Clinical Research Project Planning and Preparation

• Review of assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility, timing, and resources.

• Prepare and 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 (Investigator Meeting/SIV, Sponsor discussions, or other related meetings).

• Take the lead and/or overall coordination of all required start-up activities including, but not limited, to the following:

  • Clinic logistics planning, schedule of clinic activities, and team training.

  • Preparation, review, and/or finalization of clinic source documents, time and events tables, and other required study materials; review of Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules.

  • In collaboration with the responsible teams, establishes and/or maintains 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.

  • Confirms all required regulatory and contractual documentation is present prior to study start.

• Support the Principal Investigator as needed with study related tasks such as, but not limited to:

  • Delegation of Authority Log.

  • Management of daily tasks.

  • Visit calendar development and maintenance.

  • Scheduling and attending monitor visits.

  • Advertise, recruit, and screen potential participants for the study.

Clinical Conduct

• Perform all study activities following Good Clinical Practices (GCP).

• Manage multiple clinical trials simultaneously.

• 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; provides support as required.

• Assist with informed consent of study subjects.

• Submit data in required timeframe.

• Monitor appropriate sources for specific clinical study or federal regulation updates.

• Complete Case Report Forms.

• Facilitate audits of study data.

• Develop patient rapport to explain research protocols and minimize protocol violations.

• Develop rapport with study team to educate team on study procedures and minimize protocol violations.

• Respond to inquiries by auditors for data clarification or additional data in required timeframe.

• Take the lead and/or overall coordination of clinic activities including, but not limited to:

  • Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and provides on-call support when applicable.

  • Screens eligibility prior to randomization; oversees, coordinates and/ or performs study drug administration, and other activities as delegated and required.

  • In collaboration with the responsible teams, monitors that all study-related activities are conducted according to protocol, SOP, and applicable regulations.

  • Review and manage clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and tracker, quality control, and Monitor findings.

Post-Clinic/Close-Out Activities

• Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings.

• Review and/or oversee close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation.

• Review and update TMF documentation.

• Finalize study and/or volunteer logs.

• Ensure completion of other close-out activities as required (return of study supplies, IRB reports, archiving, etc.).

• Responsible for monitoring subjects’ compliance throughout the trial and address day-to-day. subject or study issues and escalate as appropriate.

• Prepare for and participates in sponsor/monitor/QA audits.

• Provide accurate and timely project status updates to Project Managers and sponsor.

• Collaborate within and between teams during process improvement exercises, SOP creation. and/or revision, internal and external meetings, 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

• Maintain proper protocol, consent, amendment, and yearly renewal submission if requested.

• Report adverse events relating to the trial.

• Maintain study files.

Travel up to 100%

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.

• Possess 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.