Contract oncology clinical data coordinator (onsite-villejuif, france)

POSITION SUMMARY:

Unique opportunity for a qualified, experienced, and self-motivated Clinical Trials Data Coordinator to work on-site with a renowned cancer center to abstract data, complete case report forms (CRFs), for a Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of study drug in Patients with Nectin-4 Expressing Advanced Malignancies(the “Study”).


* Position Type: Contractor/freelance position (no benefits included, or expenses reimbursed)
* Position Reports To: Medpace CRO, Principal Investigator
* Duration of Contract: 24 weeks
* Work Hours: 15 hours per week.
* Location: Villejuif, France


Clinical Trial Data Coordinators are responsible for



* Maintaining the data integrity of an assigned research study
* Abstracting data, completing case report forms (CRFs), and answering queries in EDC (Medidata).
* Meeting with the sponsor as required, supporting the monitor during their routine visits and maintaining data in an audit-ready state, meeting the contract’s requirements.
* Maintaining the research record and patient information in the appropriate site system(s).



* Eligible candidates will be:
* Well-versed in Good Clinical Practices (GCP) as defined by the International Council for Harmonization (ICH E6), applicable European Union regulations, French national laws and guidelines issued by the French National Agency for the Safety of Medicines and Health Products and the Ministry of Health, as well as data protection requirements under the General Data Protection Regulation (GDPR).
* Able to work as a clinical research team member with positive and timely written and verbal communication. This includes communicating protocol deviations or issues with study execution in a timely manner.
* Understanding of the importance for timely and accurate data entry and query resolution. Able to prioritize appropriately, complete work promptly, and demonstrate attention to detail.




ESSENTIAL JOB FUNCTIONS:

Data Management & Protocol Compliance (80%)

* Ensures all protocol procedures are ordered and completed as specified in the protocol.
* Optimizes the safety of research subjects by ensuring any adverse events (AE) are appropriately reported to the sponsor, study team, and institution according to protocol and regulatory requirements via timely EDC entry.
* Abstracts data from the medical record and completes electronic CRFs in Medidata, including responding to any requests for data clarification.
* Ensures data accuracy with source documentation.
* Ensures documentation processes are followed according to GCP.
* Maintains all necessary patient source documents for assigned studies.
* Obtains data from outside facilities, including images, specimens, and medical records, as needed.
* Uploads imaging data to vendor portal and respond to queries.
* Responds to all requests for data clarification of assigned studies in all relevant systems.
* Meets contractual or institutional requirements for timeliness of data entry and query resolution.
* Fulfills sponsor requirements related to reportable information, including AE, unanticipated problems, and other information required by the sponsor protocol.


Administration 15%


* Participates in required teleconferences, study meetings, both on and off-site, as required.
* Attends site team meetings to ensure any issues are communicated to the team.
* Participates in routine monitoring visits (RMVs) and supports the CRA to enable efficient source data verification (SDV) by the monitor.
* Reviews Follow-up letters from monitoring visits and resolves outstanding data issues identified by the monitor.
* Participates in audits and monitor visits for assigned studies, as requested.
* Identifies and promptly communicates necessary protocol and data management issues or problems to the PI, supervisor, and sponsor.


Other related duties as assigned or requested. 5%


* Participate in study team meetings.
* Participate in staff meetings.
* Serve as a resource to other staff regarding assigned protocol.
* Other duties as assigned, related to this study protocol only.
* Job descriptions are not intended and should not be construed to be exhaustive lists of all responsibilities, skills, efforts, or working conditions associated with a job.


SKILLS & ABILITIES:


•Excellent skills in time management, prioritization, and multi-tasking required. Strong organizational skills, Ability to practice independently, strong verbal and written communication skills, organizational and critical judgment skills, and be able to interact effectively with co-workers and customers. Strong attention to detail. The ability to focus on task is essential.

•Be clearly understood by verbal communication in face-to-face encounters and by telephone. Must be able to engage in a variety of telephone and face-to-face meetings related to pending and active projects daily.

•Strong command of the English and French language, including spelling, writing, and verbalizing, and ability to communicate well verbally and in writing. Must be able to read, interpret, and process large quantities of printed information. Foster/promote a positive image and professional appearance.

•Sensitivity to intercultural relations, and maintenance of confidentiality.


REQUIREMENTS:


•Bachelor’s Degree, relevant experience may substitute for degree.

•At least two years of experience in conducting oncology and hematology clinical trials. Working knowledge of clinical trials, "Applicable European Union Regulations, French national laws and regulations (including the Public Health Code), and requirements of the Comité de Protection des Personnes (CPP) or other competent Ethics Committees.

•Certificate of completion for Good Clinical Practices (GCP)/International Conference on Harmonization (ICH) training

•Microsoft products, including but not limited to word-processing software, internet, and general computer proficiency required.

•Experience with using Medidata Rave.

•Phase I oncology clinical study experience.