Job details
Salary $65 - $100 an hour
Full job description
Our consultancy is expanding and we have a great opportunity for a senior cra with oncology, metabolic or cns experience working for a cro as a contractThe site monitoring is a hybrid remote and on-site modelWe are looking for experienced cras, who currently live in san diego or the west coastThe contract duration is 3 to 12 months, and it may be renewableWe have multiple openings at 0.10-1.0 fte unblinded and blinded cra rolesPlease read the rest of the job info, and do not apply if you lack prior experience.
If you are tired of getting used up by companies and want to work for yourself alongside our clinical research group - look no furtherOur group is rapidly expanding, works to enhance our clients` culture by providing experienced professionals - and we are all passionate about doing life-changing clinical researchWe want to be in business with like-minded peopleIf you meet the qualifications and this sounds like you, apply today! please fill out the intro application survey sent via email after you applyThank you!
Compensation:
$65 - $100 hourly
Responsibilities:
Blinded or unblinded srCra west coast (hybrid: remote and on-site)
Interfaces with 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; resolves issues on a continuous basis to achieve timely database targets
We have multiple openings at 0.10-1.0 fte unblinded and blinded cra roles
May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, and 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 reviewMonitor 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 monitorConduct 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 create study tools, study plans, mentor staff, review line listings, and/or conduct staff training/sign off visits
May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, and 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 reviewMonitor 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 monitorConduct 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 create study tools, study plans, mentor staff, review line listings, and/or conduct staff training/sign off visits
Qualifications:
3 years or more as a cra with site monitoring responsibility and 1 year or more in oncology monitoring
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
5 years or more as a cra with site monitoring responsibility and 3 years or more in cns 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, and with 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 within the west coast
The candidate must have availability for this contract for 3 to 12 months
Must possess exemplary verbal skills in the english language with the ability to solve complex problems using medical terminology
Must be proficient at tactfully and succinctly managing intra-team communication, as well as interpersonal communication with the site
About company
Caritas clinical is a clinical operations partner that provides highly specialized consulting services for the pharmaceutical, biotechnology, and device industries.
We chose the word `caritas` to define our company because in medieval english caritas was often posed as the chief concept guiding relationships, directing government, even the rule behind mathematics and order in the universeIt was the word used for `love` in the principal: love your neighbor as yourselfIt is also the root of our modern english word `charity`.
Caritas 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.
