Clinical Trial Lead

As the Clinical Trial Lead you are responsible for oversight of the team of field Clinical Research Associates (CRA) or In-House CRAs who provide qualification, selection, monitoring, and close out of sites performing clinical trial(s).  Lead Clinical Research Associates/Clinical Trial Managers review workload requirements and provide resourcing for all clinical in-house and field activities.  You will ensure that staff perform their duties in line with all country governing agency regulations and the International Conference of Harmonization- Good Clinical Practice (ICH-GCP).  You work closely with study Project Management to ensure clinical delivery and execution in line with project contracts.

Position Accountabilities/Responsibilities:

• Participate in the feasibility process, assisting with site selection and overseeing site evaluation activity.
• Oversee the conduct of monitoring/co-monitoring activities for site initiation, interim site monitoring, and closeout, in compliance with all governing laws, regulations, guidelines, protocol, and internal SOPs/policies.
• Ensure the monitors are adequately trained on the therapeutic area and study requirements and are prepared to train the site staff during the Site Initiation activities and at other times, as necessary.
• Identifies site findings with the ability to re-train, place corrective action in place with the site, and follow-up as required. 
• Assist Project Management with risk assessment and mitigation strategies.
• Develop and monitor metrics to evaluate the CRA and site performance (trip report tracking, days on site needed, etc.).  In the event of CRA performance concerns, evaluate cause and mitigate risk to the study. Escalate CRA performance issues to Clinical Monitoring Management as needed.
• Review and approve monitoring visit reports.
• Lead regular project level CRA meetings and documents meeting minutes.
• Co-monitor as required to assist with source data verification, IP accountability and Investigator Site File review, or to provide coaching and manage performance of CRAs.
• Prepare study documents such as annotated trip reports and visit report templates, Clinical Monitoring Plan, study specific templates,
• SIV training presentation, study operations manual, source data verification plan, laboratory manual and informed consents.
• Implement processes for distribution and tracking of SAEs, safety documentation, and pregnancies. Monitors compliance of these processes.
• Help with the planning and participation of Investigator Meetings.
• Reviews/creates/tracks trial newsletters, memos, mass correspondence or other appropriate trial-related documentation.
• Assists in evaluation of vendor performance during conduct of the study.
• Maintains clinical monitoring activity tracking information pertaining to the study.  Serve as the point of contact for client related to clinical monitoring activity.
• Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation); assists with maintenance of Trial Master File as needed.
• Develop and maintain collaborative relationships to manage study issues and support milestone achievement; convey project information; answer study questions in a timely manner escalate issues to study management as needed; troubleshoots and follows up on study progress; and reviews report data for completeness and accuracy.
• Participate in project audits, as necessary, and assist with audit/inspection responses.
• Prepares key reports and documents on progress of study for client or internal Project Manager as appropriate.
• Assists with identification of out-of-scope activities and escalates to the Project Manager as appropriate.
• Assists in driving patient recruitment at sites and participates, in conjunction with site assigned CRAs, on the development of enrollment plans.
• Liaises with data management to identify trends in data entry and review.

Position Qualifications and Requirements:

Education: University/college degree (life sciences preferred) or certification in a related allied health profession from an appropriately accredited institution, such as nursing, medical or laboratory technology.

Experience: 

A minimum of 5-7 years of field monitoring experience (e.g., independent monitoring, co-monitoring, accompanied site visits). A minimum of 1-2 years Lead CRA/CTL experience supporting oncology studies. Indication specific experience as dictated by the study protocol or as specified by client requirements.

Required Certifications: GCP

Required Skills:

• Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.
• Good knowledge of therapeutic area assigned.
• Strong knowledge of FDA, MHRA or EMA regulations, as appropriate, and ICH GCP guidelines.
• Excellent verbal and written communication skills; excellent interpersonal and organizational skills with demonstrated attention to detail.
• Familiarity with EDC and CTMS systems; ability to learn required systems quickly and to train others, especially site staff.
• Ability to meet deadlines, multitasks, and prioritize based on study needs.
• Ability to make sound decisions based on available information.
• Ability to establish and maintain a good working relationship with site personnel/ colleagues. 
• Ability to work both in a team and independently.
• Ability to facilitate team meetings and teleconferences. 
• Familiarity with video and audio tools such as ZOOM, WebEx, GoTo Meeting, Teams, etc.
• Experience using SharePoint site as a way of managing and organizing documents and work for the role and for the CRA team
• Ability to present at internal study team meeting(s).

• Ability and willingness to travel up to 30%, as needed.
• Proficient with Microsoft Office Suite.
• Proven ability to handle multiple projects and meet deadlines.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.

Supervisory responsibilities include:

• Take part in hiring and training monitors (CRAs)
• Ensure the monitors are adequately trained on the therapeutic area and study and are prepared to train the site staff during the Site Initiation Visit (SIV) and at other times to trial-specific industry standards
• Review and approve CRAs time within time management system. Monitor compliance with timely entries
• Take part in performance review for the CRA

Working Conditions: General office working conditions apply. Employee may be office or home based.