Clinical Research Associate

3 weeks ago

San Diego, United States Viva USA, Inc. Full time

Title: Clinical Research Associate (CRA) - Onsite

Description:

Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary. 3-5 Years Experience Level.

RESPONSIBILITIES:

Carry out assigned functions applying knowledge and skill in an accurate, timely manner.

Apply knowledge of FDA regulations to site monitoring and clinical study design duties.

Monitor and maintain necessary supplies, with approval by senior department staff.

Maintain effective, professional, timely, and consistent communications with clinical sites both in person, and via all available correspondence media (telephone, email, web, etc.)

Support and/or lead clinical research study start up activities (includes creation of study binders, study logs, work instructions, case report form, and other study related materials)

Ability to train site personnel on study activities including investigational product usage, maintenance and accountability, sample collection, testing and shipping, data entry and query resolution

Study monitoring (includes assessing the familiarity of the site personnel with the protocol, procedures and investigational product, assessing protocol compliance and investigational product accountability as applicable, source document verification, identifying protocol deviations, writing queries, writing monitoring reports, notes to file, and other documentation as necessary)

Independent site management skills to assist with study problem identification and solving, and ensure timely study progression

Understanding of clinical research activities including tasks associated with study start up, interim monitoring, close out, data collection and central files

Team player able to deliver on project timelines.

Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships

Other duties as assigned, according to the changing needs of the business.

Education:

Bachelors Degree or Higher Looking to start selected candidate ASAP after screenings clear Top 3 skills you’re looking for on resume:

• 1) on-site and remote monitoring experience 2-5 years.

• 2) experience with study start up, monitoring, and close out activities

• 3) ability to work independently, get training done and able to hit the ground quickly.

Apply knowledge of FDA regulations to site monitoring and clinical study design duties. Monitor and maintain necessary supplies, with approval by senior department staff. Maintain effective, professional, timely, and consistent communications with clinical sites both in person, and via all available correspondence media (telephone, email, web, etc.) Support and/or lead clinical research study start up activities (includes creation of study binders, study logs, work instructions, case report form, and other study related materials) Ability to train site personnel on study activities including investigational product usage, maintenance and accountability, sample collection, testing and shipping, data entry and query resolution. Study monitoring (includes assessing the familiarity of the site personnel with the protocol, procedures, and investigational product, assessing protocol compliance and investigational product accountability as applicable, source document verification, identifying protocol deviations, writing queries, writing monitoring reports, notes to file, and other documentation as necessary)

Note :

Onsite

9:00 - 5.00

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