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Research Document CoordinatorCompany NCGS, Inc
Location Charleston, SC
Update 5 Day ago
Bachelor's degree (BA or BS) from four-year college or university and one to two years related experience and/or training, or equivalent combination of education and experience.
Associate's degree (AA) or equivalent from two-year college or technical school; or
One to two years related experience and/or training; or equivalent combination of education and experience and certifications.
Knowledge, Skills and Abilities:
RA 1 is an entry level position requiring capabilities to learn work instructions related to gathering and processing regulatory documents.
RA 1 works under direct supervision and does not make independent decisions outside of work instructions developed by more experienced staff
RA I has a beginning understanding of essential regulatory documents required for site initiation and globally understands the proper processing of all documents
RA I has a beginning understanding of the elements of informed consent (ICF) and remains familiar with ICF, assent and HIPAA guidances as well as state, local, country, FDA, ICH, GCP mandates.
RA I is capable of following the instructions collaboratively developed between regulatory, Clinical Operations Department and QA in quality assurance efforts in designing and enhancing quality management systems to facilitate overall regulatory compliance.
Notifies regulatory and/or clinical lead of any regulatory compliance issues with regard to reporting or maintaining proper regulatory documentation.
Assist regulatory manager, clinical operations and any quality assurance efforts by track quality metrics and/or quality intervention method success
Work with clinical operations and defined quality assurance plans to maintain adequate file audits internally and at the clinical site to ensure audit ready status
Closely follows policies and procedures to ensure compliance with government regulations and Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) guidelines.
RA responsible for database tracking of study sites; regulatory documents and status from site recruitment/ targeting to study close, including database design and management, query and report design.
Responsible for the distribution of regulatory documents to the sites, including materials needed for IRB submission/approval, site activation, drug shipment, study completion, Investigational New Drug (IND) safety reports, regulatory correspondence, correspondence from the Sponsor, protocol(s)/ amendments and Regulatory binders in accordance with the Code of Federal Regulations (CFR), NCGS Standard Operating Procedures (SOPs) and Sponsor guidelines.
Responsible only for initial review of Regulatory documents to ensure all documents transmitted are present and legible.
Responsible for tracking study site's IRB submission sites, IRB meeting dates, IRB approval status, IRB approval of protocols, Informed Consents, investigator brochures, advertisements, patient recruitment materials and IRB approval letter expiration dates.
Responsible for submission of Regulatory documents to Sponsor before activation, during the study and at study closeout.
Responsible for the dissemination of study sites' outstanding Regulatory documents to the NCGS Clinical team for the collection, and/ or for contacting the study sites to obtain outstanding Regulatory documents.
RA acts as regulatory liaison for medical or clinical research groups to keep regulatory affairs group apprised of research progress.
Assist central files (trial masterfile / document control) and project coordinators as needed.
Participates in conference calls and provide necessary regulatory updates to sponsor.
This job has minimal training responsibilities of others.
This job has no supervisory responsibilities.
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
RA I understands basic mathematical concepts.
RA I has the ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
RA I should have knowledge of Database software, Spreadsheet software and Word Processing software.
RA in conjunction with clinical operations and quality assurance efforts, tracks protocol compliance, IRB notification of compliance and sponsor updates regarding compliance.