Clinical Trial Assistant Resume
Headline : Responsible for set-up, tracking, and maintenance of study-specific investigator/site contracts including in-house management of documentation generated by the clinical sites.
Skills : Microsoft Office, Good Communication, Good Laboratory Practice, Professionalism, Hard Working, Compliance, Animal Care, Fantastic Time Management, Interpersonal Skills.
Description :
- Assists with the implementation and conduct of clinical research projects as delegated to assure successful achievement of quality, and financial outcomes.
- Maintain the Trial Master file Facilitate the shipment of study supplies to the investigational sites.
- Performs specific technical tasks/procedures and records data as assigned.
- Maintains inventory and track study supply returns from the sites at the end of the study
- Responsible for the maintenance of the tracking tool/database throughout the contracts process.
- Coordinates with the clinical project team and legal department in the distribution, retrieval, and negotiation of clinical trial agreements.
- Assures the accuracy of the final, executed clinical trial agreement.
- Maintains tracking tool for each clinical trial agreement within each study and resolves inquiries from investigator sites.
- Maintains communication with the clinical project team, legal department and study sites throughout the contract negotiation process and maintains related records.
Experience
5-7 Years
Level
Executive
Education
BS
Clinical Trial Assistant I Resume
Objective : Clinical Trial Assistant (CTA) is a member of the clinical research department who provides administrative support to the clinical team in the conduct of a study.
Skills : Microsoft Office, Microsoft Office, Microsoft Word, Budgeting, Excel, Fast Learner, Hipaa, Powerpoint, Team Player, Time Management.
Description :
- Responsible for evaluating potential investigators based on CRA feedback, past trial performance, and information reported to the FDA.
- Obtained signed CDAs from potential investigators, and performed site qualification visits.
- Provided access to RDC (Remote Data Capture) to global personnel at final sites, and ensured training and certifications before SIV.
- Collected and reviewed essential documents (Form 1572, Financial Disclosure Form, Protocol Signature Page, Investigator Brochure Receipt, etc.) for approval and archival.
- Responsible for vendor management, and coordinated with vendors to translate ICF into foreign languages for sites screening non-English speaking subjects.
- Collaborated with Clinical Pharmacy to ensure that the study drug is shipped and received prior to SIV.
- Reviewed Contract/Budgets to ensure that the fully executed CSA is in place prior to SIV.
- Tracked patient enrollment and test article supply.
Experience
2-5 Years
Level
Junior
Education
Certification
Sr. Clinical Trial Assistant Resume
Headline : Experienced Clinical Trial Assistant offering proven record effectively maintaining trial master files, reliably complying with GCP/ICH guidelines, and accurately performing quality control. Awarded and recognized as a dedicated team player who responds to sponsors' needs and guarantees quality performance. Excels in high-pressure environments using sharp focus, strong attention to detail, and personal drive to achieve all goals effectively.
Skills : EDC, CTMS, Microsoft Office, IVRS, ETMF, EMR.
Description :
- Prepared site binders and sent the binders to the various sites before site initiation.
- Followed-up with the study team to ensure all relevant documents are collected from the site after closeout visits.
- Budget negotiation with clinical sites and vendors for payments of services rendered.
- Ensured IP was shipped on time to the investigational site.
- Administered and coordinated logistical aspects of the clinical trials as per Standard Operating Procedures.
- Established and served as central contact between the contract laboratory, study team and study site.
- Managed on-site budget activities and logistical support for the clinical trial.
- Conducted and assisted with administrative activities as a member of the project team.
Experience
5-7 Years
Level
Executive
Education
BS
Associate Clinical Trial Assistant Resume
Objective : Clinical Research professional with an experience of over 5 years in Clinical research operations as Central CRA, Clinical Research Associate and Clinical Trial Assistant.
Skills : Microsoft Office Suite, Customer Service.
Description :
- Managing and monitoring clinical trial sites as per protocol, study-specific monitoring plan, ICH- GCP guidelines, sponsor SOPs and processes.
- Work in a team to review and understand the study protocol and the time-lines.
- Managing project activities comprising study start-up activities, site initiation, monitoring, close-out, and Database Lock.
- Conducting feasibility for Respiratory-Neuroscience and Ophthalmology therapeutic area projects and encouraging sites to deliver as per target.
- Conducting site selection visits thus ensuring robust investigator site pool.
- Maintain investigator site quality standards and undertake any relevant training for sites for the same as well as impart training to site personnel for any updates.
- Assisted CTLs with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Assisted with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
Experience
2-5 Years
Level
Junior
Education
PG
Jr. Clinical Trial Assistant Resume
Summary : Seeking to join a company that allows using the skills. A motivated quick learner, experienced in training and mentoring new hires.
Skills : Health Coaching, Microsoft Office, Customer Service.
Description :
- Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports.
- Assist with periodic review of study files for completeness.
- Assist CRS/IRS, CRAs/iCRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
- Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
- May accompany CRAs on-site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
- Perform assigned administrative tasks to support team members with clinical trial execution.
Experience
7-10 Years
Level
Management
Education
BS
Clinical Trial Assistant II Resume
Objective : Proficient and experienced in Clinical Trials Phases I-IV and in various Therapeutic Areas including but not limited to such as Oncology, Neuroscience, Diabetics, and Infectious Disease. Focused and motivated professional with an enthusiastic attitude looking to utilize the skills and the experience to best of the ability for the benefit of a pharmaceutical or biotechnology corporation.
