Clinical Research Specialist

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. 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 4 years in a row as a Top Workplace of San Diego 2020-2024! 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. About the Position The temp-to-hire Clinical Research Specialist operates with greater independence than the Research Assistant, taking on expanded clinical and administrative responsibility across delegated trials under the supervision of the Clinical Research Coordinator and Principal Investigator. The Specialist conducts study visits, manages source documentation, and independently reviews data for completeness and quality, serving as a bridge between entry-level trial support and full coordinator-level responsibility. Essential Duties and Responsibilities Administrative Duties (may include, but not limited to): Timely and accurate EDC, CTMS, and study-related vendor portal data entry. Cross-checking data across online portals and vendor systems for accuracy. Subject visit tracking and scheduling per protocol. Creation, recording, reporting, and cataloging of source documentation. Maintains and manages trial-specific source documentation and study binders. CRO and Sponsor scheduling and correspondence support for the Clinical Research Coordinator. Identifies and communicates protocol or data management issues to the supervisor in a timely manner. Assists in maintaining federal and GCP/ICH compliance during the conduct of trials. Clinical Duties (may include, but not limited to): Independently performs, records, and reports delegated study visit tasks per protocol (e.g., subject intake, EKGs, trial-specific biologic sample collection). Collects, processes, and ships trial-specific biologic samples per protocol. Assists the PI and Clinical Research Coordinator in subject recruitment, screening eligibility, informed consent, and subject retention. Responsible for the collection and reporting of subject data and AE/SAEs within accepted guidelines. Completes all required training per protocol during pre-study, enrollment, and closeout phases. Pay Range: $ Location and Type: In person, Temporary full-time role with potential for hire Required Qualifications 1–2 years of clinical research experience, preferably in clinical research, human medicine, or end-stage disease, or an equivalent combination of education and experience. Valid driver’s license and dependable transportation to travel locally between sites. Demonstrated ability to independently conduct study visits and delegated procedures per protocol (e.g., subject intake, EKGs, biologic sample collection). Experience with study protocols and a record of successful collection, recording, and reporting of data with written and online databases (EDC, CTMS). Demonstrated experience independently reviewing data for completeness and quality assurance related to the collection and reporting of clinical data. Experience interpreting medical charts and obtaining data from medical records. Experience in HIPAA and GCP/ICH, including federal and local record management. Understanding of FDA, ethics, and regulatory requirements governing clinical trials. Demonstrated interpersonal, written, and verbal communication skills, including professional correspondence with CRO and Sponsor representatives. Exhibits the capacity to work unattended and complete delegated tasks by specified deadlines. Preferred Qualifications Experience in CKD, Dialysis, or Renal Transplantation. Certification as a Clinical Research Associate or Coordinator. Bachelor’s degree in a natural science (e.g., Biology, Chemistry, BSN). Current certifications in Good Clinical Practice (GCP), the National Institute of Health (NIH), Shipping of Blood Specimens, and Blood Borne Pathogens (IATA). Skilled in lab techniques, processing, and shipping of human biologics. Established experience in medical terminology. Bilingual in English and Spanish. Required Skills Excellent verbal and written communication Ability to provide excellent customer service Ability to interpret, adapt and apply guidelines and procedures Ability to use good reasoning and judgement and react appropriately in emergency situations Ability to establish and maintain effective working relationships with patients, medical staff and coworkers Other considerations: Background check required Travel to other sites located within San Diego County may be 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 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. Must be able to safely ascend and descend stairs as a core part of the job, with or without reasonable accommodation, when no elevator or lift is present. 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). Equal Opportunity Employer *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. This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr Ultipro