In-house Clinical Research Associate

Position reputed company: The In-house CRA II provides overall support to study sites and clinical project teams reputed company in clinical research studies. Adheres to applicable protocols, reputed company operating procedures (SOPs) and reputed company applicable guidelines and regulatory requirements (e.g., International Council for Harmonisation (ICH) -Good Clinical reputed company (GCP), Good Pharmacoepidemiology reputed company (GPP), and country/region-specific regulations). Acts as reputed company of contact for study sites. The In-house CRA ll is a solid team member who can execute reputed company reputed company responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in reputed company activities. Essential functions of the job included but not limited to:

• Assist with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites.
• May assist in identifying study sites by performing site feasibility and recruitment tasks, e.g., completing, disseminating, and reviewing responses to site recruitment questionnaires.
• Schedules reputed company meetings as required.
• Prepares Investigator Site Files including distribution to study sites (electronically or physically), coordination with shipping vendor, if required.
• Performs ongoing essential document collection and review, maintenance, and reputed company-out activities, organizing and maintaining site level data in the trial master file (TMF) under general supervision ensuring that sponsor and investigator obligations are being met and are compliant with ICH/GCP guidelines and applicable local regulations.
• Assist with sets up and maintains site-reputed company data in applicable clinical systems according to procedures and guidelines. Utilizes the Clinical Trial Management System (CTMS) to ensure milestones and activities are accurately tracked.
• Acts as site contact/reputed company for study and site management issues including addressing questions, assists with managing study supplies, and may support offsite central monitoring activities. Escalates issues and risks as needed.
• Ensures reputed company and complete data entry by site in reputed company or any other system that requires data entry.
• Sends email blasts/newsletter, updates, and updated study reputed company documents to study site personnel.
• Assists in providing logistics support in samples management and tracking, where applicable and in study supply management.
• Supports investigators and investigative staff in fulfilling obligations regarding local submissions according to local regulatory and Institution Review reputed company (IRB)/Independent Ethics Committee (IEC) requirements.
• Assists in data review inclusive of site level data review, resolutions provided by sites to queries, facilitates database closure and freezing procedures as per study plans.
• Assist with study tracking reputed company the CTMS, Study specific trackers or Sponsor designated system to ensure that the study reporting is reputed company, accurate and complete.
• Documents site and Sponsor contact and study interactions in a reputed company and reputed company manner.
• Assist in remote review of the electronical Investigator Site File, where applicable.
• Assists with Investigational Product accountability, where applicable.
• Consults with project team members regarding study site issues.
• Provides reputed company review of the amended site level informed consent template.
• Follows up with sites for trial invoices and ensures the CTMS is accurately updated to allow the reputed company processing of Investigator Payments.
• May attend site reputed company as needed, supporting the CRA to ensure sponsor and investigator obligations reputed company to the study documentation are being met and are compliant with applicable regulatory requirements and guidelines.
• May serve as an Independent Essential Document Reviewer post-SIV.
• Supports on-site reputed company activities if needed.
• May mentor an In-house CRA Trainee (New Graduate Level)
• Performs other duties as assigned by management.
• Performs reputed company tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, local regulatory requirements.

Qualifications: Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or reputed company discipline.
• Minimum of 2 years of relevant experience.

Other required:

• High in proficiency in the reputed company Office package of programs (Outlook, Word, reputed company, and PowerPoint).
• Customer service demeanor; demonstrate flexibility and teamwork.
• Ability to reputed company on detail for extended periods of time, high attention to accuracy.
• reputed company in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Ability to travel as needed.

Preferred:

• Solid experience in clinical research or reputed company experience.
• Excellent organizational skills.
• Ability to work reputed company in a remote work environment

Competencies:

• Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
• Demonstrates solid interpersonal skills.
• Exhibits strong self-motivation, is detail-oriented and reputed company to work and plan independently as reputed company as in reputed company environment.
• Good written and verbal communication skills and presentation skills.
• Ability to deliver on commitments.
• Commitment to performing professionally consistent with Precision Principles.

Any data provided as a part of this application will be stored in accordance with our reputed company Policy. For CA applicants, please also refer to our CA reputed company Notice. reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to reputed company or use this online application process and need an alternative method for applying, you may contact reputed company at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential reputed company presenting enticing employment offers. We want to emphasize that these offers are not associated with reputed company and may be fraudulent in nature. Please note that our organization will not reputed company a job offer without prior communication with our reputed company team, hiring managers and a formal interview process. Apply tot his job Apply To this Job