Sr. Clinical Research Associate

Senior Clinical Research Associate

Service Overview:

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:

• 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

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.