The In-House Clinical Research Associate II (IHCRA-II) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to the IHCRA-II shall reflect their experience, and level of contribution which they can make to the project. The work will involve Clinical Operations activities which will be conducted in an office or home based setting for designated projects as well as some travel to conduct site visits or to attend client or internal team meetings as needed. The IHCRA-II will be responsible for assisting with ensuring quality and integrity of data, and additional study related activities to support the efforts of study team members. Activities will be conducted in compliance with Company or Sponsor SOPs, regulatory standards and applicable guidelines.

Essential Job Duties

1) To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.

2) To collaborate with project team and study sites during recruitment phase, tracking, patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and CTL.

3) To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.

4) To assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).

5) To provide oversight and management of maintenance activities; to ensure compliance with renewals, document and update according to applicable local regulatory, and IRB/IEC requirements.

6) To perform Case Report Form review, query generation and resolution against established data review guidelines, on Labcorp Drug Development or client data management systems, as assigned by management

7) Might be requested to work in a client facing environment as assigned.

8) General On-Site Monitoring Responsibilities: act as a co-monitor for on-site RMVs as needed.

9) Responsible for all aspects of remote visits with or without direct supervision (i.e. phone PSVs, phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan.

10) General Monitoring Responsibilities: perform visits per the monitoring plan to include those indicated in the chart below

• For visits that require direct supervision, the following staff is qualified to supervise the In-House CRA-II: Senior In-House Clinical Research Associate, Clinical Research Associate I (with 1+ years' onsite monitoring experience), Clinical Research Associate 2, Sr. Clinical Research Associate 1, Sr. Clinical Research Associate 2, Clinical Trial Leads, Project Managers or Project Directors

11) To liaise with local or central laboratories in order to ensure adherence to the protocol, ensuring that all relevant documentation is current e.g., accreditation certificates, normal ranges, etc.

12) To provide site training as needed via phone or teleconference/web meeting.

13) To conduct IVRS/IWRS review and reconciliation, ensuring that data is accurate and up to date.

14) To liaise with sponsor/medical monitor regarding clinical questions and study status.

15) To assist with the coordination of study visits and shipment of drug and laboratory samples.

16) To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.

17) To liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.

18) To demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate within the different sections; to enter weekly details in CTMS or as per study requirement.

19) To liaise with the CTA to assist the project team in the production of status reports

20) To work in a timely manner in accordance with all the activities specified in the agreed study budget, under the minimal supervision and guidance of the Clinical Team Leader (CTL) and Project Manager.

21) Assist in submissions and notifications to Ethics Committees and Regulatory Authorities, as applicable in region.

22) General On-Site Monitoring Responsibilities: assist MEA CRAIs, Senior IHCRAs and CRAs, with on-site tasks as required and according to training goals (e.g. review of Case Report Forms, SDV/SDR, Site Regulatory File and drug accountability).

23) To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements, as needed regionally.

24) To undertake other project related administrative tasks (i.e. recruitment tracking, site document preparation) as appropriate, as assigned by the Project Manager and CTL; might be requested to work in a client facing environment.

25) To attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.

26) Ensure compliance with Labcorp Drug Development SOPs, and local regulatory authority regulations for clinical conduct in all aspects of daily work.

27) To perform other duties as assigned by management.
Education/Qualifications:

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)

AND

• A minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)
• Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements
• Basic understanding of the clinical trial process
• Valid Driver's License

Experience:
Minimum Required:

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)

AND

• A minimum of 2 years of industry experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)
• Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP
• Ability to work within a project team
• Good planning, organization and problem solving abilities
• Good communication skills, oral and written
• Good computer skills
• Works efficiently and effectively in a matrix environment
• Fluent in local official language and in English, both written and verbal