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Senior Clinical Research Coordinator
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Position Number: 2172242
Location: Pomona, CA
Position Type: Laboratory and Research

Senior Clinical Research Coordinator
Western University of Health Sciences

Pomona Campus
Department 1309 - Research and Biotechnology

Job Summary
Under the direction of the Faculty Director and Principal Investigators (PI), provide day to day supervision and management of the clinical research team. Assist primarily in the administration of contract or investigator-initiated industry sponsored studies. Secondary focus will be on assisting on faculty initiated and/or student studies that may or may not be externally funded.

Job Duties
50% 1. Protocol Management:
a. Organize and prioritize all activities associated with conducting the studies assigned.
b. Review and understand protocol, ensuring applicable regulations and guidelines are followed.
c. Oversee and assure that a subject treatment schedule is developed and correctly implemented. Making sure that adequate personnel, space, and supplies available at least a week prior to anticipated patient arrival.
d. Oversee and assure that subjects are recruited and properly assigned to studies.
e. Assure that informed consent is properly obtained.
f. Double check and assure that data are properly recorded and correctly placed in the regulatory binders.
g. Overseeing subject visits and blood collections are smooth and uneventful. Assuring that specimens are properly processed and shipped. Ensuring medication dispensing/supplies/incentives is carried out and documented appropriately
h. Complete investigational product accountability documentation, and ensure product accountability is accurate if indicated.
i. Develop source documents for assigned studies, manage data collection, ensure all AEs are identified and reported appropriately.
j. Enter required data on paper, spreadsheets or electronic CRFs, audit records for accuracy, resolve discrepancies, and correct as necessary.
k. Coordinate visits with external monitors and internal quality assurance to assure compliance with protocol, SOPs, regulations and guidelines.
l. Collect, organize and maintain all essential documents required for study regulatory files.
m. Ensure research equipment is properly maintained/calibrated
n. Serves as liaison between sponsors, investigators, departmental research personnel and other individuals assigned to the study.

30% 2. Study Coordination
a..Under the Direction of PI or Faculty Director, coordinate and manage the clinical study, communications with the sponsor, and authorities; visit coordination.
b. Attend investigator meetings, site selection and study monitor visits when indicated, sometimes offsite.
c. Plan, direct, or coordinate clinical research project. Direct the activities of workers engaged in clinical research project to ensure compliance with protocols and overall clinical objectives. May assist in evaluation and analyze clinical data.
d. Direct the activities of research personnel to ensure quality patient care and adherence to research principles and policies.
e..Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, university and/or regulatory bodies.
f. Create, maintain, update, and submit regulatory documentation.
g. Generate, modify or oversee source document creation for studies.

15% 3. Center Administration- Clinical Research-related duties
a. Collaborates with the PI in planning budgets, ensures adherence to policies and procedures.
b. Ensure services area and equipment in compliance with professional standards, state and federal regulatory requirements.
c. Track and assist accounting and finance in the management of sponsor payments, including creating financial reports.
d. Generate and manage invoices for study procedures and fees.
e. Track, record and manage subject stipends.
f. Collaborates with the PI and department to prepare a categorized budget and justification. Confirms accuracy and completeness of budgeted costs.
g. Arranges secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer.
h. Assists the study/project PI in study feasibility assessments as requested.
i. Assess training needs and train other research staff/students in research related activities, as needed; maintain training documentation.
j. Maintains office equipment including computers, fax machines, copiers, printers, telephones, etc., and medical equipment including ECG machines, blood pressure cuffs, centrifuge, phlebotomy tools, etc.
k. Maintains safe working environment for self and others.

5% 4. Center Administration- Under the Direction of PI or Faculty Director manage research staff and their training, all equipment and facilities, and training of students
a. Monitors the research staff in effective use of laboratory and safety measures.
b. Coordinate inventory, orders supplies, order processing and distribution of products and services.
c. Assess training needs and train other research staff/students in research related activities, as needed; maintain training documentation.
d. Maintains office equipment including computers, fax machines, copiers, printers, telephones, etc., and medical equipment including ECG machines, blood pressure cuffs, centrifuge, phlebotomy tools, etc.
e. Maintains safe working environment for self and others.
Other duties as assigned: The University has the right to add or change certain duties at any time.

Knowledge, Skills, Abilities
Individuals must possess these knowledge, skills and abilities or be able to explain and demonstrate that the individual can perform the essential functions of the job, with or without reasonable accommodation:
- Knowledge in vendor applications unique to clinical research, and familiar with clinical research Code of Federal Regulations and ICH GCP guidelines.
- Knowledge with IRB portals, electronic data capture (EDC), and clinical trial management systems.
- Fluency in English and Spanish language
- Skills related to attention to detail, time management, and organization.
- Interpersonal skills related to leadership, patience, and promoting a teamwork philosophy with a positive attitude.
- Ability to work well with supervisor, co-workers, peers, monitors, and potential subjects.
- Ability to independently, effectively, and efficiently handle multiple tasks simultaneously with precision and adhere to sponsor requirements.
- Ability to use standard office software including Microsoft Word, Microsoft Excel, Microsoft Access
- Ability to manage invoices and financial accounts.
- Ability to problem solve using analytical skills, creativity and logical thinking.

Required Qualifications
BA/BS in a Health Sciences discipline or
medical assisting
2+ years clinical research experience
Excellent phlebotomy skills with certification in the State of California
1-2 years' experience interacting with human subjects taking brief medical history, vitals, EKG, etc.
Fluency in English and Spanish language

Preferred Qualifications
Master's degree
5+ years clinical research experience
Background in medical history intake, medical terminology, experience with research regulation, subject recruitment/visits, supervisory experiences, and research protocols.
Certification in clinical research (e.g., CCRC, CCRP, CCRA) and college degree, preferably with licensure or a background in a medical field.
5+ years' work experience in clinical research as a CRC, Regulatory Specialist, or other high level research position.
Certified in OSHA, IATA and CPR

Work Hours
Normal work hours Monday to Friday

Do the essential functions of this job require lifting?
Yes

If yes, list maximum weight and duration
The physical demands described here are representative of those that must be met by any employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to walk, sit and use hands. The employee is regularly required to reach with hands and arms and is occasionally required to stand. The employee must occasionally lift and/or move up to 20 pounds. There are no special vision requirements for this job.

Describe Work Environment
Duties are routinely performed in a typical laboratory setting. While performing duties in this setting the employee may be exposed to fumes or airborne particles, toxic or caustic chemicals, extreme cold (non-weather), and risk of electric shock.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be available to enable individuals with disabilities to perform the essential functions.

To apply for the position, please visit: https://jobs.westernu.edu/postings/18995

For full application instructions and position description, visit: https://jobs.westernu.edu/postings/18995