Senior Clinical Research Coordinator

Job Description

Job Description

Valkyrie Clinical Trials (VCT) , a Flourish Research Company, is a leading Oncology multi-site clinical research network with expertise in Oncology research. VCT approaches clinical research with a deep sense of humanity, compassion, and sincere kindness. VCT was founded by leading Clinical Oncologist, Dr. David Berz, and has multiple sites spanning California in Century City, Panaroma City, and Murrieta, and has recently expanded to Denver, Colorado.

Flourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!

We are actively hiring a Senior Clinical Research Coordinator to support our Valkyrie Clinical Trials Denver, Colorado site.

LOCATION : Onsite
FLSA : Non-Exempt
HOURS : Monday to Friday, Day Shift, 40 hours per week
COMPENSATION : $34-$39 per hour (depending on experience)

Requirements

ESSENTIAL JOB FUNCTIONS:

• Read, understand, and ensure the completion of all protocol required patient visits and procedures
• Clearly and concisely document patient assessments, treatments, observations, test results and other study related information per federal regulations, protocol requirements and GCP Guidelines.
• Obtain patient informed consent, and reconsent as required, according to federal regulations, GCP and IRB requirements while educating patients on study requirements, timelines, and visit expectations.
• As Senior CRC, lead and mentor other research staff and serve as an escalation point and SME.
• Is diligent in enrolling qualified study participants into appropriate protocols within the sponsor’s timeline while following regulations and rules governing medical ethics, IRB, GCP and ICH guidelines.
• Complete all required training in a timely manner.
• Schedule and conduct patient visits according to protocol requirements and timelines.
• Maintain written source documentation of patient visits and protocol related activities per ALCOA guidelines
• Accurately complete case report forms (CRFs &/or eCRFs) and/or worksheets and respond to queries generated by the sponsor in a timely manner
• Maintain confidentiality of all patient and protocol activities and information as appropriate and as bound by Confidentiality Agreements with Valkyrie/Flourish Research, between Valkyrie/Flourish and sponsors, and between Valkyrie/Flourish and other entities, as well as HIPAA regulations.
• Promptly document and report adverse events to supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary.
• Report Serious Adverse Events (SAEs) to sponsor within 24 hours of becoming aware of the SAE. Also report the SAE to the supervisor, Principal Investigator and/or Sub-Investigator immediately.
• Account for clinical trial materials (i.e., CRFs, study drug, lab supplies, and/or other required items) and ensure availability of appropriate amounts for the conduct of the study.
• Maintain ongoing communication with Team Lead I; Team Manager/Research Manager; Principal Investigator; Sub-Investigators and other people assisting with the trial and documenting these communications according to protocol requirements and Valkyriepolicies.
• Attend required training courses/conferences in order to stay abreast of current and changing federal regulations and Valkyrie policies.
• Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research.
• Attend Investigator Meetings, SIVs, team meetings, and/or other trainings as directed.
• Perform all study-related duties in a time- and cost-effective manner in adherence with Valkyrie, policies.
• Represent Valkyrie, Clinical Trials in a professional and courteous manner (verbal, written and in appearance) when interacting with Valkyrie staff, sponsors, IRBs, patients/participants, nursing and medical staff members of various clinics, hospitals, and physician’s offices.
• Additional duties as assigned by management.

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:

• Work is normally performed in a typical interior/office work environment.
• Travel required but minimal.
• Exposure to human bodily fluids.
• Laboratory processing procedures.
• Participant care.
• Daily computer use.
• Occasional night and weekend work schedules.
• The ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.
• The ability to drive, and daily availability of an automobile.

MINIMUM REQUIREMENTS:

• Bachelor's degree preferred but not required.
  

Experience:

• Education: Bachelor's degree preferred; however, is not required. Clinical research certification is a plus
• Experience: A minimum of 3 years’ experience as an oncology CRC, with at least 1 year of experience in early phase oncology research preferred.

Knowledge and Skills:

• Exceptional knowledge of clinical research methods.
• Strong management and leadership skills.
• Demonstrated ability to collaborate and align with operations.
• Excellent oral and written communication skills.
• Excellent computer skills to include Office365 products.
• Experience in writing and reviewing Standard Operating Procedures.
• Strong problem solving, risk assessment and impact analysis abilities.
• Demonstrated experience in process improvement.
• Strong negotiation and conflict management skills.
• Flexible and able to multi-task and prioritize competing demands.
• Ability to think independently and influence when appropriate.
• Develops and implements key initiatives in the department.
• Identifies and implements process improvements for increased efficiency.
• Builds and fosters relationships across teams.
• Serves as preceptor, mentor and subject matter expert in department.
• Demonstrates strong critical thinking and decision-making skills.
• Continually demonstrates core values and is regarded as a leader.
• High proficiency of skills set.
• Must have industry certification, as applicable by Valkyrie Clinical Trials.

Benefits

Flourish Research offers an excellent comprehensive benefits package to include: Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, employee referral program, employee assistance program, life insurance, disability insurance, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays.

Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.