Molecular Templates is seeking an experienced and highly-motivated professional to be an integral part of the Company’s clinical research team. The Clinical Research Associate (CRA), with support, will act as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility for allocated sites. Qualified candidates must possess comprehensive knowledge of clinical trial conduct in accordance with ICH/GCP and other related regulations or guidelines; excellent organizational, project management and time management skills; and ability to function independently and exercise good judgement, work in a fast-paced environment and travel (up to 80%).
Job Responsibilities will include:
With support, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.
Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
May contribute in the design of clinical trials, and review trial documents including but not limited to study protocols and amendments, patient information and informed consent forms, study manuals, monitoring plan, progress reports, clinical trials reports.
Perform a comprehensive checklist of study requirements.
Conduct pre-study visits and draft pre-study evaluation reports.
Conduct site feasibility checks, designs and implement training to site’s personnel and assess the trial site and applicable personnel on an ongoing basis.
Conduct site-initiation visits and writes initiation visit reports.
Perform monitoring in the field.
Communicate with investigators and their staff, and ensure compliance with protocols, regulatory requirements, and good clinical practices.
Perform on-site data verification, data integrity and monitor CRF completion and queries.
Assist site personnel with internal audits or regulatory inspections, if applicable.
Track site performance applying metrics standards and write follow-up visit reports.
Draft an appropriate intervention plan for the avoidance of redundant errors and deviations.
Verify the receipt, handling, accounting, storage conditions, and availability of IMP and other study materials in collaboration with the assigned resources.
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close- out.
Verify the integrity of investigator files, ensuring the availability of clinical and non-clinical materials, maintain the required documentation in the Trial Master File according to the company standards and applicable guidelines, and check for consistency with the contents of sponsor files.
Ensure compliance with the procedures to apply in the event of serious adverse events.
Jointly review with investigators the obligations inherent at the end of the study and writes closure visit reports.
Contribute with the project plan and monitor related budgets and resources allocation in collaboration with the clinical study managers.
Perform ongoing follow-up with the in-house clinical project team.
Prepare/review clinical documentation and ensure on time availability of critical documents and progress reports.
Anticipate, recognize and resolve issues proactively with the project team.
Travel up to 80%
Performs other duties, as requested.
This position has no supervisory responsibilities. This position reports to the Director of Clinical Operations.
Bachelor of Science degree in life sciences.
4+ years of experience as CRA in pharmaceutical industry or CRO with on-site monitoring responsibilities, preferably in oncology.
2+ years specific experience in oncology.
ACRP or SoCRA certification, a plus.
Comprehensive practical knowledge of the principle clinical trial conduct in accordance with ICH/GCP and other related regulations or guidelines.
Thorough knowledge of clinical development processes and conduct of clinical studies and awareness of global regulatory and pharmacovigilance environments.
Experience in coordinating collaboration with investigative centers, clinical staff and CROs required.
Experience in site selection and contract negotiation, a plus.
Excellent written and verbal communication skills. Professional proficiency in both spoken and written English is required.
Excellent organizational, project management and time management skills.
Quality-oriented with excellent attention to detail.
Excellent computer skills, including proficiency with all office suite tools (MS Word, Excel, PPT, Visio).
Ability to function independently and exercise good judgement.
Ability to work in a fast-paced environment.
Ability drive and willingness to travel for study monitoring and auditing (up to 80%).
Ability to work in Jersey City, NJ office when not traveling.
Additional Salary Information: Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.
Molecular Templates (MTEM) is a clinical stage biopharmaceutical company focused on the development of a next generation immunotoxin platform technology called engineered toxin bodies (ETB) in oncology. MTEM’s lead program, MT-3724, is in clinical development for non-Hodgkin’s lymphoma and additional pipeline drug candidates are being advanced toward clinical development for a variety of cancers. For more information, please visit MTEM’s website at www.mtem.com.