DaVita Director, Regional Clinical Research in EL SEGUNDO, California
Director, Regional Clinical Research
DaVita Medical Groupmanages and operates medical groups and affiliated physician networks inCalifornia, Nevada, New Mexico, Florida, Colorado and Washington in its pursuitto deliver excellent-quality health care in a dignified and compassionatemanner. As of June 30, 2016 DaVita Medical Group (formerly HealthCare Partners)provided integrated care management for approximately 760,000 patients. DaVitaMedical Group’s leadership development initiatives and social responsibilityefforts have been recognized by Fortune, Modern Healthcare, Newsweek andWorldBlu.
We are committed tobringing the benefits of coordinated care to our patients and to taking aleading role in the transformation of the national healthcare delivery systemto assure quality, access, and affordable care for all.
If you're looking tomake a difference with a large, financially stable, well-recognized medicalgroup, DaVita Medical Group may be the employer for you.
Seeking a Full-TimeDirector of Regional Clinical Research in El Segundo
Responsible for theoverall planning and implementation of developing the clinical researchprogram. Manages the overall operations of the clinical research programin California that includes hiring, training and oversight of the researchstaff, ensuring that studies meet enrollment goals, and study data is completedaccurately and on a timely basis. This position is also responsible forbusiness development and marketing strategies to expand the clinical researchprogram.
- Consistently exhibits behavior and communication skills that demonstrate HealthCare Partners’ (HCP) commitment to superior customer service, including quality, care and concern with each and every internal and external customer.
Selects principal investigator and sub-investigator staff with National Senior Director, Clinical Research Operations..
Evaluates new protocols with selected principal investigator for potential new studies.
Negotiates contracts and prepares budget for new studies.
Oversees the preparation and maintenance of regulatory documents for new studies.
Follows-up with sponsor/CRO grants and contracts office regarding clinical trial agreements and indemnification letters.
Plans and designs new forms/source document tools to be used in protocol implementation.
Coordinates activities for tracking financial with the Accounting department including A/P and A/R.
Hires, trains and evaluates productivity and quality of work of clinical research staff using the annual performance appraisal.
Develops a plan for resource allocation including budget preparation for program and staff needs.
Assures that all aspects of the clinical research program is in compliance with current FDA regulations.
Coordinates sponsor site visits with research staff.
Complies with any and all reasonable requests in the event of a possible FDA audit and site visit.
Maintains all clinical research records in a safe and permanent location to comply with FDA regulations.
Generates reports for the National Senior Director, Clinical Research Operations.
Management of dailyoperations:
Evaluates data management programs and selects appropriate program to track daily clinical research activities by studies.
Oversees clinical research staff to ensure quality of care (Good Clinical Practices Guidelines) and provides appropriate safeguards for the welfare and safety of clinical research subjects including the obtaining of an informed consent.
Ensures all contract obligations are met by evaluating the accuracy of completed research papers.
Oversees the Clinical Research Coordinators’ preparation for monitor visits.
Oversees staff scheduling, determines distribution of workload, minimizes use of overtime, and encourages time management principles.
Develops team cooperation and motivation to accomplish goals set for each protocol.
Motivates and encourages each individual staff member to develop potentialities and new skill sets.
Keeps abreast of the latest developments and trends in clinical research.
Marketing topharmaceutical industry, HCP staff and community:
Develops and maintains relationships with the pharmaceutical industry to promote HealthCare Partners’ (HCP) ability to capture new studies.
Maintains effective communication lines between industry representatives and HCP’s clinical research staff.
Networks with trade organizations to locate new studies.
Works with Marketing department to develop brochures to present to sponsors/CROs.
Coordinates advertising campaigns for print coverage and press releases with Marketing department.
Conducts site evaluation visits for potential sponsors/CROs.
Receives IRB approval for all ad placements, posters and flyers distributed at the research sites.
Develops and cultivates relationships with providers to encourage referrals of potential qualified patients to open studies.
Updates Marketing department with information on new studies for publication in HCP’s house organs.
Writes reminder memos to HCP’s clinical staff to announce open studies.
Requests queries from the IS department to identify appropriate patients.
Serves as a spokesperson for the Clinical Research Center at professional and community meetings.
Maintains professionaland technical knowledge:
Attends educational workshops.
Review professional publications.
Participates in professional societies.
Implements qualitycontrols and assurance measures:
Monitors compliance with study procedures and GCP standards.
Conducts quality assurance audits as requested.
Works with internal and external quality assurance team.
Uses, protects, and discloses HCP patients’ protected health information (PHI) only in accordance with Health Insurance Portability and Accountability Act (HIPAA) standards.
Performs additional duties as assigned
Bachelor’s degree from a four-year college and/or a professional certification requiring formal education beyond a two-year college.
RN license preferred.
Over 5 years and up to and including 7 years of experience in clinical research preferably in a managed care setting.
3 to 4 years management experience.
2 or more years of experience in a managed healthcare organization.
4 to 6 years of analytical and/or financial experience.
Proficient in Microsoft applications.
Clinical knowledge of major therapeutic areas.
Contacts with pharmaceutical companies and clinical research organizations.
Effective verbal and written communication skills
Primary Location CA-EL SEGUNDO - 90245
Req ID: 306972