Clinical Research Coordinator - Early Phase Program

UCSF Health is a healthcare and biomedical research organization dedicated to advanced research, education, and patient care. The Clinical Research Coordinator will independently or with general direction coordinate multiple early-phase oncology clinical research studies, including patient scheduling, study procedures, data management, specimen handling, regulatory compliance, and support for phase 1 and phase 2 clinical trials.

Responsibilities

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

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

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

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

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

Preferred

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:

iMEDris System

Human Research Protocol Submission

Protocol Renewal

Electronic Medical Records

UCSF Policy Knowledge

Research Policy Compliance

Reimbursement Procedures

HIPAA Compliance

Confidentiality Practices

Patient Safety Procedures

Medical Terminology

Infectious Substance Shipping

Database Building

Data Analysis

Data Management

Microsoft Access

Stata

SAS

SPSS

Teleform Programming

Patient Population Knowledge

Breast Oncology Research

Oncology Clinical Trial Management

Clinical Research Regulations

Clinical Research Society Membership

Analytical Skills

Scientific Writing

Rapport Building

Patient Communication

Benefits

Flexible 2 Days On-Site

Company

Integrated hospital and health care network

San Francisco, California, USA

https://www.ucsfhealth.org/

Founded in 1990

5001-10000 employees

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

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)

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:

Required skills

Clinical Research, Oncology Clinical Trials, Clinical Research Regulations, Clinical Practice (GCP), HIPAA, Specimen Processing, Medical Data Interpretation, OnCore, iMEDris, Electronic Medical Records, Microsoft Office, Data Management

Preferred skills

Experience with electronic medical records, Knowledge of clinical research in breast oncology, Membership in a clinical research professional society

Experience

Mid level