| Location | California, CA |
JOB PURPOSE: Perform duties related to the coordination of clinical studies. Coordinate moderately complex aspects of one or more clinical studies and work under close direction of the principal investigator and/or study coordinator/supervisor CORE DUTIES: · Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout. · 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.
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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: · Strong interpersonal skills. · Proficiency with Microsoft Office. · Knowledge of medical terminology. Certifications and 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, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. · Ability to drive day or night, if applicable.
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Questions that determine what background check package to run
This is the pay range that RightSourcing (a part of Magnit) reasonably expects to pay someone for this position, however, as a supplier your expected pay range may vary and/or include certain benefits like: Medical, Dental, Vision, 401K.
1317300-100-TBBHI - 15% (Allen Lee)
1259457-100-VAELW - 15% (Dawna Robinson)
1307396-100-VAKUP - 55% Dawna Robinson)
1310643-100-VALCN - 15% Dawna Robinson)