Clinical Research Director
Clinical Research Director
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Job Description
Summary:
The Clinical Research Coordinator is a fulltime onsite role responsible for overseeing clinical research activities and ensuring the smooth execution of research studies. Key responsibilities include obtaining informed consent managing clinical trial protocols conducting research and coordinating clinical trial processes. This position works closely with the clinical research team to maintain compliance with regulatory guidelines and deliver highquality outcomes.
Responsibilities:
Manage daytoday clinical trial operations including patient screening enrollment and followup.
Ensure protocol compliance and maintain accurate study documentation.
Coordinate with sponsors contract research organizations (CROs) and study monitors.
Conduct informed consent processes and patient visits.
Manage regulatory documentation and site files.
Handle data entry and query resolution.
Assist with study startup and closeout activities.
Collaborate with principal investigators and study staff.
Maintain subject recruitment and retention strategies.
Ensure compliance with protocol requirements and regulatory guidelines.
Prepare for and participate in sponsor monitoring visits and audits.
Requirements
Requirements:
35 years of experience in clinical research and clinical trials.
Strong knowledge of ICHGCP guidelines and FDA regulations.
Handson experience with clinical trial management systems (CTMS) eSource and EMR platforms.
Proven skills in informed consent and protocol management.
Excellent attention to detail and organizational abilities.
Strong communication and interpersonal skills.
Degree in Life Sciences Nursing or a related field.
Experience in mental health studies is preferred.
Employment Type
Full Time
