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Position Overview:
Under the supervision of the Research Director, provides independent coordination of multiple, complex clinical research studies in order to ensure the efficiency and accuracy of clinical research studies through all stages as the study progresses and shows vigilance in participant safety, protocol compliance, and data quality. This job evaluates, initiates and maintains all activities related to the conduct of clinical research studies in assigned area(s) of responsibility. The clinical research process the CRC supports involves regulatory, including federal and SRHS compliance, case finding for potential clinical research study enrollment, case management and data management

Mission Statement:
With pride, passion and commitment, we will improve health and save lives in our community every day. We are Singing River Health System.

Education:

  • Bachelor's degree in science or related field or nursing degree preferred.
  • Associate's degree considered with sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.

Certification:

  • Basic Cardiopulmonary Life Support (BCLS) is required; however, training will be provided, as needed.
  • Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) or Registered Nurse (RN) preferred.
  • Phlebotomy experience is preferred or completion of course works within three months of accepting the position.

Experience:

  • One to two years relevant experience in a clinical research setting required. Three or more years relevant experience preferred, including regulatory experience.
  • Experience working independently, organizing work, and setting priorities.
  • Requires effective communication and time management skills.
  • Requires ability to understand and implement protocols.
  • Must be a self‐motivated individual with the ability to think critically and work independently.
  • Must have computer skills and dexterity required for data entry and retrieval of patient information. Must be proficient with Windows-style applications and keyboard.
  • Must be a self‐motivated individual with the ability to think critically and work independently.

Reports to:
Grants Program Director

Physical Demands:

  • Work is mainly sedentary: exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time with regular requirements to move about the office, move about the facility, and to travel to another facility within the System. Work involves using repetitive motions: substantial movements of the wrists, hands, and/or fingers. Work involves being able to perceive the nature of sounds at normal speaking levels with or without correction; the ability to receive detailed information through oral communication, and to make fine discriminations in sound. Work involves expressing or exchanging ideas by means of the spoken word: details, data, instructions, etc. Work requires close visual acuity to prepare and analyze data; and view a computer terminal.
  • Must have the ability to identify and distinguish colors. Work may involve being exposed to biohazards, infectious diseases, and latex.

Mental Demands:

  • Must have the ability to understand, remember, and communicate factual, statistical information and data. Must demonstrate the ability to effectively manage stress.

Special Demands:

  • Working knowledge of cancer pathology, staging procedures, and treatment modalities in review/case-finding process is preferred. Working knowledge of basic statistical software/databases, ARIA, and Microsoft Office programs including, Excel, Access, Word, PowerPoint required. Knowledge of good clinical practices and federal requirements for clinical research. Job may require traveling throughout the SRHS service area - with the employee providing his/her own transportation. Must have a valid driver license.

Essential Functions / Job Responsibilities:

  • Assists Research Director in Initiating IRB activation process following IAR completion: Prepares IRB application for activation; Prepares an ICD, HIPAA, and other privacy disclosure forms as required Prepares Patient Information Sheets (Patient Fast Fact Sheet) Submits all Research Application forms and supporting documents electronically to the IRB.
  • Has documented knowledge of and follows Good Clinical Practice (GCP), Food and Drug Administration (FDA), Office of Human Research Protections (OHRP) and Health Insurance Portability and Accountability Act (HIPAA) policies regulations.
  • Conducts all research related activities in compliance with applicable regulation and institutional policies.
  • Demonstrates electronic systems knowledge such as database and spreadsheet software, electronic regulatory systems, Clinical Trial Management Systems (CTMS) and other electronic data capture systems.
  • Works with the Clinical Research staff to support clinical research functions including the gathering and preparation of study start-up documents, regulatory, case finding, case management and data management.
  • Participates in the planning, implementation and conduct for clinical research studies from pre-study phase to study closeout.
  • Works collaboratively with the Clinical Research staff in procuring, maintaining and submitting data and source documents for participants in clinical trials as required by study sponsors.
  • Proficient in performing or assisting with all regulatory tasks, such as study feasibility assessment or facilitation, regulatory submissions and related duties.
  • Works collaboratively with the Clinical Research staff in procuring, maintaining and submitting data and source documents for participants in clinical trials as required by study sponsors.
  • Consistently performs duties according to departmental policy and procedures and professional standards.
  • Researches and collects information; enters data into established databases and retrieves as necessary
  • Conducts recruitment activities as required to achieve expected study enrollment (Prescreen / Screen study participants, including medical records review).
  • Identifies process improvements to increase productivity, effectiveness and efficiency of the department.
  • Monitors all incoming and outgoing data for federal agency requirements. Identifies any noncompliance of data or patient complications and reports as required.
  • Assists with the development and implementation of standard operating procedures to support study-specific monitoring and reporting procedures.
  • Exhibits attention to detail, performs tasks accurately and quickly and meets deadlines.
  • Performs other responsibilities as assigned.

