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Clinical Research Coordinator Associate

3 months ago

Stanford, United States Stanford University Full time
The Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine (PACCM) is seeking a full-time (100% FTE) Clinical Research Coordinator Associate (CRCA) to coordinate multicenter clinical trials investigating plasma and lung biomarkers, and emerging therapies for patients with sepsis, pneumonia, and lung injury. These studies are conducted at the Stanford Hospital and Clinics, often involving patients in the intensive care unit. The CRCA will work as part of a highly committed clinical trials research team and report to the Clinical Research Manager and various Principal Investigators conducting clinical research within the Pulmonary, Allergy & Critical Care Medicine Division. The position requires a desire to work in a fast-paced environment of an acute care setting as part of a multidisciplinary team that includes MDs, RNs, and RTs, and other research coordinators. The position will require superior organizational skills to ensure rigorous and timely compliance with multiple clinical trial protocols and adherence to regulatory standards. Responsibilities include screening and enrollment of subjects, and implementation of study protocols in accordance with Good Clinical Practice guidelines, and collection and maintenance of complete data files in accordance with HIPAA regulations. This position will also be responsible for overseeing activities related to acquisition, processing, storage and organization of human materials, including serum. Experience in sample processing, some flexibility in work hours, and knowledge of computer programming/data analysis are preferred.

Duties include:
  • Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up 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:
  • Interest in learning about clinical study design/implementation and about the care of critically ill patients.
  • Ability to coordinate research protocol activities in a fast-paced, high-stakes environment like the intensive care unit.
  • Willingness to learn how to handle specimens for shipping and willingness to learn basic processing of biospecimens for storage.
  • Strong interpersonal skills to communicate with patients and their surrogates in the context of the patient's critical illness, as well as interact with treating physicians, nurses, pharmacy and other health care providers.
  • Willingness to learn about Institutional Review Board (IRB) policy and practice, including the informed consent process.
  • Timely communication with IRB regarding Serious Adverse Event (SAE) reports protocol violations, and amendment reviews and revisions.
  • Aptitude for medical record review.
  • Responsible record keeping, including the retention of source documentation for all study data, including laboratory, pharmacy and medical records.
  • Good computer skills (able to use Microsoft Word and Excel).
  • Experience in all phases of industry-sponsored and NIH funded clinical trials.
  • Experience with REDCap, EPIC and OpenSpecimen (or similar biospecimen management system)
  • Experience in sample processing, and knowledge of computer programming/data analysis would be highly desirable but not required.
  • Fluency in Spanish
  • Preference for applicants who envision 2 years in the position.
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:
  • Working toward certification(s) to perform basic patient measurements and tests, such as phlebotomy and EKG.
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:
  • Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
  • May require extended or unusual work hours based on research requirements and business needs.
  • Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
WORKING 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. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

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The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources at . For all other inquiries . click apply for full job details