In-house CRA II
Precision Medicine Group · United States
- Hybrid
- Full-time
- $75,000 / year
- United States
Job highlights
- Support clinical study sites and project teams.
- Ensure adherence to ICH-GCP and regulations.
- Manage essential documents and site data.
- Liaise with study sites and resolve issues.
- Contribute to study tracking and reporting.
About the role
Job Summary
Precision for Medicine is seeking an In-house CRA II to provide comprehensive support to clinical research study sites and project teams. This role involves ensuring adherence to protocols, SOPs, ICH-GCP, and other regulatory requirements, acting as a primary point of contact for study sites, and independently managing complex activities with minimal supervision.
Key Responsibilities
- Assist in investigator recruitment, site feasibility, and selection processes.
- Prepare and distribute Investigator Site Files, and manage essential document collection and review for the Trial Master File (TMF).
- Maintain site-related data in clinical systems, utilizing CTMS for tracking milestones and activities.
- Serve as a liaison for study and site management issues, including supply management and addressing queries.
- Ensure timely data entry and facilitate database closure procedures.
- Support investigators and staff with local submission requirements and IRB/IEC processes.
- Assist with Investigational Product accountability and trial invoice follow-up for timely investigator payments.
- Document all interactions and ensure sponsor and investigator obligations are met in compliance with regulations.
- Potentially mentor In-house CRA Trainees.
Qualifications
- Bachelor's degree or equivalent combination of education and experience in a business, scientific, or healthcare discipline.
- Minimum of 2 years of relevant experience.
- Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
- Strong customer service demeanor, flexibility, and teamwork.
- High attention to detail and accuracy.
- Fluency in Serbian and English (verbal and written).
- Working knowledge of the drug development process.
- Ability to travel as needed.
Preferred Qualifications
- Solid experience in clinical research or related fields.
- Excellent organizational skills.
- Ability to work efficiently in a remote environment.
Competencies
- Good knowledge of ICH-GCP, Precision SOPs, and regulatory guidance.
- Strong interpersonal, self-motivation, and independent work skills.
- Detail-oriented with strong planning abilities.
- Good written and verbal communication and presentation skills.
- Ability to deliver on commitments and perform professionally.
Key skills/competency
- Clinical Research Associate (CRA)
- In-house CRA
- ICH-GCP
- Regulatory Compliance
- Clinical Trials Management System (CTMS)
- Investigator Site File
- Trial Master File (TMF)
- Drug Development
- Site Management
- Data Management
Skills & topics
- In-house CRA
- Clinical Research Associate
- CRA II
- Clinical Research
- ICH-GCP
- Drug Development
- Clinical Trials
- Regulatory Affairs
- TMF
- CTMS
- Serbia
- Healthcare
- Biotechnology
How to get hired
- Tailor your resume: Highlight your 2+ years of clinical research experience, proficiency in MS Office, and knowledge of ICH-GCP for the In-house CRA II role at Precision Medicine Group.
- Showcase language skills: Emphasize your fluency in both Serbian and English, crucial for this position.
- Demonstrate attention to detail: Provide examples of your meticulousness in previous roles, especially concerning document management and data accuracy.
- Prepare for interviews: Be ready to discuss your understanding of the drug development process and how you handle complex site management issues.
- Express remote work capability: If applicable, highlight your experience and comfort working effectively in a remote environment.
Technical preparation
Master ICH-GCP guidelines thoroughly.,Practice using CTMS and TMF systems.,Familiarize with drug development lifecycle.,Enhance MS Office Suite skills.
Behavioral questions
Describe handling multiple study sites.,How do you ensure data accuracy?,Give an example of problem-solving.,How do you manage site communication?
Frequently asked questions
- What are the key responsibilities of an In-house CRA II at Precision Medicine Group?
- As an In-house CRA II at Precision Medicine Group, your key responsibilities will include supporting study sites and clinical project teams, ensuring adherence to ICH-GCP and other regulations, managing essential documents and site data in systems like CTMS and TMF, acting as a liaison for site management issues, and assisting with data review and reporting.
- What qualifications are essential for the In-house CRA II position in Serbia?
- Essential qualifications include a Bachelor's degree or equivalent experience, a minimum of 2 years of relevant experience, high proficiency in Microsoft Office, fluency in Serbian and English, a working knowledge of the drug development process, and a strong customer service demeanor with excellent attention to detail.
- Is there an opportunity to work remotely for the In-house CRA II role?
- Yes, the job description mentions that experience and ability to work efficiently in a remote work environment are preferred qualifications, suggesting that this role can be performed remotely.
- What kind of experience is needed to be considered for the In-house CRA II role?
- A minimum of 2 years of relevant experience in clinical research or a related field is required. Experience with ICH-GCP, CTMS, TMF, and document management is highly valued.
- Does Precision Medicine Group offer opportunities for career growth for an In-house CRA II?
- While not explicitly detailed, the role mentions the possibility of mentoring an In-house CRA Trainee, which indicates potential for leadership and development within the team. The company also emphasizes professional development and commitment to its principles.
- What is the expected proficiency level in English and Serbian for this role?
- Fluency in both Serbian and English, verbally and in writing, is a required qualification for this position. This ensures effective communication with local sites and international teams.
- How does Precision Medicine Group handle application privacy for Serbian candidates?
- Precision Medicine Group stores any data provided during the application process in accordance with their Privacy Policy. For candidates in California, a separate CA Privacy Notice is also referenced.