Senior Regional Clinical Research Associate

Kelly Science, Engineering, Technology & Telecom; Chicago (IL); Presencial; USD 75.000 - 105.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision insurance

401K

Paid time off

Descripción de la vacante

Kelly Science and Clinical FSP is seeking a Regional Clinical Research Associate for a long-term engagement in the US with a MedTech client. As a Kelly FSP employee, you will receive comprehensive benefits including medical, dental, vision, 401K, and PTO.

The candidate will manage clinical activities at study sites, monitor site performance, ensure data quality, and maintain regulatory compliance across projects.

Formación

• Bachelor's degree is required.
• 4–5 years of relevant clinical research experience; Masters/PhD/MD/PharmD with at least 3 years also acceptable.
• Experience in medical device monitoring or equivalent.
• Understanding of regulations and standards in clinical research and medical devices.
• Relevant industry certifications preferred.

Responsabilidades

• Manage clinical study activities at multiple sites across projects.
• Oversee site performance and ensure data quality and timeliness.
• Coordinate site visits, monitoring, and communications with site personnel.
• Ensure compliance with study protocol, SOPs, GCP, and regulatory requirements.
• Support site recruitment and retention activities.
• Interface with Investigators, IRBs/ECs, vendors, and internal stakeholders.
• Maintain Investigator Site Files per regulations.
• Assist with training meetings and dissemination of important data.

Conocimientos

Clinical research experience

Medical device monitoring

Regulatory knowledge

Site management

Vendor coordination

Educación

Bachelor's degree

Master's degree / PhD / MD / PharmD

Descripción del empleo

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