The SCRA anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action as indicated. The SCRA should use functional expertise and exercise good judgment in seeking appropriate guidance and ensures that follow-up to any and all corrective action is taken at the clinical site and is properly documented.
- Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.
- The SCRA conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring AbbVie studies are conducted according to all applicable regulations and business processes.
- Ensures regulatory inspection readiness at assigned clinical sites.
- Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
- Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:
- Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas.
- Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives. Is proactive in managing the site and ensures action plans are put into place as needed to ensure compliance.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.
- Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
- Appropriately reports and escalates serious or outstanding issues to project team member(s) and/or ACOM/COM/ Sr COM as appropriate, as defined in the study monitoring plan.
- Facilitates Quality Assurance Audit processes as indicated. Ensures regulatory inspection readiness at assigned clinical sites.
- Implements appropriate activities to ensure the site meets the enrolment target within the agreed timeline.
- Report monitoring activities and study site conduct accurately and completely.
- Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.
- Proactively identifies issues that may impact enrollment and recruitment timelines, and provide objective comments regarding these issues.
- Collaborate with senior staff to develop initiatives and contingencies to ensure that timelines are met.
- Prepares CA and/or EC documentation, ensures submissions and/or notifications are performed as applicable. Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up.
- Supports remote monitoring, if and as applicable.
- Employs good financial management to conserve costs of departmental operation and control travel expenses, with guidance from Senior ACOM/COM/Sr COM as appropriate.
- Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders.
- Maintain and complete own expense reports as per local and applicable guidelines.
- Identifies, evaluates and recommends new/potential investigators/sites on an on going basis.
- Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
- Participates in departmental and other functional meetings as needed, including Site Management & Monitoring meetings.
- Identifies and partners with other AbbVie personnel to develop innovative processes and technologies to increase the quality, productivity, and efficiency of Clinical Operations while conserving overall departmental operating costs.
- Maintains knowledge and expertise across multi-therapeutic areas through clinical and scientific literature review, ongoing awareness and trends of industry practices and participation in professional activities.
- Creates a positive work environment by encouraging mutual respect, innovation, and accountability at all levels.
- Maintains appropriate communication with relevant functional areas.
- Undergoes and maintains training as required by Global Clinical Operations and other relevant company procedures, to ensure adherence to federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
- Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.
- Minimum of 1 year of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring.
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
- Experience in on-site monitoring of investigational drug or device trials is required.
- Demonstrated strong site management and monitoring skills.
- Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Good written and verbal communication skills. Written and verbal fluency in English and local language (if not English).
- Acute observational skills, analytical and conceptual capabilities.
- Exhibits high degree of flexibility when facing changes in the work environment. Attention to detail and strong interpersonal skills.
- Competence in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications.
- Previous experience with electronic data capture systems is desirable.
- Ability to work independently with minimal supervision.