Research Associate Ii, Clinical Trials

4 weeks ago

Irvine, United States Kaiser Permanente Full time

**Job Summary**:
Coordinates day-to-day activities of several small scale project(s) or phases of one or more larger projects. May oversee assigned work of project staff. Works under general supervision. Final review required for each phase of project.

**Essential Responsibilities**:

- Coordinates day-to-day activities of several small scale project(s) or phases of one or more larger projects. Collects project data through interviews, chart review or other methods. May collect, secure and assist with biospecimen management.
- May assist in development of study tools (e.g. tracking forms, questionnaires, chart review forms, etc.).
- Assists with and/ or oversees assigned study activities (e.g. data collection and validation, recruitment activities, pilot studies, focus groups, etc).
- Drafts project progress reports collaboratively.
- May participate in the training of new team members and/or clinical staff. If assigned to clinical trial, may work with Sponsors/ monitors at clinical sites.
- Adheres to compliance and privacy/ confidentiality requirements and standards. Adheres to GCP and compliance regulations for clinical trials.
- Assists with and/ or oversees quality assurance of study activities; ensures quality data.
- Acquires and maintains knowledge of KP systems and databases.
- Identifies, recommends and implements solutions to study issues.
- May interface with IRB and/ or draft portions of IRB protocols, amendments, continuing reviews, etc.
- May supervise the day-to-day activities of project staff (ex. assign work and evaluate performance, etc).
- May assist with staff hiring and training.
- May contribute to portions of study presentations.
- Serves as a member on department or study-related committees.
- May track expenses and monitor budget. May recommend budget actions/ decisions.
- May provide information and oversight for invoices.
- Reviews scientific literature and synthesizes and summarizes information.

**Basic Qualifications**:
Experience
- Minimum two (2) years of experience in public health, healthcare administration, epidemiology, or healthcare-related field OR one (1) year of experience in public health, healthcare administration, epidemiology, or healthcare-related field AND Masters or terminal degree in public health, healthcare administration, epidemiology, or healthcare-related field
- Minimum one (1) year of experience coordinating research projects under specific guidance.
- Minimum one (1) year of training and/or experience in research methodology/research study design, hypothesis testing; OR
- Minimum one (1) year of experience in clinical trials protocols involving research methodology/research study design, and hypothesis testing; OR
- Minimum one (1) year experience in handling, processing, and preparing biospecimens for laboratory analysis and/or transport OR Masters or terminal degree in public health, healthcare administration, epidemiology, or healthcare-related field.

Education
- Bachelors degree in public health, healthcare administration, epidemiology, or health-related field (ex. Biology, Psychology, etc.), OR four (4) years of experience in a directly related field.
- High School Diploma or General Education Development (GED) required.

License, Certification, Registration
- N/A

**Additional Requirements**:

- Experience with interviewing (by phone and/or in-person) and medical chart review.
- Experience in quantitative and/or qualitative data interpretation.
- Experience coordinating one or more projects OR
- Experience with biospecimen handling, collection, and processing
- Experience with Clinical lab activities
- Professional oral and written communication skills.
- Must be able to work in a Labor/Management Partnership environment.

**Preferred Qualifications**:

- Masters degree in public health, healthcare administration, epidemiology or related field.

PrimaryLocation : California,Irvine,Alton/Sand Canyon Medical Offices II

HoursPerWeek : 40

Shift : Day

Workdays : Mon, Tue, Wed, Thu, Fri

WorkingHoursStart : 08:00 AM

WorkingHoursEnd : 04:30 PM

Job Schedule : Full-time

Job Type : Standard

Employee Status : Regular

Employee Group/Union Affiliation : NUE-SCAL-01|NUE|Non Union Employee

Job Level : Individual Contributor

Job Category : Research and Development,Research & Development

Department : Department of Research and Evaluation

Travel : Yes, 10 % of the Time

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