Clinical Research Associate – FSP | JobSetuu

Description

Job Overview

• Source: Jobicy

Job Description

When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Typical Accountabilities:

• Contributes to the selection of potential investigators.

• In some countries, as required, CRAs are accountable for study start-up and regulatory

maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and

tracking of documents for the application process; submission of proper application/documents to

EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.

• Trains, supports, and advises Investigators and site staff in study related matters, including Risk

Based Quality Management (RbQM) principles.

• Confirms that site staff have completed and documented the required trainings appropriately,

including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.

• Actively participates in Local Study Team (LST) meetings.

• Contributes to National Investigators meetings, as applicable.

• Initiates, monitors and closes study sites in compliance with client’s Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST

• Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.

• Updates CTMS and other systems with data from study sites as per required timelines.

• Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.

• Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.

• Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.

• Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.

• Ensures data query resolution in a timely manner.

• Works with data management to ensure robust quality of the collected study data.

• Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.

• Prepares and finalises monitoring visit reports in CTMS and provides timely feed-back to the

Principal Investigator, including follow-up letter, within required timelines and in line with client’s SOP.

• Follows up on outstanding actions with study sites to ensure resolution in a timely manner.

• Follows quality issue processes by escalating systematic or serious quality issues, data privacy

breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required.

• Assists site in maintaining inspection ready ISF.

• Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and CQAD.

• Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.

• Ensures that all study documents under their responsibility (i.e., site documents, relevant

communications, etc) are available and ready for final archiving and completion of local part of the

eTMF.

• Provides feedback on any research related information including sites/investigators/competing

studies that might be useful for the local market.

• Ensures compliance with client’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

• Ensures compliance with local, national and regional legislation, as applicable.

• Collaborates with local MSLs as directed by LSAD or line manage

Education, Qualifications, Skills and Experience

Essential

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).

• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.

• Good knowledge of relevant local regulations.

• Good medical knowledge and ability to learn relevant client’s Therapeutic Areas.

• Basic understanding of the drug development process.

• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

• Excellent attention to details.

• Good written and verbal communication skills.

• Good collaboration and interpersonal skills.

• Good negotiation skills.

• Ability to travel nationally/internationally as Required

•Valid driving license (*)- to be deleted if not required in a country.

(*) to be adapted to local country market needs

Desirable

• Ability to work in an environment of remote collaborators.

• Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.

• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

• Good analytical and problem-solving skills.

• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.

• Familiar with risk-based monitoring approach including remote monitoring.

• Good cultural awareness.

• Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.

• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

Key stakeholders and relationships

Internal (to client or team)

• LSADs and Local Study Teams

• Line Manager and local SMM LT

• Clinical Quality Associate Director

• Local Medical Teams: MSLs and Medical Affairs

• Global Study Teams

• Global Clinical Solutions functions

• Clinical Data Management

• Regulatory Affairs

• Patient Safety

External (to client)

• Investigators and site personnel

• Study related vendors

• Inspectors

Expert Career Tips for Clinical Research Associate – FSP Roles

To succeed in a competitive market as a Clinical Research Associate – FSP, you need more than just technical skills. Here are some expert strategies to elevate your profile:

• Build a Strong Portfolio: For technical roles, a clean GitHub or a personal project site is essential. For non-technical roles, a case study portfolio demonstrating problem-solving and impact is equally valuable. Show, don't just tell, what you have achieved in your previous positions.
• Master the Narrative: When interviewing, use the STAR method (Situation, Task, Action, Result) to structure your answers. Quantify your results wherever possible—mentioning "increased efficiency by 20%" is much more impactful than saying "improved efficiency."
• Continuous Learning: The industry moves fast. Whether it's staying updated with the latest AI tools or mastering a new management methodology, continuous professional development is key. Consider obtaining industry-recognized certifications that align with Clinical Research Associate – FSP requirements.
• Networking: Connect with other professionals in similar roles. Join online communities, attend webinars, and engage in meaningful discussions on professional social networks. Often, the best opportunities come through referrals and community engagement.
• Soft Skills Matter: Communication, empathy, and leadership are often the deciding factors between two equally qualified technical candidates. Cultivate these skills as they are universally valued across all industries and seniority levels.

