The Sr. clinical research associate is responsible for providing support for clinical trial management. S/he will assist the clinical project manager for the trial(s) with day to day clinical trial execution and maintenance activities and will serve as a point of contact for investigative sites.
General study support activities (in conjunction with study lead for assigned projects):
Primary contact for site personnel for protocol related questions/issues, and/or outside vendors and regional CRAs
Collaborate with clinical team and vendor to (a) develop study-specific forms, (b) ensure accurate preparation and review of all regulatory and other study-specific documents and (c) ensure appropriate tracking of all study documents and maintenance of internal files
Participates in all types of study visits (pre-study, initiation, interim, and close-out)
Participates in departmental, clinical subteam, and product development/strategy team meetings, as appropriate
Drafts or receive and review monitoring visit reports
Conduct site visits as required, co-monitor (as necessary)
Collaborate with external vendors (Data Management/ Biostats) to draft, review and finalize study specific documents (Case Report Forms, etc)
Assist in study-related training of regional monitors and site personnel as requested
Respond to clinical sites in a timely fashion and maintain appropriate documentation
Work with study lead to ensure maintenance of TMF
Assist in generating investigator grant payments
Facilitate communication between department, other functions, investigative site personnel and external vendors
Participate in departmental initiatives, as requested
Support sites by assisting with IRB/IEC submissions, regulatory document collection and review, and budget and contract negotiations in collaboration with the study lead and Legal.
Minimum of 3-5 years of clinical monitoring or relevant clinical trial management experience
Experience in therapeutic area of interest to Spark (eg, ophthalmology, hematology, immunology, neurology) is a plus
Knowledge of the pharmaceutical industry, clinical research/trials, GCPs, ICH guidelines is required
Proficient in Microsoft Office applications
Employer will assist with relocation costs.
About Spark Therapeutics
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.
Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.
Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies... are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.
Challenge the inevitability of genetic disease by discovering, developing and delivering treatments in ways unimaginable – until now.
A world where no life is limited by genetic disease.