Regulatory Operations Assistant – I

Notes:

• Focused on new registration, updates, PRS systems, clinical trial.gov.

• 2+ Years of experience in CLINICAL TRIAL DISCLOSURE & TRANSPARENCY ASSOCIATE.

• 3-5 yrs in Biometrics, clinical operations, data management.

• Requisite knowledge of clinical trial process.

• Clinical Trial Manager, Clinical Data Manager, Clinical Trial Monitor – depends on strength of analytical skills.

• Heavy work load – growing pipeline and requirements that are associated with disclosures and transparency.

• Publication of documents.

• Revoking of ICH 6 and ICH 8.

• Nimble, work independently, hope they take on greater responsibility in the future.

• Preference is local to the bay area but not a strict requirement, open to remote workers.

CLINICAL TRIAL DISCLOSURE & TRANSPARENCY:

The Disclosure &Transparency function resides organizationally within Medical Writing  The Disclosures function is responsible for clinical trial registrations and result postings in ClinicalTrials.gov and the EU Clinical Trial Register. Disclosures is also responsible for the EMA Policy 0070 (Publication of Clinical Data and Reports) activities.

PROJECT INVOLVEMENT:

Does not participate formally in cross functional teams, but may attend team meetings under direction of a more senior staff member.

K

KEY CONTRIBUTIONS:

• Under close supervision, conducts Disclosures activities including:

• Registration of Clinical Trials on CTgov

• Results Posting of Clinical Trial Results on CTgov and EudraCT

• Extraction of required documents for Policy 0070

• Redaction of documents for Policy 0070

• Gains foundational understanding of industry regulations and guidances

• FDA and EMA Regulations regarding Registration of Clinical Trials

• FDA & EMA Regulations regarding Results Posting of Clinical Trials

• Disclosures work is performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.

• Registration of new Clinical Trials on CTgov

• Regular updates to Protocol Records on CTgov

• Results Posting for Clinical Trials on CTgov and EudraCT

• Policy 0070 work is performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.

• Collection, e-organization/e-filing, and tracking of Policy 0070 required documents

• Extraction and preparation of Policy 0070 required documents

• Draft Auto-Redaction and Manual Redaction of Policy 0070 documents

• Facilitation of Policy 0070 review process

• Finalization and publication of Redacted documents

• Preparation of other Policy 0070 materials (e.g. CCI Justification Tables, Anonymization Report, Cover Letter, Document Inventory, etc.)

• Performs QC/editing reviews of documents such as CSRs, IBs, CTDs, and other Clinical or Regulatory documents in line with  internal document standards.

• Has strong organization skills and attention to detail, along with ability to work on a number of projects with tight timelines is required.

• Attends and participates in routine group meetings. May attend cross-functional meetings under the direction of a more senior staff meeting.

• Has excellent verbal and written communication skills and interpersonal skills.

• Has well developed computer skills including proficiency in Word, Adobe and Excel.

TYPICAL EDUCATION & EXPERIENCE:

• 2+ years of relevant experience and a BS degree or PhD works.

• Clinical R&D experience (e.g. Clinical Operations)

• Basic understanding of Clinical Development and associated regulations (e.g. FDA, EMA) & best practices (e.g. ICH, GCP)

• Disclosures...

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