Clinical Research Associate

Position Summary

The Clinical Research Associate (CRA 1) will work closely with study managers, cross-functional team members and CROs/vendors to lead the delivery of site management clinical operations activities for global Phase 1-3 trials. The CRA will perform duties as assigned contributing to effective full life cycle study management in accordance with ICH Good Clinical Practices, FDA regulations & guidelines, applicable/local regulations, company SOPs, study protocol and plans. The CRA will also collaborate with team members to ensure overall quality and timeliness of clinical deliverables are met. The CRA will be instrumental in ensuring quality, consistency, accuracy, and timely flow of clinical trial management and documentation to support evaluation of the quality conduct of the trial, protection of safety and privacy of the subjects, quality and integrity of the data produced. This position reports to the Associate Director of Clinical Operations.

Responsibilities

• Collaborate with study managers, cross functional team and vendors to execute study timelines and company milestones
• Create and maintain tools to track key deliverables during start-up, study maintenance and close-out
• Generate, review and distribute reports from internal tracking at requested intervals (e.g., Site Status, Enrollment, Sample Management, eTMF completion)
• Collaborate with and support clinical managers to develop/review study-specific plans/manuals, tools/materials, processes, case report forms (CRFs), and informed consent templates
• Track timing/planning of site visits to ensure compliance
• In partnership with the clinical manager, may prepare meeting agenda, minutes and action items
• Taking the initiative and identifying new approaches to resolve problems and mitigate risks
• Support study team with eTMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents
• Participate in study specific tasks such as investigator identification, recruitment, collection/review of regulatory documents and site activation
• Assist clinical trial managers with design and preparation of study related materials for the training of CRO/vendor staff
• Interfaces with monitors/CROs to address and resolve queries
• Perform co-monitoring visits with assigned clinical monitor or manager and prepares/review site monitoring reports
• Assist in the preparation and review of site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)
• Act as CROs' CRA/CTA first line of contact for study related questions/issues
• Works with the CROs/vendors to arrange and prepare for Site Qualification Visits, Site Initiation Visits and Site Investigator Meetings (as applicable)
• Assist Study Lead with oversight of study vendors (CRO, Drug Supply, Central Lab) as required
• Performs data reviews, as assigned

Minimum Qualifications

• Bachelor’s degree in a relevant scientific or healthcare field, a combination of relevant education and applicable job experience may be considered.
• Minimum of three (3) years in clinical research, biopharmaceutical or similar industry
• Knowledge of FDA, GCP and ICH guidelines
• Able to proactively perform and complete assignments with minimal supervision in an accurate and timely manner
• Effective vendor management skills
• Effective interpersonal, written and verbal communication skills
• Able to work independently or within a team
• Able to carry out assignments with minimal guidance in an accurate, effective manner
• Excellent organizational skills and strong attention to detail, with proven ability to handle multiple priorities and tasks efficiently and effectively
• Flexible, able to adapt to changing priorities
• Uses professional and technical concepts to study/vendor related problems
• Experienced with eTMF systems
• Strong computer skills including: MS Word, Excel, Outlook, and PowerPoint
• Travel required

Location

Fully Remote - United States

Salary Range

$110,000 to $130,000 per year

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the years of relevant industry experience, education, and skills/abilities.

Additional Information

The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.

Cidara Therapeutics is an E-Verify Company