Senior CRA

Vita Global Sciences, a Kelly Company; Warszawa; On-site; PLN 254,000 - 372,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Paid time off

Job summary

Kelly Science and Clinical FSP seeks a Regional Clinical Research Associate to lead site management for MedTech studies in the US. The role requires coordinating site visits, monitoring progress, ensuring data quality, and maintaining regulatory compliance across projects. Strong communication with investigators and study teams is essential for timely delivery.

Qualifications

• Bachelor degree required in Life Science or related field.
• Experience: 4–5 years in clinical research; advanced degrees preferred.
• Familiarity with medical devices or regulatory requirements in clinical trials.

Responsibilities

• Manage clinical activities at study sites for multiple projects.
• Oversee site visits, monitoring, and deliverables per protocol and timelines.
• Liaise between clinical study team and site personnel.
• Support patient recruitment and retention activities.

Skills

Clinical trial management

Site monitoring

Regulatory compliance

Data quality & collection

Stakeholder communication

Education

Bachelor's degree in Life Science or related

Masters/PhD/MD/PharmD preferred

Tools

GCP (ICH) guidelines

Job description

Kelly Science and Clinical FSP is currently seeking a Regional Clinical Research Associate for a long-term engagement in the US with one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Fraudulent Applications: All information provided during the application process will be verified. Misrepresentation of credentials, identity fraud, or use of proxy interviewers will result in immediate disqualification and may be reported to appropriate authorities.

This individual will be responsible for managing clinical activities at study sites conducting studies for the MedTech group, as well as, fostering strong, productive relationships with colleagues within the MedTech Group.

Responsible for managing clinical study activities for multiple sites in single or several clinical projects. Oversees performance of appointed study sites, conducting company initiated clinical studies. Responsible for the site visits, monitoring, communication, and deliverables for the assigned study sites. Serves as a member of the clinical study team and is the liaison between the clinical study team and study site personnel for the specific clinical projects.

Key Job Activities

Clinical Study Site Management Tasks

• Verify safety and well being of study subjects are maintained for assigned study sites.
• Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.
• Execute clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements.
• Accountable for study site performance, and providing high quality data according to overall project timeline.
• Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues. Responds to problems and assists in implementing corrective and preventive actions, if required.
• Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.
• Responsible for supporting patient recruitment and retention activities.
• Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures.
• Assists with internal communication of important clinical data and events.
• Support organization of Investigator and other study training meetings, if required.
• Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.
• Understand business value of clinical projects and balances overall business objectives and functional needs.
• May be involved in other tasks to support Clinical Operations and Operating Company as needed.
• Support the implementation of new clinical systems/processes.
• Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.

Administrative Tasks

• Incumbent knows, understands, incorporates, and complies with all applicable laws and regulations relating to business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
• May be asked to provide additional support to Clinical Operations staff, as needed.

Education

• A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.

Experience

• Typically requires Bachelors degree with at least 4-5 years of relevant experience; Masters or PhD/MD/PharmD with at least 3 year of relevant experience.
• Previous clinical research experience required.
• Previous medical device monitoring or equivalent experience required.
• Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
• Relevant industry certifications preferred

Posted By: Brendan Bartosiewicz