Skills : Multitasking, Customer Service, Records Management.
Description :
- Interacted with external partners, including CRO personnel, to ensure timely and cost-effective conduct of high-quality clinical trials.
- Ensured compliance with the protocol and SOPs, regulations, and guidelines.
- Ensured proper maintenance of and communication with project team members, CRAs, and site personnel, as required.
- Assisted in the management and coordination of assigned clinical trials.
- Ensured appropriate distribution of documents, forms, supplies, equipment, laboratory samples, and study devices required for the execution of clinical trials.
- Oversaw study materials distribution to sites, as required.
- Drafted internal and external memos, reports, documents, and correspondence to assist in the ongoing management and coordination of assigned clinical trials.
Experience
2-5 Years
Level
Junior
Education
MBA
Clinical Trial Assistant III Resume
Summary : A highly versatile administrative professional known for consistently delivering outstanding results, meticulous attention to detail and a strong commitment to doing things right. Ability to effectively prioritize multiple tasks in a fast-paced environment.
Skills : Microsoft Word, Excel & PowerPoint, Outlook, Lotus Notes, Adobe Acrobat.
Description :
- Maintain and update clinical file systems and databases within project timelines.
- Accountable for accuracy and completeness of central investigator files for 80+ sites through site closeout.
- Assumed the role of Lead CTA during study closeout.
- Trained on all aspects of clinical trial file maintenance and regulatory document requirements.
- Collect and review protocol, study-specific and regulatory documents ensuring all required documentation is present and compliance requirements have been met.
- Record and track all incoming documents in designated Excel spreadsheets and/or databases; file according to authorized guidelines.
- Support the collection and tracking of study documentation as necessary.
Experience
10+ Years
Level
Senior
Education
Diploma
Clinical Trial Assistant - Part Time Resume
Summary : Clinical Trial Assistant is responsible for the support of clinical trials and related activities. This includes fabricating, processing and repackaging data, evaluating trial results and writing/reproducing reports.
Skills : Bilingual, Effective Interpersonal Skills, Good Knowledge Of Microsoft Word, Excel, Outlook And Power Point., Good Clinical Monitoring Skills And Customer Focus, Attention To Detail.
Description :
- Assisted with the preparation, planning, and execution of clinical trials.
- Assisted in preparation of documents including regulatory document templates, study binders, study communications, and presentations.
- Handled incoming and outgoing shipments, as needed.
- Assisted with all aspects of initial study drug release including regulatory packet review and study-drug release.
- Assisted in the preparation of study-specific training materials.
- Participated in the planning of investigator meetings.
- Assisted in the development of case report forms and participated in the EDC and IVRS specification process, as appropriate.
- Filed clinical documents and maintained clinical research files.
Experience
7-10 Years
Level
Management
Education
BS
Clinical Trial Assistant-Manager Resume
Objective : Responsible for Supporting Project Manager with financial tasks, oversaw of purchase order process including creating and processing, and also Organizing project team and client meetings including scheduling, meeting materials, binders, agendas and meeting minutes.
Skills : Microsoft Office Suite, Records Management, Bilingual.
Description :
- Maintained trial master file for start-up, maintenance, and close-out studies in oncology, nephrology, endocrinology, and neurology.
- Collaborated with clinical teams as their central contact for designated project communications, correspondence, and documentation.
- Represented study teams and responded to inquiries from the FDA and sponsor audits.
- Strategized with trial sponsors to optimize their study designs and avoid obstacles.
- Trained team members on updated documentation protocols and ensured they kept accurate files for all projects.
- Reviewed study files for completeness and accuracy.
- Embraced project and program leadership roles on all protocols within 2 months of hire.
Experience
2-5 Years
Level
Junior
Education
BS
Clinical Trial Assistant - Specialist Resume
Objective : Clinical Trial Assistant is responsible for assisting with the management of clinical trials. This includes helping to administer, organize and record data, as well as oversee the research team.
Skills : Project Management, Data Entry, Customer Service.
Description :
- Processes clinical records and forms; updates and maintains clinical trackers; reports site/study status to the Clinical Study Team.
- Reviews required site documentation to remain current during the conduct of a study.
- Identifies potential compliance gaps as instructed.
- Completes data entry and maintains clinical study research's electronic and paper-based filing systems.
- Ensures all required documentation has been obtained by the company and is also available in the Investigators Site Files.
- Prepares study and site regulatory binders and miscellaneous study materials.
- Coordinates the distribution of communications to all sites.
Experience
2-5 Years
Level
Junior
Education
BS
Clinical Trial Assistant Resume
Headline : Clinical Trial Assistant with excellent interpersonal and organizational skills. Recognized for attention to detail. Project management capabilities with proven ability to work independently and with a team.
Skills : Electronic Medical Record Systems, and Data Systems: Cerner, Epic, Redcap Strong Microsoft Office Skills Including Word, Excel, Powerpoint, And Access Database.
Description :
- Screen and consent potential research subjects for inclusion into clinical research trials.
- Conduct and coordinate experimental sessions with participants following the study protocol.
- Collect data from patients according to research protocols.
- Training potential participants on study procedures and compliance.
- Interpret and record lab values for study physicians.
- Interpret data collected from patients and enter data into a database in a reasonable timeframe.
- Review and monitor documents for completeness and compliance of protocol and regulations.
- Create, classify, and monitor adverse events following study protocol.
Experience
5-7 Years
Level
Executive
Education
BS
