Clinical Research Associate (CRA) I
Description Responsible for the operational support of assigned clinical trials in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations and Depomed SOPs. Works closely with cross-functional representatives, including Clinical Affairs, Biostatistics, Data Management, Regulatory/QA, Drug Safety, Pharmacology, CMC, etc. to ensure the effective delivery of assigned project milestones. Also works closely with clinical investigative sites and other clinical research third party vendors as needed to support business objectives for the Clinical Operations department. ESSENTIAL JOB FUNCTIONS PROJECT SUPPORT:
Responsible for working with key individuals in clinical operations and in other functions for the planning, implementation and execution of clinical trials
Responsible for review of regulatory documentation to support study start up activities, including ensuring all site supplies are available on site for site initiation visits.
Act as primary liaison for assigned study sites to convey project information and answer questions in accordance with the clinical protocol, Clinical Operations documentation and the study escalation/communication pathway.
Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of clinical trial documentation. May collaborate with Clinical Operations and/or QA to ensure that Corrective Action Preventative Action (CAPA) with investigative sites are completed and adhered to.
Attends Investigator Meetings and study-specific training for assigned clinical trials.
May perform co-monitoring and/or independent monitoring activities.
Collaborates with Clinical Operations to obtain/share trial-specific issues across all study sites concentrating on areas related to quality, site performance and metrics. Responsible for communicating issues in accordance with the Clinical Operations and/or study escalation/communication pathway as appropriate.
Develops and maintains collaborative working relationships with clinical investigative sites. Responsible for working with assigned sites to ensure patient safety and regulatory compliance.
Ensures all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned Clinical Operations personnel.
Accountable for the maintenance of the electronic Trial Master Files (eTMF) in accordance with Depomed SOPs and best working practices for clinical studies where monitoring is being performed by Depomed.
Provides oversight of the eTMF at a CRO when the monitoring activities are outsourced.
Performs ongoing reviews of all eTMFs to assure quality of the documentation files and compliance with Depomed SOPs, GCP and ICH Guidelines.
Liaises with Legal and Finance to secure confidentiality agreements, master service agreements, clinical trial agreements as appropriate. Uses this information to prioritize sites for Greenlight/Initial approval.
Prepares and reviews various study-related tracking systems to determine and report status of clinical trial documents (i.e., distribution, status, retrieval of such documents as protocol, IB, etc.). Responsible for the follow up to collect outstanding documents.
Provides quality overview and consistency check on all developed informed consent forms and completes the informed consent checklist.
Responsible for the submission to the regulatory department and correction of regulatory greenlight/initial packages.
Ensures adequate and appropriate dissemination of information according to the study-specific communication plan between sites, in-house and regionally based staff to ensure project success.
Responsible to coordinate and secure IRB approval (local and central). Responsible to provide step by step guidance and partnership with sites to secure IRB approval.
Understanding of assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.
Attend study team meetings.
Provide general administrative support to Clinical Operations including filing, faxing, data entry and scheduling meetings.
May provide support in the identification of training gaps, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
May support the maintenance of guidelines, training programs, policies and procedures.
May identify training needs across Clinical Operations and provide support of the creation, development and/or training to meet those needs. This includes any lessons learned sharing across the project team members and/or Clinical Operations.
Other duties as assigned.
EDUCATION AND EXPERIENCE
Bachelor's degree preferably in a science or healthcare field.
A minimum of 2 years of direct experience in site management and logistical execution of clinical trials within a pharmaceutical, biotechnology, CRO and/or healthcare setting.
Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
Knowledge of GCP as it relates to clinical trial management.
SKILLS AND ABILITIES
Demonstrated computer skills (e.g. MS Office, MS Project, and MS PowerPoint).
Organized, detail-oriented and able to work independently with minimum supervision but also work collaboratively
Sense of urgency in completing assigned tasks
Willing and able to learn new skills to meet changing needs of the organization
Excellent teamwork and collaboration skills
Effective process and project management skills
Outstanding written and verbal communication skills
Knowledge of clinical study conduct
Ability to multi-task
DEPOMED COMPETENCIES INCLUDE
Integrity and respect: Honest, trustworthy and accountable. Ensures all activities performed are done ethically and according to Depomed procedures and regulatory guidance. Shows respect for all team members (internal and external).
Decisions and Judgment: independently completing assigned tasks by gathering relevant information systematically and considering a broad range of issues or factors when making decisions.
Accountability: Assumes personal ownership and accountability for business results and solutions. Organizes work based on company/department goals. Develops alternative strategies when confronted with obstacles. Plans and organizes work so that timelines are met or exceeded.
Agility: Able to quickly adapt to study changes. Communicates and implements changes in a positive manner.
Teamwork and Collaboration: Expresses ideas and information effectively and constructively. Provides accurate and timely information to others within the department and across functional groups. Demonstrates attention to and understanding of others' comments, questions, and views.
Sitting - 80%
Standing/ walking - 20%
Travel up to 10-30% (domestically and internationally)
Ability to carry items weighing less than 10 pounds
Ability to hear what clients are saying in a normal conversation
When not traveling maintain in-office, regular work hours to facilitate interactions with other employees
Repetitive motion: Substantial movements of the wrists, hands, and or fingers for sustained periods of time. Approximately 6-hours of keyboarding per day.
Visual Requirements: Able to see and read PC screens and read fine print.