Clinical Research Coordinator - San Diego, United States - Balboa United, LLC

Description

Job Description

Why work for Balboa:

• Balboa Nephrology is the largest kidney care practice in California and participates in a national Medicare program focused on value-based care.
• Through our joint venture with Evergreen Nephrology we are a growing organization with opportunities for professional and personal growth.
• We will help you grow in your leadership experiences while learning the new value-based care world.
• Comprehensive benefits package that includes medical, dental & vision on the 1st of the month 30 days after hire.
• Employer contribution of up to 10% of annual pay for your 401K.
• Generous paid time off plus 8 paid holidays, a birthday float day off and a mental health day
• Company paid life insurance.
• Join a fast-growing field - employment of medical and health services managers is projected to grow 32 percent from 2020 to 2030, much faster than the average for all occupations.
• Voted Top Workplace of San Diego 2017 and

Our Values: Patient-centered I Accountability I Respect I Innovation I Data-Driven

Our Mission: to consistently deliver superior care – Balboa Care – to every patient with kidney disease.

The Clinical Research Coordinator works with and under the direct supervision of the Principal Investigator. Meticulous and curious by nature, the Clinical Research Coordinator supports, facilitates, and coordinates the daily clinical trial activities and is instrumental in assuring the proper conduct of multiple trials. As the cornerstone of clinical research, the Clinical Research Coordinator is responsible for facilitating protocol related guidance regarding compliance, personnel and other relevant aspects of trials at multiple research sites, medical institutions, CRO's and Sponsors.

Work location: Kearny Mesa

Essential Duties and Responsibilities:

Administrative Duties (may include, but not limited to):

• Enters data into the study specific EDC and site CTMS in a timely manner.
• Manages Research Assistant study vendor, EDC, site CTMS and other study related data reporting entry.
• Maintains and manages all trial specific source documentation.
• Manages the collection, recording, reporting and storage of study related data, study binders, investigational product, and study equipment.
• Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner.
• Communicates and works directly with the CRO and Sponsor representatives during pre-study, IMV and site closure, adhering to site specific standard operating procedures, local and federal regulations.
• Supplies weekly and monthly reports to supervisors including but not limited to: pipeline status, current trial status, screening activities, enrollment expectations vs. actual enrollment status, study timelines and other study or site-specific needs.

Clinical Duties (may include, but not limited to):

• Comprehension of each study protocol.
• Completion of all required training required per protocol during the pre-study, enrollment and maintenance and closeout phases.
• Regular networking with local medical staff regarding study information, marketing and PR efforts related to study awareness and subject referrals.
• Assists the PI in subject recruitment, screening eligibility, informed consent, and subject retention.
• Conducts all study visits as required per protocol.
• Responsible for the collection and reporting of subject data, AE/SAE's within accepted guidelines.

Pay Range: $ $26.00/hour, depending on experience

Required Qualifications:

• 2+ years of Clinical Research experience as a Research Assistant or an equivalent combination experience and abilities related to the conduct of clinical trials.
• Demonstrated interpersonal, written, and verbal communication skills and excellent phone etiquette skills.
• Experience in industry sponsored clinical trials.
• Experience interpreting medical charts and obtaining data from medical records.
• Experience in medical assessments and patient interaction.
• Experience with laboratory procedures and values for proper recording and reporting to the Principal Investigator.
• Understanding of FDA, IRB, and other regulatory regulations regarding clinical trials.

Preferred Qualifications

• Certification as a Clinical Research Associate or Coordinator.
• Bachelor's degree in a natural science (i.e. Biology, Chemistry, BSN, ect.)
• Marketing and PR experience.
• Current certifications in Good Clinical Practice (GCP), the National Institute of Health (NIH) and Shipping of Blood Specimens, and Blood borne Pathogens (IATA).
• Experience in CKD, Dialysis or Renal Transplantation
• Bilingual in English and Spanish

Other Considerations:

• Background check required
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
• Supervisory duties – no
• Status – full time
• Work Environment – This position operates in a professional office environment and routinely uses standard office equipment such as laptop, computer, mouse, and photocopier.
• Physical Demands – While performing duties, the employee is regularly required to talk, hear, read, write, type and respond. Specific vision abilities required by this job include close vision and ability to adjust focus. This position requires the ability to open cabinets at various levels, bend, stand, stoop and drive as necessary.

Language Skills

While performing duties, the employee is regularly required to talk, hear, read, write, type and respond in English and understand clinical/medical vocabulary written and spoken.

Vision Requirements

Vision requirements include close vision, ability to adjust focus, and see color.

Physical Demands

Physical requirements may vary slightly and should be reviewed with your manger. In general, this position requires the ability to lift up to 35 pounds unassisted; ability to stand for extended periods of time and to perform repetitive stooping, walking, stretching, reaching and some sitting; ability to use full range of body motions required to lift patients, wear a lead apron, and lift and move supplies.

Work Environment

Job required tasks routinely involve a potential for mucous membrane or skin contact with blood, body fluids, tissues or potential spills or splashes. Use of appropriate personal protection measures is required for every healthcare provider in these positions. Require to routinely use standard office equipment such as laptop, computer, mouse, and photocopier.

About Balboa United

Beginning in 1973, Balboa has grown from two physicians to a comprehensive nephrology team of 52 board certified physicians and 8 advanced practitioners. On January 1, 2018, Balboa Nephrology Medical Group (BNMG) launched Balboa United, a full-service medical practice management services organization. From one small office, BNMG now has 24 clinical offices throughout San Diego, Imperial, Orange and Riverside counties. In addition to office and hospital-based patient care, Balboa physicians manage the dialysis treatments of approximately 4,500 patients at 88 dialysis centers and conduct Nephrology based clinical research at 6 centers throughout Imperial and San Diego counties (California Institute of Renal Research).

• EEO Statement Balboa United is an equal opportunity employer and makes employment decisions on the basis of merit. We want to have the best available person in every job. Our Company policy prohibits unlawful discrimination based on race, color, creed, religion (including religious dress & grooming), sex (including pregnancy, childbirth or related medical conditions), gender (including gender identity and gender expression), marital status, registered domestic partner status, military status, age, national origin or ancestry, physical or mental disability, medical condition (including cancer and genetic characteristics), genetic information, sexual orientation, or any other basis protected by applicable federal, state, or local law. We also prohibit unlawful discrimination based on the perception that anyone has any of those characteristics or is associated with a person who has or is perceived as having any of those characteristics. The Company is committed to compliance with all applicable laws providing equal employment opportunities. This commitment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee of Balboa United, including managers and co-workers. If you believe you have been subjected to any form of unlawful discrimination, submit a written complaint to your manager or Human Resources (HR). Your complaint should be specific and should include the names of the individuals involved and the names of any witnesses. If you need assistance with your complaint, or if you prefer to make a complaint in person, contact the Company's Human Resources Department. We will immediately undertake an effective, thorough, and objective investigation and attempt to resolve the situation.