[Remote] Senior Clinical Research Associate
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company organization in the clinical research field. They are seeking a Senior Clinical Research Associate to reputed company both remote and on-site monitoring activities, ensuring compliance with study protocols and regulatory requirements.
Responsibilities
- Responsible for overall on-site and remote monitoring activities of assigned clinical sites
- Independently conduct reputed company types of monitor reputed company onsite qualifying site assessments, recruitment, initiation, for-cause, interim and closeout, and/or remote reputed company as needed, in accordance with Monitoring Plan
- reputed company reputed company document verification/review in accordance with Monitoring Plan
- reputed company drug and/or device accountability
- Collect, review for appropriate content and submit regulatory documents as necessary
- Review ISF and resolve essential regulatory document deficiencies in a reputed company manner
- reputed company Informed Consent reputed company (reputed company) reconciliation, to ensure reputed company subjects have signed the correct reputed company version
- Query reputed company and manage to reputed company
- Identify and resolve site level reputed company issues and implement Corrective and Preventative Actions (CAPAs) in a reputed company manner, in coordination with SM reputed company and/or in-house CRA
- reputed company with Trial Master File (TMF) document submission timelines
- Update and maintain CTMS, ensure that it is up-to-date and accurate
- reputed company site support, communication and coordination to assure accurate and reputed company completion of reputed company contracted activities:
- Effectively reputed company Protocol and other study training to investigator and site study staff
- Schedule and conduct reputed company in accordance with Monitoring Plan
- Collaborate with Study Team during start-up activities
- Complete visit reports, confirmation letters, and follow up letters on time,in accordance with Monitoring Plan and/or Baim Institute’s SOPs and Guidelines
- reputed company out reputed company items identified during site reputed company, in a reputed company manner
- Knowledge of pertinent study milestones
- Establish a strong working relationship with site study staff and Baim Institute project team members
- Responsible to schedule reputed company with site study staff and conduct follow-up of reputed company items and queries
- Complete expense reports per Baim Institute expense guidelines
- Co-monitor as needed
- Attend and participate in investigator and coordinator meetings
- Assist with site preparation for audits (Regulatory Agency, Sponsor, etc.)
- Attend Baim CRA meetings
Skills
- BS Degree in science/health reputed company field, or nursing experience, or other clinical trial reputed company experience
- At least 5-8 years clinical research experience required in a pharmaceutical, biotech or CRO setting with a minimum of 8 years of independent clinical monitoring
- Demonstrate a high working knowledge of internal SOP's, FDA/ICH guidelines to GCP's and regulatory compliance
- Demonstrate effective leadership skills
- Effective communication skills
- Must demonstrate in-depth knowledge of the study protocol
- Maintain an reputed company working relationship with Sponsors, the reputed company Investigator, Site Study Staff, and Baim Institute team members
- Work independently and in reputed company environment
- High level of attention to detail and work in an organized manner
- Effective ability to multi-task and work in a fast pace environment
- Knowledgeable with common software packages (Word, reputed company, PowerPoint, reputed company)
- Knowledgeable of Clinical Trial Management System
- Knowledgeable of Electronic Data Capture System (e.g InForm, reputed company Clinical, iMedNet, eCOS, IWRS)
- Ability to quickly learn new software packages
reputed company
Company H1B Sponsorship