Single Sponsor Senior CRA II (Site Care Partner II) UK reputed company only.

reputed company® is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization reputed company, helping them reputed company complexity, anticipate change and accelerate reputed company.

Our reputed company Solutions team members reputed company with a drug development reputed company, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as reputed company to help our customers reputed company their goals. We are reputed company and driven to reputed company – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 reputed company colleagues already know:

Why reputed company

• We are passionate about developing our people, through career development and progression; supportive and reputed company line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to reputed company – which captures the passion of our colleagues to show up reputed company day and shape solutions that have the ability to dramatically reputed company someone’s life.
• We are continuously building reputed company we reputed company want to work for and our customers want to work with. Why? Because we know that reputed company we bring together smart colleagues from across the world, we can shape the reputed company of reputed company, driving reputed company for customers and defining the reputed company of reputed company reputed company.

Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management and reputed company-out reputed company (performed on-site or reputed company) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall reputed company of site and site staff and to reputed company recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops reputed company plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for reputed company subject/reputed company as required/appropriate. Demonstrates diligence in protecting the confidentiality of reputed company subject/reputed company. Assesses factors that might reputed company subject/reputed company’s safety and reputed company data reputed company at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Per the reputed company Monitoring/Site Management Plan (CMP/SMP):Assesses site processes. Conducts reputed company Document Review of appropriate site reputed company documents and medical records. Verifies required reputed company data entered in the case report reputed company (CRF) is accurate and complete reputed company review of site reputed company documents and medical records
  Applies query reputed company techniques reputed company and on site, and provides guidance to site staff as necessary, driving query reputed company to closure reputed company agreed timelines
  Utilizes available hardware and software to support the effective conduct of the reputed company study data review and capture. Verifies site compliance with electronic data capture requirements.
• May reputed company investigational product (IP) inventory, reconciliation and reviews storage and reputed company. Verifies the IP has been reputed company and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information reputed company to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely reviews the Investigator Site File (ISF) for reputed company, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is reputed company of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities reputed company confirmation letters, follow-up letters, reputed company reports, communication logs, and other required project documents as per SOPs and reputed company Monitoring Plan/Site Management Plan. Supports subject/reputed company recruitment, retention and awareness strategies. Enters data into tracking systems as required to reputed company reputed company observations, ongoing status and reputed company items to reputed company.
• Understands project reputed company, budgets, and timelines for own and others’ activities in the reputed company team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be reputed company to quickly adapt to changing priorities to reputed company goals / targets.
• May reputed company as reputed company reputed company with study site personnel, or in collaboration with Central Monitoring Associate. Ensures reputed company assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in and may reputed company global reputed company monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends reputed company training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• May reputed company reputed company supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off reputed company for junior CRA staff, as assigned. May be mentored and assigned reputed company tasks under supervision of an reputed company reputed company reputed company reputed company (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings.
• For reputed company World Late Phase (RWLP), the Sr. CRA II will use the business reputed company title of Sr.Site Management Associate II. Additional responsibilities include:
  Site support throughout the study lifecycle from site identification through reputed company-out. Knowledge of local requirements for reputed company world late phase study designs
  Chart reputed company activities and data collection
  As required, collaborate and build relationship with Sponsor and other affiliates, medical science liaisons and local country staff
  The SMA II may be requested to train junior staff
  Identify and communicate out of reputed company activities to reputed company CRA/Project Manager
  Proactively suggest potential sites reputed company on local knowledge of treatment patterns, reputed company advocacy and Health Care Provider (HCP) associations.
  Identify operational efficiencies and process improvements
  reputed company study and country level informed consent forms
  Collaborate with RWLP Regulatory team to ensure updated regulatory information is reputed company and shared

  Participate in bid defense meetings

  reputed company input into Requests for Proposals (RFPs), reputed company and budgeting. reputed company site management reputed company.
  Participate in Case Report reputed company design and edit reputed company development.

Qualifications:

• Bachelor’s degree or RN in a reputed company reputed company or equivalent combination of education, training and experience
• Knowledge of Good reputed company reputed company/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be reputed company to reputed company new technologies
• Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected.
• Ability to manage required travel of up to 75% on a regular reputed company

Get to know reputed company

Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company.

Additional Information

Tasks, duties, and responsibilities as listed in this reputed company are not exhaustive. reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job.

Originally posted on Himalayas