Job Title: Senior CRA
Department: Clinical Operations or Implementation
FLSA Designation: Exempt
The Senior CRA (S-CRA) independently performs and coordinates all aspects of the clinical monitoring and site management process in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) guidelines regulatory guidelines, international, national and local regulations, NCGS Standard Operating Procedures, study specific monitoring plans and/or sponsor designated SOPs. The S-CRA works closely with the Lead CRA to evolve monitoring, site management and decision-making skills required to function independently and to train less tenured CRAs. The S-CRA participates in site identification feasibility questionnaire collection and assessment for study participation, site qualification, site initiation and training, Principal Investigator (PI) meeting attendance, site monitoring and site closeout.
S-CRA conducts visits at the site and/or remotely (if remote monitoring is employed) at the frequency outlined in the clinical monitoring plan and in compliance with applicable agency regulations. Sites visits are conducted to ensure the safety and privacy of the subjects enrolled has been protected, security and accountability of investigational product has been maintained and ensure protocol and regulatory compliance has been maintained. S-CRA collects and manages required clinical, safety and/or regulatory documentation and documents findings in a visit report appropriate to the type of visit and specific to the SOP being followed or specifically modified/expanded/consolidated per sponsor instructions. S-CRA meets with PI and involved staff during visits or via teleconference for remote visits and relays findings, issues and actions noted during the visit and/or remote review of the data.
S-CRA generates follow-up letters to the clinical site informing involved staff and the principal investigator of the findings, follow up issues and actions discussed and/or required. S-CRA supports clinical sites between on-site visits to answer questions, assist in managing subjects and escalating safety issues to the safety monitor and study manager. S-CRAs assist in collection of safety data and follow-up reports in the event a serious adverse event occurs. S-CRA contacts the site weekly, or per monitoring plan specifications, and provides summary updates to the project manager of weekly site progress, screening, screening challenges and recommendations for alternate methods, enrollment and compliance and data quality and timely data collection or query resolution.
S-CRA reviews central laboratory data and data entered in the electronic data capture system (if applicable) to monitor subject and site/staff compliance. If paper CRFs are employed, the S-CRA will acquire the CRFs via transmission method outlined in the monitoring plan to assess compliance for the first few subjects. S-CRA facilitates data cleaning processes throughout the active study period and reviews and closes queries and monitors the pattern of queries suggestive of training deficits or additional instructive support. S-CRA is responsible for ensuring that clinical data, supportive clinical or regulatory documentation will pass agency audits. S-CRA develops and maintains collaborative relationships with investigational sites and interfaces with the back-up S-CRA/CRA to ensure consistency in site management. Position requires travel of 60-80% on average.
The S-CRA may develop training materials and / or train other team members on protocol, study-related procedures, regulations, etc. S-CRA may train and mentor less tenured CRAs to evolve CRA skills. The S-CRA may review protocol, CRF and edit specifications for content, logic and clinical implementation.
- Participate in the review of clinical protocols, case report forms or edit specifications and recommend clinical or operational changes
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
- Reviews or authors informed consent forms, monitoring plans, training materials, site study manuals, and related study documentation
- Coordinate efforts in study start up through closeout activities, including: study feasibility, site selection, preparation and follow-up of site regulatory packages
- Coordinate and conduct CRA and site training of protocol and operational requirements
- Ensure consistency in instructions to investigators and their personnel for compliance with protocol and regulatory requirements
- Manage key study parameters (study start-up activities, drug inventory, lab supplies, non-clinical study supplies, screening activity, subject recruitment plans and efforts, lab sample management, safety reporting procedures, metric assessment, data collection, blinding plan, vendor interface, etc.) and in collaboration with the project manager or Lead CRA and proactively identify solutions within the study team when issues arise and measure intervention success if required
- Create and implement project tools, tracking tools, etc. to report study specific metrics
- Prepare progress updates
- Manage all study supply requirements (storage, distribution, site inventory, etc.)
- Assist with the projection and management of clinical supply inventory.
- Performs independent monitoring of sites as required by needs of project
- Conduct co-monitoring visits
- Conduct audits of other monitors, clinical sites, supplier inventory, etc.
- Assist in the review of clinical study reports for accuracy
- Review, write and/or edit SAE narratives
- Use well-developed problem-solving skills to address needs of program or skill development of team members
- Perform other duties as assigned by management.
Knowledge, Skills and Abilities
- Effective interpersonal skills
- Strong oral and written communication skills
- Team builder and collaborative personality
- Strong organizational and time management skills
- Strong quality focus and attention to detail
- Good computer skills, good knowledge of Microsoft Office, ability to learn appropriate software and internet-based programs
- Functional flexibility and adaptability
- Leadership skills
- Strong presentation skills
Education and Experience
- Bachelor's degree in a science related field, physician's assistant education, nursing education and/ or equivalent certification/licensure from an appropriately accredited entity
- Previous experience as a clinical research monitor for four or more years which 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
- Valid driver's license where applicable