CRC II (Onsite) - Marietta, GA

Job Responsibilities

• Review and prepare assigned protocols and other protocol documentation (ICF, IB).
• Maintain the Investigator Site File and/or Trial Master File (TMF) for the study.
• Participate in creation and review of timelines and start-up meetings.
• Lead and/or coordinate all required start-up activities, including clinic logistics planning, schedule of clinic activities, and team training.
• Prepare and review clinic source documents, time and events tables, and other required study materials; review Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules.
• Collaborate with responsible teams to establish and/or maintain safety assessment requirements, Quality Control (QC) and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study.
• Support the Principal Investigator as needed with study-related tasks.
• Manage daily tasks, visit calendars, and attend monitor visits.
• Advertise, recruit, and screen potential participants for the study.
• Conduct all study activities following Good Clinical Practices (GCP).
• Protect the safety of human subjects.
• Monitor appropriate sources for specific clinical study or federal regulation updates.
• Collect and enter study data into the appropriate system.
• Coordinate and monitor screening activities; provide support as required.
• Aid in informed consent of study subjects.
• Respond to inquiries by auditors for data clarification or additional data.
• Take the lead and/or overall coordination of clinic activities, including supervision of clinic visits, study drug administration, and other activities as delegated and required.
• Review and manage clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and tracker, quality control, and Monitor findings.
• Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings.
• Review and oversee close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation.
• Finalize study and/or volunteer logs.
• Ensure completion of other close-out activities as required (return of study supplies, IRB reports, archiving, etc.).
• Monitor subjects’ compliance throughout the trial and address day-to-day subject or study issues and escalate as appropriate.
• Prepare for and participate in sponsor/monitor/QA audits.
• Provide accurate and timely project status updates to Project Managers and sponsors.
• Collaborate within and between teams during process improvement exercises, SOP creation, and other company-related initiatives and goals.
• Accommodate flexible schedule (available days, afternoons, nights, and weekends).
• Perform other work-related duties as assigned.
• Coordinate and perform regulatory activities.
• Report adverse events relating to the trial.
• Maintain study files.

Qualification Requirements

• Registered Nurse and/or University Degree such as Bachelor of Science Degree required.
• Clinical Research certification preferred.
• A minimum of 1 year experience in clinical research required, preferably in coordination of clinical research projects. 2+ years preferred.
• Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines.
• Required skills: problem solving, planning, and evaluation; good time management, detail-oriented, and able to multi-task; good interpersonal and communication skills with a team focus; knowledge of SOP writing; ability to anticipate problems and provide solutions in a timely manner; ability to coordinate multiple clinical research projects with competing deadlines; proficiency in computer software programs (e.g. Word, Excel, Power Point); proficiency in use of various clinical trial EDC software preferred.

Benefits

• Company car or car allowance.
• Health benefits to include Medical, Dental and Vision.
• Company match 401k.
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonus based on company and individual performance.
• Flexible paid time off (PTO) and sick time.

Pay

Salary Range: $67,700.00 - $115,100.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

Further, nothing contained herein should be construed to create an employment contract.

Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.