Ophthalmology & Gen Meds - CRA II
Fortrea · New York, United States
- On site
- Full-time
- $117,000 / year
- New York, United States
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Job highlights
- Monitor clinical trial sites and ensure data integrity.
- Manage site relationships and regulatory compliance.
- Oversee patient safety and protocol adherence.
- Report and process serious adverse events.
- Requires 1-3 years monitoring experience.
About the role
Clinical Research Associate II Ophthalmology & General Medicine
Fortrea is seeking experienced Clinical Research Associates II (CRAs) to join our Full Service Outsourcing team. This role is crucial for leading and supporting clinical trial operations, particularly within Ophthalmology and General Medicine therapeutic areas. We are open to candidates located in major hub locations on the East & West Coast. This position involves significant travel, estimated at 60-70%, with a target of 8-10 site visits 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 in accordance with clinical research standards and managing all aspects of study site monitoring.
Responsibilities
- Conduct routine monitoring and close-out of clinical sites, ensuring maintenance of study files.
- Perform pre-study and initiation visits, and liaise effectively with vendors.
- Manage all aspects of site management as outlined in project plans.
- Ensure study staff are properly trained and equipped to safely enroll patients according to the protocol.
- Protect study patients by verifying adherence to informed consent procedures and protocol requirements, and ensuring compliance with applicable regulatory standards.
- Guarantee the integrity of data by reviewing Case Report Forms (CRFs) and other data collection tools, comparing them against source documents and identifying missing or implausible data.
- Manage all aspects of registry management as prescribed in the project plans.
- Undertake feasibility work as requested.
- Complete and process Serious Adverse Event (SAE) reporting, including narrative generation and follow-up.
- Independently review CRFs, generate queries, and resolve them according to data review guidelines using Fortrea or client data management systems.
- Assist in training new employees, which may include co-monitoring.
- Coordinate designated clinical projects as a Local Project Coordinator, potentially acting as a local client contact under supervision.
- Perform other duties as assigned by management.
Requirements
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
- 1-3 years of Clinical Monitoring experience.
- Open to various hub locations.
The ideal candidate is comfortable working in a dynamic environment characterized by:
- Fast-paced operations: Strict adherence to study protocols is paramount, as even minor delays can impact quality.
- Adaptability: Priorities can shift rapidly, requiring you to adapt and prioritize effectively.
- Teamwork: Strong teamwork and interpersonal skills are essential for smooth study execution.
- Technology integration: Data is collected directly in an electronic environment, requiring proficiency with technology.
What You Get
Benefits
- Full-time or part-time employees working 20+ hours per week are eligible for comprehensive benefits.
- Medical, Dental, Vision, Life, STD/LTD insurance from multiple carriers.
- 401(k) plan.
- Paid Time Off (PTO) – Flex Plan.
- Employee recognition awards.
- Multiple Employee Resource Groups (ERGs).
- Target Pay Range: $105,000 - $117,000 annually.
Work Environment
- Work is primarily conducted in an office setting with standard office equipment.
- Requires frequent travel to client and site locations, with occasional domestic and international travel.
Physical Requirements
- Ability to sit for extended periods and operate a vehicle safely.
- Repetitive hand and wrist movements, including fast, simple movements of fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of the upper body and neck.
- Proficiency in accessing and using various computer software, both in-house and off-the-shelf.
- Ability to lift and carry light to moderate objects (up to 15-20 lbs), including luggage and laptops.
- Regular and consistent attendance is required.
- Varied hours may be necessary.
Work Arrangement: Remote
Applications are accepted on an ongoing basis.
Learn more about our EEO & Accommodations requests here.
Key skills/competency
- Clinical Research Associate
- Ophthalmology Clinical Trials
- General Medicine Clinical Trials
- Site Monitoring
- Data Integrity
- Regulatory Compliance
- CRF Review
- SAE Reporting
- Patient Safety
- Clinical Operations
Skills & topics
- Clinical Research Associate
- CRA II
- Ophthalmology
- General Medicine
- Site Monitoring
- Clinical Trials
- Regulatory Compliance
- Data Integrity
- SAE Reporting
- Patient Safety
- Fortrea
- Healthcare
- Pharmaceutical
- Biotechnology
- Medical Devices
- Life Sciences
- Remote Work
- Travel
- Nursing
How to get hired
- Tailor your resume: Highlight your 1-3 years of clinical monitoring experience, specifically mentioning ophthalmology or general medicine if applicable. Quantify achievements related to site management and data integrity.
- Craft a strong cover letter: Emphasize your understanding of fast-paced, technology-driven environments and your ability to adapt to changing priorities. Showcase your teamwork and people skills.
- Prepare for the interview: Be ready to discuss your experience with site monitoring, regulatory compliance, SAE reporting, and data review. Practice answering behavioral questions about handling deviations, managing timelines, and working in a team.
- Showcase technical proficiency: Be prepared to discuss your experience with electronic data capture systems and other clinical research technologies used at Fortrea.
Technical preparation
Master EDC systems and data management platforms.,Review protocols and source documents thoroughly.,Practice SAE reporting and query resolution.,Familiarize with regulatory guidelines (GCP, FDA).
Behavioral questions
Describe managing study timelines and deviations.,How do you ensure patient safety and data integrity?,Give an example of adapting to changing priorities.,Discuss a challenging site interaction and resolution.
Frequently asked questions
- What therapeutic areas does this CRA II role focus on at Fortrea?
- This Clinical Research Associate II position at Fortrea specifically focuses on Ophthalmology and General Medicine therapeutic areas. Your experience in these fields will be highly valued.
- What is the expected travel frequency for the CRA II role at Fortrea?
- The CRA II role at Fortrea involves significant travel, approximately 60-70% of the time, with an expectation of conducting 8-10 site visits per month. This includes frequent travel to client and site locations, with occasional domestic and international trips.
- What are the primary responsibilities of a CRA II at Fortrea?
- The primary responsibilities for a CRA II at Fortrea include all aspects of study site monitoring, such as routine monitoring, close-out visits, file maintenance, pre-study and initiation visits, vendor liaison, site management, ensuring protocol adherence, data integrity checks, SAE reporting, and CRF review/query resolution.
- What qualifications are required for the CRA II position at Fortrea?
- To qualify for the CRA II position at Fortrea, you need a university or college degree, or a certification in a related allied health profession (like nursing licensure). Crucially, 1-3 years of clinical monitoring experience is required.
- Is the CRA II role at Fortrea remote or on-site?
- The CRA II role at Fortrea is designated as remote. However, it does require frequent travel to client and site locations for monitoring activities.
- What is the target salary range for the CRA II position at Fortrea?
- The target pay range for the Clinical Research Associate II position at Fortrea is between $105,000 and $117,000 annually.
- What type of work environment can I expect as a CRA II at Fortrea?
- As a CRA II at Fortrea, you can expect a fast-paced, technology-driven environment where strict adherence to study protocols and timelines is essential. The role also requires adaptability to changing priorities and strong teamwork and people skills.
- What benefits does Fortrea offer its employees?
- Fortrea offers comprehensive benefits to its regular employees working 20 or more hours per week, including Medical, Dental, Vision, Life, and STD/LTD insurance, a 401(k) plan, paid time off (PTO), employee recognition awards, and multiple Employee Resource Groups (ERGs).