OOHA U

Knowledge of institutional SOPs, FDA regulations, and ICH guidelines; experience in protocol review and feasibility assessment.

Skilled in site initiation, monitoring visits, and collaboration with Sponsors/CROs to ensure smooth trial execution.

Experience in prescreening candidates, obtaining informed consent, and ensuring protocol adherence during study visits.

Proficient in performing blood draws, vital signs monitoring, ECGs, and reviewing laboratory results for completeness and accuracy.

Strong data recording skills, resolving queries, managing study medication inventory, and assisting with regulatory submissions.

Ability to identify and report adverse events (AEs/SAEs) promptly to investigators and sponsors.

Effective verbal and written communication skills; ability to train staff and maintain positive interactions with patients and stakeholders.

Capable of prioritizing tasks, managing timelines, and addressing challenges in a fast-paced research environment.

• Created and executed strategies for patient recruitment to achieve enrollment goals and actively engaged in participant recruitment
• Facilitated the informed consent process for research subjects, ensuring all documentation was accurately completed
• Ensured adherence to federal, local, and institutional regulatory requirements, including FDA Code of Federal Regulations (CFR) and ICH Good Clinical Practice (GCP)
• Fostered strong relationships and maintained open lines of communication with all study team members
• Completed required training for each protocol and managed the scheduling of patient and research participant visits
• Collected and maintained detailed participant history and source documentation, handled data entry, and resolved queries efficiently
• Oversaw the inventory and administration of investigational products and managed their proper dispensation to participants
• Procured necessary study supplies, including contracts, handling manuals to support study operations
• Ensured adherence to IRB-approved protocols, safeguarded participant safety, and reported any adverse events
• Followed Avacare and Sponsor policies, SOPs, and guidelines while performing other assigned tasks..

• Ensured compliance with ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures
• Conducted patient selection, consent, screening, and education on protocol-specific details
• Performed patient and protocol assessments, including safety, efficacy, vital signs, and EKGs
• Increased study engagement and supported compliance requirements to meet sponsor goals
• Maintained study regulatory documents and completed Case Report Forms (CRFs) accurately
• Coordinated clinical assessments for studies on major depression, hypertension, and diabetic medications.