Lead Clinical Research Associate (LCRA) (Clinical) - REF8987B
- Western Ave, Western Springs, IL 60558, USA
- Employees can work remotely
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
The Lead Clinical Research Associate (LCRA) is responsible for managing the development, coordination and implementation of site management and clinical monitoring responsibilities for assigned protocols with guidance from the Clinical Study Manager. The LCRA provides expertise in clinical monitoring services for all phases of clinical studies.
Essential Functions Include:
- Supports the clinical team, especially the Clinical Study Manager, in overseeing clinical monitoring and operational study execution of assigned protocol per Sponsor and SOW.
- Initiates, coordinates and manages Regional Clinical Research Associates (CRAs) teleconferences (weekly or as needed).
- Creates, maintains and reports metrics for monitoring study visit reports and study data.
- Ensures all CRA monitoring is performed on time, per GCP, and that trip reports are completed and reviewed on time and per the monitoring plan.
- Acts as the first line of contact for Regional CRAs for study specific issues and questions.
- May assist in the design and development of study related documents including (but not limited to) monitoring guidelines, monitoring plans, CRA evaluation plans, Informed Consent Form (ICF) templates, Case Report Forms (CRFs), CRF guidelines/instructions Data Management Plans, source document templates, monitoring visit report templates, site tools and worksheets.
- Assist in the review and tracking of regulatory documents and other study related documents.
- Conducts all types of monitoring, co-monitoring, CRA evaluations at study sites as required including Phase I-unit pre-study evaluations. Provides visit feedback for evaluation by the Clinical Operations group/or designee.
- Writes trip reports or evaluation reports and follow-up letters as required by SOPs for study visits. Also responsible for the tracking of all study visits and reports and make sure they are consistent with the monitoring plan.
- Interface with individuals in other functional areas to address study needs.
- Assists in the review of required documents for Clinical Trial Material (CTM) release authorization.
- Contributes to the review of protocols and other study documents. Performs data review, query generation and query resolution.
- Participates in meetings and conference calls with internal project teams and external partners.
- Participates in the training of vendors and study coordinators on study requirements. May be required to train site staff on protocol specific issues, GCPs or other necessary training.
- Identifies deficiencies and coordinates training for CRAs.
- May be responsible for the review and approval of time sheets and expense reports for CRAs. Must ensure consistency with contract and travel policy.
- Assist in the development and review of standard operating procedures (SOP) and working practices (WP).
- Up to 10% travel may be required.
Qualified candidates must have:
- Bachelor's degree or equivalent combination of education and experience.
- Must have at least 5 years direct CRA experience at a pharmaceutical company and/or CRO.
- Must have at least 1-year experience managing CRAs.
- Solid experience in field monitoring (clinical trials) as a CRA or as a Senior CRA.
- Excellent verbal, written communication skills and interpersonal and presentation skills are required.
- Excellent keyboard skills, with experience using Microsoft Office (Outlook, Word, Excel and Power Point) applications to prepare charts, tables, forms, reports and presentations required. Experience with email and calendar programs necessary
- Electronic data capture (EDC) experience required and CTMS and IVRS system experience is a plus.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
- Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision.
- Strong problem solving, organizational and time management skills.
- Must be able to offer solutions when obstacles are identified and train as necessary to achieve project goals.
- Must have a general understanding of routine project goals from an organizational perspective.
- Ability to prioritize and plan workload is essential.
All candidates must be legally eligible to work in the United States.
We are an equal opportunity employer. M/F/D/V
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***