Clinical Coordinator Jobs

About The Position

Requirements

• Bachelor’s degree in a related area and sufficient experience and demonstrated skills to perform the assigned duties, or equivalent experience/training.
• Ability to develop and adapt recruitment strategies in complex environments and across differing patient pools, independently identifying recruitment leads and meeting recruitment goals.
• In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
• Project management skills to oversee clinical-trial program administration and knowledge of human-subject recruitment strategies.
• Exceptional analytical skills and demonstrated interpersonal, verbal, and written communication skills.
• Ability to analyze complex and non-routine issues and develop innovative solutions.
• Ability to work effectively in changing organizational and technological environments.
• Ability to assess and respond to audit risk, develop project plans and schedules, and motivate teams to meet deadlines.
• Ability to interpret and apply policies and regulations.
• Financial analysis skills, including preparing and presenting financial and quantitative analyses, projections, and budgets.
• Significant project and clinical-trial management experience, or progressively responsible related experience that includes regulatory and compliance responsibilities.
• Experience using database software such as MS Access or FileMaker Pro.

Nice To Haves

• Fluency in spreadsheet software and ability to independently develop complex spreadsheets.
• Demonstrated skills in audit preparation, execution, and follow-up.
• Experience managing risk related to study subjects, federal and non-federal sponsors, and regulating bodies.
• Experience with grant application procedures, personnel documentation, contract generation, and subcontracting, preferably at UCSF.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
• Attention to detail, strong interpersonal skills, effective verbal and written communication, and ability to coordinate with subjects, teams, departments, and outside institutions.
• Ability to multitask in a fast-paced environment with a diverse subject population, work independently, complete projects on time, and prioritize essential tasks to meet deadlines.
• Fluency using the CHR online iMEDris system to submit, renew, and modify protocols.
• Understanding of the patient population and ability to build rapport while judging what is realistic and appropriate for participation.
• Experience with electronic medical records.
• Knowledge of UCSF and departmental policies for reimbursement, research, confidentiality, HIPAA, patient safety, and electronic and paper medical records.
• Knowledge of medical terminology, research policies and guidelines, infectious-substance packing and shipping, database building and analysis, and data management tools such as Access, Stata, SAS/SPSS, and Teleform.
• Experience applying Good Clinical Practice Guidelines, HIPAA, protections for human research subjects, CHR recruitment and consent regulations, effective cash-handling procedures, Environmental Health and Safety training, and Fire Safety training.

Responsibilities

• Develop research project plans, interview key sponsors, deliver project results, provide status reports, and coordinate documentation and archiving.
• Analyze project and staff performance, build pricing and cost models, review and improve business processes and workflows, develop study presentations, and monitor operational risks.
• Assess prospective groups’ interest and ability to participate in trials, including infrastructure, staffing, and funding needs.
• Negotiate pre-trial agreements and budgets; coordinate agreement execution; establish ancillary services; train staff; assign tasks; and ensure compliance with local and federal research laws.
• Provide ongoing staff training, maintain compliance and study files, coordinate amendments, recruit patients, track enrollment, and lead study close-out.
• Maintain audit readiness and systems for regulatory compliance and safe research conduct; keep CHR documents current and oversee new applications, renewals, revisions, and protocol changes.
• Report protocol violations to sponsors and adverse events to the CHR in a timely manner, and respond to sponsor, monitor, FDA, and other reviews and audits.
• Manage longitudinal cohort study infrastructure, including databases, space, equipment, and specimen storage and transportation; coordinate study execution with leadership and collaborators.
• Collaborate with universities, clinical entities, and industry on collected study data; may contribute to or lead scientific presentations and publications and contribute to grant proposals.
• Manage risk, contracts, regulatory compliance, safeguards, and audits; advise and train employees and leadership; help establish and maintain quality improvement processes.
• Assist with recruiting and training clinical research coordinators, guide coordinators and assistants, and help manage personnel needs.
• Oversee budgets, invoices, reimbursements, billing accuracy, and subject payment processes; review budget reports, maintain study budgets and projections, ensure proper use of research funds, and assist with grant budget development.