Clinical Trials Research Assistant/Associate

About the Role

The Stead Family Department of Pediatrics, Division of Medical Genetics, is seeking to hire a Clinical Trials Research Assistant or a Clinical Trials Research Associate to manage and coordinate clinical trials related to lysosomal storage disorders and other medical genetic disorders. This is a Specified Term position.

Key Responsibilities

• Assist with clinical and data coordination for research activities.
• Screen, recruit, enroll, and obtain informed consent for clinical trials.
• Assist the PI in the completion of regulatory submission and close-out processes.
• Track study participant data, study drugs, biological specimens, and study procedures.
• Maintain and disseminate a list of open protocols and informed consents.
• Prepare regulatory documents for sponsor approval.
• Consult with researchers to assist in developing a data management plan; design forms to facilitate collection.
• Design and coordinate field tests for data collection forms and assist in designing certification procedures.
• Perform daily activities for clinical trials; respond to clinical site questions regarding data collection and data entry issues.
• Coordinate scheduling and preparation of trial-related procedures and subject visits.
• Work closely with clinical trial home infusion company to coordinate subject visits and documentation.
• Develop brochures or other materials for providers to support recruitment of study participants.
• Attend training sessions as needed for the implementation of clinical trials.

Requirements & Tech Stack

• Bachelor’s degree in a related field or an equivalency of education and/or related experience.
• Institutional Review Board (IRB) procedures, FDA regulations, GCP, and study sponsor guidelines related to clinical trial research.
• Demonstrated high attention to detail with strong organizational skills.
• Demonstrated excellent written, verbal, and interpersonal communication skills.

Experience and Qualifications - Clinical Trials Research Assistant (3A)

• Six months to one year of experience in clinical research.
• Six months to one year of experience in clinical trial protocol management.
• Six months to one year of experience in data entry and management.
• Demonstrated knowledge of or experience with medical genetic and lysosomal storage disorders.
• Willingness and ability to travel.

Experience and Qualifications - Clinical Trials Research Associate (4A)

• Minimum of two years of experience in clinical trial protocol management, including but not limited to preparation of regulatory submissions, recruitment of eligible patients, and reporting of study data.
• One to three years of experience in clinical trial protocol management.
• One to three years of experience in data entry and management.
• Demonstrated knowledge of or experience with medical genetic and lysosomal storage disorders.
• Willingness and ability to travel.
• Certified Clinical Research Coordinator (CRC) or Certified Clinical Research Professional (CCRP) certification, or a Master's degree in a related field (e.g., MPH).

Position Details

• Classification Title: Clin Trials Rsrch Associate
• Appointment Type: Professional and Scientific
• Schedule: Full-time
• Work Modality Options: On Campus
• Specified Term position.
• Not eligible for university sponsorship for employment authorization.

Compensation

Clinical Trials Research Assistant (3A) Salary Range: $43,240 - $66,199

Clinical Trials Research Associate (4A) Salary Range: $47,380 - $79,386

To Apply

Applicants must upload the following documents and mark them as a “Required File”:

• Resume
• Cover Letter

Indicate in your cover letter the level of classification (3A/4A) you wish to be considered for or indicate both.

Up to 5 professional references will be requested at a later step.