Clinical Research Coordinator 2 - On-Site

DESIRED QUALIFICATIONS:

 

Experience with University research policies and procedures.  Candidates must possess strong organizational skills and a demonstrated ability to work independently with minimal supervision as well as cooperatively in a team environment.A proven capacity to set priorities, coordinate multiple assignments, work in a fast paced, multi-tasked environment, exercising sound judgment in setting priorities with a strong attention to detail. Excellent communication and problem-solving skills.Experience in CV is desired.Strong interpersonal skills.Proficiency in Microsoft Office and database applications.  

EDUCATION & EXPERIENCE (REQUIRED):

 

Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience. 

 

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

Strong interpersonal skills.Proficiency in Microsoft Office and database applications. Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.May require extended or unusual work hours based on research requirements Institutional Review Board requirements, and Good Clinical Practices.Knowledge of medical terminology. 

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver's License.

Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

 

PHYSICAL REQUIREMENTS*:

 

 

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

 

WORKING CONDITIONS:

Position may at times require the employee to work with and business needs.

 

The Division of Pediatric Surgery in the Department of Surgery along with the Prematurity Research Center in the Department of Pedaitrics, Divison of Neonatal and Developmental Medicine together are seeking a Clinical Research Coordinator 2 (1.0 FTE) to conduct clinical research and work independently on progressively more complex projects/assignments. The Coordinator will independently manage significant and key aspects of a large study or all aspects of one or more small research studies. The Coordinator will work with fellow Coordinators in Maternal Fetal Medicine, Pediatric Surgery, Neonatology and other collaborating Departments and Divisions on multiple trials.  The Coordinator will also work closely with the Maternal Child Health Research Institute and Clinical Research Support Office to ensure consistency and streamlined research practices and quality. 

 

Duties include: 

Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Oversee visits and follow-up are conducted according to protocol.New study start-up activities such as IRB application, budget development, clinical operations start-up.Ongoing regulatory requirements such as IRB amendments and modifications as well as responding to IRB questions.Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data. Ensure source documentation adheres to ALCOA.Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work. Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract. Resolve billing issues in a timely manner.Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance. Maintain study documentation, logs, CRFs, and submission of data to relevant parties.Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Collaborate with MCHRI and the CRSO to promote a Department wide effort of streamlining and enhancing clinical research to optimize patient care for our participants in clinical research.

 

* - Other duties may also be assigned

Responsibilities

Core Duties:

• Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
• Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
• Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
• Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions.
• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
• Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
• Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.
• Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance.
• Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.
   

Minimum Education and Experience

Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

Knowledge, Skills and Abilities:

• Strong interpersonal skills.
• Proficiency in Microsoft Office and database applications.
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
• Knowledge of medical terminology.
   

Certificates and Licenses Required

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.