Essential Functions
● Under general supervision, serve as Single Point of Contact (SPOC) in
assigned studies for investigative sites, Site Activation Manager (SAM),
Project Management team, and other departments as necessary. Ensure adherence
to standard operating procedures (SOPs), Work Instructions (WIs), quality of
designated deliverables and project timelines.
● Perform start up and site activation activities according to applicable
regulations, SOPs and work instructions. Distribute completed documents to
sites and internal project team members.
● Prepare site regulatory documents, reviewing for completeness and accuracy.
● 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, regulatory, ethics, Informed Consent Form (ICF), and Investigator
Pack (IP) release documents, in line with project timelines.
● Provide local expertise to SAMs and project team during initial and on-going
project timeline planning.
● Perform quality control of documents provided by sites.
● May have direct contact with sponsors on specific initiatives.
Qualifications
● Bachelor's Degree Related field
● 1 year clinical research experience. Equivalent combination of education,
training and experience.
● In-depth knowledge of clinical systems, procedures, and corporate standards
● Strong knowledge of medical terminology and regulations
● Broad knowledge of clinical research
● Strong knowledge of Microsoft Office and e-mail applications
● Effective communication, organizational, and interpersonal skills
● Ability to work independently and to effectively prioritize tasks
● Ability to manage multiple projects
● Attention to detail
● Ability to establish and maintain effective working relationships with
coworkers, managers and clients.