Clinical Research Associate

SUMMARY  

Public Health Foundation Enterprises (PHFE dba Heluna Health) and the Infant Botulism Treatment and Prevention Program (IBTPP) of the California Department of Public Health (CDPH) invite applications for the position of Clinical Research Associate. The Infant Botulism Treatment and Prevention Program (IBTPP) is a unique public health/public service orphan drug program in the California Department of Public Health. The IBTPP is the sole producer and distributor worldwide of the public service orphan drug that it created known as BabyBIG ® . BabyBIG treats the orphan (rare) disease known as infant botulism, a life-threatening, paralytic disease of babies. The program interacts with federal and state government agencies, private contractors, hospitals, physicians, and infant botulism families nationwide. The IBTPP consists of a small team of dedicated professionals who work on the diagnosis, treatment and prevention of infant botulism and related disorders. Additional program information may be found at: .

The Clinical Research Associate (CRA) will provide professional support to the Program Chief and Senior Medical Officer for the successful conduct of the new immunogen development activities for BabyBIG. IBTPP continues to evaluate an investigational botulinum vaccine for generating source plasma for BabyBIG production under an Investigational New Drug (IND) clinical study. The CRA will have primary responsibility for working with the Senior Medical Officer and part-time Clinical Research Physician, under the direction of the Program Chief, to conduct the clinical study logistics and operations including, but not limited to, communications, data collection, manual and electronic data entry, and hard-copy and electronic data management, in accord with U.S. Food and Drug Administration (FDA) regulations.

The CRA will participate in, and support as needed, all facets of the vaccine clinical study and plasma collection and will exercise discretion and good judgment in doing so. Designs, creates, and develops specific databases for clinical studies and specialized projects as needed. Communicates with the public by phone, email, and written correspondence. Incumbent uses a high degree of innovation, creative thinking, and independent planning to complete work.

The hourly range for this position is $37.00 to $39.00 per hour depending on experience/ qualifications. 

If hired for this position, you will be required to provide proof that you are fully vaccinated for COVID-19 prior to your start date or have a valid religious or medical reason qualifying you for an exemption (that may or may not require an accommodation).

ESSENTIAL FUNCTIONS  

• Implements logistics and general operations of the clinical study, inclusive of communications, supply orders, study staff trainings, data collection, manual and electronic data entry, report management.
• Exercises discretion and good judgment in coordinating participant outreach/scheduling, arranging for plasma donor transportation during plasma collection, and coordinating any additional study participant and plasma collection visit schedules and other logistics.
• Tracks clinical trial deliverables and works collaboratively with clinical trial team to align with clinical trial objectives and timely accomplishment of priority tasks.
• Communicates effectively with federal agencies program contractors, and internal stakeholders to build consensus and shared expectations for project next steps.
• Adheres to a high standard of documentation including but not limited to the preparation of regulatory submissions to FDA and records maintenance related to the clinical study IRB approval.
• Develops IBTPP clinical trial databases to ensure that accurate clinical study and source plasma unit reports can be produced with high confidence in report accuracy and usable status and current disposition of each individual plasma unit.

• Assists with development of Standard Operating Procedures, Study Procedure Manual and Trial Master File.

• Collects and maintains records related to study participant adverse event reports and assist with safety report development and submissions to FDA.
• Prepares reports, spreadsheets, and other documents.
• Performs medical records abstraction into Program database and maintains Investigator Study File, Trial Master File, and plasma donor file organization.
• Performs other duties as required.

JOB QUALIFICATIONS

• At least 3 years of prior experience in clinical research related to pharmaceutical product development.
• Knowledge of botulinum toxin, infant botulism, and its treatment

• Records organization and maintenance experience highly desired
• Fluency with Microsoft software
• Understand and comply with current Standard Operating Procedures
• Core values: Curiosity, Humility, Reliability
• Ability to handle medical and sensitive information with absolute confidentiality
• Ability to exercise discretion and good judgment at all times
• Ability to speak fluently and write clearly; good telephone skills and manners

Education/Experience

• Bachelor’s degree in biological sciences or public health
• Prior clinical research experience
• Prior experience working in public health or medical programs.
• Phlebotomy experience and possession of a current phlebotomy license, or willingness to obtain these upon hire.  

PHYSICAL DEMANDS  

• Stand: Occasionally
• Walk: Occasionally
• Sit: Constantly
• Handling / Fingering: Constantly
• Reach Outward: Occasionally
• Reach Above Shoulder: Occasionally
• Climb, Crawl, Kneel, Bend: Occasionally
• Lift/Carry: Occasionally - Up to 50 lbs.
• Push/Pull: Occasionally - Up to 50 lbs.
• See (Vision): Constantly
• Speak: Frequently
• Taste/ Smell: Not Applicable

KEY

• Not Applicable = Not required for essential functions
• Occasionally = (0 - 2 hrs./day)
• Frequently = (2+ - 5 hrs./day).
• Constantly = (5+ hrs./day) 

WORK ENVIRONMENT:  

General Office Setting, Indoors, Temperature-Controlled. The IBTPP is located at the CDPH Richmond Laboratory Campus on Marina Bay Parkway, Richmond, CA 94804.

ADDITIONAL INFORMATION:

This position may require travel within the state of California in order to conduct clinical study visits and for site visits to source plasma collection centers. 

APPLICATION PROCEDURE

REQUIRED for consideration: All applicants must complete the application, and upload both a cover letter and a resume to the recruiting portal.

Via Employer Recruitment Website. 

EEOC STATEMENT

PHFE dba Heluna Health is an Affirmative Action, Equal Opportunity Employer that encourages minorities, women, veterans, and disabled to apply.

It is the policy of Heluna Health to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)