Clinical Trial Assistant Resume Example

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Jessica Claire
  • , , 100 Montgomery St. 10th Floor
  • Home: (555) 432-1000
  • Cell:

Highly motivated pharmacist offering 10 years+ of experience ensuring accurate review, processing and dispensing of medications in alignment with orders. Skilled in collaborating with team members to expedite urgent requests while maintaining impeccable focus on safety, accuracy and confidentiality. Advanced communicator with all levels of staff, clients, management and healthcare administrators. Possess remarkable knowledge of ICH-GCP, GVP and FDA regulatory requirements and guidelines both clinical and post marketing. Experienced in providing in-depth information and specific product prescribing information, clinical studies and medical letters within various therapeutic areas. Detail oriented professional proficient in wide variety of computer systems. Experienced in AE/SAE documentation and clinical trial management.

  • Excellent organizational and documentation skills
  • Excellent interpersonal and communication skills
  • Data entry documentation, Narrative writing
  • Working knowledge of medical terminology
  • Proven ability to multi-task, manage competing priorities and timelines
  • Excellent leadership skills
  • Competence in MS Office Applications (MS Word, Outlook, Access, Excel)
  • Knowledge of MedDRA and WHODRUG coding dictionaries
  • Strong sense of responsibility and dedication
  • Detail oriented with a high degree of accuracy
  • Ability to work independently and cooperatively with teams
  • Good Clinical Practice (GCP)
  • Good Vigilance Practice (GVP)
Clinical Trial Assistant, 06/2021 to Current
Planet PharmaRichmond, VA,
  • Provided administrative support to ensure studies are conducted and documented in accordance with standard operating procedures, good clinical practices and other applicable regulatory requirements.
  • Set up, organized and maintained clinical study documents and ensured preparation for internal and external audits.
  • Assisted project teams with trial progress tracking by updating the clinical trial management systems.
  • Interacted with internal and external stakeholders to support clinical study objectives.
  • Ensured completeness and compiled regulatory documents and ethical submission documentation as appropriate and required.
  • Provided applicable updates for site related documentation for filing in the Trial Master File (TMF).
  • Maintained regular communication with teams to assist with query resolution.
  • Prioritized and organized tasks to efficiently accomplish service goals.
  • Juggled multiple projects and tasks to ensure high quality and timely delivery.
  • Worked on clinical research trials involving Oncology and infectious diseases.
Clinical Research Associate Intern, 01/2021 to Current
Aliso Ridge Behavioral Health & Anaheim Community HospitalAliso Viejo, CA,
  • Checked electronic data capturing systems for integrity and compliance.
  • Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
  • Maintained strict confidentiality to keep all personal information and collected data private.
  • Performed site qualification, site initiation, interim monitoring, and close-out visits.
Staff Pharmacist, 09/2019 to 06/2021
Yale-New Haven HealthUncasville, CT,
  • Interpreted prescriptions from healthcare providers to properly dispense medications and health products.
  • Assessed correct identity, strength and purity of medications when filling prescriptions.
  • Communicated complex medical information with physicians, nurses, insurance companies and managed care organizations.
  • Complied with all federal laws, company policies and procedures and state regulations regarding intern, technician and assistant training and licensure.
  • Provided impeccable customer service to help with building and maintaining customer relationships.
  • Reported adverse events to FDA adverse event reporting system (FAERS) and vaccine adverse event reporting system (VAERS).
  • Followed drug storage procedures to comply with protocols and Standard Operating Procedures (SOPs) requirements.
  • Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
  • Monitored compliance metrics and ensure appropriate documentation when deficient.
  • Prioritized and organized tasks to efficiently accomplish service goals.
  • Analyzed prescribing trends to monitor patient compliance and prevent excessive usage.
  • Mitigated regulatory risks by coordinating audits to comply with protocols.
  • Assessed safety procedures and federal regulations to maintain pharmacy compliance.
Pharmacy Intern, 08/2014 to 10/2018
Rite AidCity, STATE,
  • Compared prescription details against safety standards and insurance requirements to support patients.
  • Used pharmacy software to enter prescription and insurance information.
  • Interacted with healthcare professionals to support timely and proper processing of prescriptions.
  • Entered patient data to pharmacy database with strong focus on accuracy.
  • Communicated closely with patients, ensuring medical information was kept private.
  • Communicated with patients to collect information about prescriptions and medical conditions or arrange consultations with pharmacists.
  • Identified needs of customers promptly and efficiently.
Education and Training
Doctor of Pharmacy: PHARMD, Expected in 05/2018
Wingate University School of Pharmacy - Wingate, NC,
Bachelor of Arts: Chemistry, Expected in 05/2014
University of North Carolina At Charlotte - Charlotte, NC,
  • Licensed Pharmacist.
  • Medical Therapy Management (MTM).
  • Good Clinical Practices certificate (ICH-GCP).
  • IATA certificate.
  • Clinical Research Associate Training.

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Resume Overview

School Attended
  • Wingate University School of Pharmacy
  • University of North Carolina At Charlotte
Job Titles Held:
  • Clinical Trial Assistant
  • Clinical Research Associate Intern
  • Staff Pharmacist
  • Pharmacy Intern
  • Doctor of Pharmacy
  • Bachelor of Arts

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