Additionally, research the specific company's culture and values. Tailoring your application to show how you align with their mission can significantly increase your chances of moving forward in the process.

Salary & Compensation

Salary not disclosed; typically competitive for the role.

Work Arrangement

Type: On-Site

Standard business hours at the office.

Comprehensive Application Strategy & Hiring Process

Applying for a new role is a marathon, not a sprint. Follow this strategic approach to maximize your success rate:

1. Initial Research & Tailoring

Don't send the same resume to every employer. Spend at least 30 minutes researching the company. Look for recent news, their product roadmap, and their team structure. Modify your summary and core competencies to reflect the specific keywords found in the job description.

2. The Perfect Cover Letter

If the application allows for a cover letter, use it to tell a story that your resume cannot. Explain why you are passionate about this specific company and how your unique background makes you the perfect fit for the challenges they are currently facing.

3. Navigating the Multi-Stage Interview

Most modern hiring processes involve 3-5 stages. This typically includes a recruiter screen, a technical or skill-based assessment, a peer interview, and a final leadership round. Prepare for each stage differently: focus on enthusiasm and fit for the recruiter, technical depth for the assessment, and strategic vision for the leadership round.

4. Post-Interview Follow-Up

Always send a personalized thank-you note within 24 hours of each interview. Reference a specific topic discussed during the call to demonstrate your active listening and genuine interest in the role.

By following these steps, you demonstrate a high level of professionalism and attention to detail that sets you apart from the average applicant.

Typical Interview Process

1. Resume screening
2. HR call
3. Skill interview
4. Final manager interview
5. Offer

Tip: Research the company's products and culture.

Global Market Intelligence & Relocation Insights

At JobSetuu, we specialize in helping talent navigate the global job market. Here is what you need to know about the current landscape in Global and beyond:

The demand for skilled professionals is increasingly borderless. For roles based in Global, understanding the local cost of living, visa requirements (if applicable), and cultural nuances is vital. If this is a remote role, consider the time zone alignment and the asynchronous communication culture of the hiring organization.

Relocation Support: Many forward-thinking companies offer relocation packages that include moving stipends, temporary housing, and legal assistance with work permits. When evaluating an offer, look beyond the base salary—consider the total compensation package, including equity, bonuses, and healthcare benefits.

Work-Life Balance Trends: Hybrid and remote work have become standard in many regions. Research the local labor laws and common practices regarding work hours and vacation time to ensure the role aligns with your lifestyle goals.

Leveraging JobSetuu's tools can help you compare salaries across different cities and understand the "purchasing power" of your potential offer, ensuring you make an informed decision for your long-term career path.

Skills & Competency Roadmap for Professional Development

To remain competitive in Professional Development, we recommend focusing on the following core competencies over the next 12-18 months:

• Technical Mastery: Deepen your expertise in the core tools and languages relevant to your field. For developers, this might be cloud architecture; for marketers, it might be data-driven attribution modeling.
• AI Augmentation: Learn how to leverage generative AI and automation tools to increase your productivity. Understanding how to integrate these technologies into your workflow is becoming a non-negotiable skill.
• Leadership & Strategy: Even in individual contributor roles, the ability to think strategically and lead projects from inception to completion is highly valued. Focus on stakeholder management and high-level project planning.
• Data Literacy: The ability to interpret data and use it to drive decisions is essential across all business functions. Familiarize yourself with data visualization and basic analytical concepts.

By investing in these areas, you not only prepare yourself for the role you are applying for today but also build a resilient foundation for the opportunities of tomorrow.

Apply via JobSetuu

Discover your next career milestone on JobSetuu. This Clinical Research Associate – FSP position is part of our commitment to bringing you the most relevant and high-impact job openings globally. At JobSetuu, we simplify your job search by aggregating premier listings and providing the tools you need to stand out. Don't miss the chance to elevate your professional journey—explore more opportunities and career insights on our platform today.