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Clinical Research Study Manager
2 months ago
Location: On-site position
Position Type: Part-time
Role Summary
The Clinical Research Study Manager (CRSM) plays a pivotal role in ensuring that clinical trials are conducted in compliance with established protocols, regulatory standards, and ethical guidelines. This position encompasses a variety of responsibilities, including acting as a liaison among various stakeholders, ensuring that team members are adequately trained, recruiting participants, and overseeing data collection and management. The CRSM collaborates closely with the Principal Investigator (PI), departmental staff, sponsors, and institutional representatives to uphold compliance and support the integrity of the research process.
Key Responsibilities
- Monitor and assess patient progress while being vigilant about adverse events and protocol-specific requirements.
- Evaluate patient eligibility through interviews and medical record assessments in both inpatient and outpatient environments.
- Execute protocol-specific tasks under the guidance of the PI as necessary.
- Facilitate informed consent discussions, addressing study-related inquiries from patients and their families.
- Coordinate patient scheduling for required research tests and appointments, ensuring seamless integration with existing schedules.
- Maintain comprehensive logs for delegation of authority and training specific to the study.
- Ensure that all regulatory documents and data are prepared for audits and monitoring as per standard operating procedures.
- Conduct quality assurance reviews to ensure adherence to protocols and data accuracy.
- Keep meticulous records of study activities, including case report forms and regulatory documentation.
- Engage in research-related site visits and meetings to foster relationships and enhance collaboration.
- Assist in the recruitment and retention of study participants, providing clear instructions and support throughout the process.
- Manage inventory of study supplies and equipment, ensuring availability for study visits.
- Oversee the collection, labeling, storage, and transport of biological specimens.
- Ensure that all necessary equipment is calibrated and operational.
- Demonstrate strong organizational skills, professionalism, and effective communication in all interactions.
- Perform additional duties as assigned.
Qualifications
Knowledge
- Understanding of clinical research processes and their impact on organizational operations.
- Proficiency in Microsoft Office Suite, particularly Word, Excel, Outlook, and PowerPoint.
Skills
- Ability to train diverse users on clinical protocols and systems.
- Strong interpersonal and communication skills.
- Proficient in both written and verbal communication.
Abilities
- Capable of setting clear expectations and communicating effectively with stakeholders.
- Adept at interacting with staff across various levels of expertise.
- Highly organized, able to work independently, and prioritize tasks efficiently.
Physical Requirements
This role requires manual dexterity for extensive computer use. The employee will frequently sit, and must be able to see, talk, and hear to effectively engage with participants. Occasional standing, walking, and lifting of up to 25 lbs may be necessary.
Work Environment
The position is situated in a well-lit, ventilated office setting, with potential for evening and weekend commitments.
Education and Experience
Required
- Strong communication, management, and problem-solving skills.
- 0-2 years of relevant experience in research.
- High school diploma or equivalent.
Preferred
- Bachelor's degree in a related field.
- Commitment to professional development through ongoing education.
- Certification in Good Clinical Practice (GCP).
EEO Statement
OrthoAlaska LLC is committed to providing equal employment opportunities to all applicants and employees, without regard to race, color, ancestry, national origin, sex, sexual orientation, gender identity, marital status, religion, age, pregnancy, protected veteran status, disability, or other protected categories.
