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Home-Based regional sr. cra – oncology – western us

DOCS

This is a Full-time position in San Francisco, CA posted December 11, 2019.

This is an opportunity to monitor clinical trials on behalf of one of the leading pharmaceutical companies in the world.

People with experience monitoring oncology clinical trials are encouraged to apply.

Serves as primary contact point between the sponsor and the investigational site.

Assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company’s Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock.

Responsibilities include site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out.

Ensure overall site management while performing trial related activities for assigned protocols.

May contribute to process improvement, training and mentoring of other CRA’s.

PRINCIPAL RESPONSIBILITIES: List major responsibilities and duties of the position.

List most complex or difficult parts of job first.

Describe scope of responsibilities.

1.

Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team 2.

Acts as primary local company contact for assigned sites for specific trials.

3.

Attends/participates in investigator meetings as needed.

4.

Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.

5.

Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.

6.

Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.

7.

Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.

8.

Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.

9.

Arranges for the appropriate destruction of clinical supplies 10.

Ensures site staff complete the data entry and resolve queries within expected timelines.

11.

Ensures accuracy, validity and completeness of data collected at trial sites 12.

Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate.

For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.

13.

Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g.

CTMS, eTMF/IF, Trial Master Source and Sharepoints.

14.

Fully documents trial related activities in particular monitoring.

Writes visit reports and uploads into eTMF within 5 working days for review and approval.

Complete follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team with 15 working days.

Promptly communicates relevant status information and issues to appropriate stakeholders.

15.

Follows the corresponding Monitoring Guidelines for each assigned trial.

16.

Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times.

17.

Attends regularly scheduled team meetings and trainings.

18.

Complies with relevant training requirements.

Act as local expert in assigned protocols.

Develop therapeutic knowledge sufficient to support roles and responsibilities.

19.

Works to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types.

20.

Prepares trial sites for close out, conduct final close out visit.

21.

Negotiates investigator budgets at site level, if applicable.

22.

Tracks costs at site level and ensure payments are made, if applicable.

23.

Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff.

24.

May participate in the HA and IEC/IRB submission and notification processes as required/appropriate DOCS is the FSP division of ICON Clinical Research.

We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries.

Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.