Clinical Research Coordinator
- Job Title
- Clinical Research Coordinator
- Job ID
- 27705103
- Location
- Fresno, CA
- Other Location
- Description
-
Purpose:
Under the direction and supervision of the Research manager and CCARE Investigators, this position facilitates all implementation phases of new studies as well as the ongoing coordination and maintenance of open and closed studies. The position arranges and oversees all clinical trial activities and plays a key role in assisting the Principal Investigator (PI) in recruiting patients for clinical studies. The position works closely with the Principal Investigator, members of the department, study sponsors and monitors, and the institution, to support and provide guidance on the administration of all ongoing clinical studies.
Responsibilities/Essential Functions (other duties as assigned):
- Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
- Schedules study participant appointments and serves as the patient liaison to the PI and other participating physicians.
- Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
- Working closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment. Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) in order to be able to answer all questions pertaining to the study posed during the informed consent process.
- Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits.
- Completes case report forms. Extracts data from patient charts in a timely manner
- Records adverse events and confers with investigator regarding the reporting of events to Sponsor and/or CRO, per protocol requirements.
- Responds to data clarification requests in a timely manner.
- May attend Investigator meetings requiring travel and report pertinent information back to research team members.
- Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with Federal regulations, CCARE’s and sponsoring agency policies and procedures.
Experience, Qualifications/Education:- Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training.
- Maintains subject screening logs and protocol deviation logs.
- Maintains a spreadsheet tracking updates to database of all subjects enrolled on clinical trials.
- Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRB’s, Regulatory agencies, CRO’s and sponsors.
- Prepare for or participate in quality assurance audits conducted by internal staff, study sponsors, federal agencies, or specially designated review groups.
- Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.
- Ensures that all materials for each clinical trial protocol are available for subject enrollment.
- Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data.
- Performs specimen processing and shipment of biological specimen duties.
- Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
- Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.
- Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, and the sponsoring agency in accordance with Federal regulations and institutional policies and procedures.
- Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer.
- Review scientific literature, participate in continuing education activities and internal training to maintain current knowledge of clinical studies, regulatory affairs and issues.
- Trains, mentors, and supervises entry level Clinical Research Coordinators, Research Assistants and other staff members on the basics of clinical research.
- Will also provide support to clinical and basic researchers involved in the Center and have direct interaction with subjects involved in the ongoing research protocols.
- Works closely with the Clinical Research Manager and Regulatory Coordinator to ensure Standard Operating Procedures (SOPs) are implemented and documented in accordance within study sponsor, Principal Investigator, and regulatory agency specifications.
- Updates the Clinical Research Administration Division as necessary.
- Manages multiple complex clinical research protocols.
- May perform other job-related duties as requested or required
- Required - Minimum one year in a clinical research setting working as a clinical research coordinator on industry-sponsored clinical trials
- Oncology experience preferred
- Thorough knowledge of good clinical practice, FDA, OHRP, HIPAA, and CCARE policies.
- Current CPR certification required
- Knowledge of computer/telephony support, preferably in a health care environment
- Strong customer service background, preferably in health care environment
- Excellent verbal communication skills
- Competence with computer processing functions and other standard office equipment
- Ability to manage and prioritize multiple tasks
- Ability to calmly and professionally resolve customer issues with diplomacy and tact
- Ability to work independently with minimal supervision
- Strong organizational skills
Working Conditions:
- This position functions primarily indoors in a medical / business environment. Employee may be subject to blood borne pathogens, radiation, bio waste and other medically-related factors, with exposure to moderate noise levels.
- Visual acuity to read and compute screen and paper documents; close and distance vision, peripheral vision depth perception, ability to adjust focus; hearing acuity to converse with staff and customers; ability to walk, stoop, bend, kneel, and lift and move 25 pounds on a regular basis; ability to sit for hours at a time. Employee will be exposed to moderate noise levels, interruptions, and occasionally asked to work evening and weekends as needed.
