Senior Clinical Research Coordinator

JOB SUMMARY

The Senior CRC will work closely with Principal Investigators and clinical research teams to coordinate the daily operations of clinical research studies and oversee clinical research staff performing clinical functions at the designated partner site The Senior CRC will be responsible for making sure that all clinical research activities are efficiently executed, and conducted in a professional manner that is compliant with all human research subject regulations. Pediatric research experience preferred.

RESPONSIBILITIES

• Assist with mentoring and training clinical research staff.
• Perform clinical functions i.e. phlebotomy, monitoring vital signs on study participants, etc., when warranted; educate family and contribute to the care and evaluation of subjects, including determining preliminary inclusion/ exclusion criteria.
• Liaises with agencies, pharmaceutical companies, laboratories, vendors, equipment, and supply companies as needed; oversees availability of supplies and/or equipment for studies.
• Manage multiple concurrent trials - screening, recruiting, and enrollment, perform patient/research participant scheduling, coordinate protocol-related research procedures, study visits, and follow—up, collect patient/ research participant history, collect and maintain source documentation, perform data entry and query resolution, prepare IRB submissions, update required modifications, continuing reviews, and reportable events.
• Develop strong working relationships and maintain effective communication with study team members.
• Completes all protocol-related training and adheres to IRB approved protocol(s)
• Support the collection and review of required essential study documents and reports.
• Order supportive study supplies (e.g., contracts, IXRS, lab kits, non-clinical supply materials, imaging, and laboratory handling manuals, etc.).
• Assist in the informed consent process of research subjects.
• Support and advocate for the safety of research subjects.
• Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close-out activities.
• Collect, process, and ship laboratory specimens.
• Comply with company, Clinic, and Sponsor policies, standard operating procedures (SOPs), applicable regulatory requirements and guidelines.
• Performs all additional duties as assigned.

Qualifications:

• At least 3+ years of experience coordinating clinical trials, including the activities listed above.
• Pediatric research experience preferred
• BS/BA in Life Science or related discipline.
• Certified Clinical Research Coordinator (CCRC) certification preferred.
• Previous GCP training and certification required and working knowledge of current ICH GCP guidelines and applicable regulations. Experience in a clinical setting.
• Demonstrated ability in positive relationship building.
• Previous experience with training and mentoring other clinical research professionals is a plus.
• Strong interpersonal skills with attention to detail a must. Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems.
• Strong organization/prioritization skills for the management of multiple concurrent projects.
• An understanding of Regulatory and Central/Local ethic submission processes
• Ability to manage multiple competing priorities within various clinical trials.
• Excellent verbal and written communication skills required.
• Ability to work independently, prioritize, and work with a matrix team environment is essential.
• Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required.

Benefits:

• Competitive salary
• Health Insurance
• Dental Insurance
• Disability Insurance
• Life Insurance
• Paid Time Off
• Vision Insurance

Salary dependent on years of experience, education, and relevant certification