Lead Clinical Research Associate (Lead CRA) supports successful execution and timely completion of RefleXion’s clinical studies by monitoring and/or supervising monitoring activities to ensure data integrity and compliance with the FDA regulations, ICH-GCP guidelines and SOPs.
Ideal candidate has extensive experience in clinical study operations including monitoring oncology and device studies. Candidates with an understanding of project management principles and interest in developing as a Clinical Project Manager are encouraged to apply.
- Assists in preparation of clinical study documentation such as study protocols, Informed Consent Forms (ICFs), study-specific plans, manuals, Case Report Forms (CRFs), Study Master File Index (SMFI) and training materials.
- Supports identification, requirements and evaluation of clinical study sites.
- Effectively oversees site initiation, activation, patient enrollment, monitoring and close-out activities for multiple clinical studies.
- Establishes and maintains SMFI throughout the study. Ensures clinical study documentation is filed, complete and maintained per SMFI and applicable regulations.
- Oversees and participates in audit readiness activities.
- Oversees monitoring activities of CRO and/or junior CRAs; co-monitors as required.
- Develops and tracks monitoring metrics to evaluate monitoring and site performance.
- Ensures data completeness and integrity by monitoring study data (CRFs, source documents, reports etc.) to identify discrepancies and missing data via on-site or remote data monitoring.
- Supports data management and reporting activities via query generation, query resolution, tabulating, analyzing and reviewing data in collaboration with data management and biostatistics functions.
- Identifies, evaluates and properly captures Adverse Events. Ensures adequate follow up, timely documentation and reporting according to internal procedures and regulatory requirements.
- Supports clinical safety event process by coordinating adjudication body activities (DSMC, CEC, SMC or other adjudication body designated by the study protocol).
- Contributes to preparation of clinical study reports including external reports to regulatory agencies, sites and IRBs.
- Monitors study status and risks; identifies the need for, escalates, informs and implements corrective and preventative actions.
- Supports testing and training study team on clinical study systems such as electronic data capture (EDC) or electronic trial master file (eTMF) systems.
- Establishes appropriate communication processes and support interactions with clinical study vendors and external research organizations such as CROs and Core Laboratories.
- Under the oversight of project management, facilitates site agreements and budget negotiations.
- Plans and participates in investigator meetings.
- Other duties as assigned
- Bachelor’s degree (B.S. or B.A.) or nursing degree required.
- A minimum of 5 years’ experience in clinical study operations required.
- Experience monitoring oncology and/or device studies required.
- Strong understanding of clinical study operations.
- Willing to travel up to 20%.
- Masters or other advanced degree preferred.
- Experience in monitoring oncology and device studies preferred.
- Experience in IDE studies preferred.
- Certified Clinical Research Associate (CCRA) preferred.
- Some project management experience preferred.