Clinical Research Associate

Primary Role

The Clinical Research Associate (CRA) is responsible for the oversight of assigned investigative sites in accordance with all applicable protocols, project plans, Sponsor SOPs, GCP guidelines, and regulatory requirements from site initiation through site close out. The CRA assists the Clinical Trial Manager and/or Clinical Project Manager by managing their assigned clinical sites to ensure enrollment, timely review of data, identification of site issues, and prompt resolution of issues. The CRA is the primary liaison between the clinical investigator and the Sponsor to ensure the recruitment, enrollment, and site activities are executed on time, within budget, and with the highest quality data standards.

What you'll do

• Perform site management and act as the primary liaison to the investigator and site staff ensuring consistent and effective communication related to enrollment status, issues and other relevant study information
• Conduct Site Evaluation, Site Initiation, Interim Monitoring, Close-out, and other study-specific visits including the completion of visit reports and follow-up letters after each visit
• Assist with the preparation of appropriate training materials and provide protocol and study related training including GCP and regulatory requirements to assigned sites
• Evaluate the quality and integrity of site practices to ensure GCP compliance and escalate any quality issues as appropriate
• Manage site and study progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• Ensure the collection and maintenance of required essential documents and ensure these documents are filed in the Investigator Site File and Trial Master File
• Train site staff on proper preparation, handling, storage, and return/destruction of investigational product(s) and verify compliance during monitoring visits
• Develop a patient recruitment plan in conjunction with the site, address challenges and barriers to enrollment, and report the subject recruitment rate to the Clinical Project Manager
• Verify that written informed consent is obtained before each subject's participation in the trial
• Verify that source documents, other trial records, and CRFs are accurate, complete, and legible and that CRF entries reflect the source
• Determine whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the Ethic Committees (IRB/IEC), Sponsor and the applicable regulatory requirement(s) Ensure deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements are documented and communicated appropriately and take appropriate action to prevent recurrence of the detected deviations
• Assist with the coordination and conduct of investigator and study meetings, including preparation and presentation of information
• Collaborate with team members in a mutually supportive and cooperative manner, as required to achieve study and project goals

Location

Remote

Salary Range

$80-125K Base Salary

*depending on qualifications and experience level

Travel Required

60% travel required

(1-2 days per week)

Qualifications

Required Skills:

Experience monitoring clinical trials with rater-administered measures

Must have experience with CNS

Certified Clinical Research Associate (CCRA) credentialing is preferred

Proactive in identifying areas of improvement to drive efficiency within Clinical Operations

Knowledge of the clinical research discipline, GCP, and ICH-E6 is essential

Excellent interpersonal skills required

Proficiency with systems (CTMS, EDC, eTMF) and MS Office (Word, Excel, Outlook)

The CRA must possess the ability to work closely with cross-functional colleagues within a small company, displaying innovative thinking, analytical thinking, a strong sense of responsibility, accountability, and integrity

Education and Experience:

BS in scientific discipline or pharmacy, RN, or BSN degree, or equivalent combination of education and experience

Minimum 2 years of experience, relevant CRO/biotech/pharmaceutical industry, including on-site or remote monitoring experience

The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements.