Clinical Research Coordinator

A bit about us:

Prestige Hospital System
Advancing new knowledge and improving health outcomes through research

Why join us?

Competitive compensation
Medical Insurance
Dental Insurance
Vision Insurance
Life Insurance
Flexible Schedule
Job Stability
Career growth
If you are passionate, thrive in a fast-paced environment and are ready to take your career to the next level, we would love to hear from you.

Job Details

Job Details:

We are seeking a highly motivated and experienced Senior Clinical Research Coordinator to join our dynamic healthcare team. This position plays a pivotal role in overseeing the daily conduct of clinical research studies while ensuring compliance with sponsor, institutional, and regulatory requirements. This role will provide leadership, mentorship, and operational oversight to research staff and will be instrumental in the successful execution of a diverse portfolio of clinical trials.

Responsibilities:

The Senior Clinical Research Coordinator will be responsible for providing oversight of daily research activities and study conduct across multiple clinical trials. They will ensure all study procedures are conducted in compliance with sponsor, institutional, federal, and regulatory requirements. The role will also involve supporting study start-up, maintenance, and close-out activities, and monitoring study progress to proactively identify and resolve operational issues.

In addition to these operational responsibilities, the Senior Clinical Research Coordinator will also serve as a mentor and leader for the research staff. They will provide guidance on study procedures, policies, and best practices, and foster a collaborative and compliant research environment.

The Senior Clinical Research Coordinator will also be involved in process improvement, including the development, implementation, and maintenance of Standard Operating Procedures (SOPs), workflows, and study manuals. They will be expected to identify opportunities to improve operational efficiency and research quality.

Qualifications:

Candidates must have a minimum of 3 years of clinical research coordination experience, with at least 1 year of experience serving in a Senior Clinical Research Coordinator or equivalent leadership role. They must have advanced knowledge of Good Clinical Practice (GCP) guidelines, FDA regulations, and clinical research regulatory requirements, and experience mentoring, training, and supervising research staff and new team members. Knowledge of regulatory submission processes and workflows is also required.

Preferred qualifications include experience supporting a broad range of clinical research studies, including Phase I-IV clinical trials, industry-sponsored studies, investigator-initiated studies, NIH-sponsored research, interventional and observational studies, non-profit and for-profit sponsored research. Experience working within an academic medical center environment and familiarity with industry-sponsored clinical trials and sponsor interactions is also preferred.

Additional Information:

Although budget management experience is not required, NIH and multicenter trial experience are preferred. Candidates with experience in academic medical centers and exposure to diverse clinical trial portfolios are strongly encouraged to apply.

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