Sr. Clinical Research Coordinator - Dermatology

UCSF•San Francisco, CA

1d•$49 - $79

About The Position

The Senior Clinical Research Coordinator independently coordinates and is accountable for the administration of one or more clinical studies, typically using advanced-level knowledge and skills. The role may provide leadership to lower-level clinical research coordinators and other support personnel and is responsible for operational management of clinical research activities across a diverse portfolio. Studies may include multicenter NIH- or industry-sponsored trials, investigator-initiated trials, longitudinal cohort studies, clinical databases, and biorepositories. Reporting to a Principal Investigator or Director, the coordinator may have central responsibility for human research approval and compliance, contract development and negotiation, recruitment, study testing, and enrollment. The role applies medical knowledge, leadership, project and financial management, and regulatory expertise while working with UCSF clinicians, investigators, staff, administrative groups, oversight committees, sponsors, coordinating centers, FDA, NIH, and other organizations. The position leads efforts to meet research commitments and maintain high standards for efficiency, compliance, safety, financial oversight, and quality improvement. In the Department of Dermatology, the role manages research operations and clinical trials, supports longitudinal cohort studies, oversees risk and regulatory management, assists with personnel training and guidance, and manages study finances. The department operates across clinical sites including the Ambulatory Care Center, San Francisco General Hospital, Mount Zion, Mission Bay, and the Veteran’s Administration Medical Center.

Requirements

Bachelor’s degree in a related area and sufficient experience and demonstrated skills to perform the assigned duties, or equivalent experience or training.
Demonstrated ability to develop and adjust recruitment strategies in complex environments and differing patient populations, independently identify recruitment leads, and meet recruitment goals.
In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
Project management skills for overseeing clinical trial program administration and knowledge of human-subject recruitment strategies.
Exceptional analytical skills; excellent interpersonal, verbal, and written communication skills.
Ability to analyze complex and non-routine issues and develop innovative solutions.
Ability to operate 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; experience with audit preparation, execution, and follow-up.
Experience in risk management involving study subjects, federal and non-federal sponsors, and regulatory 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, ability to coordinate with subjects and internal and external partners, and ability to multitask in a fast-paced environment with a diverse subject population.
Ability to work independently, complete projects promptly, and prioritize multiple projects 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 assessing realistic and appropriate participation.
Experience with electronic medical records.
Knowledge of UCSF and departmental policies on reimbursement, research, confidentiality, HIPAA, patient safety, and records; medical terminology; research policies and guidelines; infectious-substance packing and shipping; and database building, analysis, and data management using tools such as Access, Stata, SAS/SPSS, and Teleform.
Experience applying Good Clinical Practice Guidelines, HIPAA, human-subject protection requirements, CHR recruitment and consent regulations, effective cash-handling procedures, Environmental Health and Safety training, and Fire Safety training.

Responsibilities

Develop research project plans, interview sponsors, deliver project results, report project status, and coordinate project documentation and archiving.
Analyze project and staff performance, develop pricing and cost models, review business processes and operations, and implement workflows and controls.
Prepare project presentations and monitor operational risks to clinics, physicians, staff, and the University.
Assess clinical trial participation and readiness, negotiate trial agreements and budgets, coordinate agreement execution, establish ancillary services, train staff, assign tasks, and ensure research-law compliance.
Maintain staff training and regulatory compliance; coordinate amendments; maintain study files and audit readiness; recruit patients and track enrollment; and lead study closeout.
Ensure systems support safe and compliant clinical research, keep CHR documents current, prepare and renew CHR applications, respond to revision requests, and coordinate protocol changes with sponsors.
Report protocol violations and adverse events as required, and respond to sponsor, monitor, FDA, and other reviews, including complex audits.
Manage longitudinal cohort study infrastructure, including databases, space, equipment, and specimen storage and transportation; coordinate cohort and cross-disciplinary study activities.
Collaborate with universities, clinical entities, and industry on use of collected data; contribute to or lead scientific presentations and publications; and contribute to grant proposals as appropriate.
Manage regulatory and operational risks, ensure contract and legal compliance, advise and train employees and leadership, manage audits, and help maintain a quality improvement process.
Assist with recruiting and training clinical research coordinators; guide coordinators and assistants in recruitment, scheduling, visits, subject characterization, and data entry; and help manage personnel needs.
Oversee study budgets, invoices, reimbursements, billing accuracy, subject payment processes, monthly budget reports, ledgers, and projections; ensure research funds comply with sponsor requirements; and assist with grant budget development.