Donna Cote Email & Phone Number

Mcdonough, GA, US

Remote

• Led and implemented Clinical Education strategies by providing disease and product education to community and academic institutions, hospitals, health care providers, pharmacies, and patients.
• Enhanced staff professional growth and expertise to deliver quality patient care by assessing clinical staff training needs, developing and implementing staff development programs, and initiating quality improvement.
• Collaborated with Project Manager to evaluate deliverables and milestones, complete regulatory documents and ethical documentations, and maintain unit-specific quality, accreditation, and clinical competency programs.
• Developed strategy to provide clinical education to identified population by performing feasibility studies on potential sites and conducting pre‐study, study initiation and interim monitoring visits.
• Significantly contributed to site success by mentoring less experienced CRAs and site staff, designing study specific tools and templates, providing input into design of protocols and CRFs, and monitoring/training.
• Served as Lead CRA for global studies with focus on coordinating CRAs and developing clinical monitoring plan.

United States

• Steered clinical research and trial education by performing site selection, initiation, monitoring, and close-out visits based on scope of work and good clinical practice.
• Ensured study site adherence to protocol and regulatory standards by evaluating practice quality and integrity, promptly escalating issues to appropriate authorities, and optimizing study integrity and compliance.
• Managed and monitored sites for a variety of protocols, sites, and therapeutic areas by administering protocol and related study training and reporting regularly on ongoing project expectations and issues.
• Maintained site management documentation and progress reports by tracking regulatory submissions and approvals, monitoring visit findings and action plans, developing regular visit reports, and generating follow-up.

Remote

• Conducted comprehensive site visits including selection, initiation, monitoring, and close-out in adherence to contract terms and good clinical practice standards across diverse protocols and therapeutic areas.
• Drove quality and integrity of study site practices by ensuring proper conduct and adherence to applicable regulations and escalating quality issues to Clinical Project Manager (CPM), Clinical Research Specialist.
• Proactively managed assigned studies’ progress through regulatory submissions and approvals tracking, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and.
• Orchestrated excellent documentation of site activities by monitoring and recording visit findings and action plans, submitting regular visit reports, and generating follow-up letters and other study documentation.

Atlanta, Georgia

• Significantly contributed to development of effective study strategies by partnering with clinical operations, medical affairs, and sponsors, sharing field insights, and delivering protocol, execution, and amendment.
• Served as clinical team’s contact person on project communications, correspondence, and associated documentation.
• Collaborated with sponsor, study sites, and CRAs with audit preparation/responses and quality issues.
• Effectively presented research and development concepts, competitive intelligence, and in-service education to healthcare providers, research referral networks, internal/external teams, nursing staff, interns, and.

Macon, Georgia

• Provided in-service educational clinical trial presentations to internal and external healthcare providers.
• Developed study-specific clinical trial source documents and site SOPs including appropriate site management and recruitment strategy documents.
• Drove research study awareness by creating new physician referral relationships and community referral networks.
• Cultivated strong working relationships with principal investigators, sub-investigators, sponsors, and vendors.
• Maintained IP inventory, storage, administration, and return of investigational products.

Stockbridge, Georgia

• Coordinated and led 6 phase III clinical trials in endocrinology and cardiology therapeutic areas and delivered in-service educational clinical trial presentations to internal and external healthcare providers.
• Improved research efficiency and study participants’ productivity by training study participants at each study visit, attending investigator meetings, and building strong relationships with principal investigators and.
• Collaborated closely with CRA monitors to ensure regulatory compliance for preparedness for sponsor or FDA audits.
• Ensured effective documentation by maintaining appropriate documentation of site management, recruitment strategies, IP inventory, storage, administration, and return of investigational products.
• Maintained contract-negotiated sponsor timelines for data entry, query resolution, and IMV follow-up, and developed study-specific clinical trial source documents and site SOPs.

Atlanta, Georgia

• Provided efficient administrative operations by maintaining updated records, overseeing budgeting, hiring and training new and old employees, directing activities across multiple functions, and supervising 8 nursing.
• Increased public awareness and promoted MS disease understanding by maintaining physician referral and community advocacy relationships, and creating educational programs to support MS patients and their families.
• Developed Multiple Sclerosis Association of America (MSAA) and State of Georgia-compliant MS health and wellness program objectives and comprehensive MS treatment approach to improve patients' health and well-being.
• Implemented staff training to recognize MS-related musculoskeletal, paroxysmal, and chronic neurogenic pain types.
• Maintained State of Georgia medical treatment compliance for insurance-based pain management programs.

Atlanta, Georgia

• Delivered culturally and spiritually sensitive nursing care in line with Georgia state scope of practice.
• Developed individual patient care plans and maintained patient/nurse confidentiality in line with medical compliance for mental health crises and HIPAA.
• Collaborated with behavioral health treatment team to assess patient medical, physical, emotional, and psychological needs, and delivered medication according to hospital and State of Georgia guidelines.
• Planned and implemented patient teaching modules.

Master Of Science - Ms, Biotechnology & Regulatory Affairs, 4.0

Activities and Societies: SOCRA Pharmaceutical Biotechnology & FDA, GCP Regulatory Affairs

Bachelor’S Science In Nursing, Nursing Leadership, 4.0