Lead Clinical Research Associate – Respiratory

We are seeking a Lead Clinical Research Associate (LCRA) to manage and oversee in-house CRAs that will oversee CRO CRA’s management of clinical study site activities for Apogee sponsored clinical trials.  This role will also support the study team in various trial related activities. In this role you will serve as Apogee’s primary liaison with the in-house CRAs and CRO clinical monitoring team and liaise with clinical study sites and contribute to building a culture of team, site and patient centricity.  Helping Apogee become “Sponsor of Choice” with both our CRO partner and sites will be critical.  This role is accountable for oversight of clinical monitoring activities from site identification through close out of the study site.  The LCRA has ‘in-house’ responsibilities (e.g., management/oversight CRAs), and as required by project scope, performs Sponsor monitoring or co-monitoring visits at the clinical study sites.

The LCRA collaborates closely with the Apogee Executive Director, Clinical Operations and the Clinical Study Lead, assists in the planning/management/execution of Apogee sponsored clinical trials, and contributes to the overall success of the clinical study according to company and department objectives.

Key Responsibilities

In-house responsibilities

• The Lead CRA is responsible for the leadership of in-house CRAs on a given study(s), driving the team to ensure study deliverables are met with efficiency and quality and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements
• Responsible for hiring of in-house CRAs
• Input into and assist with the development of study documents (e.g., protocols, case report forms, informed consent forms)
• Oversee development and implementation of project specific processes, tools, and documents (e.g., monitoring oversight plan, site visit report templates, monitoring tools)
• Support the training and development of in-house CRAs and ensuring study training compliance is maintained
• Works with the study team on developing and updating best practices and processes, with input on discussions around quality by design and operational delivery
• Oversight of review of monitoring visit reports and metrics, including protocol deviations and follow-up items, to evaluate for compliance and trends, summarizing for the study team, escalating issues, and involved in the development of corrective and preventative actions, as needed
• Responsible for oversight of CRA review of clinical data (e.g. electronic case report forms, eCOA data, central laboratory data, risk-based monitoring outputs, etc.) to ensure the CRAs are informed and managing their site’s data with quality and integrity
• Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times
• Responsible for compiling and providing clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities
• Lead, conduct, and document regular meetings with their in-house and CRO CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency
• Oversee the study specific performance of the CRA team(s) and implement plans of action as needed; escalate performance issues to the Executive Director, Clinical Operations
• Support and liaise with clinical site personnel, as needed
• Review and approve time sheets and expense reports
• Assist with review and revision of departmental SOPs and policies
• Assist with creation and deliver new department initiatives, improvement plans or training
• May assist with the identification and selection of appropriate clinical trial sites and investigators

Field monitoring responsibilities

• Conduct CRO co-monitoring visits or other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs

• Oversee CRO site visits to qualify, initiate, and close-out study sites, and perform site monitoring to ensure study sites’ compliance with study timelines, protocol requirements, and applicable regulatory guidelines
• Review and ensure data integrity, accuracy, and completeness at the clinical study sites
• Escalate site related issues to the study team
• Oversee the coordination for study site audit and ensure assigned study sites are inspection-ready, as needed

Ideal Candidate

• Bachelor's degree in a scientific or healthcare-related field
• Minimum of 8-10 years of experience as a CRA or related role within the pharmaceutical, biotechnology, or medical device industry
• Minimum 2 years of experience leading a team of CRAs
• Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet
• Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
• Strong understanding of clinical trial processes and study conduct
• Excellent organizational and time management skills
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight
• Experience working in a fast-paced and dynamic environment
• Certification as a Clinical Research Associate (CCRA) or equivalent preferred
• Knowledge of therapeutic areas relevant to Apogee’s portfolio a plus
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability to travel up to approximately 35% including travel to company meetings at least twice per year

The anticipated salary range for candidates for this role will be $130,000-$160,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.