Leads and manages Clinical Research Associates while overseeing monitoring and site management for clinical trials. Responsibilities include staff hiring, training, coaching, workload allocation, performance management, monitoring plan execution, CTMS oversight, sponsor communication, audit and inspection support, regulatory compliance, issue resolution, and quality improvement. The role may also conduct site visits and requires experience with feasibility, qualification, initiation, monitoring, closeout, investigational product accountability, Trial Master Files, and serious adverse event handling.
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
Celerion, a leader in clinical research, is seeking a full-time Lead, Clinical Research Associate to oversee monitoring and site management activities for clinical trials, clinical investigations and other interventional or non-interventional studies.
Essential Functions
Team Leadership and Line Management
Provide experienced leadership to a team of Clinical Research Associates involved in clinical studies that are executed at the sites conducting clinical research studies This includes, but is not limited to:
•Direct supervision / line management of CRA staff and contractors in the team in accordance with Celerion policies and applicable regulations.
•Interview, hire, and conduct onboarding training for new staff in conjunction with Human Resources; ensure that staff has the proper materials, systems access and training to complete job responsibilities.
•Prepare and implement function specific training programs; ensure training on and adherence to Celerion’s procedures and guidance documents, best business practices, legal and confidentiality constraints.
•Assign staff members to clinical projects, monitor staff workload, and liaise with the Manager of Monitoring, GCD North America (as needed) to ensure appropriate allocation of resources and optimal utilization.
•Ensure timely submission of timesheets and expense reports by staff as well as review/approve timesheets and expense reports in a timely manner.
•Develop, mentor, manage and coach CRA staff to progress their skills so that the organization's quality standards are maintained.
•Perform annual appraisals, define the performance objectives and advocate individual career development, responsibility and accountability
•Serve as escalation line for direct reports, including trouble shooting, issue escalation, deviation management, QI/CAPA management
•Advocate for the needs of the staff with other functions of the organization
•Generate action plans and provide developmental/strategic oversight to optimize monitoring services, with a focus on high quality delivery of individual/team/departmental goals
•Maintain a positive, results oriented work environment, build partnerships, model teamwork, and communicate in an open, balanced, and objective manner
•Contribute to Process Improvement initiatives for Line of Service (LOS)
Project related responsibilities
Support day-to-day execution of monitoring services for the ongoing projects; ensure deliverable of the CRAs assigned to the projects are met on time within quality and budget parameters according to the Sponsor/Client expectations. This includes, but is not limited to:
•Implementation and monitoring of clinical studies to ensure sponsor and investigator obligations are being met in compliance with local regulatory requirements, Good Clinical Practice, and the respective protocol or investigational plan as follows:
-Ensure monitoring activities are occurring according to contract, monitoring plan and SOPs
-Oversee and assist with monitoring plan and study material development (SIV Slides, SQV Waivers, etc.)
-Co-monitor as needed
-Update and review of clinical trial management tracking systems (CTMS)
-Manage all monitoring activities within CTMS (visits, open and closed queries, issues opened)
-Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings/training with pertinent departments and other vendors
-Review monitoring metrics/deliverables to evaluate quality trends and compliance to monitoring plan
•Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary;
•Interact with Clinical Project Manager/designate and other study team members to ensure timely resolution of project study issues
•Participate and demonstrate proactive involvement in project study meetings, internal project study meetings, and other activities enhancing project progress
•Participate in audits and inspections, including preparation and follow-up activities as needed
•Support Sponsor/Client in fulfilling their obligations with regard to submissions according to relevant regulatory requirements.
•May act as a CRA for selected studies where needed and defined
Additional Responsibilities
•Perform on-site and in-house tasks according to contractual agreements with Sponsor/Client
•Be thoroughly familiar with and follow all applicable procedures and policies (standard and study specific)
•Interact with direct supervisor and the study team to develop a thorough and unambiguous understanding of all tasks required as well as project study timelines and priorities
•Maintain a working knowledge of all required Celerion IT systems
•Follow administrative and reporting/documentation requirements of Celerion and clients , as necessary
•Agree to be subjected to audits, compliance, and performance reviews by Quality Assurance (QA) and Line of Service (LOS) associates
•Perform other duties as assigned
Requirements and Qualifications:
•Bachelor's degree in a biomedical-related field, life sciences or equivalent field;
•At least 5 years or more in clinical operations or related discipline either in CRO or Pharmaceutical industry with a minimum of 3 years onsite monitoring experience;
•People Management skills required;
•Excellent oral and written communication skills in English;
•High level of organization, multi-tasking, judgement , and analytical skills;
•Good time management skills to ensure adherence to timelines;
•Profound knowledge of Good Clinical Practice, 21 CRF Part 11, and other relevant regulatory requirements;
•Dedication to quality and reliability;
•Commitment to continuous training and knowledge sharing; proactively keeping up to date with procedural industry standards and international regulatory developments in clinical research;
•Ability to work well independently and as part of a team;
•Self-motivation;
•Maintain confidentiality of Subject data and Sponsor/Client information;
•Computer literate;
•Strong attention to detail while being tactful and diplomatic;
•Ability to conduct all types of site visits according to Celerion/Sponsor SOPs, GCP, and regulatory requirements;
•Experience in performing Feasibilities, Site Qualification Visits, Initiation Visits, Investigational Product Accountability, Routine Monitoring Visits, Close Out Visits and in maintaining Trial Master Files and handling SAEs;
•Flexible and willing to travel for both pre-planned and impromptu meetings/visits.
Celerion Values: Integrity Trust Teamwork Respect
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
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