Job Summary of the Sr. Clinical Research AssociateThis Sr. CRA position will operate as the main point of contact for assigned sponsored study sites and investigator-initiated studies. The Sr. CRA will perform investigator set up and site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs) including site GCP compliance, trouble shoot issues and facilitate resolution, and monitor safety at the site. The Sr. CRA will assist with training and onboarding activities for new CRAs. The Sr. CRA will coordinate with Clinical Research Managers to establish monitoring plans and ensure assigned CRAs execute according to the plan. They assume accountability for assigned study site performance, providing high quality data, according to established timelines.
Requirements of the Sr. Clinical Research Associate- Must have a bachelor's degree in a scientific discipline at a minimum.
- Four years previous clinical research experience in Phase III -IV studies. Research experience in device, trauma, orthopedic, or reconstructive surgery is a preferred
- Strong knowledge of anatomy and physiology
- Experience with assisting in protocol design, study document creation, and database design/maintenance
- Capable of working on clinical monitoring issues of moderate scope
- Demonstrates the ability to build relationships with clinical sites/investigators to ensure compliance with protocols and regulatory requirements
- Ability to read and critically interpret relevant literature. Serve as a resource for clinical knowledge.
- Oral and written communication skills are essential
- Exercises judgment on routine clinical procedures and practices to determine appropriate action
- Strong interpersonal skills, exceptional organizational and time-management skills
- Ability to work independently and collaboratively in a team environment
- Ability to manage and coordinate CRA activities as needed for assigned study projects
- Ability to quickly adapt to changes in departmental priorities and goals to meet company strategies and directives
- Knowledge of GCP/IHC regulatory requirements
- Must be willing to travel (50% of time)
- Consistently anticipates and finds ways to overcome obstacles to achieving the goals
- Holds himself/herself accountable for taking tasks all the way to completion
- Can clearly communicate important company goals and what he/she needs to do in order to accomplish them
Responsibilities of the Sr. Clinical Research AssociateThe specific duties of the Sr. Clinical Research Associate include but are not limited to:
- Assist with development and implementation of protocol design, study training documents, study documents, and plan management for sponsored and investigator initiated studies.
- Conduct Site Qualification, initiation visits, on-site monitoring visits, co-monitoring visits, and site closure visits of all phases of clinical studies.
- Interfaces with clinical sites/investigators on-site and through off-site administrative site management to ensure compliance with protocols and regulatory compliance
- Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions
- Prepares and/or tracks required documentation for clinical sites (contracts, budgets, IRB documentation)
- Conduct orientation and onboarding and training activities for new CRAs.
- Coordinate with Clinical Research Managers to establish monitoring plans and ensure assigned CRAs execute according to the plan.
- Assumes accountability for assigned study site performance, providing high quality data, according to established timelines.
- Assists Clinical Operations staff and study site staff to quickly identify, effectively resolve issues, and implement corrective and preventive actions.
- Assists with the development and maintenance of study databases
- Review, retrieve, and report study data as the requirements dictate or as appropriate
- Prepares reports of study progress to upper management
Location111 West Oak Ave., Tampa, FL 33602
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Benefits/CompensationThis position is eligible for an annual bonus.
Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.
Salary Range
$92,293-$115,367 USD
