Clinical Studies Coordinator III, Comprehensive Cancer Center

M- F 8a-5p

Pay Range

JOB SUMMARY
Under departmental direction coordinates activities to support multiple research studies of all phases and all levels of complexity including investigator-initiated IND First-In-Human gene therapy or other high profile trials. Functions independently and proficiently with minimal oversight. Serves as the principal administrative liaison for assigned studies and as a technical resource for the department. Develops and maintains recordkeeping systems and procedures to ensure compliance with study protocols and all appropriate regulations. Attends clinic as needed to perform activities including but not limited to: assist the research team with recruitment activities administer questionnaires and answer any questions about future appointments. Responsible for the compilation registration and submission of data as required by the Sponsor. Mentors and supports new and less experienced staff.

EDUCATION/EXPERIENCE

Bachelors degree with four years experience as a clinical research coordinator; or an equivalent combination of experience and education. Masters degree preferred.

LICENSURE CERTIFICATION and/or REGISTRATION

SOCRA or ACRP Certification preferred. Must complete the CITI certification for Human Subject Research if not already completed. All additional required WakeOne training for research coordinators

ESSENTIAL FUNCTIONS

Works under the direction of the Study Investigators or Clinical Research Nurse Manager with minimal supervision.

Plays an active role in recruitment of patients to study.

Performs protocol specific duties required per the research protocol.

Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families.

Fulfills sponsor requirements related to reportable information including adverse events unanticipated problems and other information required by the sponsor protocol.

Abstracts data from the medical record and completes paper and electronic case report forms including responding to any requests for data clarification and maintains all necessary source documents.

Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner.

Provides staff relief as required to meet the needs of the department. Participates in scheduled team/department meetings. Participates in quality improvement projects on an on-going basis.

Mentors new and less experienced staff.

Follows established Wake Forest Baptist and department policies procedures objectives performance improvement attendance safety environmental and infection control guidelines includingadherence to theworkplaceCode of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.

Performs other related duties as assigned or requested.

SKILLS/QUALIFICATIONS

EPIC/WakeOne proficiency to include appropriate documentation of research notes

Good interpersonal and communication skills (verbal non-verbal and listening skills)

Proficient in the use of OnCore/WISER Clinical Trial Management System

Basic computer skills required

Excellent oral/written communication and organizational skills.

Excellent reading comprehension.

Foster/promote a positive image and professional appearance

Sensitivity to intercultural relations

Sensitivity to the maintenance of confidentiality

Knowledge of Microsoft Products

WORK ENVIRONMENT

Clean comfortable office environment

Our CommitmenttoYou:

Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs competitive compensation generous retirement offerings programs that invest in your career development and so much more so you can live fully at and away from work including:

Compensation

• Base compensation listed within the listed pay range based on factors such as qualifications skills relevant experience and/or training
• Premium pay such as shift on call and more based on a teammates job
• Incentive pay for select positions
• Opportunity for annual increases based on performance

Benefits and more

• Paid Time Off programs
• Health and welfare benefits such as medical dental vision life andShort- and Long-Term Disability
• Flexible Spending Accounts for eligible health care and dependent care expenses
• Family benefits such as adoption assistance and paid parental leave
• Defined contribution retirement plans with employer match and other financial wellness programs
• Educational Assistance Program