Clinical Research Associate to CTM

Primary Responsibilities (all levels):

• Performs all study monitoring visits and completes supporting visit reports, including applicable visits such as site/investigator qualification, site initiation, interim monitoring, remote monitoring, and close-out visits
• Trains investigator(s) and site staff on study protocol and all relevant study procedures
• Support study start-up, conduct, and closeout activities. May assist in developing study-related plans and documents including clinical protocol, clinical brochures/IFUs, development of CRFs, reviewing informed consent forms, monitoring plan, etc. May coordinate IRB/EC approvals
• Functions independently in the field and interacts professionally with all levels of medical and scientific professionals
• Identify early on any unsatisfactory results, operations or specific problems and take immediate action to appropriate groups including escalating and assisting in resolving any study related issues that arise during study conduct
• Assures adherence to GCP, study protocol, procedures, all applicable requirements, and regulations throughout the study monitoring visits. Responsible for implementing and maintaining the effectiveness of the quality system
• Collect and review site regulatory and essential documents for accuracy and completion. Maintain the study Trial Master File (TMF)/or eTMF and ensure the Investigator Site Files (ISFs) are current and maintained
• Perform Source Data Verification (SDV) and data cleaning in accordance with study monitoring plan. Reviewing all study logs and documentation ensuring audit trail and chain of custody is maintained
• Performs Investigation Use Only (IUO) or Research Use Only (RUO) inventory and accountability, in accordance with study monitoring plan. Facilitates return or destruction of any unused IUO/RUO material as required
• Serve as the primary point of contact for assigned sites and works with sites to resolve data queries and monitoring findings. Maintains accurate and timely communications with sites and ensures records are filed in TMF/ISF
• Ensures TMF/ISF is audit ready. Assists with site audit(s) and site quality management activities, as needed. Tracks site progress against contractual agreements
• Contribute to organizational and departmental process development, improvement, and implementation

CRA II Responsibilities:

• In addition to the primary, CRA II will also be expected to take on the following responsibilities
• Assist and/or develop study-related plans and documents including clinical protocol, clinical brochures/IFUs, development of CRFs, informed consent forms, monitoring plan, etc.
• Assist in training new CRA I staff by supporting remote monitoring, co-monitor and/or mentoring
• Assist the project management team in identifying risks in study execution at study sites, implement mitigations, monitoring outcomes, and communicate observations.
• Demonstrate an ability to influence others, especially study site staff, to achieve positive results and collaboration through diplomacy and respect for others, appropriate prioritization and facilitation of the decision-making process

Sr. CRA Responsibilities:

• In addition to the primary and CRA II responsibilities, Sr. CRA will also be expected to take on the following responsibilities
• Demonstrating a high degree of competence in clinical research with prior exposure to all aspects of clinical study and functions at a proficient level of independence with a significant degree of autonomy in conducting clinical research
• Provide guidance and mentorship to junior team members
• Sr. CRA may also serve as Lead CRA or Lead monitor for assigned studies.
• Works closely with other assigned CRAs to track monitoring deliverables and metrics in accordance with the study monitoring plan.
• May actively participate as a member of the cross-functional project team

Qualifications:

• Bachelor's degree or higher, or equivalent credentials
• Knowledge of International Council for Harmonisation (ICH)/GCP guidelines, 21 CFR (Code of Federal Regulations) part 812 (Investigational Device Exemption) (IDE)), and monitoring procedures/best practices (ICH E6(R2))
• Demonstrating strong written and verbal communication skills and presentation skills
• Track record demonstrating strong organizational and problem-solving skills
• Track record demonstrating a strong work ethic and ability to deliver tasks on time
• Proficient with Microsoft Office Suite including automation tools
• For CRA I: 1+ years direct clinical research experience at a sponsor, CRO, device manufacturer, IVD, companion diagnostics or investigator site
• For CRA II: 3+ years direct clinical research experience at a sponsor, device manufacturer, IVD, companion diagnostics or CRO as a CRA/study monitor or equivalent experience.
• Excellent interpersonal skills (verbal and written), organizational, and prioritization skills, and able to communicate at multiple levels of an organization and with sponsors/clients.
• For Sr CRA: 5+ years direct clinical research experience at a sponsor, device manufacturer, IVD, companion diagnostics or CRO as a CRA/study monitor, or equivalent experience
• Excellent interpersonal skills (verbal and written), organizational, and prioritization skills, and able to communicate at multiple levels of an organization and with sponsors/clients.

Preferred Qualifications:

• Bachelor’s degree in biological sciences or medical specialty or higher, or equivalent credentials
• Molecular diagnostic, medical device, in vitro diagnostic (IVD), companion diagnostics, oncology and/or pathology experience
• Previous experience with Next Generation Sequencing (NGS), Immunohistochemistry (IHC), and/or pathology
• Prior experience working with high-complexity CLIA or CAP certified/accredited/ laboratories conducting clinical trial testing
• Certification in clinical research is highly preferred (CITI, CCRA, CCRP, ACRP, SOCRA, etc.) or clinical laboratory certification (MT, ASCP, or equivalent)
• Experience with Electronic Data Capture (EDC) systems and eTMF systems