CRA II/ SCRA
3 weeks ago
CRA II/ SCRA (8 positions available)
Global CRO
Home based, UK
Proclinical Staffing are currently partnered with an established and well respected CRO in the UK who are looking for multiple CRA II/ SCRAs to join their team on a permanent basis due to their recent project wins. Our client has a fantastic reputation in the industry for career progression, their collaborative working environment and for the way they treat their staff well which is why they have one of the lowest turnovers of staff in the CRO industry. These are multi-sponsor positions where you can progress quickly from applying their renowned training and development programs.
18 months+ of on-site monitoring experience is essential for this position as they're looking for experienced candidates who have the capacity to "hit the ground running" straight away. They're also flexible on where you're based in the UK (except for candidates based in Northern Ireland) and are well known for providing regional site visits to their CRAs so you're spending less time on the road and as a result, have a better work-life balance.
The Role:
Performs and coordinates all aspects of the clinical monitoring and site management process.
Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation..
Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.
Ensures audit readiness.
Develops collaborative relationships with investigational sites.
Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
A day in the Life:
Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-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 on-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.
Brings up 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 follows-up on findings as applicable
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS).
Performs QC check of reports generated from CTMS system where required.
Participates in investigator meetings as necessary.
Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Gives to other project work and initiatives for process improvement, as required.
Education and Experience:
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
Valid driver's license
Full Right to work in the UK
Fluency in English language
What's on offer?
A highly flexible basic salary depending on your experience, car allowance, pension, life insurance, bonus + much more.
For more information, please apply today.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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