Clinical Research Associate II - Northeast

General Description:

The CRA will assume the role of a primary CRA. The CRA will conduct site visits (i.e., PSSV, SIV, IMV, COV) and function as the site manager. The CRA is responsible to build and maintain relationships with key site personnel and ensure an effective line of communication.

The CRA will also monitor data quality and patient safety through monitoring and site education.

CRAs are to complete all aspects of the clinical monitoring process in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.

Essential Functions of the job:

• Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices

• Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation

• Develop collaborative relationships with investigative sites, and study vendors

• Provide protocol and related study training to assigned clinical study sites

• Attend disease indication and/or project specific training, as required

• Maintain oversight of site performance by tracking metrics for enrollment, data entry into Case Report Forms (CRFs), protocol deviation trends, and overall site issues

• Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues

• Communicate site performance to the Clinical Study Team (CST)

• Perform study-specific training with project team

• Perform Serious Adverse Event (SAE) reconciliation and work with study sites to resolve discrepancies

• Collaborates with CST and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.).

• Attend regional investigator meeting and site booster visits, as required

• Provide audit/inspection preparation support to clinical study sites and ensure quality issues or findings are followed to resolution, as needed

• Assist with other assigned clinical responsibilities within scope of role, as required

Supervisory Responsibilities:

• Provides site level management for established protocols and portfolio under general supervision

• Provides mentoring/support to CRAs for CRA related topics

• Co-monitoring with CRAs and support site visits, as needed

Education Required:

BS/BA in a relevant scientific discipline and minimum

of 2+ years of relevant Clinical Operations experience, and minimum of 1+ years of monitoring

experience. Experience in global oncology trials

preferred.

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and budget.

Computer Skills:

• Efficient in Microsoft Word, Excel, PowerPoint and Outlook

• Familiar with industry CTMS and data management systems

Other Qualifications:

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines

• Excellent communication and interpersonal skills

• Excellent organizational skills and ability to prioritize and multi-task

• Fluent in English (writing and speaking)

Travel:

Up to 70% travel

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.