Sr. Clinical Research Associate - CoolSculpting
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Senior Clinical Research Associate is responsible for coordination and management of all aspects of clinical studies, including regulatory compliance, documentation requirements, monitoring, and close-out. Contributes technical and clinical operations expertise.
Essential Duties and Responsibilities include the following (other duties may be assigned.):
- May coordinate the activities of relevant colleagues within the Company and Investigators to ensure compliance with the overall scientific study objectives.
- Maintains frequent contact with clinical site staff, preparing and tracking required documentation and assuring regulatory compliance with corporate SOPs as well as FDA and ICH guidelines.
- Develops and maintains clinical data summaries and analyses and presents data for inclusion in regulatory submissions and/or other company uses.
- Proven skill and experience in managing CRO outsourcing
- May act as lead on assigned projects.
- Processes and applies specific knowledge to the completion of difficult work assignments.
- Develops clinical study documentation, including study protocols, investigator brochures, informed consent forms, case report forms, clinical study reports, annual reports, various study materials, and monitoring tools.
- Maintains site files. Prepares and conducts initiation visits, interim visits and termination visits.
- Tracks patient recruitment produce status reports and monitoring reports, track SAEs, conduct study close-out activities, conduct query resolution, and other duties associated with monitoring and managing clinical studies.
- Aids in setting the strategy, budget, and goals for the clinical department.
- Provide training for company and clinical site staff through formal presentations.
- Function as mentor and role model for other clinical team members
- Maintains a high level of professional expertise and follows all procedures related to this job that can affect the quality of products or services provided to our customers.
- Up to 40% (or more) domestic and international travel may be required.
- Bachelor’s degree in a scientific discipline or related field required.
- Minimum 2 years of related Clinical Research Associate experience.
- Proven track record of successful clinical study management.
- Ability to focus on and achieve scheduled milestones, including contingency planning.
- Good clinical knowledge with an understanding of medical terminology.
- Knowledge and understanding of ICH GCP guidelines and FDA regulations related to clinical studies.
- Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
- Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
Ability to work with mathematical concepts such as probability and statistical inference.
Ability to use MS Excel to perform calculations and interpret results/data.
Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.
Language and Verbal Skills:Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, specifications, business correspondence, and procedure manuals in English. Ability to effectively present information and respond to questions from groups of managers, clients, and customers. Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Analytical and Reading Skills:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to analyze a variety of technical instructions in mathematical or diagram form and interpret various abstract and concrete variables. Ability to read technical and clinical literature and documents and extract important concepts.
The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear; up to 8 hours per day. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.
Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate.
Zeltiq is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.