Description
Description:Our client seeks a highly qualified Sr. CRA to join a team devoted to a Phase I, study for subjects with locally advanced or metastatic pancreatic cancer. This is a US based trial partially monitored by a CRO, but offers the opportunity for some monitoring visits with travel expected to be 25-40%. We are starting additional oncology trials in Pancreatic Cancer this year.
The Sr. CRA is a leader within the clinical team and integrated in the Clinical Trial Operations. We are looking for individuals with experience in study start-up, vendor management and CRO oversight. We are seeking Sr. CRAs that have experience in managing quality deliverables and with oversight experience of field monitors.
Typically, the candidates will have a minimum of a bachelor's degree in a relevant scientific discipline, with at least 5-7 years of CRA experience with excellent knowledge of GCP/ICH guidelines and several years of monitoring and site management experience as well. Title will be dependent upon level of experience.
Responsibilities
The Senior Clinical Research Associate is assigned to a clinical trial team and leads various clinical operational aspects of the trial management in collaboration with other clinical team members. These activities include study start-up, vendor selection and management, interim study monitoring and management as well as trial closeout activities. This position typically reports to a Clinical Program Director (CPM) or an AD in Clinical Development.
Specific Duties
A Sr. CRA is expected to:
Perform qualification, initiation, interim monitoring and closeout visits at clinical study sites for data collection, source data verification, review of regulatory documents/files and drug accountability
Manage assigned study sites and train the clinical site staff to ensure protocol and regulatory compliance
Participate in the CRO selection, management and budget negotiations
Participate in the clinical site budget and contract negotiations
May assist in or be responsible for development of protocols, informed consents, case report forms, monitoring plans, edit specifications, clinical study reports, and investigator brochures under direction of CTM/CPM.
Assist CPM / CTM with projection and management of clinical supplies
Coordinate and/or participate in investigator meetings
On assigned sites, interact with investigators in protocol development, presentations and publications
Responsible for updating study timelines and metrics
Provide mentoring to CRAs and Clinical Trial Assistants (CTA's)
Job Requirements:
Bachelor's degree in a relevant scientific discipline or equivalent
At least 5 years of relevant clinical experience in a CRA functional role in the pharmaceutical industry, Biotech or equivalent, with at least 6 years desired in the biotech / pharmaceutical industry or equivalent.
1 year experience as a Sr. CRA or equivalent preferred.
Knowledge of GCP and ICH guidelines required
Excellent communication and interpersonal skills
Detail oriented
Able to work within a team
Able to perform assignments with general instructions
Proficiency with MS Word, Excel, Outlook, and PowerPoint
Must be willing to travel (25-40%)