An opportunity exists for an ambitious professional to be part of the clinical operations team in support of Xcovery. Xcovery is a biopharmaceutical company working to improve the lives of patients by discovering medicines to develop a pipeline of oncology therapies. This position offers the right candidate a significant opportunity for career development and growth.
The Senior Clinical Research Associate (Sr. CRA) will lead project activities associated with monitoring and oversight functions of clinical research studies while continuing to develop a solid understanding of the drug development process. The Sr. CRA will coordinate with sponsor partners to oversee the monitoring functions and assess the progress of clinical studies at assigned investigative sites (either on site or remotely) to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Primary Responsibilities include but are not limited to the following:
Essential Functions: Monitoring Oversight
Assure compliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) and Good Clinical Practice (GCP) guidelines, and Company and Sponsor SOPs.
Critically evaluate adequacy of investigator sites (qualifications, facilities, equipment and performance).
Evaluate the monitoring team on tasks required for onsite/remote monitoring including but not limited to source document review (SDR) and source document verification (SDV).
Accompany the CRO on study visits for investigator sites.
Ensure appropriate planning techniques are applied for efficient/effective monitoring visits.
Report their findings and performance metrics to the management team and implement any corrective plans when necessary.
Manage and prioritize workload effectively.
Review monitoring visit reports in accordance with SOP/Work Instructions or Sponsor requirements as agreed in the scope of work.
Maintain awareness of key study performance indicators for all global sites.
Support subject recruitment and retention strategies.
Update study and subject status information.
Track the resolution of all outstanding site-specific protocol-related issues recorded by the CRO and anticipate/ identify potential issues and implements corrective actions.
Provide guidance to resolve complex issues.
Ensure that the CRO follows standard process for documentation of site communications and initiatives (visits, phone, email etc.).
Maintain specified project metrics within appropriate limits.
Collaborate with teams and Xcovery to ensure proper documentation/filing practices are being maintained.
Ensure CRO is aware of archiving requirements for essential documents in accordance with the local guidelines and regulations.
Verify project compliance with requirements for electronic data capture. Maintain effective, accurate, and timely communication with study partners and project team, ensuring appropriate issue escalation.
Effectively communicate and lead Sponsor monitoring initiatives to CRO.
Participate in global conference calls and meetings to review progress of ongoing clinical trials.
Education and Skills Requirements:
BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience.
Minimum of 5 years of experience as a clinical research associate and site management
At least 2 years oncology monitoring experience is preferred.
Able to collaborate and work in a small, yet dynamic team environment.
Strong understanding of ICH, GCP and relevant regulatory requirements.
Strong operational and management skills with attention to detail.
Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project.
Proven ability to operate in a home office environment with flexibility to travel and report to corporate offices, as appropriate.
Must be able to travel approximately 65%-85%, domestic or international, as required.
Bilingual in English and Spanish a plus.
Please submit your Resume/CV, Salary history and cover letter
Xcovery is a biopharmaceutical company working to improve the lives of patients with cancer by discovering medicines to fight advanced tumors. Xcovery is developing a pipeline of oncology therapies to target a wide range of advanced tumors. Xcovery’s lead product, X-396, is a small molecule that inhibits anaplastic lymphoma kinase (ALK). X-396 is being investigated for the treatment of ALK positi...ve non-small cell lung cancer. The Company is currently enrolling patients in its Phase 2 and Phase 3 human clinical trials. Xcovery is also developing MET and PI3K/mTOR kinase inhibitors for advanced tumors.