Job details
Job type full-time
Full job description
Principal clinical research associate - (21010711) description
Principal clinical research associate / remote
Who we are
Synteract®, a syneos health® company, is a leading full service contract research organization (cro) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companiesWith our mission of bringing clinical trials to life tm, we provide customized phase i through iv services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.
Position overview
The principal clinical research associate utilizes extensive experience in clinical research to contribute to the quality of clinical trial conduct through monitoring, site management and mentoringThe principal clinical research associate is responsible for the monitoring of clinical trials and tracking study progress, thereby contributing to the overall management of clinical trials in accordance with the appropriate quality standards including ich-gcp guidelines, standard operating procedures (sops), applicable regulations, rules and guidanceThe job may include clinical trial management activities, as well as the mentoring and training of less experienced cras..
Specific tasks would include:
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 initiationCollects and reviews essential documents received from clinical sites to ensure all required documents are obtained, accurate and complete
May assist with the preparation, review and submission of all relevant regulatory documents to the appropriate regulatory authorities and irb/iecs
Assists with the ongoing management of the trial master file (tmf) and/or investigator site files ensuring essential documents are filed appropriately; assists with the file review and reconciliation process in preparation for audits and archival
Assists with maintaining and updating project-related data in an existing database, e.gCtms, etmf, etc.
Reviews patient information sheet/informed consent forms (pis/icfs) and/or data protection authorizations as required
Performs on-site monitoring activities of clinical studies and escalates major site issues to the clinical trial manager (ctm)/project manager (pm); documents activities in monitoring reports and follow-up correspondence
Collaborates with the ctm/pm to ensure study milestones are met, e.gEnrollment, data cleaning, etc· reviews and manages data on site and remotely; resolves issues on a continuous basis to achieve timely database lock targets
Responsible for escalating study issues to the ctm/pm and/or line manager (lm) in a timely manner
Responsible for training of site staff and communicating directly with investigative sites to provide study direction, answer questions, assess recruitment rates and respond to sponsor requests
Responsible for continuous site management to include remote data review, ongoing collection and review of essential documents, and timely query and action item resolution
Monitors and reports study progress/status on a site level
Prepares or contributes to study related correspondence including, but not limited to, meeting minutes, tracking spreadsheets and the preparation of presentations
Represents the company and clinical operations at study team meetings
Prepares sites for audit(s) by sponsor or inspection(s) by fda or other competent authorities; participates in internal audit preparation; assists with audit responses
Performs training and mentoring of clinical research associates; serves as cra expert within the organization
May develop and/or contribute to the development of clinical documents, e.gStudy manuals, plans and monitoring tools
May also include:
Assistance with the translation process of study documents
Coordination and assistance with investigator/site contract preparation and negotiation
Coordination and assistance with feasibility studies
Assistance with processing of clinical investigator payments, study expense reports and other financial items o attendance and participation in client-facing meetings
Assistance in the planning, organizing and executing of project-specific meetings including, but not limited to, client, cra, and investigator meetings; presents at such meetings
Conducting cra assessment visit(s) o contributing to local, regional or global initiatives
Subject matter expert for given system/tool
Qualifications
Qualifications:
Degree & experience
Bachelor’s degree in a life science or related field of study or equivalent combination of studies, nursing qualifications, and/or work experience
Minimum of 6 years relevant experience, to include extensive monitoring experienceGlobal monitoring experience ideal, but not required specific knowledge
In-depth knowledge of ich-gcp guidelines, and applicable regulations, rules and guidance, as applicable.
Keeps abreast of regulatory requirements and scientific knowledge and maintains technical expertise by reading relevant publications, attending courses and through membership in relevant industry/professional associations skills
Proven it proficiency and skills, including microsoft office.
Proficient in problem solving, time management and organization
Effective verbal and writing skills; english and local language, if relevant
This position requires the ability to perform varied tasks, to maintain an appropriate work pace, to exercise logic and reasoning, and to comprehend and follow instructions
This position requires the ability to travel 50-75% and may include overnight travel
Must have a valid driver’s license
Performing the duties of this job regularly involves speaking and listening, repetitive hand movement (at least 15 minutes), and sitting for long periods of time; involves some standing, walking, grasping, reaching and lifting of up to 10 poundsSpecific vision abilities include close vision and the ability to adjust focus(us requirement only)
This job excludes colorado applicants.
As a healthcare company we have an important responsibility to protect individual and public healthThis position will require individuals to be fully vaccinated against covid-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious beliefSubmission & approval of an exemption does not guarantee that an exemption can be accommodated.
Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected categoryApplicants for positions with synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hireThe company will not sponsor applicants [to this position] for work visas.
Primary location: north america - us home-based
Other locations: north america - usa-california-home-based
Job: clinical research
Schedule: full-time
Travel: yes, 75 % of the time
Employee status: regular
