CNS - Clinical Research Associate (CRA) - W2

Our clinical research firm is expanding and we have an opportunity for a Senior CRA with CNS, oncology, or metabolic experience for our pharmaceutical company client. Site monitoring is a hybrid model of risk-based remote and on-site monitoring. We are looking for CRAs with experience, who currently lives in Southern Florida or Eastern US. This is for a W-2 contract. We have two openings at ~100%, and the same company is potentially looking for 1 FTE to hire internally.

If you want to work for a great sponsor with career opportunities - look no further. Our group working with this client is rapidly growing, they enhance our clients' culture as well-established professionals - and we are all passionate about doing life-changing clinical research. We want to be in business with like-minded people. If you meet the qualifications and this sounds like you, apply today! Please fill out the intro application survey sent via email after you apply. Thank you!

• Sr. CRA Eastern USA (On-site). See remote ad for remote position.
• Interfaces with the study team to ensure timely initiation and completion of clinical trials
• Responsible for the identification, evaluation, and qualification of investigators and sites
• May prepare and submit essential document packages required for clinical site initiation
• Performs on-site monitoring activities for clinical trials and escalates site issues to Clinical Trial Manager (CTM)/Project Manager (PM); documents activities in the monitoring reports and follow-up correspondence
• Reviews and manages data on-site and remotely; resolve issues on a continuous basis to achieve timely database targets
• May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, close-out visits of clinical sites, and maintenance of study files, with or without guidance
• Ensure the protection of research subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Identify, track, and follow up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensure all applicable SAEs are reported to sponsor and regulatory authorities
• Ensure the accuracy and integrity of the data submitted on electronic or paper case report forms (CRFs), or other data collection tools, by comprehensive source document review. Monitor the study database for missing or discrepant data compared to the source record at the clinical site
• Ensure that all required monitoring tasks are conducted according to site SOPs, established guidelines, work instructions, and project plans (e.g., monitoring plan)
• Maintain study blindly and act as a blinded study monitor. Conduct eCRF/CRF review, query generation, and resolution against established data review guidelines, with or without direct supervision
• Attend investigators’ meetings, project team meetings, and teleconferences, as needed.
• Understands and applies knowledge regarding local, state, country regulations (i.e., TGA, etc.) and ICH-GCP
• Maintain training on ICH-GCP, study protocol, and client procedures
• May track regulatory documents may track recruitment, may evaluate study site quality and integrity, and may motivate assigned sites to meet client deadlines
• May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, close-out visits of clinical sites, and maintenance of study files, with or without guidance
• Ensure the protection of research subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Identify, track, and follow up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensure all applicable SAEs are reported to sponsor and regulatory authorities
• Ensure the accuracy and integrity of the data submitted on electronic or paper case report forms (CRFs), or other data collection tools, by comprehensive source document review. Monitor study database for missing or discrepant data compared to the source record at the clinical site
• Ensure that all required monitoring tasks are conducted according to site SOPs, established guidelines, work instructions, and project plans (e.g., monitoring plan)
• Maintain study blindly and act as a blinded study monitor. Conduct eCRF/CRF review, query generation, and resolution against established data review guidelines, with or without direct supervision
• Understands and applies knowledge regarding local, state, country regulations (i.e., TGA, etc.) and ICH-GCP
• Maintain training on ICH-GCP, study protocol, and client procedures

• 3 years or more as a CRA with site monitoring responsibility And 1 year or more CNS

Or

• 3 years or more as a CRA with site monitoring responsibility And 1 year or more in either: Phase 1, a complex indication with in-patient monitoring, Or metabolic studies

Or

• 3 years or more as a CRA with site monitoring responsibility And 1 year or more in Oncology Monitoring 

And

• The candidate possesses a 4-year university degree, ideally in a scientific field
• In lieu of a 4-year university degree, a candidate with 7 or more years of relevant clinical research experience, nursing/possibly another medical certification, and 5 years of monitoring in a complex indication (in-patient, oncology, phase 1, etc.) may be considered
• Must have working rights in the United States
• Must be located on the East Coast, within 1 hour of an airport
• The candidate must have availability for this contract for at least 1 year
• Must possess exemplary verbal skills in the English language with the ability to solve complex problems using medical terminology
• Bi-lingual is a plus
• Must be proficient at tactfully managing intra-team communication, as well as interpersonal communication
• Note: the travel rate is 50% regular rate

C-Clinical is a clinical operations partner that provides highly specialized consulting services for the pharmaceutical, biotechnology, and device industries.

Our chief concept is in guiding relationships and directing government. We go by "love" in the principle: love your neighbor as yourself, and charity.

C-Clinical was not an act of compulsion, but the care one would have for family.

Bottom line - we created this company to do what we love to do: life-changing medical research; and to dedicate our time, talents, and resources to those who need them.