Clinical Research Coordinator Associate (Fixed-term 2 years)

The Department of Anesthesiology, Perioperative, and Pain Medicine, at Stanford University’s School of Medicine, is a world-leading department that offers comprehensive training and perioperative patient care, pain management, and critical care medicine as well as cutting-edge research, encompassing a wide spectrum of programs in basic, translational, clinical, health services and medical education.

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We are looking for a highly motivated and personable Clinical Research Coordinator Associate (CRCA) Fixed-term 2 years to join the research group of Dr.

Boris Heifets MD PhD in the Department of Anesthesiology at Stanford University School of Medicine. Dr. Heifets’ research group conducts both basic neuroscience and clinical research aimed at understanding how therapies, like ketamine and psilocybin, might function in the brain and how they could be used to improve outcomes for patients undergoing surgery and in chronic pain.

Join a dynamic, highly collaborative research group as a clinical research coordinator. This job involves coordinating clinical care, patient recruitment, follow-up, and managing communications with IRBs, the FDA, and the DEA.

Our group is currently running two clinical trials and collaborating with several other research groups on additional trials.

Direction and academic mentorship will be provided by the principal investigator, and opportunities for academic contributions are certainly available.

You will be responsible for day-to-day operations of two or more clinical studies, working with a highly collaborative team that includes Principal and co-investigators, fellows, residents, research nurses, medical students, and colleagues in the Psychiatry department at Stanford and UCSF, and Stanford’s Pain Medicine Division.

Duties include :

• 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.

DESIRED QUALIFICATIONS :

• Knowledge of principles of clinical research and federal regulations.
• Ability to work effectively in a fast-paced environment with multiple projects and timelines.
• Familiarity with IRB guidelines and regulations.
• Previous experience with SPSS and other related database applications.
• Previous experience working with Biobehavioral studies and use of psychiatric scales.
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
• Fluency in Spanish is a plus.

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) :

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

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, and rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

WORKING CONDITIONS : Occasional evening and weekend hours.

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.

The expected pay range for this position is $31.73 to $36.54 per hour.

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position.

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