Clinical Research Operations Specialist 1
Clinical Research Operations Specialist 1
Job Number: 74993
The Stanford Center for Clinical Research (SCCR) is an Academic Research Organization within the Stanford Department of Medicine that has the mission to innovate, support and promote high impact global reaching clinical research to improve human health. SCCR leverages the physical and intellectual resources of Stanford University and its affiliated teaching hospitals and research centers to achieve this mission. The Stanford Center for Clinical Research is seeking a Clinical Research Operations Specialist I to conduct and assist in the coordination of multi-site clinical trials. Research will be conducted in a variety of therapeutic areas including but not limited to cardiovascular, neurology and pulmonary. The Clinical Research Operations Specialist I will be responsible for supporting research sites for one or more studies by ensuring adequate study start up, regulatory submissions and training of each of the study sites in preparation for site activation. This position will work together with the project team members, sponsor and study PI to meet study objectives. This position will assist in the management of the entire study from startup to closeout and will ensure that regulatory requirements are adhered to. Duties include:
- Coordinate studies from startup through close-out by assisting with site startup activities for multiple sites and performing site management activities throughout the study period and closeout.
- Assist in developing recruitment strategies and recruitment aids such as brochures and flyers.
- Manage research project databases in conjunction with the study data managers, develop site flow sheets and other study related documents, and follow up with study sites to ensure completion of study documents/case report forms.
- Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
- Assemble and ship study kits for study sites, ensure sites recruit participants and schedule procedures according to the study protocol.
- Track tasks and deliverables and invoice components of the study budget.
- Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
- Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
- Participate in monitor visits and regulatory audits.
- Demonstrated superb communication skills in speaking and writing
- Project management experience
- Clinical research experience
Two year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Strong interpersonal skills.
- Proficiency with Microsoft Office.
- Knowledge of medical terminology.
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
- 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.
Occasional evening and weekend hours.
- 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.
Location: School of Medicine
To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu
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.