Senior Clinical Research Coordinator and Project Manager
School of Medicine, Stanford, California, United States
Stanford University is seeking a Clinical Research Coordinator 2 (CRC2) project manager to join the Department of Radiology within the School of Medicine.
Stanford Radiology has been among the top ten NIH-funded radiology departments each year since 2005, including drug and devise studies from phase I to IV. The Department of Radiology takes on a unique position within the School of Medicine. It includes a wide area of modalities and disease groups and collaborates with numerous clinicians and researchers in other departments to develop improved scientific, diagnostic, and therapeutic applications.
We are seeking a CRC2-PProject Manager to help us enact our mission to reduce disease through comprehensive research, treatment, education, and outreach programs. The CRC2-project manager will be working with an unparalleled leading-edge community of faculty and staff who are fundamentally changing the world of health care. Candidates need to demonstrate excellent CRC2 skills, outstanding communication, and organizational skills, and attention to detail to work independently on projects and clinical trials across a wide range of diseases. The CRC2-project manager will work in a dynamic atmosphere within and with a multifaceted team of fellow coordinators and physicians, scientists, technologists, nurses, and research fellows. Outstanding communication and organizational skills and attention to detail are required in a successful candidate. The coordinator will be responsible for ensuring compliance with federal, state, local, and sponsor regulations and work under the direction of their manager.
EDUCATION & EXPERIENCE (REQUIRED):
- The CRC2 project manager will serve as a liaison between sponsor and investigators and is the primary point person for all new study startups in Radiology.
- Collaborate with staff and principal investigators to develop study budgets for clinical trials (e.g., trials with a large number of participants, high profile industry trials) within the Department.
- The CRC2 project manager will coordinate all logistical aspects of a new project.
- The CRC2 project manager will instruct CRCAs on new projects.
- The CRC2 project manager will be responsible for monitoring data collection for clinical trials. More specifically, help transfer all ongoing and future studies to secure data systems such as RedCap to align with the School of Medicine data security requirements.
- For clinical trials, the CRC2 project manager will delegate data tasks to CRCAs in the group and is therefore responsible for the oversight of those tasks.
- This position will perform regular internal auditing of clinical trial documentation and compliance with appropriate regulatory agencies, such as the FDA and NRC.
- In cases of non-compliance found on internal audit, this position will work with the Principal Investigator to develop a corrective action plan and monitor adherence to that plan.
- Prepare and track study invoices to sponsors and study subject stipends.
- This position will work hand-in-hand with the Clinical Trials and Translational Research Manager and the Translational Research Steering Committee to identify key challenges in clinical trials / clinical translational research and recommend and implement improvements to the Department Clinical Trials and Translation capabilities and processes.
KNOWLEDGE, SKILLS AND ABILITIES (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.
CERTIFICATIONS & LICENSES:
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, Scientific Review Committee, and Good Clinical Practices.
- Relevant work experience - i.e., in clinical research, device development, pharmaceutical industry etc.
- Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines.
- Demonstrated experience working independently and as part of a team.
- Excellent interpersonal, written and oral communication skills.
- Proficiency with Microsoft Office and database applications.
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver's License.
* - 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:
- 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.
- Hybrid (on-site 2-3 days per week; on occasions more)
- 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.
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
As an organization that receives federal funding, Stanford University has a COVID-19 vaccination requirement that will apply to all university employees, including those working remotely in the United States and applicable subcontractors. To learn more about COVID policies and guidelines for Stanford University Staff, please visit https://cardinalatwork.stanford.edu/working-stanford/covid-19/interim-policies/covid-19-surveillance-testing-policy
To be considered for this position please visit our web site and apply on line at the following link: https://apptrkr.com/3058016
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
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