Clinical Research Coordinator II : Molecular Imaging and Therapy

Primary Duties and Responsibilities

Reporting to the Clinical Research Supervisor, Clinical Research Manager, or Director of Clinical Research Operations, the Clinical Research Coordinator II (CRC-II) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians, inter- and intradepartmental stakeholders, and sponsors. The CRC-II provides study management, support, and coordination for FDA regulated research industry-sponsored, government funded, and/or investigator initiated clinical research trials.

This may include blood collection, data and trials that have therapeutic or device component. The CRC-II ensures smooth, accurate process of clinical studies from the planning, implementation, and post-study closure procedures.

The CRC-II is involved in all aspects of the clinical research process included, but no limited to protocol review, preparation and administration of the informed consent, development of study treatment plans, completion of study related visit forms, ensuring protocol required assessments are completed per study guidelines, processing of lab samples per IATA standards, and regular communication with study sponsors and their collaborators.

He/she will ensure accurate completion of case report forms (CRFs), adverse event/serious adverse event (SAE) reporting and scheduled subject follow-up visits. Discusses research study with potential study subjects and answers any questions (may refer questions to Principal Investigator or Sub-Investigator when appropriate) while obtaining informed consent.

Responsible for development of study flow sheets, prepare study source documentation, gather study data, and assess subject for study eligibility (inclusion/exclusion). In addition, the CRC-II will record protocol specific assessments and treatments, ensure collection and shipment of samples, complete study forms to submit to sponsors and/or appropriate agencies, collect, enters and clean data into study database while maintaining data quality. I.

He/she will host study team meetings, attend site initiation visits (SIVs) and perform other duties as assigned.

Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research.

Qualifications

• Education and Experience
• High School Diploma with 2-3 years of Clinical Research Coordinator experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Excellent verbal and written communications and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team.
• Attention to details.
• Proficiency with Microsoft Word, PowerPoint, and Windows.
• Excellent analytical and problem-solving skills.
• Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects.
• Ability to establish cooperative working relationships with patients, co-workers, & physicians.

PREFERRED QUALIFICATIONS

• Medical terminology required. Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines.
• Understanding of clinical trial methodologies and experience filing Institutional Review Board documents.
• Ability to abstract data from medical records and transfer it to data collection forms or directly into databases.
• International Air Transport Association (IATA) Certification
• Current ACRP or SoCRA Certification.
• License Required: N/A
• License Preferred: N/A Certifications Required
• N/A Certifications Preferred
• May only perform blood draws by meeting and maintaining State of California Certified Phlebotomy Technician I (CPTI) Certification