Senior Clinical Research Associate

Elechi Wegh

Email: *********@*****.*** Phone: 845-***-****

Professional Summary

Results-driven Clinical Research Professional with over 11 years of comprehensive experience across all phases of clinical trials (Phase I–IV). Proven expertise in site monitoring, regulatory compliance, subject safety, and data integrity. Skilled in fostering strong site relationships, leading monitoring activities, and ensuring adherence to FDA and ICH/GCP guidelines. Proficient with clinical trial systems including CTMS, EDC, eTMF, and IRT.

Therapeutic Areas

Oncology- Solid Tumor, Prostate Cancer, Lung Cancer, Ovarian Cancer, Gastrointestinal Stromal Tumors

Cardiovascular: Hypertension, Myocardial Infarction Neurology: Pain, Parkinson’s Disease, Alzheimer Disease, Multiple Sclerosis Endocrine: Obesity

Professional Experience

Senior Clinical Research Associate II COVANCE May 2020 – Present

• Performed routine and remote monitoring visits and managed site closure activities.

• Reviewed protocols thoroughly to ensure in-depth understanding of study requirements.

• Facilitated site selection and conducted personnel training pre-study and throughout the trial.

• Led initiation, interim monitoring, and close-out visits across multiple investigator sites.

• Served as the primary liaison to convey updates and resolve site-level issues.

• Supported audit readiness and assisted during inspections, providing timely responses.

• Collaborated with clinical teams to maintain adherence to study timelines.

• Oversaw investigator/site selection and ensured required documentation was in place.

• Prepared presentations and training materials for investigator and coordinator meetings.

Clinical Research Associate II IQVIA May 2018 – May 2020

• Provided operational and logistical support for the development of clinical trial documentation.

• Assisted in evaluating investigative sites and participated in co-monitoring activities.

• Executed all visit types including PSSV, SIV, IMV, and COV in compliance with SOPs.

• Drafted timely and accurate follow-up letters and reports post-visit.

• Ensured timely resolution of queries and submission of final monitoring reports.

• Identified site issues and proposed corrective action plans to maintain compliance.

• Managed essential and non-essential site documentation in accordance with ICH-GCP and regulatory requirements.

• Reconciled site files and verified completeness and accuracy of regulatory documentation.

• Verified source data accuracy, initiated and resolved data queries promptly. Clinical Research Associate I MEDPACE February 2016 – May 2018

• Monitored study participant safety, data integrity, and protocol compliance.

• Maintained adequate supplies at trial sites and ensured inventory control.

• Tracked subject recruitment progress and data query resolutions.

• Oversaw investigational product (IP) management and compliance.

• Verified drug accountability, batch tracking, and storage per protocol.

• Submitted trip reports within defined timelines and quality standards.

• Supported subject enrollment through recruitment strategies and site engagement.

• Ensured sites followed ICH/GCP and protocol standards for trial execution.

• Conducted site visits and trained site staff on study and regulatory procedures. Clinical Research Associate MEDPACE July 2013 – February 2016

• Co-monitored with senior CRAs during study start-up, monitoring, and close-out visits.

• Resolved site issues with the support of clinical project teams.

• Maintained clinical trial tracking and monitoring systems for oversight.

• Prioritized tasks independently while meeting project milestones.

• Ensured compliance with study timelines through departmental collaboration.

• Participated in site/investigator selection and feasibility assessments.

• Prepared site materials and coordinated investigator meetings.

• Monitored regulatory documentation from initiation through close-out.

• Validated informed consent documentation and subject eligibility. Clinical Research Coordinator Bronx Lebanon Hospital April 2009– June 2013

• Provided administrative and clerical support to clinical project teams.

• Managed study tracking logs and maintained updated status reports.

• Compiled and distributed study-related materials and forms.

• Reviewed and processed regulatory and administrative documents.

• Ensured site documentation was accurate and compliant with guidelines.

• Coordinated study supply requests and issue resolution.

• Reviewed study data tables and listings for accuracy.

• Supported project planning and updates to project management tools.

• Maintained regulatory tracking logs and managed site communications. Education

Registered Nursing – Helene Fuld College of Nursing 2017

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