Syneos - Clinical and Corporate - Prod
Senior Clinical Research Associate II
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We convert unique clinical, medical affairs and commercial insights into outcomes that can address today’s market realities.
Our Clinical Development model puts the customer and the patient at the center of what we do. We aim to make our work simpler and more straightforward in order not only to simplify working with Syneos Health but as well make it easier for us to be worked for.
When you join us in either Functional Service Provider partnership or Full-Service environment, you will partner with passionate problem solvers who innovate as a team in order to help customers achieve their goals. We are agile and driven by our passion for changing lives, thus accelerating therapy delivery.
WORK HERE MATTERS EVERYWHERE: Find out what our 29,000 staff spread across 110 countries already know
Why Syneos Health
We truly care about our colleagues’ growth; therefore, we focus on career development and progression; having supportive line management who are engaged; training on technical and therapeutic areas; total rewards program including peer recognition.
Total Self culture mind-set – where you can be yourself genuinely. This culture is shared throughout the organization globally as we take care of each other.
Why continue building the company everyone wants to work for and where customers want to bring their business? It is simply because such diversity of thinking, experiences, cultures and perspectives creates an environment where everyone feels they belong.
Job responsibilities
Site qualification visits, site initiation visits (on-site or remotely), interim monitoring visits/site management visits including close-out visits ensuring regulatory authority/ICH-GCP/GPP compliance & protocol adherence. Uses experience & judgments in assessing overall performance of site & its staffs’ capabilities providing recommendations regarding actions specific sites may need undertaking: immediately communicating/escalating serious issues to project leader escalating action plans thereafter. Has a working understanding of the ICH/GCP Guidelines or other relevant guidance, applicable regulations, and company SOPs/processes.
Ensures that consent process is adequately executed and sufficiently documented for every subject/patient where required/appropriate. Protects confidentiality of any subject/patient with devotion. Evaluates factors that may impact on safety/well-being of patients/subsequently jeopardize integrity of clinical data at the investigator/physician site (e.g., protocol deviations/violations & pharmacovigilance issues).
As per Clinical Monitoring/Site Management Plan (CMP/SMP):
Analyses site processes
Conducts Source Document Review of appropriate site source documents and medical records
Confirmation that the necessary clinical data recorded in the case report form (CRF) are complete and fully accurate as evidenced by a review of site source documents and medical records
Uses remote query resolution techniques thereby guiding staff at site level where necessary to prompt early closure within agreed timescales
Makes use effective hardware & software when evaluating study data remotely & for its capture purposes
Ensuring compliance by sites with EDC requirements
May do a stock count, reconcile and review of investigational product (IP) storage and security. Checks that the IP has been dispensed to subjects as per protocol and received by subjects/patients before it is administered. Ensures issues/risks with blinded or randomized information associated with IP are verified. Puts GCP/local regulations knowledge into practice to ensure IP is suitably (re)labelled, imported and released/returned.
Orally checks study for accuracy, timeliness and completeness according to ISF file standard operating procedures. Matches ISF contents with TMF records. Ensures the investigator site understands that they must archive essential documents as required by local guidelines and laws.
Writes confirmation letters, follow-up letters, trip reports, communication logs etc., as described in SOPs/Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment strategy, retention strategy & awareness creation. Tracks all observations/ongoing status/action items through data entry into tracking systems.
Sets up sites’ level activities / communication so that projects’ objectives are met within deliverables/timescales; know project scope/budgets/timelines for own and others’ work within clinical team; ability to change priorities quickly when goals/targets are not being met.
Might act as a principal contact between site staff or in partnership with Central Monitoring Associate. Ensures everyone in their team (project specific sites/study team members) has the necessary training including one’s assigned sites.
Arranges attendance at Investigator Meetings and/or sponsor face to face meetings; participation in global clinical monitoring/project meetings (including Sponsor representation where appropriate) can be organized. Apart from site-level guidance on audit readiness standards this individual prepares for audit itself along with any subsequent actions required as well.
Possibly supervises junior level CRAs directly or trains them or acts as mentor for this role description.Prepares training and sign off visits for junior CRA staff when assigned.
Under supervision of an experienced Clinical Operations Lead (COL) or operational line manager, may be mentored and assigned lead tasks. Could include participation in business development proposals and/or defense meetings. #LI-NC1
Qualifications
Who we are looking for
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
Strong CRAs background with few years as a SCRA, gained from Pharma/CRO in UK. Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.
Experience of Oncology is required.
Good communication skills including oral presentation skills, good interpersonal skills; moderate level of critical thinking skills expected.
Must travel 50% of the time as needed
About Syneos Health
Over the past five years alone, Syneos Health has supported over 200 studies across 73k sites involving more than 675k trial patients including 94% of Novel FDA Approved Drugs and 95% of EMA Authorized Products.
Regardless of your role, you will drive the initiative by challenging status quo in a highly competitive environment that is constantly changing. Find out more about us here at Syneos Health’s website.
Additional Information:
This job description is not all inclusive. The Company may add new duties for this job role at any time at its sole discretion without prior notice. Such qualifications as equivalent experience, skills and/or education in other words imply that the particulars of those occupying the position could vary from what has been stated in the Job Description. Also, the determination of what constitutes ‘equivalent’ to these qualifications will be made solely by the company. Moreover, this document does not create an employment contract.
Some times job requirements are expressed concisely. All language contained herein should meet its obligations under any applicable laws of nations where it operates including EU directive 2000/78/EC concerning equality in relation to recruitment and employment process involving their employees. It is a policy of this organization to comply with ADA including reasonable accommodations necessary to enable employees or applicants who are qualified to perform essential functions of jobs.
#LI-NC1