Newark, United States
over 1 year ago
Senior Clinical Research Associate (Senior CRA)
Reporting to a Sr Clinical Manager, assist the Clinical Project Manager or Senior Manager in the preparation and execution of clinical study tasks, including: documents (may include plan, protocol, report), initiation, monitoring, and completion of clinical studies for verification and/or validation of Siemens Healthcare Diagnostics in vitro diagnostic products (new or modified).
Represents the clinical affairs department on multi-functional core teams to ensure the project requirements are met and clinical trials are conducted successfully. Also may function as clinical affairs leads on project element teams, when applicable.
Ensures adherence to Good Clinical Practice (GCP) and department standard operating procedures for conducting device clinical studies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Other duties may be assigned.
- Under supervision of Clinical Affairs Sr. Manager or Project Manager, works with relevant departments (R&D, Regulatory Affairs, Medical Affairs, Validations, Product Support, Marketing) to aid in design and preparation of clinical and analytical in vitro diagnostic device performance study plans, protocols, and reports, statistical data analysis plans, and associated study data collection forms.
- Remains current with regulatory requirements for in vitro diagnostic products.
- With minimum supervision, completes all activities related to the set-up, initiation, execution and close-out of in vitro diagnostic device clinical trials including collection, timely review and analysis of data generated.
- Schedules and completes on-site monitoring visits to ensure protocol compliance, accuracy and completeness of clinical data.
- Communicates with study investigators via phone, fax, email and/or letters regarding activities in all phases of the study. Develops and maintains ongoing relationships with investigators/institutions/vendors with access to specimens needed in clinical trials.
- Completes the coordination with biostatisticians and data managers to manage incoming clinical site data, design/maintain databases, and ensure integrity of the database.
- Provides up-to-date clinical study progress reports.
- Negotiates site specific study budgets, initiates and oversees contract origination, compliance approval, and execution.
- Completes the tracking of budgets for studies.
- Represents Clinical Affairs on multifunctional team tasked with preparing responses to regulatory agencies.
- Represents Clinical Affairs on multifunctional team tasked with the preparation of scientific abstracts, posters, and publications reporting results of the clinical studies.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The Senior Clinical Research Associate must also possess:
Excellent communication skills, both verbal and written Excellent interpersonal skills, including negotiation skills Excellent organizational skills Knowledge of GCP and Human Subject Protection for the conduct of clinical trials Knowledge of regulatory requirements for in vitro diagnostic products Working knowledge of databases (e.g., Excel, Access), database management, and statistical applications Good knowledge of the in vitro diagnostics industry Good technical background to understand and communicate current and new technologies Laboratory experience is desirable
Ability to work on multiple projects simultaneously. Must be able to work within constraints of time and budget 25% travel required
EDUCATION and/or EXPERIENCE
B.A./B.S. or equivalent; three to five years related experience and/or training; or equivalent combination of education and experience.
Demonstrates understanding of the Voice of the Customer and be capable of understanding their expectations, and needs in order to develop appropriate rational solutions.
Ability to read, analyze, and interpret scientific and technical journals, financial/budget reports, regulatory and legal documents.
Ability to complete the writing of reports, abstracts and papers for peer reviewed journal publication, business correspondence, and procedural SOPs/manuals.
Ability to effectively complete the presentation of information and respond to questions from groups of managers, investigators, customers, and the general public.
Ability to work with statistical concepts such as mean, standard deviation, %CV, correlation, agreement, p-values, contingency tables, ROC curves.
Ability to develop clinical study budgets and manage the studies within approved budgets.
Ability to prioritize work and resources and to work to tight and changing deadlines, within budget limitations.
Ability to define problems, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
The physical demands described here are representative of those that must be met by an employee to successfully perform 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 use hands to finger, handle, or feel and reach with hands and arms. The employee frequently is required to stand, walk, sit, talk or hear, and smell. The employee is occasionally required to climb or balance and stoop, kneel, or crouch.
The employee must occasionally lift and/or move up to 10 pounds.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
The work environment characteristics 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 occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and outside weather conditions; humid conditions; high places, bloodborne or other pathogens; and risk of radiation.
The noise level in the work environment is usually moderate