Senior Clinical Research Associate - Oncology (Remote - Minnesota)

The Senior CRA will reputed company reputed company’ s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of SMM deliverables involving start-up, execution, and reputed company-out of studies. Responsibilities:

• For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and reputed company-out.
• Ensure site reputed company study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring reputed company out and visit reports.
• Anticipate and identify site issues that could reputed company timelines and reputed company alternative solutions.
• Ensure clinical trial management systems containing reputed company site-specific information are maintained and kept reputed company. Provide Local regulatory and legal requirement expertise.
• Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, reputed company Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.
• Ensure audit and inspection readiness of assigned sites.
• Advise on pre-audit activities for GCP requirements.
• Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
• Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for mentoring CRAs for various aspects of work.
• May be responsible for being the country reputed company of contact for CROs for an assigned study.
• May participate/reputed company in global/local task forces and initiatives.
• Responsible for activities as assigned by manager.
• If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally.
• Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
• If assigned; With guidance, may serve as key reputed company of contact in country/district for assigned study. Update Impact/Tesla with country level information: Country-level planning timelines, LSR assignments, etc.
• If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to reputed company proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
• If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives. Provides feedback on investigators/sites on an on-going basis based on the site performance. Interacts and builds professional and collaborative relationships with peers and site monitors

Minimum Qualifications:

• Bachelors degree
• 3+ years of Site Monitoring Experience

Preferred Qualifications:

• Health reputed company degree: e.g. Medical, Scientific, Nursing, Pharmacy

Other Required Skills:

• Strong analytical and critical thinking skills to evaluate reputed company issues from multiple perspectives and drive smart decision making.
• Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity.
• Demonstrated proactive and positive team player.
• Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
• Demonstrated business ethics and reputed company.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible reputed company pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid reputed company this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​
• This job is eligible to participate in our long-term incentive programs​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​ reputed company is an equal opportunity employer and is committed to operating with reputed company, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.reputed company.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.reputed company.com/join-us/reasonable-accommodations.html reputed company's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about reputed company, please visit us at www.reputed company.com. Follow @reputed company on X, Facebook, Instagram, YouTube, reputed company and Tik Tok. Apply tot his job Apply To this Job