AbbVie
More roles at AbbVieClinical Research Associate II
Remote role where the employee must remain based in a particular country.
China only
From the listing details: Source listing states candidate location: "Shanghai, Shanghai, China, Shanghai, cn, Remote"
Employer listed it 3 weeks ago · Added 3 weeks ago
Been open since 3 weeks ago, still being checked, but it has been live a while.
Salary
Not stated
Location
China only
Timezone
Not stated
Contract
Full-time
Experience
Entry
Category
Other
The employer did not publish a salary, and we have too few comparable roles to estimate one.
What the advert says
Quoted word for word from the employer's advert. Where it says nothing, we say so.
- Working hours
- Not mentioned in the advert
- Where you can work from
Familiar with risk‐based monitoring approach, onsite and offsite monitoring.
- Contract
- Not mentioned in the advert
- Experience asked for
- Not mentioned in the advert
- Pay
- Not mentioned in the advert
Remote flexibility
Work from home
This is a remote role, but the employee must be based in China. It is work from home rather than work from anywhere.
What the employer says
- Source listing states candidate location: "Shanghai, Shanghai, China, Shanghai, cn, Remote"
What Nomaders makes of it
- Residency required in China
- Payroll and tax are likely handled in that country only
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
Before you apply
Experience: employer states
Written as a requirement
- “Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials.”
Questions worth asking: Nomaders interpretation
- No pay is stated. Ask for the salary range before investing time in interviews.
- The advert does not say whether this is employment or a contractor arrangement. Ask, as it affects tax and benefits.
Produced automatically from this advert's text; not reviewed by a person. The employer's own page is the final word.
About the role
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at  www.abbvie.com . Follow @abbvie on  LinkedIn,   Facebook ,  Instagram ,  X  and  YouTube.
Purpose
Describe the primary goals, objectives or functions or outputs of this position.
Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.
Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials.
Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.
May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
Ensures audit and regulatory inspection readiness at assigned clinical site at all times.
Manages investigator payments as per executed contract obligations, as applicable.
Qualifications
Requirements
- ·List required and preferred qualifications (up to 10). Include education, skills and experience.
- ·Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.
- ·Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
- ·Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
- ·Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
Benefits
No benefits package published with this listing. Ask about it at first interview.
How to apply
- 1Check the flexibility label above, work from home, matches where you plan to live and work.
- 2Tailor your CV to the role at AbbVie, mentioning your remote working experience.
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 20d ago. Last checked today. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
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