Incumbent contributes to the preparation of study protocols, informed consent forms, 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. Coordinates the identification and qualification of clinical study centers/investigators. May conduct pre-study site evaluation visits, study initiation, monitoring, and closeout visits ensuring compliance with federal regulations, company policies, and standard operating procedures (SOPs) to assure the site in compliance with the study protocol and all regulatory requirements. May prepare trip reports and investigator/site correspondence. Develops and helps to ensure Clinical Study Specialists maintain Trial Master Files (TMFs) for assigned studies and study sites. Works to resolve data discrepancies and provides timely and adequate distribution and return of drug supplies and other study-related supplies. Contributes to the development and maintenance of departmental SOPs. Assists the Clinical Study Manager (CSM) with vendor management, overseeing field clinical research associates assigned to studies, and mentoring junior level team members.
- Oversees Monitoring of Clinical Trials including:
- Preparing monitoring plans for assigned studies.
- Conducting pre-study visits (as needed) to assure the site has adequate facilities, staff, and subject population for conducting the study within established timeframes.
- Overseeing coordination of the distribution of supplies to study sites and assure adequate quantity of supplies are on hand during the course of the study.
- Tracking distribution and return of all study materials and drug supplies.
- Conducting site initiation visits (as needed) 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.
- Performing interim site monitoring visits (as needed) and document findings in a monitoring report which will be completed in a timely manner.
- Conducting periodic telephone contacts to ensure that the study is progressing according to schedule and the site has all necessary materials to properly conduct the study.
- Ensuring adverse events and serious adverse events are being properly recorded and reported.
- Ensuring that all essential regulatory documents are complete and up to date.
- Performing close-out visits (as needed) for all active study sites. The close-out visit will entail accurate accountability of all study drug and material.
- Developing and help to ensure Clinical Study Specialists and Clinical Research Associates maintain Trial Master Files (TMFs) for assigned protocols and study sites according to the company SOPs.
- Training and mentor more junior level Clinical Research Associates, and Clinical Study Specialists.
- Contributing to protocol drafting preparation.
- Preparing sample informed consent forms (ICFs), case report forms (CRFs), and study support documents (i.e., manuals, training tools, diary cards, source document worksheets) for assigned studies.
- Reviewing site generated ICFs for compliance with the study protocol and federal regulations.
- Reviewing data management documents (data management plans, coding plans, etc.) for assigned studies.
- Reviewing pharmacovigilance plans for assigned studies.
- Reviewing statistical analysis plans and data outputs 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.
- Ensuring the collection, review and updating of all essential documents defined by FDA regulations, company SOPs, and general industry standards.
- Tracking 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.
- Developing solutions for logistical and operational issues that arise during trials execution, and communicate these in a timely fashion to investigators, coordinator and company staff.
- Understanding and applying 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.
- Assisting with the selection, oversight, and management of vendor functions.
- Working closely with CSM to manage study deliverables, timeline and overall study budget.
- Reviewing clinical research literature as needed.
- Acting as point of contact for day to day study operations for monitoring team.
- Other duties as assigned.
- R.N. or Bachelor’s degree in biological sciences or other healthcare-related field.
- 5+ years of pharmaceutical, clinical or bioresearch experience.
- 3+ years of experience Clinical Research Associate.
- Exposure to multiple therapeutic areas preferred.
- Self-starter with the ability to work independently and in a team environment.
- Excellent written and verbal communication skills.
- Strong computer literacy skills required.
- Detail-oriented, organized, and the ability to multi-task and meet deadlines.
- Ability to travel up to 25-30% of the time.
- Excellent interpersonal skills necessary.
- Experience in drafting and reviewing monitoring plans
- Experience in site monitoring and some CRA team management.
- Ability to adapt to changes in the work environment.
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.