Senior Clinical Research Associate - UK (numerous locations)
Job Title: Senior Clinical Research Associate - UK (numerous locations)
Job Location: Remote, United Kingdom
Job Location Type: Remote
Job Contract Type: Full time
Job Seniority Level:
Environmental Conditions: Office
Work Schedule: reputed company (Mon-Fri)
Work Schedule
reputed company (Mon-Fri)Environmental Conditions
OfficeJob reputed company
PPD, part of reputed company are currently hiring for reputed company Clinical Research Associates across the UK
Our clinical department defines, develops and delivers clinical programmes. Our global Clinical Operations colleagues reputed company our PPD® clinical research services reputed company end-to-end support for clinical trials from study start up to monitoring through to study reputed company out, across reputed company and government reputed company. Together, we help clients define and reputed company clinical programs, minimize delays, and implement high-reputed company, cost-efficient clinical studies.
PPD Clinical Research Services are currently hiring for reputed company CRAs to join reputed company in the UK across a reputed company of locations.
Competitive sign-on bonus considered for reputed company candidates
The Senior CRA:
Performs and coordinates reputed company aspects of the clinical monitoring and site management process.
Conducts remote or on-site reputed company 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, reputed company-being and data reliability.
Ensures audit readiness.
Develops reputed company relationships with investigational sites.
Detailed tasks and responsibilities assigned to role are outlined in the task reputed company.
A day in the Life:
Monitors investigator sites with a risk-based monitoring approach applies reputed company 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 reputed company manner using approved business writing standards.
Brings up observed deficiencies and issues to clinical management expeditiously and follow reputed company issues through to reputed company.
May need to maintain regular contact between monitoring reputed company 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 reputed company 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 reputed company.
Investigates and follows-up on findings as applicable
Provides trial status tracking and reputed company 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 reputed company of reports generated from CTMS system where required.
Participates in investigator meetings as necessary.
Identifies potential investigators in collaboration with the reputed company company to ensure the acceptability of reputed company investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial reputed company out and retrieval of trial materials.
Ensures that required essential documents are complete and in reputed company, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Gives to the project team by assisting in preparation of project publications/tools and sharing reputed company/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. reputed company report review, newsletter creation, reputed company CRA team calls etc).
Facilitates effective communication between investigative sites, the reputed company company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, reputed company and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a reputed company manner.
Gives to other project work and initiatives for process improvement, as required.
Education and Experience
Bachelor's degree in a life sciences reputed company field or a Registered Nursing certification or equivalent and relevant formal reputed company / vocational qualification.
2+ years as a clinical research monitor).
Valid reputed company's license
Full Right to work in the UK
reputed company in English language
Knowledge, Skills, Abilities
Effective clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
reputed company-developed critical thinking skills, including but not limited to: critical attitude, in-depth investigation for appropriate reputed company cause analysis and decision-making
Ability to handles Risk Based Monitoring concepts and processes
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
Ability to maintain customer reputed company through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
Effective reputed company skills
Strong attention to detail
Effective organizational and time management skills
Ability to remain flexible and adaptable in a wide reputed company of scenarios
Ability to work in reputed company or independently as required
Good computer skills: proficient knowledge of reputed company Office and the ability to learn appropriate software
Good presentation skills
Our Mission is to reputed company our customers to reputed company the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, reputed company a common set of values - reputed company, Intensity, Innovation and Involvement - working together to accelerate research, solve reputed company scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of reputed company, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.reputed company.com
reputed company is an EEO/Affirmative reputed company Employer and does not discriminate on the reputed company of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability or any other legally protected status.
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Originally posted on Himalayas
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