Celerion Remote Jobs USA 2024 | Clinical Document Specialist
About Celerion Remote Jobs USA 2024
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines.
With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings.
Job Description For Celerion Remote Jobs USA 2024
- Create 1572 packets for all studies and ensure completeness prior to sponsor delivery and subsequent filing
- Create Financial Disclosure documents for key staff members for each
- Maintain electronic master signatures for all clinical staff
- In collaboration with training team, maintain all current and historical copies of laboratory accreditations, reference ranges, staff Curriculum Vitae (CVs), medical licensures, and related forms. Coordinate updates when necessary.
- Track IRB letters and ensure that the documents referenced are placed in the ISF
- May be involved to ensure all protocol and protocol amendments are signed accordingly
- Responsible for all study and non-study specific approvals and study expiry tracking
- May be responsible for submitting any and all pertinent documents to the IRB or Sponsor for acknowledgement or approval
- Perform Quality Control (QC) on all regulatory binders before the Quality Assurance (QA) audit of critical documents is completed
- Respond to any QA findings in critical documents audit to ensure proper documents are placed in the regulatory binder
- Special projects as needed
Assist Celerion IRB Services in the following:
- Assist in the creation and QC of eConsents
- Provide backup to IRB Services in the submission of documents to the IRB as well as processing the IRB Approval letters
- Assist with Veeva-related administrative tasks (e.g. responding to Veeva Help Tasks)
- Assist with research staff Financial Conflict of Interest survey
- May be involved in providing back up to ICF writers
Knowledge/Skills/Education/Licenses:
- Associate’s degree in life sciences or equivalent preferred
- Two or more years of industry experience or training is preferred
- Strongly prefer experience with IRB/FDA and/or other regulatory bodies and guidelines
- Must have strong organizational, attention to detail, multi-tasking, and time management skills
- Excellent oral and written communication skills
🌐 APPLY HERE: Click Here
