Collins Dialah Email & Phone Number

Oversees activities performed by clinical investigative sites in relation to AbbVie clinical studies, ensuring protocol adherence and successful execution. Guarantees compliance with federal regulations, local regulations, Good Clinical Practices (GCP), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and quality standards throughout the clinical research process.▪ Executes site qualification, initiation, interim monitoring, and study closeout visits for Phase 1-4 studies, aligning with relevant regulations, Good Clinical Practices (GCP), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and business protocols.▪ Supervises the overall activities of site personnel who do not directly report, motivating and influencing them to achieve study objectives. Proactively manages sites, implementing action plans as necessary to ensure compliance and readiness for regulatory inspections.▪ Ensures the quality of data submitted by study sites and facilitates timely data submission, including reporting and follow-up on safety events by site personnel.▪ Upholds the safety and welfare of study subjects by adhering to the study monitoring plan, AbbVie SOPs, ICH Guidelines, and relevant regulations.▪ Administers investigator payments in accordance with contractual obligations. Negotiates agreements with investigators/hospitals and ensures timely completion of expense reports following local and relevant guidelines.▪ Continuously identify evaluate, and recommend new potential investigative sites.

Texas, United States

 Knowledge of Good Clinical Practice (GCP) and the regulations Solid understanding and skills in the process of clinical trial start-up; site qualification, selection, initiation, study maintenance and close-out Skilled in monitoring of the regulatory binder – all essential clinical study documents Knowledge and understanding of the IRB process, IRB registration and submissions. Knowledge of the strategies for subject identification, recruitment and retention Skilled in clinical trial safety monitoring and reporting: adverse event, serious adverse event, and subject safety Monitor preparation and conduct of monitoring visits: PQV, SIV, IMV, and COV Skilled in and full understanding of various clinical trial software including IVRS, CTMS, eTMF and the EDC Other tasks as many be required by supervisors and mentors

Bronx, New York, United States

With a diverse background spanning over a decade, I've seamlessly navigated dynamic roles in General Office Management, Sales Leadership, and Customer Service. Led bi-weekly payroll processing, ensuring smooth compensation for an expanding team. Enhanced client interactions by overseeing inventory control communication, boosting transparency and trust. Displayed dedication to employees' financial security by adeptly managing 401k and retirement accounts. Proactively ensured compliance through strategic audits, augmenting procedural transparency and precision. Maintained up-to-date technical expertise, elevating role proficiency and organizational insight.

Gcp Certification, Research And Development Management

Clinical Research Associate Certification, Research And Development Management

Bachelor Of Science - Bs, Business, Management, Marketing, And Related Support Services