Kaitlin Daly Email & Phone Number

Winthrop, Ma, Us

United States

• Maintained excellent communication skills with a global staffing team through respectful, open and collaborative calls.• Managed staff ranging from new hire to +15 years in industry experience within the U.S.• Broke down and provided comprehensive education and guidance on core site management concepts to novice and experienced staff.• Developed standardized tools and assessments for program use.• Conducted training seminars and educational forums with >30 staff at a time.• Used innovation and creative thinking in an individual and team setting to develop an industry novel training program for Parexel.• Continuously met changing expectations and deadlines with minimal oversight.• Conducted 150+ behavioral interviews with junior candidates as well as with experienced candidates. • Administrative management, including billing time, expense reports, HR and company specific guidelines implementation.• Assessed staff skills maintaining quality and GCP compliance while on site.• Conducted assessments both in person and remotely for staff.

United States

consistently meeting and exceeding role and company expectations.

Billerica, Massachusetts

consistently meeting and exceeding role and company expectations.

Billerica

• Consistently meet the requirements of CRA with a high degree of proficiency.• Wrote accurate and detailed monitoring visit reports within required timelines and with minimal review from management.• Worked in trials in blinded and unblinded roles, across multiple software systems.• Applied working knowledge and judgement to identify and evaluate potential data quality issues and determine and implement appropriate follow up response.• Prepared sites for sponsor, internal and FDA audits.• Monitored and maintained completeness and quality of on site files.• Recognized impact of issues, delays, changes on study timelines and communicated with functional leads.• Participated in internal audits, client meetings and investigator meetings with minimal supervision.• Maintained a positive results-oriented work environment, moded teamwork, and created an open and balanced communication pathway.• Managed sites and protocols across multiple therapeutic areas independently.• Participated in internal audits and client meetings with minimal supervision.• Trained team members on select tasks as requested by management.• Monitored and maintained ICH-GCP compliance, and completeness and quality of on site files. • Performed clinical monitoring aspect of designated projects in accordance with procedures, applicable SOPs and regulations.• Acted as a direct contact with assigned clinical sites.• Applied expertise and independent judgment to situations at clinical sites.• Assessed overall integrity of study implementation and study protocol at clinical sites.• Performed qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP Guidelines.

• Conducted general site contacts according to study specific monitoring plans and sponsor timelines.• Ensured site issues and concerns are addressed in a timely manner.• Prepared, collected, and compiled quality essential regulatory documents.• Collaborated closely with supporting team members on site issues or required actions.• Performed work in accordance with ICH GCP guidelines, local regulatory requirements and sponsor/Parexel SOPs.