MUST BE BILINGUAL SPANISH/ENGLISH
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Prepare, complete, and submit to appropriate IRBs / IBCs all documents required to initiate investigational trials, enabling the ability to meet aggressive start-up deadlines. Coordinate study start-up documentation requests in one package
- Collect CVs, licenses, certificates, training logs, and financial disclosures for all study staff to be involved in a trial; ensure all CVs have been signed and dated within the previous two years
- Maintain sponsors' Site Investigator Portals
- Complete 1572 and/or Investigator Agreement Form (and obtain PI signatures)
- Submit all essential documents to the sponsor
- Collect lab certifications (CLIA and CAP) and the lab director’s CV and license for local and central labs; submit copies to the sponsor and file copies in the regulatory binder
- Learn, apply, and utilize computer software applications to enhance workflow and study activity efficiency (e.g., CTMS)
- Attends PSIVs, SIVs, and monitoring visits with Pharmaceutical companies
- Prepares Regulatory Binder for internal audits.
- Perform additional regulatory duties when assigned or directed to do so.
- Serve as contact person for regulatory questions before, during, and after sponsor visits
- Has a working vehicle to travel to local sites to conduct company business.
During the study and after the study:
- Collaboration with the clinical research coordinators to prepare, complete, submit, and maintain all active study regulatory documents, including but not limited to revisions, correspondence, deviation reports, renewals, 1572, protocol signature pages, safety reports, CV, medical license, credentialing, financial disclosure, laboratory documentation, delegation of authority, etc.
- Track the status of all pending submissions to the sponsor and IRB
- Work with coordinators to ensure that monitor follow-up letter actions, findings, and corrective action plans are completed and addressed.
- Ensures appropriate PI signatures are obtained on essential documents (i.e. safety reports, IB, protocol, DOA, deviations, etc.)
- Relay timely information regarding protocols and important regulatory information to all appropriate clinical staff to ensure compliance with the protocol and all applicable internal and external regulations
- Ensure all regulatory documents are kept up to date and filed in the regulatory binder, and/or eRegulator binder
- Provide updates and necessary documents to the sponsor as required
- Prepare regulatory documents and binders for long-term storage after a study ends
- Prepare for quality assurance audits and regulatory inspections as needed
REQUIRED EXPERIENCE AND EDUCATION:
Bachelor’s degree in clinical research, or administrative area, or other relevant field, and at least three years of functional research, regulatory, or administrative experience. Required GCP certificate. Experience with collecting, completing, and consolidating required regulatory documents per local institution policy, state, FDA, and/ or GCP requirements.
REQUIRED SKILLS:
- Strict attention to detail
- Exceptional organizational skills
- Strong written and verbal communication skills
- Ability to manage multiple studies simultaneously
- High level of professionalism
- Ability to work effectively as part of a high-performance work team
License/Certification:
- GCP certificate
- Driver's License (Required)
Ability to Commute:
- Greater Washington DC Region: District of Columbia, MD, and No. VA (Required)
Ability to Relocate:
- Greater Washington DC Region: District of Columbia, MD, and No. VA
o Relocation before starting work is required.
Required
Clinical Trials
FDA Regulations
Regulatory Compliance Categorization
Research Regulatory Compliance
Regulatory Submissions
Compliance Audits & Assessments
Bilingual
Spanish
English
Attention to detail is a must
