Clinical Trial Assistant Resume Samples

Description :

1. Assisted in the implementation and conduct of clinical research projects, ensuring quality and financial outcomes.
2. Maintained the Trial Master File and facilitated the shipment of study supplies to investigational sites.
3. Performed technical tasks and recorded data accurately as assigned.
4. Managed inventory and tracked study supply returns from sites at the end of the study.
5. Maintained tracking tools and databases throughout the contract process.
6. Coordinated with project teams and legal departments for clinical trial agreements.
7. Ensured accuracy of final executed clinical trial agreements and resolved inquiries from investigator sites.

Experience

5-7 Years

Level

Executive

Education

BS

Description :

1. Evaluated potential investigators based on CRA feedback and past trial performance to ensure quality site selection.
2. Obtained signed CDAs from investigators and conducted thorough site qualification visits.
3. Provided access to RDC Remote Data Capture for global personnel, ensuring training and certifications were completed before SIV.
4. Collected and reviewed essential documents such as Form 1572 and Financial Disclosure Forms for approval and archival.
5. Managed vendor relationships, coordinating translations of ICF for non-English speaking subjects.
6. Collaborated with Clinical Pharmacy to ensure timely shipping and receipt of study drugs prior to SIV.
7. Reviewed contract budgets to confirm fully executed CSAs were in place before SIV.

Experience

2-5 Years

Level

Junior

Education

Certification

Description :

1. Prepared and organized site binders, ensuring timely delivery to sites pre-initiation.
2. Coordinated with study teams to collect essential documents post-closeout visits.
3. Negotiated budgets with clinical sites and vendors for service payments.
4. Ensured timely shipment of investigational products to trial sites.
5. Administered logistical aspects of clinical trials in compliance with SOPs.
6. Served as the primary contact between laboratories, study teams, and sites.
7. Managed budget activities and logistical support for clinical trials.

Experience

5-7 Years

Level

Executive

Education

BS Biology

Description :

1. Oversee clinical trial sites, ensuring adherence to protocols, ICH-GCP guidelines, and sponsor SOPs.
2. Collaborate with teams to review study protocols and timelines for effective project execution.
3. Manage project activities including site initiation, monitoring, and database lock to ensure timely delivery.
4. Conduct feasibility assessments for various therapeutic areas, optimizing site selection and performance.
5. Perform site selection visits to establish a robust pool of qualified investigators.
6. Maintain high-quality standards at investigator sites, providing necessary training and updates to site personnel.
7. Facilitate communication between sites and sponsors to resolve issues and enhance trial efficiency.

Experience

2-5 Years

Level

Junior

Education

PG

Description :

1. Assist clinical teams in preparing, handling, and archiving clinical documentation and reports.
2. Conduct periodic reviews of study files to ensure completeness and compliance.
3. Support CRAs with the distribution of Clinical Trial Supplies and maintain tracking information.
4. Manage Case Report Forms (CRFs) and clinical data flow, ensuring accuracy and timeliness.
5. Accompany CRAs on-site visits to assist with monitoring duties after training completion.
6. Perform administrative tasks to support clinical trial execution and team collaboration.
7. Ensure adherence to Good Clinical Practice (GCP) guidelines throughout trial processes.

Experience

7-10 Years

Level

Management

Education

BSc CR

Description :

1. Collaborated with CROs and external partners to ensure efficient and compliant clinical trial execution.
2. Monitored adherence to protocols, SOPs, and regulatory guidelines throughout trial phases.
3. Maintained effective communication with project teams, CRAs, and site personnel to support trial progress.
4. Assisted in the planning and coordination of clinical trials, ensuring timely completion of milestones.
5. Managed distribution of essential trial documents, supplies, and equipment to facilitate smooth operations.
6. Oversaw the logistics of study materials, ensuring timely delivery to trial sites.
7. Prepared and distributed internal and external communications to support trial management activities.

Experience

2-5 Years

Level

Junior

Education

BS Biology

Description :

1. Maintain and update clinical file systems and databases, ensuring project timelines are met.
2. Ensure accuracy and completeness of central investigator files for 80 sites during closeout.
3. Acted as Lead CTA during study closeout, overseeing documentation processes.
4. Trained team members on clinical trial file maintenance and regulatory requirements.
5. Reviewed protocol and regulatory documents to ensure compliance and completeness.
6. Tracked incoming documents in Excel and databases, adhering to guidelines.
7. Supported collection and tracking of study documentation as needed.

Experience

10+ Years

Level

Senior

Education

B.S. Biology

Description :

1. Coordinated the preparation of regulatory documents, study binders, and presentations to support clinical trials.
2. Managed incoming and outgoing shipments of clinical trial materials efficiently.
3. Oversaw initial study drug release processes, ensuring compliance with regulatory requirements.
4. Developed and maintained study-specific training materials for clinical staff.
5. Organized and facilitated investigator meetings to enhance study collaboration.
6. Contributed to the design of case report forms and participated in EDC and IVRS processes.
7. Maintained accurate clinical research files and documentation for audits and inspections.

Experience

7-10 Years

Level

Management

Education

BSc CR

Description :

1. Maintained trial master files for oncology, nephrology, endocrinology, and neurology studies, ensuring accuracy and compliance.
2. Served as the primary contact for clinical teams, facilitating effective communication and documentation.
3. Represented study teams during FDA and sponsor audits, ensuring all inquiries were addressed promptly.
4. Collaborated with trial sponsors to enhance study designs and mitigate potential challenges.
5. Trained team members on documentation protocols, ensuring adherence to regulatory standards.
6. Assumed leadership roles in project management within two months of hire, driving team success.
7. Monitored study progress and compliance, providing regular updates to stakeholders.

Experience

2-5 Years

Level

Junior

Education

BS Biology

Description :

1. Processes clinical records and updates, maintaining clinical trackers and reports for the study team.
2. Reviews site documentation to ensure compliance during study conduct.
3. Identifies compliance gaps and implements corrective actions as needed.
4. Completes data entry and maintains electronic and paper filing systems for clinical studies.
5. Ensures all required documentation is obtained and organized in the Investigator Site Files.
6. Prepares regulatory binders and study materials for site visits and audits.
7. Coordinates communication and documentation distribution to all study sites.

Experience

2-5 Years

Level

Junior

Education

BSc CR

Description :

1. Screen and consent potential research subjects for clinical trials, ensuring adherence to protocols.
2. Coordinate experimental sessions with participants, following study protocols to maintain integrity.
3. Collect and manage data from patients, ensuring accuracy and compliance with research protocols.
4. Train participants on study procedures, enhancing compliance and understanding of protocols.
5. Interpret and record lab values for physicians, facilitating informed clinical decisions.
6. Enter patient data into databases promptly, ensuring data integrity and availability for analysis.
7. Review documents for completeness and compliance with regulatory standards, ensuring trial integrity.

Experience

5-7 Years

Level

Executive

Education

BSc CR