"Clinical Research Coordinator 2"

About the Position

The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is seeking a Clinical Research Coordinator 2 (CRC2) to manage life-changing clinical trials under the direction of project researchers, investigators, or managers.

The CRC2 will join a team of researchers that leads or participates in many clinical trials to develop new therapies for allergic disorders. The studies include a wide range of patients, representing a diverse group of ethnicities and socioeconomic backgrounds. The Center is aiming not only to find better treatments for children and adults with allergies and asthma, but to discover underlying immune mechanisms against the diseases and develop a lasting cure. Primary responsibilities as a CRC2 will include the oversight and coordination of complex clinical research trials, management of research coordinator associates and assistant coordinators, including the recruitment of participants, the creation of source documentation, adherence to all ICH/GCP and HIPAA regulations, management of all study participants, sample collections, data entry, and administration of the Investigator Site File.

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 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 document 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.

* - Other duties may also be assigned*

Desired Qualifications:

• California State License in Phlebotomy
• Prior experience in a clinical research setting
• Bachelor’s degree in health science, biological sciences, life research, medical technology or clinical research.

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 with 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.

Certifications & Licenses:

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

Physical Requirements:

• 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.

Working Conditions:

• Position may at times require the employee to work with 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 and business needs.
• Due to the nature of the work, this position will work 100% on-site.

Salary:

The expected pay range for this position is $86,248 to $100,158 per annum.

Cardinal at Work benefits

For more information about the department visit pathology.stanford.edu