Clinical Trials Research Assistant or Associate - Pediatrics Endocrine & Diabetes

Within the Stead Family Department of Pediatrics, Division of Endocrinology, we seek to hire a full time Clinical Trials Research Assistant (PRV1) or Clinical Trials Research Associate (PRV2). This position will provide support for Pediatric Endocrinology and Diabetes Clinical Research by conducting study visits, collecting and analyzing results and performing operational duties associated with human research. This is a specified term position.

The Division of Endocrinology intends to hire either a Clinical Trials Research Assistant (PRV1) or a Clinical Trials Research Associate (PRV2), based on the qualifications of the successful candidate. Please indicate in your application materials the position you wish to be considered for or indicate both.

Pay Level: 3A (PRV1) or 4A (PRV2)

Full job descriptions for both positions can be obtained by emailing [email protected].

Primary responsibilities of the Clinical Trials Research Assistant (PRV1; 3A) include:

• Perform research activities in a specialized area.
• Consult with principal investigator to design forms to facilitate the collection and tracking of participant data, study drugs and study procedures. Design study source documents, assessment tools, and participant questionnaires.
• Meet with families to introduce them to research opportunities currently available.
• Perform procedures and techniques as outlined in clinical research protocols, assure fidelity to protocols.
• Complete basic lab processing, sample storage and lab shipments per protocol.
• Use statistical analysis software (REDCap) to analyze and summarize study data.
• Submit protocols to the IRB and other review committees for approval prior to implementing research, as necessary for modifications and then annually for continuing review approvals.
• Responsible for safety programs by following guidelines and maintaining required documentation. Document all participant Serious Adverse Events and Adverse Events and report these to the primary investigator, study sponsor, and IRB.
• Attend local and national research meetings as required. Present results, findings or updates.
• Attend local fundraising events and activities to market and recruit participants for research studies.
• Conduct routine maintenance and controls on continuous glucose monitoring devices, glucose meters, YSI analyzer, and centrifuge.
• Participate in managing the student research staff to ensure task completion and compliance with UI policies and procedures. Provide directions, assignments, feedback, coaching and counseling to ensure outcomes are achieved. Provide training and oversight on basic lab requirements and protocols.

Primary responsibilities of the Clinical Trials Research Assistant (PRV2; 4A) include:

• Perform research activities in a specialized area.
• Assist in the design, development, execution administration and maintenance of protocols and clinical studies. Assist in study design and protocol development and provide input into descriptions of complex research procedures.
• Consult with principal investigator to design forms to facilitate the collection and tracking of participant data, study drugs and study procedures.
• Oversee the recruitment of subjects and scheduling of trial-related procedures.
• Meet with families to introduce them to research opportunities currently available. Responsible for subject recruitment, subject management, scheduling, phone calls, etc. to aid in coordination of study visits.
• Perform procedures and techniques as outlined in clinical research protocols, assure fidelity to protocols. Download insulin pumps and glucose meters; assist with tolerance tests, clamp studies, and other procedures.
• Participate in the design, development, and testing of clinical research trials data systems. Validate data, query resolution, and make recommendations for resolution. Revise and implement change in data collection.
• Use statistical analysis software (REDCap) to analyze and summarize study data.
• Submit protocols to the IRB and other review committees for approval prior to implementing research.
• Responsible for safety programs by following guidelines and maintaining required documentation. Document all participant Serious Adverse Events and Adverse Events and report these to the primary investigator, study sponsor, and IRB.
• Monitor implementation of study per protocol and ensure procedures are conducted using good clinical practice standards and meeting IRB guidelines.
• Manage and organize regulatory documentation from sites and regulatory authorities. Prepare regulatory submissions. Perform on-site audits of research and clinical data.
• Collaborate with Study Sponsors and Coordinating Centers to manage protocols. Meet with study monitors as requested.
• Attend local and national research meetings as required. Present results, findings or updates.
• Attend local fundraising events and activities to market and recruit participants for research studies.
• Conduct routine maintenance and controls on continuous glucose monitoring devices, glucose meters, YSI analyzer, and centrifuge. Manage study equipment to ensure safety of study participants and monitor environmental risks.
• Coordinate, manage and test equipment. Troubleshoot and resolve equipment failures, error codes and repairs.
• Participate in managing the research staff to assure task completion and compliance with UI policies and procedures. Provide direction, assignments, feedback, coaching and counseling to ensure outcomes are achieved. Provide training and oversight into basic lab requirements and protocols.
• May provide functional and/or administrative supervision. Mentor new staff under direction.
• Assist in preparing budgets for studies and timely billing compliance for studies.

Education Requirements

CLINICAL TRIALS RESEARCH ASSISTANT (PRV1) REQUIRED QUALIFICATIONS

• Bachelor’s Degree in related field or an equivalency of education and/or related experience.

Experience Requirements

• Excellent written, verbal and interpersonal communication skills.
• Demonstrated proficiency with Microsoft Office and software applications, and ability to learn new applications or systems.
• Experience working independently and in a group setting.
• Experience managing information requiring attention to detail and high level of organization.
• Experience with data entry and management.
• Minimum 6 months of research experience

Highly Desired Qualifications

• Experience in medical or clinical research directly related to endocrinology and diabetes.
• Demonstrated ability to multi-task and excellent time management skills.
• Knowledge of medical terminology related to pediatric endocrinology and diabetes.

Education Requirements

CLINICAL TRIALS RESEARCH ASSOCIATE (PRV2) REQUIRED QUALIFICATIONS

• A Bachelor’s Degree in a related field or an equivalency of education and/or related experience.

Experience Requirements

• Excellent written, verbal and interpersonal communication skills.
• Demonstrated proficiency with Microsoft Office and software applications, and ability to learn new applications or systems.
• Experience working independently and in a group setting.
• Experience managing information requiring attention to detail and high level of organization.
• Experience with data entry and management.
• Minimum of 1 year of research experience.

Position And Application Details:

In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” to the submission:

• Resume
• Cover Letter

Job openings are posted for a minimum of 7 calendar days and may be removed from posting and filled any time after the original posting period has ended.

Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.

For additional questions, please contact [email protected]

This position is not eligible for university sponsorship for employment authorization.

Additional Information

• Classification Title: Clin Trials Rsrch Associate
• Appointment Type: Professional and Scientific
• Schedule: Full-time
• Work Modality Options: On Campus

Compensation

• Pay Level: 4A

Contact Information

• Organization: Healthcare
• Contact Name: Pediatric Human Resources
• Contact Email: [email protected]