SHUMIRAI D MACHAPU

Charlton, MA *****

508-***-**** adx491@r.postjobfree.com adx491@r.postjobfree.com

Objective

Seeking a challenging position as a Clinical Research Associate to further develop my clinical research skills and contribute my knowledge and experience in the healthcare sector. Skilled in drug safety, case processing, medical records management, clinical activities coordination, data management, SAE reporting, GCP auditing, regulatory compliance, data management, monitoring, and communication.

Personal Attributes

Clear and kind communication skills – both written and verbal.

Excellent attention to detail.

Exceptional organizational skills.

Ability to prioritize and multi-task.

Quick learner and self-motivated.

Proactive and flexible.

Willingness to go the extra mile to meet deadlines.

Strong teamwork and independent work capabilities.

Effective time management.

Professional Experience.

Clinical Research Associate in-house/Regional CRA I Premier Research Company 2020 - Present

Provide regular site status information to team members and trial management, updating trial management tools.

Conduct initiation visits and collaborate with Project Managers (PMs) to select sites and develop project plans.

Communicate with Clinical Monitoring Associates regarding site issues and actions prior to planned visits.

Review site-level data in clinical systems, evaluate data quality issues, and implement follow-up responses.

Conduct on-site study-specific training and perform site facilities inspections and collection of regulatory issues.

Assess the qualifications of potential investigative sites, initiate clinical trials, instruct site personnel on proper conduct, and close clinical trials at investigative sites.

Handle document collection and email correspondence with sites.

Assist in evaluating vendor performance during the study.

Prepare and review protocols, eCRFs, study manuals, and other study documents as requested.

Verify accuracy of clinical trial data collected, both onsite and remotely.

Maintain regular communication with study sites via email and/or teleconference, providing study updates and contact reports to the sponsor.

Demonstrate expertise in clinical study processes, drug development, and medical devices.

Utilize IT literacy, particularly in Word, Excel, and PowerPoint.

Implement and monitor clinical trials to ensure sponsor and investigator obligations are met, complying with local regulations, regulatory requirements, and ICH/GCP guidelines.

Work independently with minimal oversight required.

Coordinate with external study sites and collaborate with other clinical team members to resolve trial and/or clinical issues.

Possess extensive experience in audit situations.

Perform essential document site file reconciliation and follow up with sites on submissions of AE's or SAEs.

Conduct source document verification and resolve queries.

Work within a regulated environment.

Complete monitoring activity documents as required by SOPs or other contractual obligations.

Clinical Research Coordinator Beaumont Group of Hospitals, Dearborn, MI 2019-2020

Carried out specific research studies and scanned the environment to enable management to formulate and develop business strategies.

Gathered, analyzed, and interpreted data to identify opportunities to improve clinical research.

Reviewed and compared source documentation to CRFs to ensure data completeness and accuracy.

Assisted in the development of protocols and case report forms.

Provided data analytic support for audits and monitor visits.

Ensured the collation of strategies that measure the operational and financial performance of the company and produced relevant management reports.

Implemented corporate ideas and strategies.

Participated in the review and comparison of study-specific site documents.

Created awareness and generated national interest in our products.

Developed and implemented policies, strategies, and plans.

Brain Injury Residential Manager Advocates Inc., Framingham, MA 2017-2019

Managed day-to-day operations of the program.

Recruited patients and collaborated with medical professionals to determine changes in subjects' conditions.

Coordinated laboratory samples and compiled data.

Managed budgets and ensured compliance with GCP regulations.

Served as a mediator between the state and residents for regulatory complaints.

Conducted quality control evaluations for safety.

Provided microbiology lab support to clinical programs.

Supported Product Development Lab within House Clinical Study (ICS) screening and verification testing during development.

Conducted study site feasibility assessments and qualification visits.

Managed and coordinated cross-functional project teams.

Served as the primary project contact with the Sponsor (Customer).

Monitored team performance against contract, customer expectations, and project baselines.

Education

Nursing Certification

Bachelor's in Marketing Monash University South Africa (Double Major in Marketing Management)

Technical Experience

MS Office

Veeva Vault

Inform

Medidata

CTMS

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