Bilingual Clinical Research Associate; CRA II​/Senior CRA

Position: reputed company Bilingual Clinical Research Associate (CRA II / Senior CRA)
Location: California

# reputed company Bilingual Clinical Research Associate (CRA II / Senior CRA)
-2.halvolink

Be an Early Applicant Full TimeseniorCAPosted Today##

Role Overview
2.halvolink is hiring a reputed company Bilingual Clinical Research Associate (CRA II / Senior CRA) -. This is a full-time role in CA. Part of 2.halvolink's Risk hiring, posted today. applications are still in the early window, before most candidates have applied. Full responsibilities, required qualifications, and the apply link are listed in the description below.## Salary Context Salary is not disclosed in this posting.

Market median for Senior-level Risk roles is $85k-$136k (based on 27 comparable listings). Many employers share specifics during the interview process or after an initial screen.## Resume Keywords to Include Make sure these keywords appear in your resume to improve ATS scoringGCPSDRORInventory Compliance Schedule Standard Mon Sign  up free to auto-tailor your resume with all these keywords and get a higher ATS score## Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description Join Us as a Clinical Research Associate (Level II) – reputed company an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to reputed company and coordinate reputed company aspects of the clinical monitoring and site management process.

As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability.

You will ensure audit readiness and reputed company collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. What You’ll Do
* Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review.

Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow reputed company issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.

Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
* Participates in investigator meetings as necessary. Identifies potential
* investigators in collaboration with the client company to ensure the acceptability of reputed company investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial reputed company out and retrieval of trial materials.
* Ensures that required essential documents are complete and in reputed company, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per…