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Our growing company is currently searching for a Clinical Research Assistant to join our friendly and patient-centric team. Spanish speakers are encouraged to apply! The perfect candidate will be experienced in clinical trials, a team player and have an interest in working in a multicultural environment.
Responsibilities
The Clinical Research Assistant is responsible to assist in multiple research studies and ensures that regulatory requirements are followed including adherence to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP)
Job Duties Include:
Additional Requirements
· Responsible for daily maintenance of ISFs
· IRB communication, filing, submissions (initial reports, closure reports, deviations, site changes submissions), reporting in a daily basis
· Email correspondence with the site (SCs, PIs, sub-Is, other staff), filing various documentation
· Prepare ISFs for IMVs, COVs, - resolving action items and assisting with questions from the monitors
· SIVs – initial submissions, collecting initial packet documents
· Using variety portals
· Following company SOPs, using working practices and reference documentation
· Assist with procedures for initiation, execution and termination (close out visits)
· Assist with supporting study startup process, collecting and providing Sponsors with regulatory documents (1572, FDFs, signature pages, other forms), interaction with PIs, research, clinical and administrative staff, provide back up and updates to the study team, attending SIVs, creating and filing training for staff, DOA logs
· Post initial IRB submissions - CRRFs, modifications, translation requests, IRB queries, termination reports
· Maintain ISF binders including complete forms, logs, filing CV, MLs, 1572 forms,
FDFs, signature pages, IRB approvals, Protocols, IBs, ICFs, ICFs tracking log,
safety portals correspondence, and lab documentation
· Attending daily department meetings, following deadlines, conference calls, adherence to the company SOPs
· Ensure the protection of study patients and compliance with the Good Clinical Practice ICH/GCP
· Assist to screen subject for eligibility, documenting eligibility of each potential participant, assist PI to enroll patients using specific inclusion / exclusion criteria
· Conduct daily trial visits according to the protocol, schedule patient`s visits, phone calls
· Collect and maintain accurate study data, complete CRFs as instructed, ensuring that CRFs are completed prior to monitoring visits, IWRS randomization
· Report serious adverse events and answer raised queries
· Maintains source and essential documentation
· Review ICFs, perform investigational product accountability, complete IP, temperature logs etc.
· Compliance with good clinical practices ICH/GCP regulations, specific requirements of the Sponsor/CRO and regulatory authorities
Education and Qualifications
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to speak and hear.
This role requires continuous activity levels in areas such as walking, standing, pushing, pulling, lifting, and reaching. It also requires dexterity in motion/flexibility. Ability to lift, push or pull 35 or more.
Work Environment: This job operates in a clinic and procedure room environment. There is potential to be exposed to blood, tissue, and bodily fluids.
Occasional exposure to communicable diseases and biohazards. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill and/or ability required.
Job Type: Full-time
Pay: $18.00 - $20.00 per hour
Benefits:
Medical specialties:
Physical setting:
Schedule:
Education:
Experience:
Language:
Ability to Commute:
Work Location: In person
Full Time
$77k-109k (estimate)
04/11/2024
06/10/2024
The job skills required for Clinical Research Assistant (Spanish speakers encouraged to apply!) include Clinical Research, Clinical Trial, Data Entry, Accountability, Phlebotomy, SOP, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Research Assistant (Spanish speakers encouraged to apply!). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Research Assistant (Spanish speakers encouraged to apply!). Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Research Assistant (Spanish speakers encouraged to apply!) positions, which can be used as a reference in future career path planning. As a Clinical Research Assistant (Spanish speakers encouraged to apply!), it can be promoted into senior positions as a Clinical Research Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Research Assistant (Spanish speakers encouraged to apply!). You can explore the career advancement for a Clinical Research Assistant (Spanish speakers encouraged to apply!) below and select your interested title to get hiring information.
If you are interested in becoming a Clinical Research Assistant, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Clinical Research Assistant for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Clinical Research Assistant job description and responsibilities
Certifications are also available for this position through The Society of Clinical Research Associates (SOCRA) and The Association of Clinical Research Professionals.
01/04/2022: Santa Barbara, CA
Analyze and evaluate clinical data gathered during research.
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Provide regular report updates of the progress of clinical studies to the appropriate personnel.
03/23/2022: Santa Cruz, CA
These clinical trials are very much regulated and seriously monitored to ensure that they comply with the laid down regulations.
01/04/2022: Frankfort, KY
Must be able to ensure that data gotten from clinical trials are accurate and reliable and the legal rights and privacy of the subjects are protected.
02/02/2022: Racine, WI
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Clinical Research Assistant jobs
Fact-checking, editing, and proofreading research documents for accuracy and consistency.
01/16/2022: Green Bay, WI
Research Assistants provide support to research teams who are conducting experiments or gathering and analysing data.
03/14/2022: Provo, UT
Maintained FDA clinical trial documentation for department and received excellent FDA audits of records.
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Have strong customer focus and good communication skills
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For example, clinical research associate candidates should have excellent attention to detail and organizational skills since they’re responsible for monitoring and reporting on the results of clinical trials.
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Step 3: View the best colleges and universities for Clinical Research Assistant.