Clinical Research Coordinator Associate (CRC)

Job Description

Job Description

Title : Clinical Research Coordinator Associate (CRC)

Pay Rate : $34 / hr

Job Type : 3+ month contract

Shift(s) : Mon Fri, 8am 4 : 30pm

Location : Palo Alto, CA 94305

On site; occasional 1 day remote

Job Code : JPC- 10548 / 1363120

Tekberry is looking for a highly qualified and motivated individual to work with our client, a world-class university and research center.

As a W2 employee you will have access to health benefits. Benefits include health, dental, and vision (eligible on the 1st of the month following your start date).

Job Description :

The Division of Pulmonary Allergy and Critical Care Medicine is seeking a temporary / casual Clinical Research Coordinator Associate (CRCA) at 100% time for 3 4-month period for a position to join the Lung Transplant Clinical Research Team and assist in the coordination of multiple clinical research protocols.

Job 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 protocol's 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 study's 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 project's needs.

Requirements :

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

TEKBERRY OFFERS A $100 payment FOR REFERRALS!

Tekberry, Inc. a Soal Technologies company, is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected categories under all applicable laws.

Tekberry, Inc is a Certified Minority Business Enterprise (MBE) and Certified Disadvantaged Business Enterprise (DBE).

By submitting your resume, you are explicitly consenting to receive communications from our organization via text message.

Rest assured all our texts are sent by real people and we look forward to a conversation with you about this job! Check out all our jobs at https : / / tekberry.com / search -jobs /

INDHP