The Clinical Research Coordinator is accountable for the planning, preparation, and execution of clinical trials in conjunction with the Team Leader, Project Manager, and Investigator. This role ensures that clinical studies are conducted according to the study protocol, ICH GCP guidelines, and unit SOPs. The coordinator assists in the conduct of Phase I-III studies across all therapeutic areas, ensuring studies are prepared to the highest standard within specified timelines. The role also involves clinical conduct oversight, data cleaning, and deviations management.

Key Accountabilities:

• Technical supervision of Clinical Research Nurse, assigned to the studies

• Control and direct activities and staff during key operational aspects of assigned studies

• Organization and Preparation of clinical studies, as listed below:

  • Study Protocol review and study feasibility prove

  • Review of all other study related documents e.g., CRF, Lab Manual, Reference Manual

  • Review Protocol Deviation Assessment Plan (PDAP) and Data Verification Specification (DVS). Be involved in project development, taking part in early internal project discussions.

  • Early recognition of areas of potential problems, provide contingency plans or address the issue in an appropriate way with the required departments and give input into possible solutions (RACT).

  • Escalate issues as soon as possible. Open QI in timely manner, close actions on or before the end date.

  • Record Clinical including medical deviations on the Observable protocol deviations (PD) log.

  • Review combined PD log.

  • Generation of general working instructions, source data sheets and other relevant forms and documents for the allocated clinical studies

  • Generation and maintenance of the general and emergency case files, Staff Log, Window Allowance Agreement, Source Data Verification

  • Training / Training organization of personnel assigned to the study

  • Organization of study specific training

  • Organization of the generation of dietary plans/meal plans

  • Verification and maintenance of the file containing the volunteers informed consent forms

  • Organization of study specific material and medical devices

  • Lead ClinBase setup development across pharmaceutical services, laboratory, database design, and clinical operations for all assigned studies

  • Monitor that ClinBase set up activities and ensure that it is developed within the given time.

  • Prepare ClinBase set-up requirements forms for Screening and Experimental.

  • If EDC is in use review annotated CRF and perform UAT.

  • Review the ClinBase set up procure list, time windows, normal ranges as part of pre-dummy review.

  • Check User Defined Procedures on Feasibility

  • Approve the set up for Clinical use to ensure study requirements are captured as per protocol and in accordance with sponsor requirements (WAA, Normal Ranges, Lab Profile, order of procedures, relative time User Defined Procedures)

  • Initiate ClinBase revisions and subsequent approval.

  • Care support of the volunteers participating in a study from admission to discharge

  • Coordination of study-preparations on the ward incl. providing medical technique, sample container, documentation computers, bed

  • Providing study relevant shift to shift information

  • Ensuring all study related assessments and medical measurements will be performed according to study protocol and relevant clinical guidelines (GCP and ICH guidelines)

  • Ensuring all study relevant documentations are going to performed according to study protocol and ICH/GCP guidelines

  • Overseeing, maintaining, and leading the processes and progresses of all allocated studies in conjunction with study physician, project management and data management

  • Volunteer payment management

  • Management/Organization of medication storage, drug check in and out

  • Issuing of Audit Reports on internal and external quality audit findings

  • Resolution of data clarification queries

  • Management of CRF Shipment, Source Data storing and archiving after study finalization

• Cooperation with the study monitor, incl. preparation for monitor visits, cleaning and correcting of study relevant documents according to monitor/protocol demands

• Perform investigations on subjects (physiological measurements including ECG, Blood Pressure, Lung Function, venous puncture and other) according to the study protocol

• Use of psychological and physiologic test procedures

• Cooperation with other internal departments as a company’s study team member

• Participation in project team meetings

• Study presentation in internal study initiation meetings

• Participation in client meetings

• Administration of Investigational Products

• Other tasks in the opinion of the manager and need of the CPRU

Skills:

• Intermediate English knowledge (written and spoken command)

• Computer skills (Windows Office)

• Organizational talent

• Ability to work under pressure and flexibility in working times

• Ability to work on weekends and holidays

• Knowledge of ICH-GCP Guidelines

Knowledge and Experience:

• Relevant experience in hospitals or medical surgery

Education:

• Terminated education as nurse, MTA, doctor´s assistant, paramedic, or similar/equivalent qualification/education