Performs and coordinates aspects of the field-based and office-based monitoring and data quality control functions in accordance with Good Clinical Practices (GCP), International Conference on Harmonisation (ICH), and ResearchPoint Global SOPs.
Performs field-based and in-house monitoring and site management tasks to assure conformance to current regulatory, ResearchPoint Global, and sponsor requirements.
Performs data quality control functions including, but not limited to, query management and data audit functions.
Perform other project-related duties as specified by project manager or supervisor including, but not limited to mentoring of CRA I and II personnel.
Produces and maintains documentation of activities and findings as required by ResearchPoint Global and sponsor.
Participates in team and sponsor meetings and training programs, as required.
Supervises staff as appropriate
EXPECTED RESULTS AND MEASURES:
Fiscal management of trip costs, positive feedback from site staff, low data error rates, complete and timely site monitoring, expense, and time sheet reporting.
May have responsibility to negotiate site budgets.
Position requires employee be aware of budget constraints for travel time, in-house and time at site and to manage to those constraints and to alert supervisor and project manager if they cannot be effectively managed. Mismanagement of trip costs could result in poor project profitability. High data error rates could result in missed deadlines potentially affecting contract bonuses and penalties.
Provides informal mentoring and guidance to more junior employees/contractors on project-specific tasks.
Receives direct supervision from Project Managers, Clinical Managers or above. Receives daily project supervision from project managers and data managers.
Must show ability to present solutions to issues; must show ability to apply previous lessons to future project work. Is expected to apply decisions from previous discussions to new situations and seek confirmation only. Must show ability to review regulatory documents in advance of Quality Assurance review with high level of accuracy and make decisions on the quality of the documents and take appropriate action. Must make effective decisions on managing tasks within time constraints so that deadlines are not missed. Expected to require minimal supervision on issues that can have substantial impact on clinical, data quality, or regulatory issues.
Excellent ability to communicate verbally and orally. Required skills to speak with and be understood by investigative sites and to build rapport with sites. Ability to effectively communicate issues and potential resolutions to sites, other CRAs, and supervisor. Must show excellent interpersonal communication skills.
Must exhibit positive, professional demeanor in all communications and must be able to introduce differing communication strategies to solve issues at the site level. Must exhibit concise technical writing skills with minimal grammatical or logical errors.
Expected to have a minimum of three years related clinical research experience and a minimum of three years of independent monitoring having completed all four visit types or equivalent. Candidate must have sufficient experience to be CCRA eligible.
Intermediate skills with Microsoft Office Suite applications; must have strong attention to detail and demonstrate understanding of the critical nature of ResearchPoint Global documentation. 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, using clear diction. Must be able to solve problems independently when required and must be able to anticipate risks to the project within the scope of the position and to propose solutions to supervisor. Must have positive, professional demeanor with all interactions on the phone or in the office. Excellent ability to communicate verbally and orally. Ability to organize workload and handle multiple priorities. Ability to work in team environment and effectively manage multiple priorities within established time constraints. Expected to have knowledge of Good Clinical Practices; good working knowledge of physician care in hospitals, clinics, or other healthcare settings. Ability to work in satellite environment independently, but remain engaged with home office and supervisor. Ability to supervise/mentor staff.
Bachelor’s degree or HS diploma with commensurate experience. Preference given to those with CCRC, CCRA, CCRP certifications.
Approximately 70% travel required; must have valid driver's license and be able to rent a car
Office/Travel environment. Must be able to travel
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.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled