Clinical Research Associate (I, II, Senior)
Linical is a market-leading, midsized, global Contract Research Organization (CRO) with a significant footprint across North America, Europe and Asia-Pacific. With operations in more than 20 countries, Linical is a full-service drug development partner uniquely capable of conducting large-scale, multinational studies while delivering personalized, hands-on service. We are committed to providing clients with innovative, flexible solutions and expediting promising therapies for patients through the drug development lifecycle. We have an exciting opportunity to join our team as a Project Manager. We offer a unique working environment with a global team culture, competitive salary and benefits package.
The Clinical Research Associate (CRA) is responsible for the selection, initiation monitoring and closeout of investigative sites. Major responsibilities include: ensuring the safety and well-being of study participants at assigned site(s); ensuring site compliance with Good Clinical Practices (GCPs), applicable regulations, the protocol and study plans; ensuring data integrity through the source data verification and monitoring process; and ensuring site compliance with all Investigational Product (IP) storage, inventory, dispensing, dosing, and disposition requirements.
CRA II staff will be responsible for monitoring larger, more complex studies/programs and will be assigned to manage a higher volume of studies/participants than a CRA I.
A Senior CRA will provide mentoring to other CRAs and study support staff and will contribute to department training and process improvement initiatives. A Senior CRA may be assigned a Lead CRA role on a study, which requires supervising the work performed by other CRAs. A Senior CRA must be able to adequately perform duties with minimal direction and oversight.
- Participates in the identification of potential investigative sites, conducts prestudy site qualification visits, collects and reviews site regulatory documents, and prepares site qualification reports and associated documentation; participates in the final selection of investigative sites
- Conducts site initiation visits; trains site personnel on Client and regulatory requirements for study conduct; participates in and/or conducts site meetings and investigator meetings, and prepares site initiation visit reports and associated documentation
- Conducts site monitoring visits and follow-up to identify significant problems and issues, and to ensure that all clinical aspects of studies are being carried out in accordance with study plans, GCPs, and applicable regulations; prepares monitoring visit reports and associated documentation
- Reviews on-site files and records, Case Report Forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies; initiates corrective action as required; and ensures training is provided within a reasonable timeframe, is current, and is documented appropriately
- Ensures protocol deviations are appropriately documented and action items are followed through to completion
- Ensures essential documents are filed in the TMF according to guidelines
- Ensures appropriate and timely transmission of clinical data to data management; reviews data queries, and clarifies and/or obtains changes to data as appropriate
- Assists in the close-out of clinical studies by identifying items and issues for review and/or follow-up; conducts site close-out visits to include IP reconciliation and disposition, review of completeness and accuracy of files, and retrieval of documents for the TMF; prepares site close-out reports and associated documentation
- Attends team meetings as required
- Senior CRA – assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the development of participant tracking systems; conducts monitoring assessment visits and SWAT visits for the purpose of rescuing a troubled site or performing audit preparation
- Lead CRA role – delegates and oversees work for assigned CRAs; reviews and approves monitoring visit reports, expense reports and timesheets; manages the visit schedule; provides feedback during the annual review process feedback regarding the performance of assigned CRAs
- Other duties as assigned
- Bachelor's Degree in a scientific, healthcare, or related field and/or successful completion of a recognized CRA training program
- Years and type of experience:
- CRA I requires a minimum of four years’ clinical research experience (e.g. Clinical Trial Associate, Study Coordinator, etc.) or equivalent. Successful completion of a recognized CRA training program may be considered in lieu of the four years’ clinical research experience.
- CRA II requires a minimum of two years’ monitoring and site management experience
- Senior CRA requires a minimum of five years’ monitoring and site management experience
- Excellent understanding of the clinical research process, clinical trial-related systems and procedures, regulations and GCPs, and the scientific/clinical knowledge to be able to understand the nature of the drugs being studied
- Excellent written and verbal communication skills, and time management, organizational, and problem-solving skills
- Ability to travel 75%
- Valid driver’s license
- Excellent people skills and ability to work successfully in a matrixed team environment
- Dedication to quality in all work tasks and deliverables
- Ability to prioritize and to manage multiple tasks as necessary including writing reports during travel time or remote locations such as hotels or airports
- Proficient in MS Outlook, Word, PowerPoint and Excel products
- Bachelor's Degree in a scientific, healthcare, or related field; or equivalent combination of education and work experience
Our employees enjoy a full range of comprehensive benefits to include but are not limited to medical, dental and vision insurance, company paid life insurance, paid holidays, PTO, 401K with employer match, long and short term disability, and long term career growth and development opportunities. If you have the experience required and are looking to join an energetic and collaborative team, please apply directly via our ADP portal.
Linical is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.