Lead Clinical Research Associate
Summary of Job Responsibilities:
Oversee the conduct of clinical trials at assigned trial sites, within the agreed time-scale, by regular monitoring. The Lead Clinical Research Associate (LCRA) may be the primary contact between the trial site and Veristat. All tasks are conducted in accordance with applicable Veristat Policies, Standard Operating Procedures (SOPs), conventions and instructions, as well as current Good Clinical Practice (GCP) International Conference on Harmonization (ICH) and applicable local regulations. Assist in supervising assigned regional/contract CRAs and ensure standardized and consistent performance of assigned CRAs.
- Ensure implementation of Veristat SOPs and study specific processes by assigned CRAs.
- Assist in identifying and communicating training and development needs of his/her CRA team to the Director of Clinical Monitoring.
- Ensure the appropriate training and development of assigned CRAs.
- Ensure that performance of assigned CRAs is of agreed quality and assigned work is performed within agreed timelines and with adherence to appropriate SOPs and regulatory requirements.
- Provide active coaching, and mentoring of assigned CRAs, and address any deficiencies.
- Support and/or interface with external functions/groups including service vendors and clinical site personnel.
- Provide input in the development and/or development of clinical trial related documents including but not limited to: Protocols, case report forms, informed consents, conventions/timelines, monitoring plans, site reference manuals, pharmacy manuals, laboratory manuals, training materials, and initiation slide presentation.
- Collaborate with the Director of Monitoring and client for feasibility assessment.
- Assist in identifying suitably qualified trial sites within a specified geographical area.
- Make initial contacts, conduct evaluation visits and subsequently establish relationships with selected trial sites in order to ensure study targets for recruitment, quality and costs are implemented.
- Manage regulatory authority applications and approvals.
- Supervise shipment of study drugs and materials to the site as required.
- Conduct qualification, initiation, interim and close out visits and provide visit reports as per monitoring guidelines.
- Co-monitor the study sites with the assigned CRAs as required.
- Maintain required documentation in the Investigator File/Regulatory Binder and provide required documentation to the clinical team/client for the Trial Master File.
- Maintain study specific tracking tools.
- Ensure the trial site complies with the study protocol, GCP and applicable regulatory requirements.
- Control the integrity of the data produced by trial sites through review of case report forms, source documents/medical and pharmacy records. Ensure review is conducted in accordance with the agreed study timelines.
- Verify patient eligibility, communicate and document protocol violations, non-compliance and poor performance and assure that corrective action is taken, after discussion with the Director of Monitoring and/or PM within the timeframe appropriate to the degree of deviation from the study protocol.
- Liaise with the Safety PM in the management of serious adverse events and SAE reports, and ensure appropriate action is taken at the trial site in accordance with the appropriate Policies, Standard Operating Procedures (SOPs), study specific requirements, as well as current Good Clinical Practice (GCP), International Conference on Harmonization (ICH) and applicable local regulations.
- Provide trial site updates to the PM and/or Director of Monitoring according to study specific monitoring guidelines.
- Attend Project Meetings and teleconferences as per monitoring guidelines.
- Attend and present at Investigator Meetings.
- Assist in negotiating grants and contracts, and in budget forecasting and payments.
- Manage and track investigator invoices and liaise with client on any issues that may evolve.
- Assist in managing investigational product supplies at the country (where applicable) and trial site level, keeping sites informed of drug lots/batches and expiration dates.
- Assist trial sites in meeting project timelines, and proactively inform the PM and team of corrective action, as necessary.
- Assist in the preparation for site audits and inspections and participate in the inspections and in responding to any issues identified within the timeframe specified.
- Maintain/develop a good level of scientific knowledge within the Project’s therapeutic area.
- Maintain computer skills required to work efficiently.
- Maintain good communication between study site, clinical team and client.
- Minimum Education: Must have a Biological science/Pharmacy/Nursing degree. Thorough knowledge of ICH/GCP and regulatory environment.
- Minimum Work Requirements: At least 5 years CRA experience, or combination of 3 years as CRA, plus 2 years of other relevant clinical research experience (e.g., site pharmacist, study site coordinator, clinical trial administrator, co-investigator); management skills and experience in team work. Thorough knowledge of Clinical Operations and Clinical Development processes, Veristat Processes and procedures, SOPs and standard tools; ability to mentor, train and supervise assigned CRAs when applicable; ability to support and/or manage interfaces with external functions/groups including service vendors, - e.g. central laboratories. Must have excellent presentation and communication skills. Sufficient knowledge of study specific therapeutic area to enable appropriate input to study documents (e.g., protocols, CRFs, EDC development) and provide coaching and mentoring to all assigned CRAs, when applicable. Good understanding of the Contract Research Organizations (CROs) from an in-sourcing perspective. Excellent knowledge of clinical pharmacology from Phase I through Phase IV.
- Skills: Proficient in Microsoft Word, Excel, and PowerPoint; e-mail, e-CRF and IVRS, project management tools. Excellent oral and written communication skills in English, other languages a plus, highly self-motivated and proactive, ability to be a team player, ability to work independently, accept to travel as required.