Senior Research Compliance Specialist - Research

Job Title: Senior Research Compliance Specialist | Research | Multi-City

City: Multi-City

State: Multi-State

Department *: * Clinical Research North-Ind - Research Compliance - Fargo

Job Schedule: Full Time

Shift: Days

Hours Per Shift: 8 hr

JOB SUMMARY

Provides leadership in all area of research compliance for the Sanford Clinical Research team. This includes development and implementation of regulatory strategies as they relate to Food and Drug Administration (FDA) approves and Investigational New Drug (IND) submission including managing and organizing the applications.
Plays a major role in defining and implementing standardized processes and systems/technology in support of these submission. Includes study start-up and maintenance activities. Responsible for writing, compiling, and publishing document packages for regulatory submission ensuring compliance with FDA regulations/guidance/interpretations for INDs. Includes initial submission, protocol amendments, informational amendments and required reports. Manages the planning and coordination of productive and effective regulatory submissions and meetings with FDA. Acts as regulatory project leader for the entire IND processes. Reviews technical and clinical documentation and recommends/makes changes to clinical protocols, consent forms, investigator brochures, and other trial documents. Develops and revises policy and procedures as it relates to investigator imitated trials. Monitors and analyzes appropriate FDA actives and advises Sanford Clinical Research management accordingly of new and impending regulatory standards and regulations. Evaluates proposed changes for regulatory impact. Conducts training to educate staff on regulatory requirements. Develops and manages the trial master file for specific trials including multi-center trials. Develops and maintains all forms, logs, manuals, etc. for investigator imitated trials. Maintains all regulatory files (electronic and/or hard copy) for the lead site. Assesses project plans and timelines with appropriate staff to effectively ensure all projects are prioritized and key goals are met on time. Implements strategies to improve efficiencies, speed and quality of documentation, regulatory processes and compliance efforts in support of the goals and objectives for the department. Informs team members of completion of regulatory and contractual documents for individualized sites. Reviews, tracks, and follows-up on the progress, submission, approval, and execution of documents including regulatory and contracts. Reviews and provides feedback to management on site performance metrics. Directly communicates with participating sites and Sanford's Institutional Review Board. May prepare, review, and submit sponsor/lead site regulatory documents to the IRB for new studies, amendments, annual reviews and other reporting requirements. Interprets, understands, and applies current regulatory requirements. Possesses excellent interpersonal skills including excellent written and oral communication skills. Possesses excellent organizational skills and attention to detail. Ability to independently manage processes and tasks with minimum direction. Ability to mentor and educate colleagues. Possesses excellent leadership, interpersonal, and influencing skills. Analytical, problem solving and detail oriented. Has time management aptitude. Ability to work effectively independently, within teams, and across departments. Consistent and follows through on commitments.

POSITION RESPONSIBILITIES

Takes ownership of meeting process and outcome. Checks documents thoroughly according to standard processes and procedures. Confer with organizational members to accomplish work activities. Demonstrates experience engendering collaborative processes that lead to problem solving and the achievement of business goals. Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data. Prepare study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports. Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies. Oversee subject enrollment to ensure that informed consent is properly obtained and documented. Maintain required records of study activity including case report forms, drug dispension records, or regulatory forms. Demonstrates the ability to meet deadlines.

DEPARTMENT DETAILS

This position could work out of Sioux Falls or Fargo.

QUALIFICATIONS

Bachelor's degree is required. Master's degree is preferred.
Three years of proven successful Investigational New Drug (IND) publication and submission with the Food and Drug Administration (FDA) on multiple investigator initiated projects is preferred.
The Society of Clinical Research Associates (SOCRA) Professional Certification: Certified Clinical Research Professional (CCRP) is preferred when candidate is eligible to sit for the examination.

About Sanford Health:

At Sanford Health, we are dedicated to the work of health and healing.
Every day, we show that commitment by delivering the highest quality of care to the communities we serve.
We are leaders in health care and strive to provide patients across the region with convenient access to expert medical care, leading-edge technologies and world-class facilities.
In addition to strong clinical care, we are also committed to research, education and community growth.
We engage in medical research to not only discover innovative ways to provide care, but also cures for common diseases.
We continuously seek new ways to achieve our vision of improving the human condition here in your community, across the region and around the world.
The entire team at Sanford Health recognizes the value of healthy families and communities.
We continue to gain momentum and expand our reach. Together, we can make a positive difference now, and in the future.
Sanford is an EEO/AA Employer M/F/Disability/Vet.
If you are an individual with a disability and would like to request an accommodation for help with your online application,
please call 1-877-673-0854 or send an email to talent@sanfordhealth.org .

City: Multi-City

State: Multi-State

Job Function: Legal and Compliance

Job Schedule: Full Time

Shift: Days

Req Number: WD04301