FSP CRA I / CRA II - U.S. South Central Region - Multiple Therapeutic Areas

The hiring employer is not identified in the posting. The FSP Clinical Research Associate monitors clinical trial sites, supports site management and regulatory compliance, and helps ensure participant welfare and data reliability for a sponsor.

Health Care

• Life Science
• Pharmaceutical
• Artificial Intelligence (AI)
• Accounting
• Human Resources
• Healthcare
• Publishing
• Biopharma
• Bookkeeping and Payroll
• Employment
• Freelance

Responsibilities

• 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 all 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
• Engages directly with sponsor staff and complimentary workers on a daily basis
• Investigators in collaboration with the client company to ensure the acceptability of qualified 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 close out and retrieval of trial materials
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System)
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts
• Responds to company, client and applicable regulatory requirements/audits/inspections
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner
• Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members
• Contributes to other project work and initiatives for process improvement, as required

Benefits

• Remote work arrangement
• AI-powered talent hiring platform for life sciences, pharma, and IT.
• London, England, GBR
• https://lifelancer.com
• Total Funding
• $0.68M
• 2025-03-01
• Pre Seed· $0.24M
• 2024-03-01
• Pre Seed· $0.11M
• 2023-03-01
• Pre Seed· $0.12M
• Leadership Team
• Jayesh Pandya
• Co-Founder & CEO
• Company data provided by
• AI Tools
• Customize Your Resume
• Maximize your interview chances
• Build Cover Letter
• Make your application stand out
• Analyze How Well You Fit
• Understand your strength & weakness

Qualifications

• Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship
• Valid driver's license where applicable
• Proven clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• Ability to remain flexible and adaptable in a wide range of scenarios
• Ability to work in a team or independently as required
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

Required skills

• Clinical Monitoring, Clinical Trial Management Systems, ICH-GCP, Medical Terminology, Microsoft Office, Risk-Based Monitoring, Root Cause Analysis, Therapeutic Area Knowledge

Experience

• 1+ years