Core Values:

  • strong>Our patients are guests. I will always make patient care and safety my highest priority at all times, serving them with exceptional levels of compassion, empathy and attention that exceed expectations and form unbreakable bonds. Patients and their families are our guests. They are the reason we are here.
  • Quality means everything. I will always ensure that my work is of the highest quality, adhering to clinical and business best practices to protect our patients (or guests), our organization and my person reputation as an effective team member. I will never cut corners to save time and will always make things right. I understand that accuracy, safety, privacy, consistency, punctuality, cleanliness and dependability are our shared responsibilities.
  • Caring communication is key. I will always devote myself to demonstrating that we care. My speech, body language, tone of voice and professional appearance will demonstrate my commitment to caring and understanding. I will always smile, be first to greet, listen more than speak, call our guests by name, say “Thank You”, seek opportunities to educate and inform, and end every interaction with: “What else may I do for you?”
  • It’s all about service. I will always demonstrate the highest standards for customer service in my work with patients, guests and fellow team members. I understand the simple things like a smile, a kind word, a thank you or escorting guests to their destination can change their day. I will take ownership for our guests’ needs because we are the friendliest and best health system anywhere. I understand everything matters and I will do my utmost to amaze my patients, guests and team members with acts of kindness, compassion and service.
  • Yes is the answer. I will always seek ways to “get to YES” when caring for others.  I will always find options that are in the patient’s best interest. If I make a promise, I will always follow through and deliver.
  • Teamwork always wins. I will always work as part of a TEAM with the mindset of a WINNER to deliver our best with creativity, efficiency, stewardship and cooperation. I understand it takes all of us working together to deliver the best care, and I will contribute my best work and best ideas every day. I will do my best to make my work environment a pleasant and fun place to work. We are family caring for families and we like what we do!

Commitment to the Standards of Behavior:

  • Consistently adheres to the Attitude and Communication standards. Example: Displays a polite, positive attitude; expresses thoughts clearly; listens effectively and provides appropriate feedback; maintains open lines of communication.
  • Consistently adheres to the Appearance and Pride standards. Example: Strives to portray a professional image at all times. Takes pride in the appearance of work area and facility.
  • Consistently adheres to the Sense of Ownership standards. Example: Understands, accepts, and carries out assigned responsibilities. Does the right job the first time. Pays attention to details. Always focused on our guests needs.
  • Consistently adheres to the Commitment to Coworkers standards. Example: Treats coworkers with respect. Works as a team member. Demonstrates cooperation, respect, and consideration with peers and supervisors. Demonstrates a high level of integrity.
  • Consistently adheres to the Courtesy standards. Example: Always offers to escort guests to their destination. Apologizes to guest for problems or inconveniences. Addresses guests in a courteous manner.

 

Contact

Elisabeth Naff
HR Strategic Staffing Specialist
Elisabeth.Naff@MYSRHS.COM
www.singingriverhealthsystem.com


1801 Research Boulevard Suite 400
Rockville, MD 20850
Tel: 301.984.9496 | Fax: 301.770.1949
mos-missouri.com
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