Clinical Research Coordinator Associate (CRCA ) - Apidel Technologies
Stanford, CA 94305
About the Job
Description:
Schedule: On site with occasional 1 day remote. 8 AM 4:30 PM
The Division of Pulmonary Allergy and Critical Care Medicine is seeking a temporary/casual Clinical Research Coordinator Associate (CRCA) at 100% time for 34-month period for a position to join the Lung Transplant Clinical Research Team and assist in the coordination of multiple clinical research protocols.
DUTIES:
Serve as primary contact with research participants, sponsors, and regulatory agencies for research projects within our Lung Transplantation team.
Coordinate studies during start-up, activation, and through close-out. Studies may include PI-initiated and industry-sponsored drug treatment and also observational protocols in the area of Lung Transplantation.
This CRCA is the primary contact for a variety PI-initiated, NIH, and industry sponsored research protocols in the area of Lung Transplantation including the following: 1. BOSTON 3 nebulized cyclosporine study, 2. CF Lung Transplant Consortium, and 3. the CareDx study.
The CRCA recruits, screens, and consents participants, and coordinates protocol study visits and reviews adverse events with research participants, the PIs, Clinical Research Manager, sponsors, and regulatory agencies for these studies.
The CRCA is responsible for regulatory oversight, initiating and maintaining IRB submissions, monitoring weekly billing reports, and coordination of site initiation, monitor and close-out visits.
Determine eligibility of and gather consent from study participants according to protocol criteria.
Screen patients in the Lung Transplant clinics, and recruit participants for drug, tissue repositories, and observational Lung Transplant studies.
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.
Enter study data into existing electronic databases in accordance with each protocols guidelines.
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.
The CRCA addresses and resolves study queries, protocol deviations, or other audit or monitoring findings and reviews with a Research Manager as needed.
The CRCA is responsible for IRB revisions and renewals and also the maintenance of current regulatory documents for all protocols.
Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
The CRCA prepares for study-related visits including preparation of study kits, appointment scheduling and monitoring meetings.
The CRCA serves as the primary contact for participants and sponsors with oversight by the Clinical Research Manager as needed.
Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
Adverse events or other side effects from study treatment are reported to the PI by the CRCA. The CRCA meets every other week with the PI and the Research Manager to review study progress, recruitment, AEs and compliance. Study updates are presented in prepared slides.
Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
The CRCA maintains study files in the PACCM share drive and BOX, per each studys requirements.
The CRCA interacts with a variety of study sponsor and regulatory agencies that include the NIH auditors, industry-sponsored study monitors, and other foundation-sponsored research.
The CRCA meets weekly with the Clinical Research Manager to review and resolve any regulatory, budget, or other study-related issues.
Participate in monitor visits and regulatory audits.
The CRCA schedules monitor visits and/or regulatory audits and reviews in advance with the Clinical Research Manager and the PI of the study to prepare for each visit accordingly. Study monitor visits occur about every 3-6 months per each projects needs.
Requirements:
DESIRED QUALIFICATIONS:
Desired qualifications include experience with interventional drug treatment trials, clinical experience with patients with pulmonary disease, and completion of a clinical trials certification program or related courses.
REQUIRED EDUCATION & 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 (REQUIRED):
Strong interpersonal skills.
Proficiency with Microsoft Office.
Knowledge of medical terminology.
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.
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.
Schedule: On site with occasional 1 day remote. 8 AM 4:30 PM
The Division of Pulmonary Allergy and Critical Care Medicine is seeking a temporary/casual Clinical Research Coordinator Associate (CRCA) at 100% time for 34-month period for a position to join the Lung Transplant Clinical Research Team and assist in the coordination of multiple clinical research protocols.
DUTIES:
Serve as primary contact with research participants, sponsors, and regulatory agencies for research projects within our Lung Transplantation team.
Coordinate studies during start-up, activation, and through close-out. Studies may include PI-initiated and industry-sponsored drug treatment and also observational protocols in the area of Lung Transplantation.
This CRCA is the primary contact for a variety PI-initiated, NIH, and industry sponsored research protocols in the area of Lung Transplantation including the following: 1. BOSTON 3 nebulized cyclosporine study, 2. CF Lung Transplant Consortium, and 3. the CareDx study.
The CRCA recruits, screens, and consents participants, and coordinates protocol study visits and reviews adverse events with research participants, the PIs, Clinical Research Manager, sponsors, and regulatory agencies for these studies.
The CRCA is responsible for regulatory oversight, initiating and maintaining IRB submissions, monitoring weekly billing reports, and coordination of site initiation, monitor and close-out visits.
Determine eligibility of and gather consent from study participants according to protocol criteria.
Screen patients in the Lung Transplant clinics, and recruit participants for drug, tissue repositories, and observational Lung Transplant studies.
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.
Enter study data into existing electronic databases in accordance with each protocols guidelines.
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.
The CRCA addresses and resolves study queries, protocol deviations, or other audit or monitoring findings and reviews with a Research Manager as needed.
The CRCA is responsible for IRB revisions and renewals and also the maintenance of current regulatory documents for all protocols.
Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
The CRCA prepares for study-related visits including preparation of study kits, appointment scheduling and monitoring meetings.
The CRCA serves as the primary contact for participants and sponsors with oversight by the Clinical Research Manager as needed.
Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
Adverse events or other side effects from study treatment are reported to the PI by the CRCA. The CRCA meets every other week with the PI and the Research Manager to review study progress, recruitment, AEs and compliance. Study updates are presented in prepared slides.
Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
The CRCA maintains study files in the PACCM share drive and BOX, per each studys requirements.
The CRCA interacts with a variety of study sponsor and regulatory agencies that include the NIH auditors, industry-sponsored study monitors, and other foundation-sponsored research.
The CRCA meets weekly with the Clinical Research Manager to review and resolve any regulatory, budget, or other study-related issues.
Participate in monitor visits and regulatory audits.
The CRCA schedules monitor visits and/or regulatory audits and reviews in advance with the Clinical Research Manager and the PI of the study to prepare for each visit accordingly. Study monitor visits occur about every 3-6 months per each projects needs.
Requirements:
DESIRED QUALIFICATIONS:
Desired qualifications include experience with interventional drug treatment trials, clinical experience with patients with pulmonary disease, and completion of a clinical trials certification program or related courses.
REQUIRED EDUCATION & 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 (REQUIRED):
Strong interpersonal skills.
Proficiency with Microsoft Office.
Knowledge of medical terminology.
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.
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.
Source : Apidel Technologies