Job Title: Lead CRA
Department: Clinical Operations or Implementation
Effective Date: 30APR20
The Lead Clinical Research Associate (LCRA) is instrumental in ensuring quality, consistency, accuracy, and timely flow of clinical trial management and documentation to permit the evaluation of the optimal quality conduct of the trial, protection of safety and privacy of the subjects and the quality and integrity of the data produced to demonstrate compliance of the Investigator, Sponsor, Vendor (if applicable) and NCGS dedicated staff with International Conference on Harmonization Good Clinical Practices (ICH-GCP), Code of Federal Regulations (CFR) of Food and Drug Administration (FDA) guidelines, local regulations, NCGS Standard Operating Procedures (SOPs), study specific monitoring plans and/or Sponsor designated SOPs.
The LCRA is expected to assist the Director of Clinical Operations or Project Manager with coordinating a clinical trial and could potentially have a significant degree of autonomy in overall management of smaller scale clinical trials (e.g. phase 1 clinical trials; device trial; diagnostic trial) as well as managing vendors (e.g. central laboratory, central IRB, drug distribution, cardiac monitoring, etc.) and the day-to-day activities during the launch, maintenance and closeout of phase 1-4, device or diagnostic clinical trials.
LCRA duties can include, but are not limited to, the following: developments, reviews and edits of protocols; develops site feasibility questionnaires; site selection and qualification; reviews monitoring reports for sites conducted by other CRAs; reviews timesheet and expense reports for CRAs; conducts site visits; develops study reference manual; writes informed consents; develops blinding plan templates; co-monitors as required ; performs quality visits; performs internal and external audits; performs Serious Adverse Event (SAE) reporting procedures; reconciles SAE database; conducts vendor audits; participates in PI meetings; develops monitoring plan; trains CRAs; implements Corrective and Preventive Action (CAPA) initiatives and measures success; establishes quality metrics measures and manages the collection of metric data. Required travel up to 50%.
- Independently and proactively performs In-House CRA responsibilities, such as: maintenance and Quality Control (QC) of Trial Master File (TMF), review of regulatory documents, Informed Consents, and monitoring reports, and the tracking of invoices and purchase orders
- Key participant in the start-up, implementation, management, and close-out of clinical trials; including preparation of clinical study protocols, CRFs, Informed Consent Forms, clinical study reports, Investigational New Drug (IND), and New Drug Applications (NDA)
- May act as operational lead for all day-to-day organizational activities of the maintenance phase of clinical trials including vendor management (e.g. centralized laboratories and contract CRAs)
- May be responsible for overall trial management for limited focus clinical trials (phase 1 or small phase 2 - 4 trials) including study team management
- Drafts Study Informed Consent Form templates and independently manages the review and approval of site specific Informed Consent Forms
- Develops presentation materials for and presents at Investigator Meetings, and prepares presentations for and performs Site Initiation Visits
- Assists with development and review of study manuals (monitoring plan, site regulatory binder, pharmacy instructions, etc.)
- Performs and documents Qualification, Initiation, Interim Monitoring and Close-Out Visits; reviews monitoring reports generated by CRAs
- May accompany monitors on site visits to monitor CRA performance to ensure adherence to the Monitoring Plan, Protocol, and GCP/SOP compliance
- Provides research and data analysis supporting vendor selection and evaluation, provides recommendations
- May provide training/mentoring on data management and operational tasks/projects to more junior staff
- Liaise with investigators and site staff conducting the trial as required to ensure monitors are meeting expectations
- Develop and monitor metrics to evaluate monitor and site performance. In the event of performance concerns, evaluate the cause and mitigate the risk to the study
- Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring
- Track patient enrollment and recommend solutions to monitoring staff to increase appropriate enrollment of qualified subjects
- Assists the CTM in the oversight of SAE reporting including documentation, tracking, and follow-up
- Assists in the site audit process and coordinates the audit responses to ensure conformance to industry and company standards
- Blinding Plan review prior to enrollment period.
- Perform other duties as assigned by management.
- This job has supervisory responsibilities.
Knowledge, Skills and Abilities
- Proficiency in Microsoft Office and internet research skills
- At least 4 years of experience in clinical research
- Ensuring successful and timely completion of all aspects of Clinical Studies
- Proven strength in problem resolving, coordination and analysis
- Communication and Interpersonal skills
- Effective Presentation Skills
- Demonstrated ability to work independently and in a team environment
- Demonstrated working knowledge of GCP, ICH Guidelines and FDA regulations
- Ability and willingness to travel 25%-50% of the time (internationally and domestically)
Education and Experience
- Bachelor's degree in one of the life sciences including physician's assistant education, a nursing education, or equivalent certification/licensure from an appropriately accredited institution
- At least six years of relevant industry experience as a clinical research monitor or manager that provides the knowledge, skills, and abilities to perform the job
- In some cases, an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered