Jen Pinnow, Msn Email & Phone Number

REGULATORY WRITING • Development of Phase 1 and 2 clinical study reports (CSRs), including all appendices• Creation of and substantive updates to Investigator's Brochures• Response to regulatory questions (RTQs)• NDA documents (CSRs, Modules 1, 2, and 5); including quality and consistency checks of summary documents, clinical study reports and supportive documents, and submission dossier for all clinical deliverables prior to submission to regulatory authorities• Subject narratives CLINICAL TRIAL-RELATED • Protocol development• Creation of study documents; including informed consent forms and assent forms, study imaging charters, CRFs, source documents, monitoring tools, training materials, study plans (e.g., communication plan, monitoring plan, safety plan, study manual, pharmacy manual), study newsletters, and IRB submissionsPATIENT-FACING • Master informed consent form (ICFs) and assents• Study subject diaries, subject instruction manuals• Patient advertising (brochures, posters, radio scripts)EDUCATIONAL • Creation and delivery of education initiatives aimed at physicians, sales-force, and clinical research professionals• Training materials for investigators’ meetings, protocol-specific, and disease-state trainingADDITIONAL WRITING• Collateral for conferences and/or publication; abstracts, posters, manuscripts• Literature searches • Whitepaper research and authorship• Standard operating procedure (SOP) development• Script for DVD presentation to regulatory authorities• Study newsletters

Seattle, Wa, Us

• Proven track record of turning around “problem sites” including doubling site recruitment and building relationships with troubled sites • Responsible for site evaluation, initiation, interim monitoring, and close-out visits • Was the sole unblinded individual in the company, responsible for unblinded pharmacy monitoring including drug accountability, and maintaining the blind in all communications with the sponsor • Prepared protocol submissions to IRB, coordinated review of site contracts and budgets • Served as primary resource for all site questions and conducted investigator’s meetings and site training visits • Trained several employees who were new to clinical research • Experienced with protocol and Investigator’s Brochure development, CRF design, and creating educational programs for investigators and new employees

Responsible for unblinded pharmacy monitoring including drug accountability and reconciliation, and maintaining the blind in all communications with the sponsor. Protocol development, scientific image reading (measuring study endpoints). Training of new contract CRAs. Serve as primary resource for pharmacy site questions and conduct investigator's meetings and site training visits. Company-wide regulatory document reconciliation; create medical narrative information for annual report.; Responsible for site evaluation, study initiation, regular monitoring, and close-out visits ensuring site compliance with study protocol, regulations, and overall clinical objectives. Prepared protocol submissions to IRB, coordinated contracts, and prepared study budgets. Served as primary resource for study site questions and conducted investigator's meetings and site training visits. Trained several employees who were new to clinical research. Proven track record of turning around "problem sites" including doubling site recruitment and building relationships with troubled sites. Experienced with protocol and Investigator's Brochure development, CRF design, and creating educational programs for investigators and new employees

Seattle, Wa, Us

Coordinated, designed, and negotiated research budgets and contracts for individual research sites. Wrote informed consent and assent forms. Designed and created CRFs and managed sub-site regulatory documents. Completed IRB applications and assisted with NIH grant writing.

Seattle, Wa, Us

Managed multiple clinical trials, recruited subjects, conducted informed consent, determined eligibility and completed all study visits. Was primary contact with commercial IRBs and sponsors. Ensured drug accountability, source document and CRF completion. Facilitated interdepartmental contracts. Directed and trained two part time assistants.

Master'S, Family Nurse Practitioner

Ba, Psychology/Sociology

Education record