Job Description

Clinical Research Coordinator Associate - Bilingual Mandarin Overview The Division of Cardiovascular Medicine, within Stanford University Department of Medicine, is a dynamic and innovative center dedicated to excellence in research, medical education, and clinical care. Our Division is driven by over 90 faculty members and a cadre of staff who support ongoing efforts into the prevention and treatment of cardiovascular disease. We are seeking a Clinical Research Coordinator Associate (CRCA) who is passionate about clinical research and wants to deliver results. The CRCA will work with a robust clinical research team, hand in hand with Principal Investigators, Clinical Research Managers, Assistant Clinical Research Coordinators and other stakeholders in support of cardiovascular patients. The CRCA will be responsible for the overall implementation of an assigned set of research protocols assuring efficiency and regulatory compliance. Other responsibilities include recruiting, screening, assisting in the informed consent process and enrolling subjects in accordance with good clinical practice guidelines as well as collecting, recording and maintaining complete data files using good clinical practice per HIPAA regulations. He/she will participate in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies. CV Med Clinical Research is a growing, dynamic team dedicated to supporting translational medicine and contributing to Stanford Medicine’s mission. If you are eager to quickly achieve lasting results, we invite you to join our team! Duties Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies. Coordinate collection of study specimens and processing. Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete 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 study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff. 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. Other duties may also be assigned. Qualifications

EDUCATION & EXPERIENCE (REQUIRED):

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):

Fluency communicating/translating in Mandarin. Previous research coordinator experience conducting patient-facing clinical trials (drug/device/IIT) is required, such as: Coordination and execution of components of a study, including set up, IRB submission, implementing protocols, implementing recruitment and scheduling strategies, acquiring multiple types of data, reporting recruitment milestones, ensuring compliance, coordinating study databases, contributing to study reports, tracking project activities with study budgets, coordinating and leading relevant project meetings and interactions with investigators. Familiarity with Good Clinical Practice (GCP) guidelines and FDA regulations is essential. Strong data management skills with attention to detail for accurate record keeping. Knowledge of medical terminology. Experience in clinical development processes or previous roles in clinical research is a plus. Ability to work collaboratively within a team environment while managing multiple tasks effectively. Excellent communication skills, both verbal and written, for effective interaction with various stakeholders. Strong interpersonal skills. Proficiency with Microsoft Office.

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: Occasional evening and weekend hours This position offers an exciting opportunity for individuals passionate about advancing medical research through rigorous clinical trials. Note: Certain boilerplate statements and salary information included in the original posting have been preserved for completeness where applicable. Specific compensation details will be discussed during the hiring process. Working at Stanford University provides access to a comprehensive benefits package. Specifics about the rewards package for this position may be discussed during the hiring process. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Seniority level Entry level Employment type Full-time Job function Research, Analyst, and Information Technology Industries Higher Education #J-18808-Ljbffr Stanford University School of Medicine

Job Tags

Full time, Work experience placement, Work at office, Afternoon shift,

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