Position Scope:
The role of the Senior Clinical Research Associate (Sr. CRA) is to assist in the conduct of clinical trials and ensure the study is conducted in accordance with Good Clinical Practice and ICH/FDA regulations.
Strategic Focus Areas:
The strategic focus of the Sr. CRA is to ensure that the study is conducted in accordance with the approved protocol; that the study subjects’ rights and privacy are protected; and that the integrity of the conduct of the study is sound and free from falsification or other bias.
Specific Tactical Responsibilities:
· Conduct monitoring to verify accuracy of study data vs. source records
· Ensure HIPAA requirements for patient privacy are met
· Ensure no study tasks are conducted prior to IRB/EC approval, CA/FDA approval, and formal site activation
· Work details of study budgets and contracts with sites
· Generate study documents such as Case Report Forms and CRF completion guidelines
· Collect study documentation from site such as completed CRFs, Investigator Agreements, Investigator CV’s and licenses, training forms, protocol deviations, queries, adverse event reports, etc.
· Build and maintain tracking sheets to track progress of sites to initiation, enrollment and screening, interim monitoring, and close-out requirements
· Maintain documentation in electronic and paper Trial Master Files
· Maintain close communication with study sites, investigators, and vendors to execute the trial in accordance with the protocol, study timeline, and study budget
· Conduct Site Qualification, Initiation, Interim Monitoring, and Close-out visits and write corresponding visit reports, as needed
· Provide oversight of contract monitors including co-monitoring
· Ensure adverse event reporting is done in accordance with regulatory requirements
· Verify the accuracy of study results
Job Complexity:
The Sr. CRA role requires detailed knowledge of the clinical indication, the medical status of the patient population, and details of the study device/drug and the protocol. The Sr. CRA must have training and significant experience as a site monitor per FDA requirements.
Supervisory Responsibilities: None
Required Qualifications:
- Bachelor’s degree in the life sciences or related field or RN
- Strong working knowledge of guidelines, systems for clinical trial management and of ICH, FDA, and GCP regulations and practices
- Travel up to 25% is required
Desired Experience, Knowledge, and Skills:
- 5+ years of current clinical trial monitoring experience
- Medical and clinical knowledge of indications, therapies, and patient population
- Proven track record of having good sponsor, investigator, site, and vendor relations
- Excellent interpersonal, verbal, and written communication skills
- Attention to detail and strong organizational skills
- Strong computer skills including EDC system experience
- Excellent interpersonal, verbal, and written communication skills
- Attention to detail and strong organizational skills
- Good problem solving skills
- Ability to establish strong relationships with physicians and study staff
- Enthusiastic and energetic