget related matters, including processing invoices, tracking payments etc. The maintenance and updating of the Trial Master File (and preparation for relevant QC checks when applicable) also falls within the CTA’s remit.Functioning as a key component of the clinical study team, the Clinical Trials Assistant (CTA) may also be responsible for scheduling meetings, updating Excel trackers, coordinating the translation of site documents and providing ad-hoc support as appropriate.RequirementsTo be considered for this position, you must be have a degree (or equivalent) in a relevant life-sciences discipline (nursing, biology etc) along with previous experience in a similar role, either in a pharmaceutical company or a CRO. Fluency in English is essential, along with proficiency in the use of Microsoft Office suite. Demonstrable experience of working to high quality standards and resolving issues will also feature in your profile. The ability to effectively communicate with others and foster positive working relationships will guarantee success within this role.
企业介绍
Headline:Do you want to watch clinical development change, or do you want to be the one to shape it?Sub-head:Because we’re hoping you’re here for the latter.Body Copy:Who are we?We Are PRA.We are 11,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.Who are you?You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Clinical Research Associate, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.Still here? Good. Because if this is you, we’d really like to meet you.Also, we have sign on bonus opportunities up to $15,000 which are pretty cool too.What will you be doing?As a Clinical Research Associate (CRA), you will monitor the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.What do you need to have?? Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution; a licensed healthcare professional (ie, registered nurse); or equivalent work experience required? 18 months of clinical monitoring experience required Knowledge of ICH and local regulatory authority regulations regarding drug (PREFERRED)? All therapeutic experience is welcome including but not limited to: Oncology, Hematology, Respiratory, Cardiovascular, Pain, CNS, Infectious Disease, Metabolism, Vaccines, Transplant and OphthalmologyPRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities
