Ophthalmology & Gen Meds - CRA II
Fortrea · United States
- Hybrid
- Full-time
- $117,000 / year
- United States
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Job highlights
- Monitor clinical trial sites and ensure protocol adherence.
- Manage site operations and data integrity.
- Handle Serious Adverse Event reporting.
- Liaise with vendors and study staff.
- Utilize electronic data collection systems.
About the role
Clinical Research Associate II - Ophthalmology & Gen Meds
Fortrea is seeking experienced Clinical Research Associates II (CRA II) to join our Full Service Outsourcing team. This role is open to candidates in major hub locations on the East & West Coast, with an expected travel requirement of 60-70%, managing 8-10 DOS per month.
What You Will Do
As a CRA II, you will leverage your expertise, knowledge, and clinical judgment to ensure a high standard of care for participants in clinical trials. You will be responsible for responding to emergency situations according to clinical research standards and ensuring all trial activities meet regulatory requirements.
Responsibilities
- Oversee all aspects of study site monitoring, including routine monitoring, close-out visits, and maintenance of study files.
- Conduct pre-study, initiation, and close-out visits; liaise with vendors; and perform other assigned duties.
- Manage all aspects of site operations as detailed in project plans.
- Ensure study staff are adequately trained and equipped to safely enroll patients.
- Verify adherence to informed consent procedures and protocol requirements to protect study participants.
- Ensure the integrity of data by reviewing Case Report Forms (CRFs) and other data collection tools against source documents.
- Monitor data for completeness and plausibility, identifying and resolving missing or implausible data.
- Manage all aspects of registry operations as prescribed in project plans.
- Undertake feasibility assessments as requested.
- Complete Serious Adverse Event (SAE) reporting, including processing reports, narratives, and follow-ups.
- Independently review CRFs, generate queries, and resolve them against data review guidelines using Fortrea or client data management systems.
- Assist in training new employees, including co-monitoring.
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if needed) and potentially serve as a local client contact.
- Perform other duties as assigned by management.
Requirements
- University or college degree, or certification in a related allied health profession (e.g., nursing licensure) from an accredited institution.
- 1-3 years of Clinical Monitoring experience.
- Open to various hub locations on the East & West Coast.
The ideal candidate will thrive in a fast-paced environment characterized by strict adherence to study protocols, dynamic prioritization of tasks, and a strong emphasis on teamwork and people skills. Proficiency in technology-based data collection, including electronic environments, is essential.
What You Get
- Benefits: Comprehensive benefits package for full-time and part-time employees (20+ hrs/week) including Medical, Dental, Vision, Life, STD/LTD insurance, 401(K), Paid Time Off (PTO), Employee Recognition Awards, and multiple Employee Resource Groups (ERGs).
- Target Pay Range: $105,000 - $117,000 annually.
Work Environment
This role operates in an office environment, with frequent travel required to client and site locations (domestic and international). Exposure to standard office equipment is expected.
Physical Requirements
- Ability to sit for extended periods and operate a vehicle safely.
- Repetitive hand movements, with dexterity for fast, simple movements of fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of the upper body and neck.
- Ability to access and use various computer software.
- Light to moderate lifting (up to 15-20 lbs) including luggage and laptop.
- Regular and consistent attendance, with potential for varied hours.
Work Arrangement: Remote (with frequent travel).
Applications are accepted on an ongoing basis.
Key skills/competency
- Clinical Trial Monitoring
- Site Management
- Source Document Verification (SDV)
- Case Report Form (CRF) Review
- Serious Adverse Event (SAE) Reporting
- Regulatory Compliance
- Data Integrity
- Patient Safety
- Protocol Adherence
- Ophthalmology Clinical Research
Skills & topics
- Clinical Research Associate
- CRA II
- Ophthalmology
- General Medicine
- Clinical Monitoring
- Site Management
- Drug Development
- Pharmaceuticals
- Healthcare
- Clinical Trials
How to get hired
- Tailor your resume: Highlight your 1-3 years of clinical monitoring experience, focusing on ophthalmology or general medicine studies. Quantify achievements whenever possible, such as the number of sites managed or data quality improvements.
- Showcase your skills: Emphasize your ability to manage study sites, review CRFs, handle SAE reporting, and ensure data integrity. Mention experience with electronic data capture systems and your comfort in fast-paced, technology-driven environments.
- Prepare for travel: Be ready to discuss your experience with frequent travel (60-70%) and your ability to manage 8-10 DOS per month across different locations. Highlight your organizational skills for managing logistics and site visits effectively.
- Understand the culture: Research Fortrea's commitment to quality, patient safety, and compliance. Be prepared to discuss how you maintain high standards in a demanding, rapidly changing environment.
Technical preparation
Master GCP and relevant regulatory guidelines.,Practice source document verification techniques.,Familiarize with electronic data capture systems.,Review ophthalmology-specific trial protocols.
Behavioral questions
Describe managing difficult site staff.,How do you handle protocol deviations?,Share an experience of adapting priorities.,How do you ensure data integrity remotely?
Frequently asked questions
- What is the target pay range for an Ophthalmology CRA II at Fortrea?
- The target pay range for this Ophthalmology CRA II position at Fortrea is $105,000 to $117,000 annually. This range reflects the experience and responsibilities associated with the role.
- What is the expected travel percentage for this Clinical Research Associate II role?
- This Clinical Research Associate II position requires a significant amount of travel, approximately 60-70%. You can expect to manage 8-10 days of study (DOS) per month, involving frequent visits to client and site locations both domestically and internationally.
- What are the main therapeutic areas for this CRA II position?
- This CRA II role focuses on Ophthalmology and General Medicine studies. Your experience in these or related therapeutic areas will be crucial for success in monitoring and managing clinical trial sites.
- What specific experience is required to be considered for the CRA II role?
- Fortrea requires candidates to have 1-3 years of direct clinical monitoring experience. A university or college degree, or a certification in a related allied health profession such as nursing licensure, is also necessary.
- What type of work environment can I expect as a CRA II at Fortrea?
- You can expect a fast-paced, technology-driven work environment. The role demands strict adherence to study protocols, adaptability to changing priorities, and strong teamwork and communication skills to ensure smooth clinical project execution.
- Is this a remote position, and what does that entail for a CRA II?
- Yes, this position is designated as remote. However, it involves substantial travel (60-70%) to client and site locations for monitoring and other study-related activities, requiring you to be organized and adaptable.
- What are the core responsibilities of a Clinical Research Associate II at Fortrea?
- Core responsibilities include monitoring clinical trial sites, ensuring protocol compliance and data integrity, managing study files, conducting site visits (pre-study, initiation, close-out), handling Serious Adverse Event reporting, and liaising with study staff and vendors.
- What benefits does Fortrea offer to its employees?
- Fortrea offers comprehensive benefits for employees working 20+ hours per week, including Medical, Dental, Vision, Life, STD/LTD insurance, a 401(K) plan, paid time off, employee recognition awards, and participation in multiple Employee Resource Groups (ERGs).