Bachelor's degree (BA or BS) from four-year college or university and two to four 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
Two to three years related experience and/or training; or equivalent combination of education and experience and certifications.
General experience is two to four years of progressively responsible industry experience, 1 year of which demonstrates the ability to analyze problems to identify significant factors, gather pertinent data, and recognize solutions; plan and organize work; communicate effectively orally and in writing.
Knowledge, Skills and Abilities:
RA understands essential regulatory document and globally understands the proper processing of all documents
RA understands the elements of informed consent (ICF) and remains familiar with ICF, assent and HIPAA guidance as well as state, local, country, Agency, ICH, GCP mandates.
RA works in partnership with Clinical Operations Department and in quality assurance efforts in complying with and enhancing quality management systems to facilitate overall regulatory compliance.
Notifies regulatory, eTMF Lead and/or clinical lead of any regulatory compliance issues with regard to reporting or maintaining proper regulatory documentation.
Assist regulatory manager, eTMF lead, clinical operations and any quality assurance efforts by tracking 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
Establishes and maintains 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 and CTMS (Clinical Trial Management System) input
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 for initial review of Regulatory documents to ensure compliance with Agency, Sponsor, and NCGS SOPs.
Responsible for tracking study site's IRB submission sites, IRB meeting dates, IRB approval status, IRB approval of protocols, Informed Consents, investigator brochures 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.
Assist central files (trial master file / document control) and project coordinators as needed.
Participates in conference calls and provide necessary regulatory updates to sponsor.
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 review procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
RA understands basic mathematical concepts.
RA 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 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.
NCGS Incorporated, founded in 1984, is an international, full-service CRO that specializes in conducting and managing clinical trials.
NCGS’ mission is to protect research subjects, capture quality data and maintain integrity of the science with the same passion one would protect their own domain. Each staff member is charged to function under the mantra:
“these research individuals or subsequ...ent consumers could just as easily be your mother, your brother, your sister or yourself. The data NCGS collects will change healthcare for the future; believe in the impact we have on that process and appropriate characterization of the product. To be a part of the NCGS team, passion for our mission has to exist within each individual.”