Regulatory affairs specialist Jobs in Uedem

Job Title : Senior Clinical Research Associate

Job Location : Klein MT 59072 USA

Job Location Type : Remote

Job Contract Type : Fulltime

Job Seniority Level : MidSenior level

Job Description

Position Summary :

The Sr. Clinical Research Associate will oversee outsourced clinical operations activities including but not limited to site management site monitoring and site level TMF filing. Additional responsibilities may be assigned (e.g. management of central labs).

Job Duties :

• Oversee outsourced clinical trial monitoring by reviewing monitoring plans monitoring visit reports deviation listings and conducting periodic oversight monitoring visits. Review site training materials including Site initiation visit slides and related materials. May attend / present at site initiation visits (e.g. present company overview and pipeline slides).
• Develop or oversee development of study / country master ICFs; facilitating internal reviews as appropriate and applicable. Review subject facing documents (e.g. subject ID cards subject instruction material) for accuracy against the protocol IB consent and other documents as applicable.
• Oversee site management activities by :
• Ensuring sites are compliant with GCP and CROs are appropriate and timely escalation of deviations or noncompliance etc. Serve as primary point of contact for the CRO regarding site level issues.
• Review site level documents as relevant e.g. site recruitment plans site level ICF changes (including facilitation of internal review where appropriate).
• Ensuring timely collection / submission of updated regulatory documents and that TMF site files are in an inspection ready state. May also conduct or assist with study and country level TMF QC.
• Track distribution of safety letters to site. Escalate deviations from regulatory timelines to Clinical Project Manager.
• In coordination with other clinical team members ensure study data quality by :
• Ensuring timely data entry and query resolution by sites.
• Serve as primary escalation point for late data entry / query resolution or lagging source data verification percentage.
• Support internal clinical data review process (e.g. review data for accurate subject disposition). Action followup items as applicable after internal data review meetings (e.g. schedule calls or followup with sites where additional discussion may be required).
• Provide updated site level documentation and applicable updates to regulatory as appropriate (e.g. updated 1572s communicating site activations / site lists).
• Contribute to development of vendor oversight plans for outsourced clinical operations activities.
• Remote position in the U.S.

Candidates Must Meet Minimum Qualifications To Be Considered.

Minimum Qualifications :

Differentiating Qualifications :

Skills and Knowledge Required :

Orano Med LLC

Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead212 (Pb212) and radiolabeling technologies Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of molecules in development capable of targeting various forms of cancer and a reliable supply chain for Pb212 Orano Med aims to become a leader in targeted alpha therapies in particular for patients with currently unmet medical needs.

Find out more about Orano Med

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Key Skills

CSS,Cloud Computing,Health Education,Actuary,Building Electrician

Employment Type : Full Time

Vacancy : 1