- PURPOSE
Perform tasks at country level associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May participate in feasibility and/or site identification activities.
RESPONSIBILITIES
Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.
Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions .Distribute completed documents to sites and internal project team members.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Review and provide feedback to management on site performance metrics.
Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
Inform team members of completion of regulatory and contractual documents for individual sites.
Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory,
ethics ICF and IP Release documents, in line with project timelines.
Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In-depth knowledge of clinical systems, procedures, and corporate standards
Effective communication, organizational, planning and interpersonal skills
Ability to work independently and to effectively prioritize tasks
Ability to work on multiple projects
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
Knowledge of applicable regulatory requirements, SOPs and companys Corporate Standards
Understanding of regulated clinical trial environment and knowledge of drug development process
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelors Degree in life sciences or a related field and 1 years clinical research or other relevant
experience; or equivalent combination of education, training and experience.
PHYSICAL REQUIREMENTS
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time.
May require occasional travel.Company Profile:
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