Clinical Research Coordinator Associate
Location: Redwood City, CA, United States · Reference: 200795
Stanford University's Department of Dermatology is seeking an experienced
Clinical Research Coordinator Associate (CRCA) to perform duties related to
the coordination of clinical studies. The CRCA will coordinate moderately
complex aspects of one or more clinical studies and work under the close
direction of the principal investigator and the clinical research manager. The
CRCA will support federal and non-federal clinical research studies, including
dermatological and investigative work in support of clinical trials, clinical
research, or biomedical research focusing on “bench to bedside” treatment.
This position requires in-person attendance between the Redwood City and Palo
Alto sites.
Interested candidates, please apply with your resume and a cover letter.
DESIRED QUALIFICATIONS:
A Bachelor's degree with an educational background in medicine and/or
scientific field (biological sciences, social sciences, etc.)
Three years of clinical research experience preferred.
Clinical research project management experience.
Experience with research protocols and regulatory or governing bodies,
which include HIPAA and FDA regulations, Institutional Review Board
requirements, and Good Clinical Practices.
Proven ability to work independently and take ownership of a project.
Proven ability to work collaboratively and cooperatively in a team
environment.
Ability to work effectively in a fast-paced environment with multiple
projects and timelines.
Strong oral and written communication skills.
Detail-oriented with excellent organizational skills.
Proficiency in using computers, software, and web-based applications in a
previous administrative setting.
Fluency in Spanish is a plus.
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.
- 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:
Occasional evening and weekend hours. Infrequently, the CRCA may be
required to work over the weekends in order to meet the clinical trial
deadlines and/ or work on any other duties assigned.
This role is hybrid, though the coordinator should expect to be in person
at the RWC campus three to four days per week to support the studies.
WORK STANDARDS:
• 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,
https:// adminguide.stanford.edu.
Responsibilities
Core Duties :
Serve as primary contact with research participants, sponsors, and
regulatory agencies. Coordinate studies from start-up through closeout.
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.
Minimum Education and 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 :
Strong interpersonal skills.
Proficiency with Microsoft Office.
Knowledge of medical terminology.
Certificates and Licenses Required
Society of Clinical Research Associates or Association of Clinical Research
Professionals certification is preferred.
Qualifications
REMOVE STATEMENT BEFORE POSTING - KEEP LANGUAGE BELOW, IF APPLICABLE.
REMOVE IF NOT APPLICABLE
Drivers License Requirements
Must possess and maintain a valid California non-commercial Class C
Driver's License.
Ability to drive day or night.
When conducting university business, must comply with the California
Vehicle Code and Stanford University driving requirements.
