Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we're hoping you're here for the latter.
Who are we?
We Are PRA.
We are 17,000+ employees strong, operating in more than 90 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 life saving drugs into the hands of 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 an Associate 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.
What will you be doing?
With support, acts as primary site contact arid site manager throughout all phases of a clinical research study, taking responsibility of monitoring allocated sites.
Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
Performs clinical study site management/monitoring activities are compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Gains an in-depth understanding of the study protocol and related procedures.
Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
Participates & provides inputs on site selection and validation activities.
Performs remote and on-site monitoring & oversight activities using Various tools.to ensure:
Data generated at site are complete, accurate and unbiased
Subjects' right, safety and well-being are protected
Conducts site visits including but not limited to validc1tion visits, initiation visits, monitoring Visits, dose-out visits: and records clear,. comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, it audits/inspections and overall site performance.
Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRM and PLM.
Manages and maintains Information and documentation in CTMS, eTMF arid various other systems as appropriate and per timelines
What do you need to have? Education required:
Minimum 2 years' experience as an Oncology Study Coordinator
Read, write and speak fluent English; fluent in host country language required
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA Health Sciences