Sr Clinical Research Associate I

Clinical Research Associate I

• Location: Remote / Home office located near major cities in NC, FL, GA, NY, NJ, PA
  
• Travel: Regionally aligned for East Coast travel (up to 80% as needed)
  
• Employment Type: W-2 hourly, full-time contract (6 months with potential to extend )
  
• Pay Rate: $55.86 – $62.07/hour door-to-door (limited benefits options available)

Summarized Purpose

Kelly Science and Clinical is hiring on behalf of one of our large CRO clients to support a six-month project with the potential for future extension. We are looking for strong CRA monitors to support regional studies at sites across the East Coast. The ideal candidate will have at least two years of experience monitoring complex therapeutic studies, with prior large CRO experience preferred. The CRA I performs and coordinates all aspects of the clinical monitoring and site management process. This role conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation across various monitoring environments (e.g., FSO, FSP, Government). As a site processes specialist, the CRA I ensures trials are conducted in accordance with approved protocols, ICH‑GCP guidelines, applicable regulations, and SOPs to guarantee subjects’ rights, well-being, and data reliability while maintaining audit readiness. The CRA I develops collaborative relationships with investigational sites and project team members. Detailed tasks and responsibilities are outlined in the project task matrix.

Essential Functions

• Site Monitoring & Compliance: Monitors investigator sites using a risk-based monitoring approach; applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions (CAPA) to bring sites into compliance.
  
• Data Integrity: Ensures data accuracy through Source Document Review (SDR), Source Document Verification (SDV), and Case Report Form (CRF) review during on-site and remote monitoring activities.
  
• IP Management: Assesses investigational products through physical inventory checks and records reviews.
  
• Documentation & Reporting: Documents observations in reports and follow-up letters in a timely manner using professional business writing standards.
  
• Issue Escalation: Escalates observed deficiencies to clinical management expeditiously and follows all issues through to resolution.
  
• Site Relations & Follow‑Up: Maintains regular contact with investigative sites between visits to confirm protocol adherence, track issue resolution, and ensure timely data entry.
  
• Trial Execution: Conducts monitoring tasks in accordance with the approved monitoring plan, assists with the investigator payment process, and participates in investigator meetings as needed.
  
• Tracking & Systems: Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM). Updates study systems (e.g., CTMS) per agreed study conventions and performs QC checks on CTMS-generated reports as required.
  
• Site Selection & Initiation: Collaborates with the client company to identify qualified investigators, initiates clinical trial sites according to relevant procedures, and makes recommendations as warranted.
  
• Study Close‑Out: Oversees trial close‑out procedures and the retrieval of trial materials.
  
• Regulatory & Essential Documents: Ensures required essential documents are complete, accurate, and filed according to ICH‑GCP guidelines and applicable regulations. Conducts on‑site file reviews per project specifications.
  
• Team Contribution: Contributes to the project team by assisting in the preparation of project publications and tools, as well as sharing actionable ideas and suggestions with team members.
  
• Study Tasks & Leadership: Performs additional study tasks assigned by the CTM, such as trip report reviews, newsletter creation, and leading CRA team calls.
  
• Stakeholder Communication: Facilitates effective communication between investigative sites, the client company, and the project team through written, oral, and electronic channels.
  
• Audits & Quality Assurance: Responds to company, client, and applicable regulatory requirements, audits, and inspections.
  
• Administrative: Completes administrative tasks, including expense reports and timesheets, in a timely manner.
  
• Process Improvement: Contributes to project initiatives and process improvement efforts as required.

Education and Experience

• Bachelor’s degree in a life science‑related field, a Registered Nurse (RN) certification, or equivalent relevant academic/vocational qualification.
  
• 2+ years of experience as a clinical research monitor or equivalent experience demonstrating the necessary knowledge, skills, and abilities.
  
• Prior monitoring experiencecomplex therapeutic areas, with large CRO experience preferred.
  
• Valid driver’s license.

Knowledge, Skills, and Abilities

• Effective clinical monitoring skills across full study lifecycles.
  
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
  
• Strong understanding and practical application of ICH‑GCP guidelines, applicable regulations, and procedural documents.
  
• Well‑developed critical thinking skills, including root cause analysis (RCA) and proactive problem‑solving.
  
• Ability to apply Risk‑Based Monitoring (RBM) concepts and processes.
  
• Clear oral and written communication skills with the ability to interact effectively with medical personnel and site staff.
  
• Strong customer focus with active listening skills, high attention to detail, and the ability to address underlying customer needs.
  
• Excellent interpersonal, organizational, and time‑management skills.
  
• Ability to remain flexible and adaptable across a range of study scenarios.
  
• Proven ability to work effectively both independently and as part of a collaborative team.
  
• Computer proficiency, including Microsoft Office applications, with the ability to quickly learn EDC and CTMS platforms.
  
• Strong English language and grammar skills.
  
• Effective presentation and communication skills.