Clinical Research Coordinator - Early Phase Program

Job Summary:

The Early Phase program has a multi-disciplinary team that works closely with patients, providing the resources and close cooperation of many specialists with deep expertise in diagnosing and treating early and late- stage cancer. Our physician-scientists are also researching and developing new and effective treatments for cancer, including clinical trials. The Early Phase program is seeking a Clinical Research Coordinator with an interest in investigational drugs to have oversight over multiple clinical research projects and support our growing program.

The Clinical Research Coordinator (CRC) will independently, or with general direction, execute, manage, and coordinate clinical research protocols, as directed by the Clinical Research Manager, Principal Investigator (PI), and/or the Associate Director of Clinical Research Programs for the Early Phase program. The CRC will coordinate the administrative, data, and patient scheduling operations of several concurrent clinical research studies under the guidelines of research protocols and regulatory policies. The CRC will assist in the care of early and late-stage cancer patients while they participate in phase 1 and phase 2 clinical trials. In the role, the CRC will attend clinic appointments, follow test results, and assist in ordering appropriate study-related procedures/tests. The CRC will have the opportunity to learn certain aspects of oncology including but not limited to prevention, early detection, treatment/medication management, and end of life care for cancer patients.

The duties may include, but will not be limited to, supporting the management and coordinating the tasks of single or multiple clinical research studies. This involves coordinating study required procedures and treatments for study patients; managing and updating databases to insure data integrity; acting as intermediary between sponsors, research staff, and various UCSF departments; assuring compliance with all relevant regulatory agencies; assisting Clinical Research Manager, Associate Director of Clinical Research Programs and/or PI with research tasks; maintaining relevant regulatory documents in partnership with the Regulatory department; reporting study progress to investigators; participating in any internal and external audits or reviews of study protocols; and performing other duties as assigned.

Department Overview:

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is the only cancer center in the Bay Area to receive the prestigious designation of “comprehensive” from the National Cancer Institute. We combine basic science, clinical research, epidemiology, cancer control and patient care throughout the University of California, San Francisco. Currently, the HDFCCC conducts over 700 clinical trials across various departments.

%

of timeEssential Function (Yes/No)

Key Responsibilities(To be completed by Supervisor)

50

YES

Study Coordination, Implementation, and Data Collection

• Work with the PI, Lead CRC, and research team to identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects;
• Prepare protocols for initiation, which includes working knowledge of federal, state, and local research regulations and guidelines, and cancer center clinical practice methods
• Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform study procedures.
• Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; discuss study outcomes with providers to ensure continuity of care.
• Review information with subjects; assess and advocate for patient safety throughout each protocol procedure.
• Oversee subject billing and reimbursements; work to resolve discrepancies and issues in a timely manner.
• Work with study and clinic staff to ensure study procedures are completed. Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency;communicate with any affiliated groups to ensure patient safety.
• Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
• Under the supervision of the PI, the study investigators, and the Lead CRC, help educate and provide to the clinical staff specific protocol information on clinical care to treat study patients safely; relay information on the study drug and help provide study information to the clinical staff and to the patients.
• Suggest modifications to the study process to improve efficiencies.

25

YES

Data management, reporting of results, and quality control

• Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
• Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner.
• Collect, report and manage data for patients on follow-up in a timely manner.
• Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed.
• Create and maintain study source documentation, tracking of blood/tissue samples, and other protocol activities to ensure compliance.
• Create and maintain comprehensive data sets as requested by the Lead CRC and/or PI.
• Maintain data collection forms for effective data collection, entry, and analysis.
• Respond to queries and analysis in databases in a timely manner.
• Work with Supervisor to maintain complete and accurate data in the study database and other internal databases such as OnCore; analyze the data as they become available.
• Utilize various data collection and data reporting instruments, including databases of sponsored studies, OnCore, iMEDris, Apex EMR.
• Maintain subject tracking systems in all databases as applicable.
• Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management.
• Update and maintain a procedure manual documenting all study-related procedures; ensure consistency in data collection and data entry.
• Implement and maintain periodic quality control procedures

10

YES

Specimen Management/ Maintenance

• Ensure that specimens are properly processed, stored, and shipped according to all laboratory policies and safety measures.
• Arrange the exchange of and transport of specimens with collaborating Investigators and staff.
• Oversee the incoming data interpreted from samples and ensure that it is correctly entered into respective databases, and reviewed by the Investigator
• Ensure integrity and security of samples.

5

YES

Regulatory responsibilities

• Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
• Initiate and follow-up on iMEDris submissions for single-patient exceptions, adverse event reporting, and protocol violations.
• Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments.
• Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
• Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.

10

Other duties

• Assist the Supervisor to train staff and peers, and others on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures.
• Attend and actively participate in regular team meetings as well as professional development opportunities
• Must be a team player and participate in staff-wide assignments outside of protocol management, including: filing, cleaning and maintaining study supplies, maintaining common work spaces (office space and laboratory space); development of policies and procedures, and other duties as assigned by the Lead CRC, Principal Investigator, and Research Personnel Manager.

100%

(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)Required Qualifications:

• High School Degree
• Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
• Demonstrated knowledge and understanding of research, especially in the areas of biological sciences.
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• Prior experience with various computer programs (Microsoft Office; internet-based databases) and using specialized software such as OnCore.
• Ability to sit and work at a computer for several hours per day. May need to travel between one or more campuses via UCSF shuttle. Ability to stand for several hours of the day.
• Experience in clinical research or demonstrated knowledge of research or training experience that translates into a clinical research setting. Familiarity with specimen processing
• Working knowledge of federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting
• Ability to apply relevant information to the assessment, interpretation, and processing of medical data
• Ability to independently interpret and apply policies, respond to requests, resolve issues, and provide assistance to faculty and staff at all levels in a team-oriented environment
• Ability to work with a sensitive population of patients (oncology patients)

Preferred Qualifications:

• Prior analytical and writing skills in a science/research environment
• Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system.
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
• Experience with electronic medical records.
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.
• Knowledge of clinical research in breast oncology
• Knowledge and experience in managing oncology clinical trials.
• Membership in a clinical research professional society.
• Experience applying the following regulations and guidelines:

-Good Clinical Practice Guidelines
-Health Information and Accountability Act (HIPAA)
-The Protection of Human Research Subjects
-CHR regulations for recruitment and consent of research subjects
-Effective Cash Handling Procedures
-Environmental Health and Safety Training
-Fire Safety Training