In-house CRA I

---

Job description

The In-House Clinical Research Associate (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
IHCRA shall reflect their experience, and level of contribution which they can make to the project. The
work will involve Operations activities which will be conducted for designated projects as well as some
travel to conduct site visits or to attend client or internal team meetings as needed. The 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 SOP, 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 monitor site performance and implement action plans for sites not meeting expectations, in
conjunction with the CRA.
3) 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).
4) Perform Case Report Form review, query generation and resolution against established data review
guidelines, under direct supervision on Labcorp Drug Development or client data management systems,
as assigned by management.
5) To assist with the coordination of study visits and shipment of drug and laboratory samples.
6) To manage sites to ensure subjects are complying with protocol requirements, study visits, and
timelines.
7) To liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case
labcorp.com
Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue
recruitment.
8) To liaise with Study Start-up and assume maintenance activities after Site Activation. Maintenance
responsibilities include: revision of FDA form 1572, Medical license expiration, CV (if applicable),
Laboratory Certificate expiration, Protocol Signature Page collection, Investigators Brochure
acknowledgement of receipt, Institutional Review Board submission/Approval for Annual Renewals and
PI Changes.
9) To proactively work with sites and project teams to ensure maintenance activities (including
Amendments, revised documents, etc.) are completed for assigned sites as applicable in region.
10) 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.
11) To liaise with the CTA to assist the Project Team in the production of Status Reports.
12) 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.
13) To assist in submissions and notifications to Ethics Committees and Regulatory Authorities. As
applicable in region
14) General On-Site Monitoring Responsibilities: Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks
as required and according to training goals (e.g. review of Case Report Forms Site Regulatory File and
drug accountability).
15) Perform remote visits (i.e. Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the
monitoring plan, but does not perform remote monitoring that requires SDV/SDR.
o General Monitoring Responsibilities: perform visits as the co-monitor 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: MEA CRAI (after successful completion of Evaluation
Sign-Off visit), Senior In-House Clinical Research Associate II, Clinical Research Associate 1 (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
16) To facilitate translation and back translation of all necessary documents, as appropriate for local
country requirements. As needed regionally.
labcorp.com
17) To undertake other project related administrative tasks (i.e. meeting minutes, 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
18) To attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the
meetings.
19) To perform other duties as assigned by management.
Education/Qualifications:
o 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)
Or
o In lieu of the above requirement, •candidates with 2-3 or more years of relevant clinical
•Research experience in pharmaceutical or CRO industries may be considered
Experience:
Minimum Required:
o Basic understanding of biology and biological processes
o Good organizational and time management skills
o Good communication skills, oral and written
o Exhibit general computer literacy
o Works efficiently and effectively in a matrix environment
o At least one year of experience in a related field, (i.e., medical, clinical, pharmaceutical,
laboratory, research, data analysis, data management or technical writing). One year of clinical
research is preferred.
Or
o An equivalent combination of education and experience to successfully perform the key
responsibilities of the job