Sr In-house CRA
- Experience Level
- Experienced (non-manager)
The Senior In-House CRA (Sr. IHCRA) 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 Sr. IHCRA 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 client or internal team meetings as needed. The Sr. IHCRA 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 support 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) Perform CRF review, query generation and resolution against established data review guidelines, and Labcorp Drug Development or client data management systems, as assigned by management
6) Might be requested to work in a client facing environment.
7) Independently perform CRF review; query generation and resolution against established data review guidelines on Labcorp Drug Development or client data management systems as assigned by management
8) Responsible for all aspects of study site monitoring with or without direct supervision per the study monitoring plan. This includes remote and/or onsite conduct of pre-study visits, site initiation visits, routine monitoring visits and close-out visits of clinical sites.
9) Perform remote visits (i.e. Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan.
10) General Monitoring Responsibilities: perform visits either as the primary monitor or the co-monitor as required by the monitoring plan to include those indicated in the chart below.
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 CTA and CRA to distribute and track clinical trial supplies, e.g. CRFs, 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 supervision and guidance of the Clinical Team Leader (CTL) and Project Manager.
21) Assist in submissions and notifications to Ethics Committees and Regulatory Authorities.
22) To serve as a mentor to less experienced In-House CRA staff.
23) To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements.
24) To attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.
25) Ensure compliance with Labcorp Drug Development SOPs, and local regulatory authority regulations for clinical conduct in all aspects of daily work.
26) Conduct site management activities, maintain site regulatory file, liaise with vendors; perform other duties, as assigned.
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
- Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements
- Thorough knowledge of monitoring procedures
- Basic understanding of the clinical trial process
- Valid Driver's License
- Thorough knowledge of Company SOPs regarding site monitoring
- A minimum of 2-4+ years of Clinical Monitoring experience as a CRA is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted.
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines
- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Ability to work with minimal supervision
- 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