Sr. Oversight Clinical Research Associate

We are seeking a Sr. Oversight Clinical Research Associate to manage and oversee clinical study site activities for Apogee sponsored clinical trials. In this role you will serve as Apogee’s primary liaison with the clinical study sites and contribute to building a culture of team, site and patient centricity. This role is accountable for clinical site activities from site identification through close out of the study site. The Sr. CRA has ‘in-house’ responsibilities (e.g., management/oversight of vendors, enrollment tracking), and as required by project scope, performs visits at the clinical study sites (e.g., site monitoring visits, co-monitoring visits).

The Sr. Oversight CRA collaborates closely with the Apogee 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

• Input into and assist with the development of study documents (e.g., protocols, case report forms, informed consent forms)
• Draft or assist with the development and implementation of project specific processes, tools, and documents (e.g., monitoring oversight plan, site visit report templates)
• Coordinate or manage, either directly or through supervised delegation, study-wide activities such as external vendors, sample handling, drug re-supply, investigator payments, overall data quality, and overall central records quality
• Assist with the identification and selection of appropriate clinical trial sites and investigators
• Participate in internal study team meetings (e.g., protocol deviation review) and external team meetings (e.g., sponsor-vendor meetings) and draft meetings minutes as required
• Assist with investigator meeting preparations, including the creation of training materials for both CROs and clinical study sites, and help coordinate the investigator meeting planning and logistics
• Track study metrics (e.g., enrollment) for report to management
• Assist with the review and approval of site visit reports; ensure resolution of action items in a timely manner
• Collate and track site protocol deviation and non-compliance for study team revie

Field monitoring responsibilities

• Oversee and/or provide study specific training [e.g., SIV, eData Capture (eDC), study specific procedures and assessments, drug accountability] to study site staff
• Oversee and/or perform site visits to qualify, initiate, and close-out study sites, and perform co-monitoring visits to ensure study sites’ compliance with study timelines, protocol requirements, and applicable regulatory guidelines and monitor CRO CRA’s performance
• Review and ensure data integrity, accuracy, and completeness at the clinical study sites
• Escalate site related issues to the study team
• Assist with the coordination for study site audit and ensure assigned study sites are inspection-ready
• Oversee drug supply inventory and compliance

Ideal Candidate

• Bachelor's degree in a scientific or healthcare-related field
• Minimum of 5 years of both monitoring experience and experience as a Sr. CRA/CRA from the biotechnology industry.
• Dermatology, Respiratory and or Gastrointestinal experience a plus
• Experience performing PSSVs, SIVs, interim monitoring and closeout visits.  Experience monitoring from the beginning of the trial to the end of the trial.
• Certification as a Clinical Research Associate (CCRA) or equivalent preferred
• Experience performing site activations, IRB submission, drug supply management, essential document review & “green light” process, etc.
• Support of in-house team strongly preferred
• Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
• 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
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 50% travel

The anticipated salary range for candidates for this role will be $120,000 - $150,000 per 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.