RESEARCH COORDINATOR

2 weeks ago

Mishawaka, United States Beacon Orthopaedic Partners MSO LLC Full time
Job DescriptionJob Description

Essential Functions

  • Coordinate all aspects of clinical research studies from inception to completion, including planning, execution, and closeout.
  • Develop and maintain study timelines, ensuring adherence to project milestones and deadlines.
  • Ensure all research activities comply with our companies’ policies as well as local, state, and federal regulations.
  • Prepare and submit regulatory documents, including Institutional Review Board (IRB) applications, amendments, and continuing review reports.
  • Oversee the collection, entry, and management of study data, ensuring accuracy and completeness.
  • Conduct regular data quality checks and resolve discrepancies in a timely manner.
  • Serve as a point of contact for study sponsors, investigators, and other stakeholders.
  • Facilitate communication between multidisciplinary teams, including surgeons, physician assistants, nurses, and other healthcare professionals.
  • Train and supervise research assistants, interns, and other support staff involved in research activities.
  • Provide ongoing mentorship and support to team members, fostering a collaborative and productive work environment.
  • Prepare and submit regular progress reports to study sponsors, regulatory bodies, and institutional stakeholders.
  • Maintain comprehensive and organized study files, ensuring all documentation is up to date and readily accessible.

Skill and Abilities

  • Ability to communicate clearly and possess excellent phone skills in order to establish/maintain a cooperative relationship with patients, physicians, requesting entities and staff.
  • Ability to organize and prioritize tasks effectively.
  • Ability to work on several projects simultaneously.
  • Navigate and comprehension of computer software systems in an office setting.
  • Proficient and experienced with computer software.
  • Ability to follow oral and written instructions.
  • Able to work alone and part of a team.

Physical/Mental Demands

  • Work requires hand dexterity using office machines such as keyboards, calculators, phones, and faxes.
  • Stooping and bending to reach files and supplies, mobility to complete office errands.
  • This position requires extended sitting time per day (7- 8 hours per day) while doing computer input and responding to phone call questions.
  • Must be able to view computer screens for extended periods. Occasional stress related to workload and patients’ demands.
  • Requires use of computer equipment, fax, calculators, printers, and any other equipment found in an office setting.
  • This position requires the ability to sit, walk, stand, use hands and fingers, reach with hands and arms.
  • May require lifting items seen in an office setting like rims of paper, laptops, able to lift boxes of charts or additional boxes of paper and this could go to up to 45 lbs.

Environment Working Conditions:

  • This position may require occasional travel to research sites, conferences, and meetings.
  • The role involves working in both office and clinical environments, requiring adherence to health and safety protocols.
  • Work requiring moderate speed and high degree of accuracy.

Standard Qualifications:

  • Bachelor’s degree in a relevant field (e.g., life sciences, healthcare, public health) required; master’s degree preferred.
  • Minimum of 2-3 years of experience in clinical research, preferably within the orthopedic industry.
  • Strong knowledge of clinical research regulations and guidelines (e.g., FDA, ICH GCP).
  • Excellent organizational and time management skills, with the ability to manage multiple projects simultaneously.
  • Exceptional attention to detail and problem-solving abilities.
  • Proficiency in using electronic data capture systems and other research-related software.
  • Certification as a Clinical Research Coordinator (CCRC) or similar credential is preferred.

This description is intended to provide guidelines for meeting job requirements. Responsibilities, knowledge, skills, abilities, and working conditions may evolve as needs change.

The job holder must demonstrate current competencies applicable to the job position.

South Bend Orthopedics (SBO) has the right to revise this position description at any time. This position description is not a contract of employment and does not alter the employee’s at-will employment status.

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