Clinical Research Associate I resume example with 13+ years of experience
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Accomplished Clinical Research Associate with years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
I am also Detail-oriented, well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.
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Massachusetts General Hospital – Natick, MA,
• Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case
report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
Bd (Becton, Dickinson And Company) – Lyon, MS,
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Applied extensive knowledge to troubleshoot and resolve regulatory document issues.
- Submitted routine reports and follow-up letters to facilitate internal and external communication.
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
- Submitted routine reports and follow-up letters to facilitate internal and external communication.
- Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
- Conducted meetings with sponsor representatives to discuss clinical study developments.
- Assisted in investigator selection and qualification process to provide capable investigators with Jessicaquate resources to properly conduct trials.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
Biomarin – Novato, CA,
- Efficiently performed insurance verifications, pre-certifications and pre-authorization functions.
- Followed appropriate procedures to minimize patient's exposure to radiation.
- Prepared lab specimens for diagnostic evaluation.
- Oriented and trained new staff on proper procedures and policies.
- Collected and documented patient medical information such as blood pressure and weight.
- Liaised with patients and addressed inquiries, appointment requests and billing questions.
- Measured patient pulse oximetry.
- Measured patient spirometry.
- Updated inventory, expiration and vaccine logs to maintain current tracking documentation.
- Assisted with routine checks and diagnostic testing by collecting and processing specimens.
- Collected pertinent data and calculations to aid physician in interpreting results.
- Maintained detailed records of test results by entering data and patient information into computer.
First Choice Dental – Waunakee, WI,
- Established rapport and relationships with patients and external partners to cross-train and support medical staff.
- Reviewed each step of patient care and mJessica proactive adjustments to avert issues.
- Trained nurses and employees and fostered growth through consistent hands-on learning.
- Informed patients and caregivers on clearance procedures to maintain patient health and facilitate recovery goals.
- Aided in development and betterment of patient management and workflow processes.
- Measured effectiveness with team and implemented recommendations for long-term improvements.
- Cross-trained to support other medical staff with emphasis on establishing patient rapport and developing relationships with external partners.
- Explained upcoming treatment preparation, instructions and other facts to patients.
- Delivered excellent patient experiences and direct care.
- Completed documentation of care, hospital actions and patient activities.
- Performed in advisory resource capacity by providing patient and family care expertise.
- Maintained confidentiality of patient data and condition to safeguard health information.
- Liaised with pharmaceutical representative to schedule presentation appointments with physician.
- Maintained accurate and detailed inventories to keep sufficient supplies in pharmaceutical office.
- Managed prescriptions by sending electronic requests for new medications and refills.
- Resolved problems with communication and billing to foster seamless services.
- Updated policies and procedures, leading continuous improvement of resident assessments and care.
University of Lagos - Lagos,
- Member of Statistics Club
- Elected Captain of the Further Calculus and Statistics
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Resume Overview
School Attended
- University of Lagos
Job Titles Held:
- Clinical Research Associate I
- Clinical Research Associate
- Clinical Trial Assistant
- Patient Coordinator
Degrees
- Bachelor of Science
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