Associate Specialist, Clinical Trials

Location
Redwood City, CA, US
Posted
Mar 23, 2021
Ref
725371200
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The Associate Specialist, Clinical Trails (Clinical Trials Management Associate CTMA) is responsible for supporting the day-to-day implementation and operation of clinical study execution, monitoring activities as well as other clinical trial supportive activities according to Emergent Standard Operating Procedures, Good Clinical Practices and applicable regulations.
This role interacts with functional groups to maintain and develop systems which promote regulatory compliance, enhance efficiency, and achieve organizational goals.

Essential Functions
• Support the preparation and ongoing review of study documents (i.e.: protocols, consent forms, site instructions, study specific materials/plans, etc.).
• Participate on study team meetings and provide input to support discussions.
• Provide required data from studies and sites to comply with regulatory and government requirements (Sunshine Act, FWA, Human Subject Protection training, Clinical Insurance).
• Conduct monitoring or co-monitoring activities for site visits, including site qualification, site initiation, interim and close-out visits, with the necessary supervision.
• Assist with vendors management; including RFP review process, contracts/budget, performance accountability, invoice review and timeline management.
• Setup and maintain internal clinical systems (CTMS, eTMF, RTSM, etc.) and tracking tools. Assess study progress against QTL's, KPI's and generate trend reports.
• Oversee ongoing document review and collection into the TMF throughout study start-up, maintenance and close-out periods. Collaborate with Regulatory, Quality and other departments as necessary to ensure appropriate oversight of TMF.
• Collaborate and oversee the coordination of study start-up activities (site feasibility, site selection, essential document collection/review, budget/contract negotiations, site activation, clinical trial registration, trial insurance, etc.).
• Support Investigational Product Management (labelling, packaging, shipping, temperature excursions, accountability/reconciliation, destruction).
• Assure appropriate oversight for timely shipment of clinical supplies (lab kits, binders, etc.), and collection and tracking of clinical samples in collaboration with sites, central labs and vendors.
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools.
• Co-Monitor data for missing or implausible data; implement risk-based monitoring, as applicable.
• Ensure tracking of subjects' status throughout the study at investigative sites through collaboration with data management by monitoring subjects' safety trends and alerts and protocol deviations (track, report and follow-up).
• Assist with DSMB meetings logistics.
• Provide clinical team oversight to field CRAs and other vendors' staff by participating in meetings between Emergent and Vendors, contract CRAs and Investigative sites as needed.
• Collaborates with sites to ensure completion of action items identified during audits or inspections. Liaise with QA as required.
• Contributes to the generation of appendices for the Clinical Study Report (CSR).
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills
• BA/BS degree or higher, preferably in life sciences, accompanied by over two years of relevant work experience, clinical trial monitoring experience preferred.
• Ability to deal with competing timelines and multiple assignments, prioritizing successfully Knowledge of ICH Guidelines and GCP, and/or other regulatory requirements as applicable.
• Good oral and written communication skills required with the ability to effectively understand and present information, and deal confidently with internal and external stakeholders
• Initiative, excellent attention to detail, with highly-developed organizational, and time- management skills are required.
• Self-starter with the ability to work both independently and as part of a multidisciplinary team.
• Computer literate with well-developed skills in the use of Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
• Prior experience with eTMF, CTMS and EDC systems preferred.
• Travel may be required, predominantly in the United States and/or Canada but may include international travel.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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