The In-House CRA is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The In House CRA 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’s and regulatory standards and guidelines applicable. All In-House CRA's tasks are to be conducted in the office, and no site visits are expected.
Core responsibilities:
- 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.
- To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
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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).- Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Labcorp or client data management systems, as assigned by management.
- Assist with the coordination of study visits and shipment of drug and laboratory samples. Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or clinical data management system assigned by management
- Assist with training, mentoring and development of new employees, e.g. co-monitoring
- Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contacts as assigned
- Perform other duties as assigned by management
- To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
- 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.
- Assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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