Senior Clinical Research Associate Oncology

The Senior CRA will enable AbbVie 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 close-out of studies.

Responsibilities :

• For assigned sites / study(s) ensure successful protocol level execution of SMM deliverables involving start-up execution and close-out.
• Ensure site related study execution including but not limited to monitoring visits site evaluations site selection and activation and monitoring close out and visit reports.
• Anticipate and identify site issues that could affect timelines and develop alternative solutions.
• Ensure clinical trial management systems containing all site-specific information are maintained and kept current. 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 AbbVie 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 point of contact for CROs for an assigned study.
• May participate / lead 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 point 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 achieve 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

Qualifications :

Minimum Qualifications :

Preferred Qualifications :

Other Required Skills :

Additional Information :

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 base 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 within 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.

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more :

Work :

Yes

Employment Type : Full-time

Key Skills

CSS,Cloud Computing,Health Education,Actuary,Building Electrician

Experience : years

Vacancy : 1