Clinical Research Coordinator Associate
The Department of Orthopaedic Surgery has a national and international presence in orthopaedic research that is based on a broad representation of the varied subspecialties within this surgical field for treatment of problems in infants, adolescents, middle-aged and older individuals. The goal of the Orthopaedic Research Program is to develop fundamental knowledge to advance the treatment of musculoskeletal injuries and diseases. In pursuit of this goal, the department has an immediate opening for a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical studies focused in three main areas: quantitative imaging and biomarker development for early diagnosis and staging of joint and cartilage injury and degeneration; cartilage tissue engineering and stem cell base cartilage repair; and molecular and biological therapies for joint restoration and rejuvenation. Cornerstones of this program include teamwork and a focus on personalized medicine, and the CRCA will serve in a dynamic and supportive environment under the direction of the Vice Chair of Research and have the opportunity to work closely with fellow coordinators and research assistants, physicians, nurses, and medical assistants that are fundamentally changing the world of orthopaedic research. To learn more about the Department please visit us at: https://ortho.stanford.edu/
The successful candidate will demonstrate:
- Outstanding communication and relationship building skills;
- Strong attention to detail, and competence to manage multiple priorities and respond effectively with limited guidance;
- Commitment to uphold Stanford University’s compliance with federal, state, local, and sponsor regulation; and
- Drive to establish themselves as a leading contributor within the Department of Orthopaedic Surgery and Stanford Medicine.
- 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 including data entry, 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
- Knowledge of the principles of clinical research and federal regulations.
- Previous experience with clinical trials.
- Familiarity with EPIC, E-protocol, Redcap and Stride Databases.
- Familiarity with IRB guidelines and regulations.
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.
- Experience in Human Subject Research and knowledge of statistics, preferred.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Strong interpersonal skills.
- Proficiency with Microsoft Office.
- Knowledge of medical terminology.
- Ability to conduct clinical research with a strong attention to detail.
- Excellent oral and written communication skills.
- Strong computer skills.
- Knowledge of clinical research study principles including protocol adherence and human subject research ethics.
- 2 years of experience in research program coordination.
- Prior work with clinical research preferred.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification, 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.
* - 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.
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.