Incumbent contributes to the preparation of study protocols, informed consents, case report forms, and study support documents (manuals, training tools, diary cards, source document worksheets). Collects and reviews essential regulatory documentation prior to study initiation and during study to assure regulatory compliance. Coordinate the identification and qualification of clinical study centers/investigators. Conduct pre-study site evaluation visits, study initiation, monitoring, and closeout visits ensuring compliance with federal regulations and company policies and standard operating procedures (SOPs) to assure the site in compliance with the study protocol and all regulatory requirements. Prepare trip reports and investigator/site correspondence. Develop and maintain Trial Master Files (TMFs) for assigned studies and study sites. Works to resolve data discrepancies and provide timely and adequate distribution and return of drug supplies and other study-related supplies. Contributes to the development and maintenance of departmental SOPs.
- Monitoring of Clinical Trials by:
- Assist with the development of monitoring plans for assigned studies
- Conduct pre-study visits to assure the site has adequate facilities, staff, and subject population for conducting the study within established timeframes.
- Coordinate the distribution of supplies to study sites and assure an adequate quantity of supplies are on hand during the course of the study
- Track distribution and return of all study materials and drug.
- Conduct site initiation in order to ensure that all elements are in place for performing the study according to the protocol and in compliance with all applicable regulations and good clinical practice guidelines.
- Perform interim site monitoring visits and document findings in a monitoring report which will be completed in a timely manner.
- Conduct periodic telephone contacts to ensure that the study in progressing according to schedule and the site has all necessary materials to properly conduct the study.
- Ensure adverse events and serious adverse events are being properly recorded and reported
- Ensure that all essential regulatory documents are complete and up to date.
- Perform close-out visits to all study sites. The close-out will entail accurate accountability of all study drug and material.
- Develop and maintain Trail Master Files (TMFs) for assigned protocols and study sites according to the company SOPs.
- Contribute to protocol drafting preparation.
- Assist with the preparation of informed consent, case report forms (ICFs), study support documents (manuals, training tools, diary cards, source document worksheets) for assigned studies.
- Reviews site generated ICFs for compliance with the study protocol and federal regulations.
- Reviews data management documents (data management plans, coding plans, etc) for assigned studies.
- Reviews pharmacovigilance plans for assigned studies.
- Independently evaluate and recommend selection of investigators/study sites; participate in identification of potential sites.
- Independently train investigators, coordinator, and other trial staff in data collection methods to ensure collection of patient data that is accurate, complete, and conforms to project data standards and protocol requirements.
- Ensure the collection, review and updating of all essential documents defined by FDA regulations, company SOPs, and general industry standards.
- Tracks enrollment at both the study and site levels for assigned studies against required projections; identifies and investigates enrollment issues and provide potential solutions to keep
- Develop solutions for logistical and operational issues that arise during trials execution, and communicate these in a timely fashion to investigators, coordinator and company staff.
- Understand and apply clinical scientific research and knowledge of the drug development process, including significance of and differences between Phase I-IV clinical trial design, in all CRA activities.
- Review clinical research literature as needed.
- Other functions as assigned.
Specific Job Knowledge, Skill And Ability:
- R.N. or Bachelor’s degree in biological sciences or other healthcare-related field.
- 2+ years of pharmaceutical, clinical or bioresearch experience, including a minimum of two full years as a Clinical Research Associate.
- Candidate must be able to work independently and with teams.
- Candidate must have excellent written and verbal communication skills.
- Strong computer literacy skills required.
- Candidate must be detail-oriented, organized, have the ability to multi-task and meet deadlines
- Candidate must be willing to travel up to 50% of the time.
- Excellent interpersonal and customer relations skills necessary.
- Candidate must be a self-starter, have the ability to work as part of a team and individually.
- Ability to travel up to 50% of the time.
Leadiant Biosciences, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other legally protected characteristics. The EEO is the Law poster is available here: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to Jobs@leadiant.com and let us know the nature of your request and your contact information.