The Senior Clinical Research Associate performs and coordinates aspects of field-based and office-based monitoring and data quality control functions in accordance with Good Clinical Practices (GCP), International Conference on Harmonization (ICH), and WuXi Clinical Standard Operating Procedures (SOPs). This is an office or remote-based position and requires approximately 50-75% travel.
Responsibilities
Essential Job Functions:
Responsible for all aspects of clinical monitoring and required reporting, including pre-study visits, site invitation visits, routine monitoring visits (both onsite and remote), and close-out visits.
Completes all monitor and sponsor queries in a timely manner and tracks and resolves protocol deviations and action items.
Trains and manages site staff personnel on protocol requirements and other related study items.
Assists in the development of patient recruitment strategies.
Monitors and manages investigational supplies and products.
Produces and maintains documentation of activities and findings as required by WuXi Clinical and sponsor.
Performs data quality control functions, including but not limited to query management and data audit functions.
Performs other project-related duties as specified by project manager or supervisor, including but not limited to mentoring of Clinical Research Associate (CRA) personnel.
Participates in team and sponsor meetings and training programs.
Responsible for fiscal management of trip costs, positive feedback from site staff, low data error rates, complete and timely site monitoring, and expense and timesheet reporting.
Responsible for assisting with negotiating site budgets and contracts.
Manages budget constraints for travel time, time spent in-house and at site, and to manage those constraints and to alert supervisor and project manager if they cannot be effectively managed.
Reviews documents in advance of Quality Assurance review with high-level of accuracy and make decisions on the quality of the documents and takes appropriate action.
Collects and reviews site regulatory documents for accuracy and completion. Maintains study Trial Master File/Investigator Site File.
Solves problems independently and anticipates risks to the project within the scope of the position and proposes solutions to supervisor.
Performs job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
Required to perform other duties as assigned, including assisting in other departments as required.
Qualifications
Experience / Education:
Bachelor’s degree, preferred or High School Diploma, plus equivalent experience.
Minimum of 5 years of related clinical research experience and a minimum of 3 years of independent monitoring, having completed all four visit types or equivalent.
Experience using Good Clinical Practices and a good working knowledge of physician care in hospitals, clinics, or other healthcare settings.
CCRC, CCRA, and CCRP certifications preferred. Candidate must have sufficient experience to be CCRA eligible.
Knowledge / Skills / Abilities:
Must have strong attention to detail and demonstrate understanding of the critical nature of WuXi Clinical documentation.
Must possess a thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND, and other applicable regulations.
Must have ability to initiate steps according to established processes without intervention.
Must have ability to interact with internal and external customers and sites professionally.
Must have excellent verbal and written communications skills in English and concise technical writing skills with minimal grammatical or logical errors.
Ability to connect and effectively communicate with people from various backgrounds.
Proficiency with Microsoft Office Suite applications.
Ability to organize workload and handle multiple priorities.
Ability to work in a team environment and independently while effectively managing multiple priorities within established time constraints.
Ability to work in satellite environment independently but remain engaged with home office and supervisor.
50 – 75% travel is required. Travel is primarily domestic and infrequently international. Daily and overnight travel are required.
Must have a valid driver’s license and the ability to rent a vehicle as required.
Physical Requirements:
Must be able to work in an office or medical site.
Ability to stand or sit for most of the work day.
Must be able to perform some activities with repetitive motion, such as keyboarding.
Must be able to travel in various methods of transportation (i.e., car, airplane, shuttle bus, etc.).
Must be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop.
If working remotely, must have access to high-speed internet service and have knowledge and ability to resolve IT and computer related challenges through remote communications channels.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Houston, Texas
Other